Medical Design & Outsourcing — JANUARY 2021 by WTWH Media LLC

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INSIDE: THE TOCPH MEDTES OF STORIE 2020

BLACK ENGINEERS GROUP SEEKS DIVERSITY IN MEDTECH, EQUITY IN HEALTHCARE MEDTRONIC CEO GEOFF MARTHA ON THE IMPORTANCE OF COMPETITION

in crisis management from Stryker CEO

Kevin Lobo

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www.medicaldesignandoutsourcing.com JANUARY 2021

INSIDE: THE TOCPH MEDTES OF STORIE 2020

BLACK ENGINEERS GROUP SEEKS DIVERSITY IN MEDTECH, EQUITY IN HEALTHCARE MEDTRONIC CEO GEOFF MARTHA ON THE IMPORTANCE OF COMPETITION

in crisis management from Stryker CEO

Kevin Lobo

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Lessons learned help medtech move ahead

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he most unsettling year that most anyone can remember had some upsides. We learned more than we wanted about a virus that continues to surprise even the brightest minds in science. In the wake of George Floyd’s killing by police, Americans also found we could no longer ignore our racial biases. Companies of all sizes declared their positions on diversity, inclusion and equity. Some sheepishly admitted they had a long way to go. Others crowed about how far they’d already come. Many pledged to do better, and realized they’ll likely be held more accountable for these efforts than ever before. All of these events made us realize that we share a powerful yearning for leadership. Depending on what segment of medtech you were in, that leadership took different forms. In this issue, we cover several of them. In an article by assistant editor Sean Whooley, ResMed executive Jim Hollingshead tells how the company responded to the demand for ventilators nearly a year ago and how the COVID-fueled explosion of digital healthcare enabled ResMed to remotely track more patients’ adherence to therapy. Massive orders in the summer and fall for yet-to-be authorized vaccines sent drug-delivery companies into overdrive to manufacture the needles and syringes needed to inoculate millions. Executive editor Chris Newmarker describes Becton Dickinson’s efforts in that arena. Pharma editor Brian Buntz writes about how pharmaceutical shipping departments and Nancy Crotti independent shippers prepared in late fall and Managing Editor early winter for a most welcome but challenging cargo — Medical Design & the first FDA-authorized vaccine against SARS-CoV2. The Outsourcing vaccine from Pfizer and BioNTech requires transport and n c ro tti @ wtwh m e di a .c o m in sub-Arctic temperatures to maintain its potency. On the other end of the spectrum, leaders of firms that make devices used in mostly elective procedures had to manage through sudden slowdowns. In this issue’s cover story by DeviceTalks editorial director Tom Salemi, Stryker CEO Kevin Lobo recounts how he drew on years of crisis management experience to lead the world’s largest orthopedic device manufacturer through one of the segment’s most challenging years. Rising to CEO of Medtronic in 2020, Geoff Martha rewrote the playbook at the world’s largest medtech company — splitting it into 20 semi-autonomous operating units in a bid to accelerate growth. In this month’s DeviceTalks column, Martha tells us how this new system could drive competition and innovation.

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In another article penned by Whooley, longtime Dexcom CEO Kevin Sayer recounts his efforts at taking care of employees and patients during the pandemic and how COVID gave the insulin-delivery technology developer a new market. We also tell how 2020 yielded opportunities for other organizations. In the months after George Floyd’s death, the National Society

that might otherwise go unnoticed and untreated. I remain awed by what medtech did for humanity in 2020 and believe that 2021 will be a better year. My wish for the New Year is that we will take what we learned about the shortcomings and strengths in healthcare, industry, government and ourselves and apply those lessons to make that happen.

I remain awed by what medtech did for humanity in 2020 and believe that 2021 will be a better year. My wish for the New Year is that we will take what we learned about the shortcomings and strengths in healthcare, industry, government and ourselves and apply those lessons to make that happen. of Black Engineers (NSBE) invited the historically nondiverse medtech industry to engage further with its members and programs. Of the 3,300 members in NSBE’s Healthcare Innovation Special Interest Group, only 300 work in the medical device industry. In a Q&A with senior editor Danielle Kirsh, NSBE treasurer Theodore Nicholson describes how medtech can boost the ranks of its Black employees and leaders while working to eliminate healthcare disparities and close the gaps in care delivery to Black communities. And finally, I write about bigmedtech veteran Aimee Garza’s entry into the world of startups. In April 2020, Garza founded CoraVie Medical to develop an implant to continuously monitor blood pressure and alert physicians to potentially dangerous irregularities 1 • 2021

Medical Design & Outsourcing 9

CONTRIBUTORS

RAJAN

SKOYLES

JORDAN MACAVOY is VP of marketing at Reciprocity. He previously served in executive roles at Fundbox and Intuit, via its acquisition of the SaaS marketing and communications solution Demandforce. ROGER MASSENGALE is the chief commercial ofﬁcer of Eitan Medical – a developer of infusion therapy systems for hospitals, ambulatory and home settings, as well as wearable solutions for easy self-administration. He holds more than 100 patents and has launched products that have generated over $1 billion in medical device sales. KAI RAJAN is an associate in Finnegan’s Washington, D.C. ofﬁce, focusing on patent portfolio development, patent litigation and postgrant proceedings in a broad range of technologies. He develops portfolios with multiple types of intellectual property protection including utility patents, design patents, trademark and copyright, and also focuses on IP issues for 3D printing.

AIDAN SKOYLES is a partner and patent attorney in Finnegan’s Washington, D.C. ofﬁce, representing clients at the U.S. International Trade Commission and at the Patent Trial and Appeal Board. He has technical experience with electrical engineering and information technology, including medical devices, semiconductor design and processing, computer software, optical ﬁlters and database design. JAY TOURIGNY is SVP at MicroCare Medical. With more than 25 years in the medtech industry, he holds numerous U.S. patents for cleaningrelated products that are used daily in medical and precision-cleaning applications.

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CONTENTS

medicaldesignandoutsourcing.com ∞ January 2021 ∞ Vol7 No1

COLUMNS 8

HERE’S WHAT WE SEE:

CONTRIBUTORS

DIGITAL HEALTH:

DRUG DELIVERY:

• • • • • THE LEADERSHIP IN MEDTECH ISSUE

ON THE COVER 9 LESSONS IN CRISIS MANAGEMENT FROM STRYKER CEO KEVIN LOBO

Lessons learned help medtech move ahead

Stryker CEO Kevin Lobo shares how years of medtech leadership prepared him for managing during the pandemic

How the shift to online healthcare affects the entire ecosystem BD’s role in delivering COVID-19 vaccines is crucial

22 INTELLECTUAL PROPERTY: Many

3D bioprinting innovations developed to combat COVID-19 can be protected with patents.

FEATURES

26 ORTHOPEDICS:

58 THE TOP MEDTECH STORIES OF 2020

The top 5 orthopedic device industry stories of 2020

The pandemic dominated the news, but a whole lot more was going on in medtech.

30 PHARMA:

With some COVID-19 vaccines requiring sub-Artic temperatures, cold chain logistics have taken center stage

34 REGULATORY: Here’s how HIPAA can affect medical devices

ResMed plans to further boost its digital health efforts post-pandemic.

76 EVEN EXPERIENCED MEDTECH CEOS WERE Dexcom’s Kevin Sayer kept his focus on his workers and the patients who beneﬁt from the company’s technology.

The top 10 catheter innovations of 2020

92 DEVICETALKS:

81 BLACK ENGINEERS GROUP SEEKS

DIVERSITY IN MEDTECH, EQUITY IN HEALTHCARE

Medtronic CEO Geoff Martha talks competition and change from within

The National Society of Black Engineers wants to work with medtech companies that are ready to initiate or continue to foster change — within and without.

96 PRODUCT WORLD

86 TAKING THE GUESSWORK OUT OF HIGH BLOOD PRESSURE

100 LEADERSHIP IN MEDTECH 2020

CoraVie Medical CEO Aimee Garza has taken her 25 years of experience in Big Medtech and applied it to her startup.

184 AD INDEX Medical Design & Outsourcing

HAS ALWAYS BEEN IMPORTANT TO RESMED

THROWN FOR A LOOP BY THE PANDEMIC

40 TUBING TALKS:

70 KEEPING IN TOUCH WITH ITS CPAP USERS

1 • 2021

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Medtech sales are going digital: Here's what it means Image courtesy of Shutterstock via Eitan Medical

Medtech manufacturers are making the shift to provide remote, virtual sales and tech support for device implementation, training and more. Roger Massengale | Eitan Medical |

Medical Design & Outsourcing

s the world grapples with COVID-19, we continue to come to terms with our new, strictly virtual realities. Understandably, the healthcare industry has also been affected by this virtual shift, made apparent by the recent rise in the use of remote patient monitoring and telehealth solutions. This shift has not only changed many of the standard protocols and processes for medical teams, but affects the entire ecosystem — from device manufacturers, supply chain and distributors to sales teams responsible for training and demonstration of new medical technologies and devices. When it comes to sales teams, a lot has already evolved over the years. There was the introduction decades ago of the Anti-Kickback Statute and the Stark Law, whose combined goal was to prevent unethical transactions and kickbacks, in which something of value is

1 • 2021

knowingly and willingly provided to induce a referral. AdvaMed instituted its own code of ethics for the industry in 2003, setting new standards for ethical interactions between healthcare practitioners and medical device companies. Healthcare providers meanwhile began to assemble value analysis committees to provide multidisciplinary reviews of the efﬁcacy and cost effectiveness of new devices. This new hurdle forced device representatives to adjust their sales approach to address the concerns of multiple decision makers, adding an extra layer of difﬁculty to the demonstration process. Health providers also restricted facilities’ access with new vendor credentialling systems, which allow sales representatives to demonstrate new solutions upon request and invitation only. Additionally, gaining access compliance with facility policies proved to be complex, time consuming and very expensive.

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Virtual device implementation — The new normal With COVID-19 in full swing, an unprecedented new hurdle has come into play for company sales teams: social distancing. Understandably, company representatives are only allowed into hospital environments for critical and urgent situations. This means that in-person meetings with key decision makers and value analysis committees are extremely challenging, requiring further adaptation from the medical device industry to address this new reality. If they haven’t already, medtech sales reps will have to restructure their work processes to support online training and in-servicing. Company sales representatives will have to adapt to virtual training with customers over internet-based communication platforms, like Zoom, Microsoft Teams and company websites, which now need much more educational material than ever before.

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For device demonstrations, manufacturers will need to become accustomed to shipping a sample device to the prospective hospital and then have company representatives demo the device to key medical staff and decision makers via video conferencing platforms. Surprisingly, this virtual interaction can be more comfortable for potential customers, as there is less pressure with the company representative on the other side of a screen as opposed to being in the room with them. In fact, many have voiced their preference for this new approach. Virtual sessions can easily be recorded (with permission, of course) for later consumption by providers who couldn’t attend the meeting. From a support perspective, manufacturers must shift to make materials and education resources available online for medical teams and maintenance staff to access ondemand, not only when a representative or manufacturer technician is present. Considering that each hospital system is unique, device manufacturers can incorporate custom learning models into their digital repertoire to cater to the needs of individual hospitals and health systems and to better streamline employee training certification, device usage and maintenance. Going digital also comes with notable benefits for manufacturers. COVID-19 has forced all of us to recognize that companies do not always have to fly sales representatives or technicians to prospective customers or current clients and incur substantial travel-related expenses. Representatives can meet virtually with more customers from the convenience of their home, expediting the process while reducing costs. The virtual medical device sales cycle has, in fact, brought about surprising new operational efficiencies for many companies. Going digital and beyond While this switch to digital interactions does not come as a surprise, its comprehensiveness is unique and requires seismic efforts to adapt. This new virtual approach to medical device demonstration and training has brought about new levels of sophistication and efficiency. Going forward, new medical devices need to speak for themselves. 16

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DRUG DELIVERY

BD is playing a crucial role delivering COVID-19 vaccines: Here's how Hundreds of millions of vaccine doses will require hundreds of millions of syringes from companies such as BD.

Chris Newmarker | Executive Editor |

s much-hoped-for COVID-19 vaccines roll out to the public, Becton Dickinson faces an impressive challenge: The Franklin Lakes, N.J.–based medtech giant already has commitments to provide more than 1 billion needles and syringes to deliver COVID-19 vaccines in the U.S., UK, Canada and elsewhere. CEO Thomas Polen said in an early November earnings call that the demand for syringes and needles to deliver vaccine represented a $100 million to $150 million sales opportunity through 2021. Over the summer, HHS’s Biomedical Advanced Research and Development Authority (BARDA) covered more than

half of the $70 million in costs for BD to expand syringe and needle production in Nebraska. The company recently announced $1.2 billion to expand and upgrade multiple drug-delivery facilities to support the expected transition to preﬁllable syringes for COVID-19 vaccines. “Drug-delivery devices are really the foundation of our company, and we have a long history in supporting global immunization campaigns,” Elizabeth Woody, BD’s SVP of public affairs, explained to MDO’s sister publication Drug Delivery Business News. (Listen to the interview in our ﬁnal DeviceTalks Weekly podcast of 2020.) The stakes couldn’t be higher as

TAKING THE FIGHT TO COVID-19 – BD, DHL, NOVANT ON DELIVERING, SHIPPING AND ADMINISTERING THE VACCINE For our Dec. 18, 2020 podcast, we visited with the medtech professionals who are working to get the vaccines into the right hands – and arms – of the people who need them most. Guests included: • Elizabeth Woody, SVP, Public Affairs at BD • Claudia Roa, VP Life Science & Healthcare Sector, Americas Global Customer Solutions at DHL • Dr. Eric Eskio lu, EVP & Chief Medical Ofﬁcer, Novant Health www.devicetalks.com/category/podcasts/ 18

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1 • 2021

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1. Ramping up needle and syringe production takes time. The process of setting up additional manufacturing lines in Nebraska, announced a few months ago, is a 9- to 12-month process, according to Woody. “You need the equipment to establish the lines,” she said. “Fortunately, we have the space in Nebraska. We’re not needing to build a new facility, but there is a lot of engineering behind a plastic-molded syringe and the needle on the end that may not seem obvious. … It is a pretty intense engineering feat to deliver those products, particularly at the scale that we do.” For now, BD has to use its current global manufacturing infrastructure in order to meet demand.

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2. Manufacturing syringes isn’t as straightforward as one might think. Syringes have been a prime vehicle for delivering drugs and drawing blood since the 19th century, but manufacturing them can still be demanding. “In the state of Nebraska, where we manufacture a number of these products, we’re actually one of the largest consumers of energy — because the process of actually molding the syringe is so energy-intensive,” Woody said. The manufacturing process starts with the heating of plastic pellets called resin, which are melted and injected into molds to create syringe parts, including the barrel and plunger rod. BD creates the plastic parts that hold a needle — the hub and shield — in the same way. To produce the needle, a stainless-steel strip is rolled into a tube and welded. A metalworking process called drawing shrinks the tube to the proper wall thickness and gauge and then cuts to length. The blunt metal tubes, or cannula, then go through a grinding process to form the sharpened point. Everything then gets fed through high-speed assembly and packaging machines. Case cartons with

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the individual units are sterilized on-site before they’re stacked onto pallets and shipped out via trucks. BD quality engineers oversee the entire process to ensure that strict safety standards and specifications are met. “We know we know how to manufacture needles and syringes. We’ve been doing it for a long time and we’ve really perfected the process. We’re confident in the volumes that we’ve committed to, based on that long track record,” Woody said. 3. BD learned lessons from 2009 The 2009 swine flu pandemic, caused by a new strain of H1N1 virus, proved to be a dry run for BD in supporting vaccination efforts. It drummed home the need for early planning and preparation — and to work with governments around the world to pre-position supplies of syringes and needles so that a vaccine can be administered once it’s available. Even as BD ramps up production

Drug-delivery devices are really the foundation of our company, and we have a long history in supporting global immunization campaigns to ensure devices are in place to deliver COVID-19 vaccines, it must also continue supporting flu shots and child immunizations. “We learned a lot of lessons from that experience that we’re definitely applying now,” Woody said. “We didn’t know then that we were preparing for coronavirus, but we did know that we needed to take some more steps to be prepared for a full-fledged pandemic like the one we find ourselves in now.” 4. Making sure there are enough syringes wherever vaccine shipments go BD’s supply team members are making sure that the syringes for COVID-19 vaccine are going to distribution centers set up by McKesson, which the U.S. government chose as its COVID-19 vaccine distributor partner. “They’re preparing the kits that they’re then sending out,” Woody said.

Syringes and needles are just two of many products that BD has been making to manage the COVID-19 pandemic. The company has been an important producer of testing swabs, tools for testing and transport, actual tests for the virus, and machines running the tests. In July, the company announced the U.S. launch of a SARS-CoV2 antigen test for use with the BD Veritor Plus system, following an FDA emergency use authorization. Health Canada authorized the test in November, pledging to buy $7.6 million worth of them. “From a work perspective, it is just energizing to know that we’re part of something bigger here, and we’re committed to making that difference,” Woody said.

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Medical Design & Outsourcing

IP ISSUES

Image courtesy of Shutterstock via Finnegan

Patenting the 3D bioprinting innovations that combat COVID-19

The usual patenting process need not delay protecting the IP of pandemic-related technologies.

Aidan C. Skoyles | Finnegan |

Kai Rajan | Finnegan | 22

Medical Design & Outsourcing

he COVID-19 pandemic has accelerated advancements in pharmaceutical, medical device and manufacturing technologies due to disrupted supply chains and new demands for treatments and materials. Among them is 3D bioprinting, which involves arranging encapsulated cells or other biological materials (bioinks) using a 3D printer to construct tissue, organs or biocompatible scaffolds that promote tissue growth. 3D bioprinting is decades old, and yet the past 12 months of the pandemic have yielded breakthroughs in treatment techniques and vaccinations in record time. Pandemic-related bioprinting appears to fall into three general categories: • Modeling human tissue and organs to understand how SARS-CoV-2 affects the human body. • Modeling the effects of therapeutic agents and techniques on human tissue and organs for combating the novel coronavirus. 1 • 2021

• Developing tissue and organ replacements for treating those already affected. It is easy to overlook intellectual property protection during a pandemic, but skipping the patenting process can mean forfeiting up to 20 years of IP protection. In the U.S., patent applications must be filed within one year of any public disclosure of the invention. Other countries and regions, such as Europe, require patent applications to be filed before any public disclosure. When an invention could have immediate worldwide value, the best way to ensure strong intellectual property coverage is to file at least a provisional patent application before even mentioning the invention to the public. Provisional patent applications are a quick and inexpensive avenue for beginning the patenting process. If time is short, a provisional patent application can be as informal as a simple coversheet and

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a set of notes or a slide deck describing the invention. Patent applicants have 12 months to convert the provisional application to a nonprovisional one, providing time to decide whether to proceed with the full patenting process. Indeed, provisional applications are fast, inexpensive, and allow applicants to defer IP protection decisions.

After resolving the questions of when, where and how to file for patent protection, the inquiry turns to what can be patented? The answer, it turns out, is not simple. Machines, materials and methods are typically patentable — “anything under the sun made by man,” as the U.S. Supreme Court put it in 1980, quoting Congressional testimony from 1952 on the

devices used to print the products can be patented. Examples of patentable inventions include: bioprinter designs or functionality; bioink used in the printers, so long as the bioink is something different than purely natural material; cells encapsulated or modified to be suitable for printing; and even

3D bioprinting is decades old, and yet the past 12 months of the pandemic have yielded breakthroughs in treatment techniques and vaccinations in record time. then-pending patent laws. But technology has come a long way since then, when the possibility of machine-made human tissue was science fiction. Patent protection is widely available for bioprinting inventions aside from printed products. The process, materials and

business methods involving bioprinting. The techniques for creating manmade biological structures using bioprinters will continue to be eligible for patent protection. One of bioprinting’s overarching goals is to replicate and improve on parts of the human body, which puts

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bioprinting inventions in a grey area of patent-eligibility. Simply put, things that exist in nature are generally not patenteligible, but the full analysis is more involved and case-specific. Due to the interplay between eligibility and other patentability requirements, available IP protection varies depending on the specific bioprinting innovation. While replicating the human body can model the effects of the virus and treatments on the body, research may yield tissue structures that are better than natural counterparts for repairing the body. Enhanced tissues may stand the best chance of being easily distinguishable from natural tissue and therefore found to be patenteligible, assuming the enhancements require different material structures or compositions. Although patent law will continue to develop, distinguishable bioprinted tissue will likely remain easier to patent than bioprinted tissue replicas. Whether man-made tissues can be patented will be an ongoing patent law issue. At this time, patents are not granted for natural tissue. Eventually, bioprinting machines will print implantable tissue and organs. Patent eligibility may depend on whether the products are distinguishable from natural versions. Many COVID-19-related bioprinting innovations are patent-eligible and will remain eligible for the foreseeable future. As many institutions are actively engaged in COVID-related research, delaying patent application filings would be a mistake. It could allow others to file competing applications first, blocking later filers on identical innovations. Provisional applications can be filed quickly and cheaply, securing a filing date with the patent office without tying up significant resources. Provisionals provide time to consider filing a nonprovisional application that could bestow exclusivity on use of the innovation for 20 years to come, and it is anyone’s guess what inventions will be useful in the years following this global pandemic. As the race to prevent and treat COVID-19 continues, it is important to seek protection on the inventions that will protect the world, while sharing knowledge for the greater good. Unlike trade secrets, which must remain guarded, patents promote the dissemination of ideas in exchange for IP rights. 1 • 2021

Medical Design & Outsourcing 25

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ORTHOPEDICS

The top 5 orthopedic device industry stories of 2020 The COVID-19 pandemic presented a host of challenges, but major mergers in the orthopedic device space still got done.

deadly coronavirus pandemic is certainly not a good environment for people to go in for knee and hip surgeries. But despite the tough business climate, orthopedic device companies worked through big M&A deals, and there was even a significant product launch in the robotic ortho surgery space. Here are five orthopedic device industry stories that garnered the most attention on MassDevice and Medical Design & Outsourcing this year. 1. Stryker closes Wright Medical buy, sells some businesses to DJO The world’s largest orthopedic device company has grown even bigger. Stryker announced in November that it had closed its $4.7 billion purchase of Wright Medical after months of negotiations with antitrust regulators in the U.S. and UK. To appease regulators, Stryker agreed to divest all assets associated with its total ankle replacements and finger joint implants to DJO Global. “This acquisition enhances our global market position in trauma and extremities, providing significant opportunities to advance innovation and reach more patients,” Stryker CEO Kevin Lobo said when the deal closed.

Chris Newmarker | Executive Editor |

Smith+Nephew made a faster surgical tool (center) and a console (bottom) that was the size of a large book volume when creating the company’s next-gen Cori ortho surgical robotics system. Optical cameras (top) track the procedure so that tool’s burr automatically turns off when it is outside of the operating area — the robotic feature of the system. Image courtesy of Smith+Nephew

Medical Design & Outsourcing

1 • 2021

2. Fewer elective procedures amid COVID-19 The COVID-19 pandemic hit orthopedic device companies especially hard ﬁnancially. The pandemic caused a curtailment of elective procedures — and sometimes even not-so-elective procedures — as health providers focused on managing COVID-19 and patients stayed away in droves. Companies generally reported some procedure recovery in the third quarter, but there may have been more problems in Q4 as an even bigger wave of cases hit the world.

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Here are how some of the largest companies performed: • Stryker’s sales were down –6.2% yearover-year, to more than $10 billion for the first nine months of 2020. Stryker saw sales recover during Q3, though Lobo warned of uneven growth within the company and an uncertain environment during the pandemic. • Johnson & Johnson’s orthopedics business saw sales fall –15.1% yearover-year, to roughly $5.6 billion for the first nine months of 2020. Sales were only down –2.6% during Q3. • Zimmer Biomet sales were down –15.7% year-over-year, to nearly $5 billion for the first nine months of 2020. But there was also some sales recovery in Q3. “While the strongerthan-expected recovery of elective procedures in the third quarter was encouraging, we also remain focused on ZB’s strong operational execution, which continues to drive confidence in

our underlying business,” CEO Bryan Hanson said at the time. • Smith+Nephew’s orthopedics and sports medicine businesses were down about –7.5% year-over-year, to roughly $2.3 billion for the first nine months of 2020. The British medtech giant also saw improved sales performance in Q3. 3. Sales reps lose access to the OR Having technical sales reps in ORs for procedures has been an important strategy for orthopedic device companies to maintain relationships with their health provider customers — but that all changed during the COVID-19 pandemic. To overcome the challenge, orthopedic device companies (and medtech companies in general) turned to remote solutions. Smith+Nephew, for example, inked a deal with Avail Medsystems in September to bring its high-level telecommunication system to operating rooms and surgery centers.

Stryker also experimented with remote case coverage after the pandemic hit, according to Spencer Stiles, group president of Stryker’s orthopaedic and spine groups. The doctors, however, actually want the sales reps in the room, especially when they’re short-staffed or have newer staff, Stiles said during a DeviceTalks Weekly podcast in November. “There’s a demand then that they need our experts who know where products are, who could be there to cover, who could help make sure the right inventory is in the right place that can guide a new staff member through a procedure.” 4. Smith+Nephew launches next-gen surgical robotics system Competition continues to heat up in the robotic orthopedic surgery space, with Smith+Nephew announcing the launch of its next-gen Cori robotic knee surgery system in July. The Cori system is the latest salvo as major medical device companies seek to take on Stryker, which has long

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ENJOY A FEAST OF INSIGHTS FROM SPENCER STILES (STRYKER) ART COLLINS (EXPLORER) AND MARK LEAHEY (MDMA) Our Nov. 23, 2020 podcast included: • Mark Leahey, president of the Medical Device Manufacturers Association, who explains where medtech might fits in this evolving political climate. • Spencer Stiles, group president of orthopaedic and spine at Stryker, who shares details on the Wright acquisition and the secret to the success of placing Mako surgical robots in hospitals • Art Collins, senior advisor to Explorer Surgical. The former chairman and CEO discusses leadership, Medtronic and the future for startups like Explorer. www.devicetalks.com/category/podcasts/

enjoyed success with its Mako robotic systems in the orthopedic surgery space. Sara Schneider, the director of robotics program management at S+N, spoke with Medical Design & Outsourcing and used three descriptors for the Cori system: faster, smaller and more accessible. Smith+Nephew officials are betting that there will be interest in a system that isn’t the size of a mini-fridge with an arm, that doesn’t rely on pre-operative imaging, and that includes a handheld cutting tool that can fit a particular surgeon’s techniques. “There’s more flexibility in the approach when you have that handheld piece that’s not anchored into this mammoth piece of

equipment,” Schneider said. Since the Cori launch, S+N introduced a couple of key additions to its Real Intelligence portfolio. They included RI.INSIGHTS, designed to enable orthopedic surgeons to benchmark robotics surgical experiences with other users, and RI.KNEE and RI.HIP navigation platforms for total knee and hip arthroplasty. 5. Smith+Nephew to buy Integra extremities business for $240M Smith+Nephew in September 2020 announced an agreement to spend $240 million to acquire the extremity orthopedics business from Integra LifeSciences. The deal closed Jan. 4. S+N officials say the acquisition will significantly strengthen the company’s extremities business by adding a combination of a focused sales channel and complimentary shoulder replacement and upper and lower extremities portfolios, plus a new product pipeline.

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Medical Design & Outsourcing 29

PHARMACEUTICALS

Environmental monitoring technology from PharmaWatch offers continuous monitoring of COVID-19 vaccine temperature and provides alerts if storage conditions deviate from a target range.

Image courtesy of PharmaWatch

Demand for ultra-cold vaccine storage and logistics surges Two of the biggest challenges of the early COVID-19 vaccination eﬀorts are keeping, and holding, vaccines at uncommonly cold temperatures. Brian Buntz | Pharma Editor |

hile public hesitancy in getting the vaccine will be a barrier in battling the COVID-19 pandemic, the storage requirements for SARS-CoV-2 vaccines will invariably add a significant hurdle. The BNT162b2 vaccine from Pfizer — with its subarctic storage requirements of –70° C (–94 ° F) — may prove especially vexing. Approximately 5% of the vaccine, which Pfizer developed with partner BioNTech, could be made unusable after becoming too hot or cold in transit, said Jean-Pierre Emond, CEO of cold-chain logistics company BlueEye, in a UBS briefing note. Little ultracold experience Cold-chain problems often stymie vaccination efforts. Relatively few logistics and healthcare organizations have freezers capable reaching such low temperatures. And as vaccine makers work to prioritize speed to market, their ability to perform stability testing over a range of temperatures is diminished. “That, of course, puts a lot more pressure

Medical Design & Outsourcing

1 • 2021

on the requirements associated with ultralow cold temperature requirements,” said Dusty Tenney, CEO of Stirling Ultracold, a manufacturer of ultracold freezers. While the Pfizer-BioNTech vaccine became the first to win emergency use authorization from the FDA, a similar vaccine from Moderna is stable at standard refrigerated conditions of 2° to 8° C (36° to 46° F) and gained an EUA on December 18. By late December, the Pfizer-BioNTech vaccine was one of the most broadly deployed, but few care providers have experience storing vaccines at the über-cold storage temperatures it requires, said Robin Grimwood, president and COO of Infinity Biologix, a biorepository with experience in biobanking and bioprocessing. For one thing, there is little need. Flu vaccines, for example, are refrigerated. The relatively few vaccines that are stored at frozen temperatures are held at –15° C to –50° C. “Clinics or local hospitals may have –20° C capabilities, but they’re just not used to storing at –80° C,” Grimwood said. What’s more, few developing countries

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have the infrastructure to ensure ultracold COVID-19 vaccines are stored at the appropriate temperature. “Ebola provided a big example of some of the challenges of getting vaccines to remote areas,” Tenney said. Stirling Ultracold is working to alleviate such problems by offering a standardized power port that can be used while vaccines are in transit. “In addition to that, we have a battery technology, and we are developing an application to use solar panels,” he added. Ultra-low temperature storage has traditionally relied on dry ice or liquid nitrogen. Both require special handling.

When used in closed areas, both dry ice and liquid nitrogen can cause asphyxiation. “The real challenge from the last-mile perspective is, how do you get it out of the distribution hub down to the clinics and pharmacies that in a traditional world don’t necessarily deal with that level of infrastructure?” Tenney said. Yet ensuring that vaccines are stored at the correct temperature is one factor needed to shore up public support for vaccines. Currently, about three out of five Americans plan on getting a COVID-19 vaccine, according to Pew Research Center. Effective cold-chain logistics are vital to ensure vaccines are effective and win

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public support, but widespread logistical cold-chain problems could further undermine public trust, Tenney said. If a COVID-19 vaccine “doesn’t have the desired impact, you’re going to have a world that’s just questioning the validity of the vaccine, which is the last thing that needs to take place,” he added. Keeping vaccines at the right temperature Pfizer has worked to simplify the challenge of safely distributing its vaccine by developing suitcase-sized, dry-ice-cooled storage containers. The containers, however, can only be opened twice each day for less than three minutes each time. Exceeding those requirements can cause the vaccine temperature to warm beyond the recommended specifications. Keeping vaccines cold is just as important after they reach their final destination as it is in the supply chain. Just as few healthcare facilities and retail pharmacies have experience with ultracold storage; ultracold temperature monitoring is not common in hospitals, clinics and pharmacies. “Traditional monitoring techniques that use data loggers or mercury thermometers are not going to work in those ultra-cold environments,” said Nicholas Ioli, COO of PharmaWatch, a company that offers continuous temperature monitoring for healthcare environments, including those planning on storing COVID-19 vaccines. Even for vaccine candidates with less-stringent requirements, temperature excursions — deviations from a prescribed temperature range — should be a worry. “If the cold chain is not properly maintained, vaccine potency may be lost, resulting in a useless vaccine supply,” warned the Centers for Disease Control and Prevention (CDC). Temperaturecompromised vaccines could also be responsible for adverse events, although data on that subject are lacking. “With COVID vaccines, there hasn’t been a lot of runtime on stability studies,” Ioli said. “There’s not a lot of data to support how stable or resilient these vaccines are to conditions that would compromise their temperature.” Many healthcare facilities and retail pharmacies lack the ability to offer sustained monitoring of COVID-19 vaccines’ temperatures, according to Lindsay Meloy, sales and account executive 32

Medical Design & Outsourcing

1 • 2021

at PharmaWatch. The CDC recommends using a digital data logger that records at intervals of at least every 30 minutes. But organizations storing vaccines “really need a continuous temperature monitoring system,” Meloy said. PharmaWatch’s technology offers a five-minute sampling rate and continuous monitoring to ensure that the vaccines are not compromised by temperature excursions. Healthcare facilities and retail pharmacies also need a functional alert system, Meloy added. If a freezer goes “out of range in the middle of the night, somebody should get an alert so they can deal with that before the vaccine’s viability is affected,” she said. PharmaWatch did a study with the state of Arkansas, which implemented real-time vaccine monitoring. Over a five-year period, state officials documented more than 300 instances of temperature excursions that would have been undetected with traditional temperature logging, the company noted. Thankfully, there has been a growing awareness of the need for effective temperature management of vaccines in transit or storage. “Pharmaceutical companies are engaging with cold-storage specialists to ensure a smooth supply of the vaccine when it does become commercially available,” said Vinie Varkey, a senior pharma analyst at GlobalData. Healthcare workers also seem to be increasingly aware of the topic, Ioli said. “I’ve spoken with nurses, physicians and pharmacists who have said, ‘I’ll only get the COVID-19 vaccine from facilities that are monitored in real-time, and where I can make sure that their cold chain was clean from manufacturer to the point of use.’” The ultracold temperature situation will apparently be with us for a while, but perhaps not forever. Pfizer is developing a powdered version of its vaccine that would be stable at higher temperatures — possibly even at room temperature. Several other COVID-19 vaccine candidates, such as those from AstraZeneca and Johnson & Johnson, are stable at refrigerated temperatures. But regardless of the vaccine, maintaining it within the prescribed temperature range will be vital.

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Medical Design & Outsourcing 33

How does HIPAA affect medical devices? Medical device manufacturers need to understand patient privacy law and how to comply with it.

Jordan MacAvoy | Reciprocity Labs |

oncern for protecting and safely handling private health information continues to grow, especially with the reliance on electronic transmission. Federal regulations in the U.S. such as the Health Insurance Portability and Accountability Act (HIPAA) provide guidelines to help ensure that healthcare providers, institutions and their business partners protect patient records. While it’s clear what health entities should do to ensure private health data safety, the role of medical devices in this effort is less well understood. Understanding protected health information (PHI) Numerous medical devices can collect and transmit data. For example, m-health devices monitor vital signs, transmit patient records to doctors and allow remote examinations on mobile phones, tablets, and other portable medical devices. These devices often carry personal

Medical Design & Outsourcing

1 • 2021

records such as patient names, phone numbers, addresses, insurance information, Social Security numbers and health information. HIPAA’s privacy rule requires the protection of private health information, which applies to covered entities, hybrid entities and business associates. HIPAA also has a security rule to ensure the conﬁdentiality, integrity and availability of health information. And it creates standards for administrative, technical and physical safeguards for private patient information. These standards include: • Conﬁdentiality: A patient’s private health information must not be disclosed to a third party unless the patient authorizes it. • Integrity: The data should be valid, and the users of the information should trust its reliability. • Availability: The data should be available for use, especially in life-ordeath situations.

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Covered entities HIPAA deﬁnes healthcare providers, medical clearinghouses and health plans as covered entities. These are individuals and organizations that transmit health information electronically. The transmission can be for claims, payments, treatments and operations.

accounting, legal matters, ﬁnancial services and data management, among others. How does HIPAA affect manufacturers? For device manufacturers, compliance begins with understanding user needs. If you’re creating devices for use

Hybrid entities HIPAA deﬁnes hybrid entities as organizations that perform covered and non-covered functions. For example, a university may have a medical center that transmits patient information electronically and runs other operations.

While it's clear what health entities should do to ensure private health data safety, the role of medical devices in this effort is less well understood.

Business associates According to HIPAA, business associates are organizations that run operations on behalf of a covered entity. If your business includes the disclosure of private patient information, you’re a business associate. This includes processing claims, consulting,

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• Include security features that control access to information according to the covered entity’s rules. For example, enabling password features to access a system, tracking the users through personal IDs, and encrypting internal and external transmissions. • Consider providing transmission options that conceal patient names while providing relevant information such as patient health history and room numbers to ensure privacy and availability. • Consider incorporating advanced privacy measures such as biometric authentication through ﬁngerprints for critical data. • Sign a business associate agreement with the covered entity you’re in contract with. This agreement should demonstrate that you understand how to follow the privacy and security rules. The documents should also show how you plan to protect, use and disclose PHI in your hands. • Create a stable workﬂow that ensures all data is captured and secured correctly. This ensures the reliability of data and keeps the information secure from the source to the storage. • Understand which operating systems and software are in use, and check for upgrades and compatibility issues that may affect PHI safety. Frequent security patches may be necessary to ensure security.

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Medical Design & Outsourcing

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TUBING TALKS

The top 10 catheter innovations of 2020 As the COVID-19 pandemic took over the world in 2020, medical device companies continued to showcase new catheter-based innovations.

Danielle Kirsh | Senior Editor |

Boston Scientiﬁc’s DirectSense technology

Image courtesy Boston Scientiﬁc

Medical Design & Outsourcing

hroughout 2020, we saw FDA clearances, approvals and product launches for a variety of catheter-based technologies, including renal denervation systems, heart failure treatment catheters, mechanical thrombectomy systems and more. The list of companies boasting new catheter-based tech includes medtech giants like Boston Scientific and Philips, but also smaller companies like ReCor Medical and Revamp Medical. Based on reader interest, here are the top 10 catheter-based innovations that dominated the news on Medical Tubing + Extrusion, Medical Design & Outsourcing and MassDevice in 2020. 1. Boston Scientific: DirectSense Boston Scientific launched its DirectSense technology in June 2020. The technology monitors the effect of radiofrequency energy during cardiac ablation procedures. The system offers data on the impedance around the catheter tip to measure the ability of the tissue to respond to radiofrequency (RF) energy before physicians deliver therapy. It tracks local impedance change up to 4 mm during ablation to indicate how the tissue is affected to lead to a reduction in the chances of overablation and complications, according to the company. DirectSense is available only on Boston Scientific’s Rhythmia HDx mapping system, which monitors electrical resistance around the tip of the IntellaNav MiFi openirrigated ablation catheter. 1 • 2021

2. Rist Neurovascular: Rist Cath radial access long sheath Rist Neurovascular received FDA clearance in February 2020 for its Rist Cath radial access long sheath for access to the neurovasculature. Rist Cath is designed to reach the neurovasculature through the radial artery in the wrist, which could potentially open up the possibility of performing a number of neuromuscular procedures transradially, according to the company. Rist Cath is a single-lumen, variablestiffness catheter with a stainless steeland nitinol-reinforced shaft that has a radiopaque marker band on the distal end to aid in visualization. The catheter has an outer diameter of 0.093 in. and an inner diameter of 0.079 in. It comes in working lengths of 95 cm and 100 cm and has a PTFE-lined lumen to enable the movement of other devices passing through it.

Rist Neurovascular Rist Cath radial access long sheath

Image courtesy Rist Neurovascular

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3. Johnson & Johnson: Cerenovus clot removal products Johnson & Johnson’s Cerenovus launched three new clot removal products in September 2020. The three devices are designed to help physicians perform mechanical thrombectomy procedures. The three devices include the Cerebase DA guide sheath, Cerenovus large-bore catheter and Embotrap III revascularization device. Cerebase DA guide sheath is a long guide sheath that is designed with more trackability to allow physicians to navigate challenging anatomy and secure distal access for geometric anchoring. The Cerenovus large bore catheter is designed for atraumatic vessel wall interaction to balance trackability with more durability and compatibility. It has distal kink resistance in a thin wall design and allows for rapid navigation to the middle cerebral artery based on anatomically optimized design, according to the company.

Johnson & Johnson describes its Embotrap III revascularization device as a stent retriever designed to engage a range of clot types and provide more tailored options to achieve the ﬁrst-pass effect, which is an independent predictor of good functional outcome and can result in faster patient recovery times. It is indicated for vessels from 5 mm to 1.5 mm and has a dual-layer design to engage and grip the clot differently. It has been shown to retrieve different thrombus types, including ﬁbrin-rich and RBC-rich clots, according to J&J.

Medical Design & Outsourcing

1 • 2021

Image courtesy J&J

Johnson & Johnson’s Embotrap III

Image courtesy J&J

Johnson & Johnson’s Cerebase DA guide sheath Image courtesy J&J

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Johnson & Johnson's Cerenovus large-bore catheter

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Philips' QuickClear mechanical thrombectomy system Image courtesy Philips

4. Philips: QuickClear mechanical thrombectomy system Philips launched its QuickClear mechanical thrombectomy system in the U.S. in September 2020. The device is designed to remove blood clots from the peripheral arterial and venous systems. QuickClear is a compact, single-use system designed to provide an all-inone aspiration pump and catheter to remove blood clots. The device is compact enough to be placed on the table next to the patient.

The system can be started by pressing a button, which brings QuickClear up to maximum aspiration power within seconds. It provides the same aspiration power as competing mechanical thrombectomy systems without capital equipment, according to Philips. QuickClear can use catheters in sizes 6 Fr, 8 Fr and 10 Fr. Its components include a T-connector, 60 cc booster syringe, inline ďŹ&#x201A;ow control switch, hemostasis valve y-connector, QuickClear aspiration pump and 1400 ml disposal container.

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TUBING TALKS

Revamp Medical's Doraya acute heart failure catheter

Image courtesy Revamp Medical

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5. Revamp Medical: Doraya acute heart failure catheter Revamp Medical won FDA breakthrough device designation for its Doraya acute heart failure catheter in July 2020. The device is a temporary intravenous catheter that is placed in the inferior vena cava below the renal veins and temporarily applies partial adjustable flow. The device has a flow regulator mechanism that is designed to temporarily reduce central venous pressure and improve the diuretic response in patients with acute heart failure and insufficient response to diuretic therapy. The manageable flow-reducing central venous catheter is deployed in the infrarenal IVC for up to 12 hours to help cardiologists temporarily manage venous hemodynamics, central venous pressure, renal afterload and venous returns. 6. Johnson & Johnson: Thermocool SmartTouch SF ablation catheter Johnson & Johnson’s Biosense Webster business won FDA approval for its Thermocool SmartTouch SF ablation catheter in October 2020. The catheter was approved to treat persistent atrial fibrillation. The ThermoCool SmartTouch catheter has a porous tip that provides uniform cooling at half the flow rate of earlier generations of irrigated catheters, according to Biosense Webster. The catheter is integrated with the company’s Carto 3 system, which combines contact force technology, 3D mapping and advanced navigation capabilities to provide active measurement of stable contact force and catheter tip location. The unidirectional catheter also provides consistent movement in response to contact force and sends accurate location reference signals through a location sensor and transmitter coil, according to J&J. The catheter helps promote consistent lesion formation, reduces ablation time and improves outcomes with more stable catheter-tissue contact force, the company said.

Johnson & Johnson’s ThermoCool SmartTouch catheter

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Image courtesy Johnson & Johnson

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7. Penumbra: Lightning 12 clotretrieval system Penumbra’s Indigo Lightning 12 aspiration catheter system won expanded FDA clearance in November 2020. The expanded clearance covers the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems and for pulmonary embolism treatment. Lightning 12 combines the company’s Indigo system CAT 12 aspiration catheter with Lightning Intelligent aspiration to allow physicians to focus on optimizing thrombus removal using the system’s clotdetection mechanism. The CAT 12 catheter in the system is a large-lumen aspiration catheter that uses laser-cut, hypotube-based catheter engineering to improve delivery and torque within the body. Lightning has dual pressure sensors for real-time ﬂow monitoring, a microprocessor with a thrombusremoval algorithm, automatic valve control and intraprocedural audio-visual cues. The Indigo Cat 12 multipitched hypotube catheter is made of stainless steel. It has a large lumen size and circumferential sweep to remove the blood clot, and 1:1 torque transfer and advanced deliverability with separator technology.

Penumbra Indigo Lightning 12 aspiration catheter

Image courtesy Penumbra

8. PreCardia: Catheter-based heart failure treatment system PreCardia won FDA breakthrough device designation for its catheter-based heart failure treatment system in June 2020. The PreCardia system is designed to rapidly and effectively reduce congestion in the venous system to improve overall cardiorenal function. The technology includes a balloon catheter and pump controller that is designed to address acute decompensated heart failure through the intermittent superior vena cava occlusion. 9. SoniVie: Tivus renal artery denervation tech SoniVie won FDA breakthrough device designation for its Tivus renal artery denervation technology in December. The technology is designed to treat resistant hypertension through renal artery denervation. Tivus (therapeutic intra-vascular ultrasound system) is a catheter-based technology that can cause denervation of nerves surrounding blood vessels and other structures like the bronchus. The catheter technology generates non-focused ultrasound waves that pass through ﬂowing blood and through the wall of the artery where the nerve bundles absorb the energy. Once the nerves are heated to the point of necrosis, they lose their ability to pass signals. Tivus’s ablation results in a decrease in sympathetic hormones that are released from the nerves. This relaxes the blood vessels, reducing resistance and pressure in them. In pulmonary hypertensive patients, the technology reduces the resistance in the right side of the heart.

Tivus renal artery denervation technology

Image courtesy SoniVie

Medical Design & Outsourcing

1 • 2021

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10. ReCor Medical: Paradise renal denervation system ReCor Medical won FDA breakthrough device designation for its Paradise ultrasound renal denervation system in December. The system is an investigational device that is designed to treat hypertensive patients who may not be sufﬁciently responsive to or are intolerant of anti-hypertensive medical therapy. The technology is catheter-based and uses ultrasound energy to interrupt the renal sympathetic nervous system for better blood pressure control.

ReCor’s Paradise requires a minimally invasive procedure to treat overactive nerves that lead to the kidneys. Doctors make a small incision in the groin to insert a small, ﬂexible catheter and place it in the artery supplying the kidney. The device delivers ultrasound energy to the tissue surrounding the artery for several seconds. That energy creates heat to decrease the over-activity of the nerves leading to the kidney, allowing both kidneys to be treated. Once the treatment is completed, the device is removed.

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in crisis management from Stryker CEO Kevin Lobo

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Medical Design & Outsourcing

7 • 2020

TOM SALEMI DEVI CETALKS EDI TORI AL DI RECTOR

he past year presented extraordinary leadership challenges for CEOs. First came the COVID-19 pandemic, then social unrest following the killing of George Floyd, and ﬁnally a contentious election that tore at the political connective tissue of the nation. The year may have been unique, but Stryker CEO Kevin Lobo said his strategies at the orthopedics giant drew upon upon basic tenets of leadership that he learned leading businesses in ﬁrst the chemical and then medical device industries. He joined medtech in 2003 upon taking a senior post at Johnson & Johnson. “All crises have similarities,” Lobo told Medical Design & Outsourcing. “Obviously the magnitude of this is unprecedented. I’ve never been through anything like this, but I’d been through other crises before.” Lobo’s leadership skills appear to have paid off for the world’s largest orthopedic device company, which performed better than other top competitors amid the pandemic.

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Stryker’s revenue was down –6.2% yearover-year, to more than $10 billion for the ﬁrst nine months of 2020 as COVID-19 caused a curtailment in elective procedures. But sales during the same period were down –7.5% for Smith+Nephew, –15.1% for Johnson & Johnson’s ortho business, and –15.7% for Zimmer Biomet. Stryker even closed a major M&A deal — its $4.7 billion purchase of Wright Medical, which Lobo said “helps us toward our goal of achieving category leadership in all areas of our business. “We’re excited about bringing Wright Medical’s people, products and pipeline into Stryker,” Lobo added. “With a longer sign-to-close period, we had more time to develop our integration plans and, shortly after closing, announced specialized business structures that will help us remain close to the customer and set us up for success in 2021 and beyond.” In an interview, Lobo described how he managed as the world unraveled. He also discussed his unique position as chair of AdvaMed, medtech’s largest industry organization, as the sector fell into the crosshairs of then-President Trump and other politicians. Here are the past learnings Lobo applied to leading in 2020. 1. State what’s most important to you In spring, the pandemic closed hospitals and work sites, creating previously unseen uncertainty. From experience, Lobo knew that setting clear priorities is paramount in a crisis. “We came up with our three priorities very quickly: Protect our employees, serve our customers and have strong ﬁnancial discipline,” he said. It was essential to Lobo that Stryker employees knew their safety was at the top of the list. “Even now, those three priorities still resonate with all our employees,” he added. The promise to protect employees would factor into later decisions. 2. Communicate clearly and often The frenzy that took hold during the pandemic’s early days unleashed a cascade of information, not all of it true or helpful. Stryker management established “incident response teams” to answer employee questions. Each week, managers talked about personal 50

Medical Design & Outsourcing

1 • 2021

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protective equipment (PPE), changes in geographic regions and when the company’s ofﬁces would ofﬁces open or close. Initially, the calls were weekly, then biweekly. Now, they occur monthly. “You just cannot overcommunicate when you’re in a situation that’s very foreign and not normal,” Lobo said. “Employees want to see their leaders and hear from their leaders.” 3. Don’t try to hide concerns In uncertain times, managers may not have all the answers and that’s okay, Lobo said. Coworkers are savvy enough to detect false bravado. “You just have to be authentic and transparent,” he said. “I'm an optimistic person by nature. So normally when I talk to employees, I tend to see the positive sides of things, but you don't sugar-coat things, yet you have to be realistic about the challenges.”

Meanwhile, Stryker’s revenues were dropping as elective surgeries, such as hip and knee implants, were postponed and people avoided medical settings unless absolutely necessary. Second-quarter sales dropped by nearly -25%, a first for the company. Lobo told employees that Stryker would keep workers as long as possible, but he couldn’t guarantee cuts wouldn’t come because no one knew the duration of the pandemic. Stryker ultimately furloughed an undisclosed number of employees, but Lobo said management adhered to the first priority of protecting employees. The company paid production workers through April even though there was no work. “We didn't want them to have to go into the unemployment lines when that was a chance for them to contract the virus,” he said. Once furloughs became necessary, the company continued to provide healthcare benefits.

Stryker wouldn’t reveal how many were furloughed, but a spokesperson said, “We’ve been focused on bringing employees back safely over the past several months. Our manufacturing employees are now back at work at almost all locations.” Kaila Krum, managing director of Truist Securities, said Lobo made some “controversial and difﬁcult” decisions early in the pandemic to control costs as revenues dropped. “But no one can argue against the fact that he’s executed against those decisions,” she said. “And the business under his leadership has held up really well during the pandemic.” 4. Highlight the heroes Communication isn’t limited to bad news and worry. Lobo says Stryker used its open lines to instill hope when possible. “There are a lot of inspirational hero stories,” he said. “We balanced the

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negatives with these positive, inspiring stories. We heard what customers were looking for from us, and we heard from customers directly.” Hearing from customers and other Stryker personnel was “very powerful” for employees, Lobo said. 5. Push harder for diversity Lobo had made diversity, equity and inclusion clear priorities when he took over as CEO in 2012. The company made progress bringing women into senior management and the sales team, but Lobo conceded that Stryker hasn’t made progress in bringing in more people of color. Lobo credits Stryker’s early push for diversity with fostering a dialogue following the police killing of George Floyd in Minneapolis. The outrage following Floyd’s death convinced many medtech companies, including Stryker, to condemn the act and pledge to improve diversity in their own workforces. Lobo, who is of Indian descent and grew up in Canada, shared his own thoughts and experiences as well. “I wrote a note to our employees that was fairly raw and talked about that,” he said. “The fact that we've been talking about this all this time already, [meant] it wasn't a new reaction.”

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6. Let employees lead Stryker also responded by leaning on its employee resource groups, internal organizations that had been established to represent people of different races and ethnicities. Employees in Stryker’s African American Resource Group asked if they could meet without any managers or other employees present. The raw feelings and emotions shared at the meeting led to a report to senior managers about problems at Stryker. “They told us some things about our company that were tough to hear, to be honest, about their own experiences,” Lobo said. “They shared some positive things and some very negative things. We sort of knew some of these things probably were happening, but to hear it… They felt very free to speak openly, and I think that was the most powerful part of this.” In December, the company launched a new resource group for employees of Asian descent.

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Medical Design & Outsourcing

7. Patients and policy — not politics The national election didn’t create new challenges for Stryker, according to the CEO, who said managers and employees remained customer-focused and that the company is focused on “policy, not politics.” In that spirit, Stryker gave no quarter in requiring face masks. “If you come to a Stryker facility, we're going to have masks there. We're going to temperature-check you, and you're going to have to wear a mask,” Lobo said. “There was no debate about it. And I said, this is not a political statement, wearing a mask. This is about protecting our employees. Our ﬁrst priority is protecting our employees.” Lobo applied that same clear line at AdvaMed. Asked if AdvaMed ofﬁcials considered taking a stance in the disputed presidential election, Lobo said leaders at the organization did discuss issuing a statement as other industry organizations had done.

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However, AdvaMed leadership chose to remain neutral. Lobo said the organization works well with both Democrats and Republicans. “We’re an apolitical association, focused on policy,” he said.

8. Dig into the details Lobo’s appreciation for the medtech industry only grew after he watched it respond to the demands of customers, patients and politicians during 2020. Lobo acknowledged he “wasn’t prepared to be leading during this time. I’ve learned a lot about ventilators and diagnostic tests and PPE — areas that frankly, Stryker doesn’t play in. But as leader of the association, I had to become very knowledgeable.” Nadim Yared, CEO of CVRx and Lobo’s predecessor at AdvaMed, said the Stryker CEO “did admirably well as chairman of AdvaMed during this crisis.” Not only did the association have to stand front-and-center in advocating for the industry, but it had to do all this while facing its own ﬁnancial challenges as the pandemic squeezed conference revenue and membership fees. Yared credits Lobo with drawing support from other medtech leaders, citing the appointment of Vince Forlenza, former CEO of Becton Dickinson, as the leader of the COVID-19 diagnostic testing task force.

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9. Trust your decisions A year after becoming Stryker’s CEO in 2012, Lobo pushed for the company to acquire Mako, a smaller, publicly traded company that had developed the first orthopedic surgery system to gain adoption. Stryker became the first established medtech company to place a significant bet on robot-assisted orthopedic surgery. At the time, many company insiders and surgical customers questioned Lobo’s and Stryker’s path. Today, Mako remains a strong performer for Stryker and has surprised many, including Lobo, by continuing to sell during the pandemic — proving itself an important revenue driver for the company. Stryker placed its 1,000th Mako system in the fall. Time proved out Lobo’s decision to purchase Mako. But did Lobo lose any sleep over the deal when the criticism began to pile up? “Not really. You have to make the bets you think are right,” he said. “That’s what leadership is about … You get the information you need. You involve your team in the decisionmaking process. You hear the arguments on both sides. Then once you make a decision, you just go. You just lean in. If you’re wrong, you admit you’re wrong later and you course-correct.”

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E T D E M

ated n i m uch o d m 9 o 1 s was e COVID r e h t but , s w ch. e e t d e the n n in m o g n i o more g

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et’s face it: These are soul-trying times, and no one is going to miss 2020. We’re leaving behind a year of tragedy and disaster — with the COVID-19 pandemic and its more than 1.6 million deaths (more than 400,000 in the U.S. alone) at the top of the list. But in the midst of it all, people adapted as best they could and went on — and so did the medical device industry. Medtech, in fact, played a crucial role in efforts to manage the pandemic. Here are 10 stories that dominated the news on MassDevice and Medical Design & Outsourcing in 2020: 1. Medtech joins the ﬁght against COVID-19 Medical device companies aided in the management of the pandemic in a host of ways: •

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Johnson & Johnson is among the companies that have COVID-19 vaccine candidates being evaluated in Phase 3 clinical trials, though a partnership between Pﬁzer and BioNTech was the ﬁrst to receive a vaccine EUA in the U.S. in December. Moderna’s vaccine soon followed. Becton Dickinson on Dec. 16 announced that orders have surpassed 1 billion for syringes and needles needed to deliver COVID-19 vaccines. Abbott, Siemens Healthineers, BD and Danaher are among the top providers of COVID-19 tests. Abbott is even planning to get 30 million of its rapid COVID-19 test cards into people’s homes in early 2021.

Abbott and eMed plan to deliver and administer 30 million BinaxNow at-home COVID-19 tests in the ﬁrst quarter of 2021.

Image courtesy of Abbott

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RKER A M W E N CHRIS TIVE EDITOR U EXEC

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3M, Medline Industries, Cardinal Health, Henry Schein and Owens & Minor are important providers of protective equipment such as masks, gowns and gloves to protect health workers from the coronavirus. Medline Industries agreed to reprocess tens of thousands of N95 respirators and other face masks per day in its facilities — and it started cranking out hand sanitizer at an infectionprevention products plant in Wisconsin. 1 • 2021

Medical Design & Outsourcing

MEDTECH IN 2020

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The company has started repurposing its Lithia Springs, Ga. plant to make face masks in North America for the ﬁrst time, after receiving a more than $6 million U.S. Department of Defense grant to support the effort. Medtronic publicly shared its ventilator IP to help alleviate shortages of the machines early in the pandemic. The COVID-19 pandemic increased demand for patient monitors, ventilators and digital health products coming out of Philips’ Connected Care business. GE Healthcare is also a major producer of ventilators needed to treat people with severe COVID-19 cases. Baxter is playing an important role, providing kidney dialysis machines and infusion pumps to treat critically ill COVID-19 patients. Over the course of the year, ventilator

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manufacturers increased production from 700 per week to 10,000 per week, according to the trade group AdvaMed. Leading COVID diagnostic manufacturers have shipped approximately 270 million molecular COVID-19 tests since March, including some 200 million commercial tests and about 70 million extraction reagents. In the U.S. alone, PPE production topped 100% capacity, with some manufacturers running production lines 24/7.

Medtech companies’ efforts against the coronavirus came at the same time that many took a revenue hit amid a curtailment of elective procedures — and sometimes even not-so-elective procedures — as health providers focus on managing COVID-19 and patients stay away in droves. Procedures saw some

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Medical Design & Outsourcing

1 • 2021

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recovery in the third quarter of 2020, but then a new wave of the novel coronavirus hit the world. – CN 2. Medtronic embarks on a major reorganization under its new CEO Medtronic, the world’s largest medical device company, faced down the pandemic and the resulting recession under its new CEO, Geoff Martha, who assumed the corner ofﬁce after holding senior- and executive-level roles at the company since 2011. “The pandemic forced us — in particular with the ventilator work that we were doing — to innovate quickly, because literally lives were on the line and it felt like every minute counted,” Martha said during a recent DeviceTalks Weekly podcast. . Martha found himself slashing through a great deal of corporate bureaucracy to help the ventilator project succeed and decided that

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MEDTECH IN 2020

the company needed to speed up plans for a major restructuring. Now underway, the restructuring is expected to produce annual savings of $450 million to $475 million by 2023, and Martha has said he’s looking forward to whatever the post-pandemic, new normal brings. The restructuring includes a new operating model designed to reduce the layers of decision-making, separating the company into 20 “empowered operating units,” or segments that are given control they didn’t have before. Martha is also excited about the pipeline of products the company has built in areas as diverse as surgical robotics, leadless pacemakers, renal denervation, neurostimulation and more. He’s said that it is time to play offense and expand market share now that the pipeline is kicking in. – CN

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3. Johnson & Johnson, Medtronic prepare to compete against Intuitive Surgical J&J in November shared details on its surgical robotic platform, saying its six arms offer unrivaled flexibility and control. The Ottava platform’s arms are integrated into the operating table. Ottava also has a zero-footprint design to enable access to patients, save space in the operating room and improve workflow. The company plans to begin verification and validation processes for Ottava in 2021, followed by enrollment in clinical trials in 2022. The robotic system is J&J’s bid to take on Intuitive Surgical — the dominant player in the space. Medtronic, meanwhile, is on a faster track to compete with Intuitive Surgical; it plans to file for a CE Mark and U.S. IDE approval for its Hugo system in early 2021. – CN 4. Industry leaders rally against racism The killing of George Floyd by police in Minneapolis struck at the heart of the medtech community. CEOs from large medtech companies issued statements condemning the death and supporting those who continue to push for change. Kevin Lobo, CEO of Stryker and the chair of AdvaMed, had been pushing for inclusion and diversity at both his company and industry. “I wrote a note to our employees that was fairly raw and talked about that,” Lobo told DeviceTalks Weekly. “I think the fact that we've been talking about this all this time, and it already, it wasn't a new reaction.” Boston Scientific similarly had been pushing for progress, including a decadesplus campaign called Close the Gap to increase accessibility to healthcare by people of color, according Camille Chang Gilmore, VP of human resources and global chief diversity officer at the company. “I have to say, one of the proudest moments of my career at Boston Scientific was when our CEO, Mike Mahoney, and the executive committee wrote an open letter two days after George Floyd's death that not only took a stance as far as where we stood regarding racism, but also made a commitment to $2.5 million to combat racism, a 400-year old sin,” Chang Gilmore said in an interview with DeviceTalks Weekly.

MEDTECH IN 2020 CAN BOSTON SCIENTIFIC CLOSE THE GAP IN HEALTHCARE? INNOVATOR JEFF KARP, MD, SHARES EARLY CHALLENGES Boston Scientific’s Camille Chang Gilmore, vice president, human resources, global chief diversity officer, and Michael Jaff, MD, CMO of its peripheral vascular group, reintroduce us to the company’s Close the Gap program. Launched in 2006, Close the Gap seeks to address the lack of care being delivered to underserved populations, including people of color and people earning lower incomes. The two Boston Science executives will explain why Close the Gap is more essential than ever, and what we as an industry need to do to bring equality to care. www.devicetalks.com/category/podcasts/ Medtronic hired Dr. Sally Saba as its chief inclusion and diversity officer in March. On Dec. 10, the company announced it is a founding member of OneTen, a coalition of leading chief executives and companies committed to training and hiring one million Black Americans who do not yet have a four-year degree into family-sustaining jobs with opportunities for advancement over the next 10 years. "Medtronic needs to play a bigger role in society than maybe we have in the past,” CEO Geoff Martha said in an interview with DeviceTalks Weekly. “We're an innovation company, and innovation is still a people game. We need to have the best and brightest people working at Medtronic. And the best and brightest people today want to work for a company that stands for something." – TS 5. Big shifts in regulatory and reimbursement This year saw the FDA issuing a slew of emergency use authorizations (EUAs) amid the desperate need for medtech to better manage the pandemic and save lives. Time will tell whether the easing of regulation will stick around as the pandemic crisis recedes and the new Biden administration seeks to fulfil its own priorities. In July, the agency released the second list of Class II devices it has exempted from 510(k) clearance requirements, as required by the 21st Century Cures Act. Less 1 • 2021

Medical Design & Outsourcing

comprehensive than its first lists, released in 2017, this final order includes certain reproductive, orthopedic, rehabilitative exercise and therapeutic massage technologies. The pandemic and a lack of notified bodies needed to review new and updated applications led the European Commission to delay its Medical Device Regulation (MDR) by one year to May 26, 2021. The commission, however, is still intent on requiring manufacturers of in vitro devices to comply with new regulations governing those devices, set to go into effect May 26, 2022. On the reimbursement side, good news for medical device companies came as CMS agreed to cover “breakthrough” medical devices. This news was followed by more than a dozen breakthrough device designations in the second half of 2020. – NC

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6. Medtech IPOs and M&A continue Medtech IPOs and major M&A deals continued through the pandemic and recession, too — a sign of hope for the future after COVID-19. Top stories on MassDevice in 2020 included the Butterfly Network’s announcement in November that it had entered into a definitive business combination agreement and would go public with Longview Acquisition Corp. Butterfly is developing the Butterfly iQ system, a transducer that uses semiconductor technology to perform whole-body imaging using a single handheld probe. Other notable IPOs included Outset Medical, maker of the all-in-one Tablo hemodialysis system. Outset raised nearly $278 million. Meanwhile, a major acquisition closed in the orthopedics space as Stryker completed its $4.7 billion purchase of Wright Medical,

selling some of its arthroplasty systems to DJO to appease antitrust regulators in the U.S. and UK. Another major medtech M&A deal — Siemens Healthineers’ $16.4 billion acquisition of Varian Medical Systems — is slated to close in the first half of 2021, creating what the companies say will be the most comprehensive cancer care portfolio in the industry. – CN 7. Bayer settles most Essure claims for $1.6B Bayer announced in August that it has settled approximately 90% of the 39,000 U.S. claims involving women alleging injuries related to its Essure device. The settlement could be the final chapter in one of medtech’s worst failures over the past decade, featured in industry critiques including Netflix’s 2018 documentary The Bleeding Edge. Marketed as a permanent birth control device, Essure has not been available for

implantation in the U.S. since December 2019, having had U.S. sales for the device discontinued in December 2018. The Essure agreement was part of a host of legal settlements as corporate leaders decided it was better to resolve legal disputes rather than risk more money contesting them amid the COVID-19 pandemic and resulting recession. Abbott and Edwards Lifesciences agreed in July to settle all outstanding patent disputes related to transcatheter mitral and tricuspid repair products, with Edwards paying Abbott $368 million. Also in July, Medtronic and Tandem Diabetes Care announced that they’d inked a non-exclusive, patent crosslicense agreement related to diabetes treatment tech. The companies said the agreement will allow them to focus on innovation while avoiding the distraction of potential legal disagreements. – CN

MEDTECH IN 2020

The Avail system broadcasts a procedure — conducted by Dr. James Harvey, an interventional cardiologist at WellSpan York Hospital — for educational training. Image courtesy of Avail Medsystems

8. Medtech sales reps go remote Sales reps and surgeons have one of the most central relationships in medtech, not only for promoting new sales but more importantly for ensuring that surgical procedures go smoothly. As surgeries become more complex and sites for surgery more numerous, the demand for medical device sales reps is growing. Yet the limitations imposed by COVID-19 has kept many sales representatives out of hospitals and operating rooms. To maintain or strengthen those ties, many tech companies — including Avail Medsystems, Explorer Surgical and Proximie — stepped up to offer virtual connections between medical sales reps and surgeons in the OR. Chris Landon, SVP and business leader of image-guided therapies at Philips, told the DeviceTalks Weekly podcast that the adoption of new technologies is going to “change the way that we interact with physicians for the better.” The commitment to ﬁnding a permanent solution led Philips in July to acquire Montreal-based company Reacts, which had supplied technology for Philips’ Lumify point-of-care ultrasound solution. The Reacts tech allows for the 66

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PHILIPS’ IMAGE GUIDED LEADER LANDON SHARES GLOBAL GIANT’S PLANS FOR MINIMALLY INVASIVE DEVICES The DeviceTalks Weekly podcast on Oct. 26, 2020 included a visit with Chris Landon, SVP and business leader of image guided therapy devices at Philips, about that company’s plans to build a medtech powerhouse.

In this conversation we’ll learn • Why Landon left Medtronic • Where Philips ﬁts into medtech’s future • How Philips hopes to expand • Will Philips invest directly in startups? • How did Covid-19 impact Philips? www.devicetalks.com/category/podcasts/

remote sharing of the ultrasound stream used during a procedure. “We’ve created our own virtual presence in the cath lab,” Landon said, adding that the stream could connect physicians and reps over long distances. “We certainly see a new type of sales repphysician interface happening.” Dr. Neil Moat, chief medical ofﬁcer www.medicaldesignandoutsourcing.com

and divisional VP of Abbott’s structural heart business, told the podcast he sees a similar transition. Abbott is working with outside companies to provide telemedicine connections for its sales reps. “We’re intimately involved in looking at remote technologies or virtual technologies for training and for supporting procedures,” he said. – TS

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MEDTECH IN 2020

9. CGMs move into hospitals As the COVID-19 pandemic ramped up in March, the FDA issued temporary guidance allowing increased remote monitoring of hospital patients in order to limit contact with hospital staff. The guidance, which included continuous glucose monitors made by companies such as Dexcom and Abbott, appears to have opened up an entirely new market for CGMs. Dexcom CEO Kevin Sayer, in fact, recently told Medical Design & Outsourcing that nearly 250 U.S. hospitals contacted the company amid the pandemic, with more than 100 using the G6 CGM to manage patients’ glucose values so staff can respond to other health issues. – CN

The Dexcom G6 CGM product family Image courtesy of Dexcom

10. Boston Sci throws in the towel on Lotus TAVR The hotly contested space of transcatheter aortic valve replacement (TAVR) lost one of its main competitors in November when Boston Scientific initiated the global, voluntary recall of its Lotus TAVR device and subsequent device retirement. The company is instead focusing on its Acurate neo2 aortic valve system — apparently ceding ground for now to the dominant TAVR space players, Edwards Lifesciences and Medtronic. Boston Scientific’s decision came down to the complexities related to the Lotus delivery system. Considering the additional time and investment needed to develop and reintroduce an enhanced system, the company chose to retire the device and cease all related commercial, clinical, R&D and manufacturing activities. Boston Scientific confirmed that the valve achieved positive and clinically effective performance post-implant, and said that patients currently implanted with the device do not have any safety issues to be concerned about. The company’s decision had wideranging implications, though, as layoffs in Minnesota were followed by further position eliminations in Ireland, all related to the retiring of Lotus. “We’re clearly disappointed by the news, but we make difficult choices in our portfolio to maximize shareholder value,” Boston Scientific chairman & CEO Mike Mahoney said at the Evercore ISI 2020 HealthCONx Conference. “We wanted to be very objective about our current position with Lotus and more importantly what we saw as the future of the next two to three years. “Essentially, the cost to invest to further advance the Lotus device and its delivery system, plus the timeline to do that and make it more of a workhorse valve, wasn’t feasible compared to other options we had.” – SW DeviceTalks editorial director Tom Salemi, managing editor Nancy Crotti and associate editor Sean Whooley contributed to this report.

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Boston Sci has turned its focus to its Acurate neo2 aortic valve system, shown here.

Image courtesy of Boston Scientiﬁc

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How ResMed is advancing sleep and respiratory care S E A N W H O O LEY A S S O C IATE ED ITO R

ResMed has been at the forefront of connectivity and remote care in the sleep and respiratory space for years and now hopes to build on that with advances in digital health.

he COVID-19 pandemic’s propulsion of widespread telehealth adoption has ResMed eyeing remote technologies for the next phase of its sleep and respiratory businesses. The president of that business for the San Diego– based company, Jim Hollingshead, told Medical Design & Outsourcing in a recent interview that the future lies with remote care and digital health offerings. “Right before the crisis, we got up to a point where home sleep testing was done at about 40% of the time,” Hollingshead said. “Right now, I think it’s more like 50/50 because of the way sleep labs are using home testing instead of bringing people in.” ResMed’s remote diagnostic technology includes mail-order delivery of an elastic belt that wraps around the user’s chest and connects to a pulse oximeter and a cannular tube that goes over the ears and sticks on the nose. The home sleep test looks for oxygen saturation while the belt measures chest movement as the user breathes. If the belt is moving and there’s no airﬂow while blood oxygen levels drop, the subject is having an apnea event and a sleep doctor will look at the results to determine if the user has sleep apnea and needs a CPAP.

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Image courtesy of ResMed

SLEEP AND RESPIRATORY CARE

Instead of having patients sleep in a strange bed with wires hooked up everywhere and a technician watching, creating an unnatural sleeping situation, ResMed is leaning toward at-home testing. “We think it’s a better patient experience,” Hollingshead said. “We’ve been pushing for many years for this testing to be the norm.” ResMed has been at the forefront of connectivity and remote care in the sleep and respiratory space for years and now hopes to build on that with advances in digital health. Beyond diagnostics, ResMed’s AirSense 10 system includes a cell chip to connect to devices in the cloud and monitor a patient’s adherence to therapy. It’s quite an advance from the previous method of phone calls to check up on the patient’s usage, according to Hollingshead. ResMed offers remote ﬁtting routines for CPAP masks and operates provider apps that have remote management

Image courtesy of ResMed

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capabilities and 2.5 million users. These technologies give the company confidence about using data, machine learning and artificial intelligence in a post-pandemic market. “We’re really focused on the patient experience,” Hollingshead said. “Our industry was already headed there. Our offerings were already headed there, but we’re going to drive harder and faster on those things. “That’s the trend we’re going to continue to try and pioneer in our space. … COVID created so much disruption in healthcare, but there’s an opportunity here for us to continue to use digital tools to get patients more access to good care.” Coping with COVID-19 Ahead of this effort to change the sleep and respiratory space, in what seemed like the blink of an eye, ResMed went from treating sleep apnea to treating COVID-19. When the coronavirus pandemic took hold in the spring, ResMed joined the fight against the virus, pivoting much of its business toward ventilator production. Hollingshead said that the “mad scramble” resulted in many extra shifts for employees and a lot of work, but also an impressive outcome. “I think we ended up increasing ventilation production by 3.5 times during that span,” he said. “As we made thousands and thousands of vents, we were able to service a lot of demand. … During that early crisis period of March, April, May, it was a huge pivot for everybody, and I was proud of what we were able to accomplish.” In April, AdvaMed promoted clinical evidence that it said revealed the benefits of non-invasive ventilators, like ResMed’s CPAP machines, for use in less severe cases of COVID-19-related respiratory issues. Shortly after, the company received a U.S. government contract worth nearly $32 million to produce 2,550 ventilators. Demand for ventilators shot up, with ResMed’s earnings in its third and fourth quarters reflecting sales growth of 16.2% and 9.3%, respectively. With the pivot to ventilation came plenty of adjustments, though. Hollingshead cited supply chain as the biggest obstacle, with component suppliers in China forced to shut down and air and sea freight limited, too. 74

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Looking ahead Now, with the ventilator demand returning to baseline and some underlying operating expenses coming in higher than usual, the company has work to do. “There’s a constrained supply,” Hollingshead said. “That means there’s a little bit of disruption in domestic shipping in the U.S., so in some instances, that’s been slower for us and the cost of that is up. We’re still wrestling through that.”

Given how the company responded to the pandemic’s initial wave, Hollingshead believes ResMed has proven that it can adapt to whatever situation comes next. “I was really proud of what we were able to accomplish in terms of getting those products built and getting them out,” he said. “Thousands of patients ended up on ResMed ventilators, which was terriﬁc for us to feel like we had the ability to help in a crisis.” Image courtesy of ResMed

Hollingshead foresees steady growth in new patient demand over the next two or three quarters, although the unpredictability of the virus could throw a wrench in that. An analysis shared with MDO by William Blair’s Margaret Kaczor highlights expectations for acceleration in sleep revenues in 2021, creating a “more durable trend” down the line as ResMed introduces more diagnostic options. Kaczor also noted that ResMed’s digital health investments aren’t being valued today but should drive growth and represent opportunities for innovation in untapped spaces. Kaczor said the analysts believe ResMed has a long runway in sleep, COPD and out-of-hospital healthcare information technology, while smaller business moves that have the potential for signiﬁcant gains are cause for optimism. William Blair projects consistent double-digit, top-line growth, rating ResMed’s stock as “outperform.” www.medicaldesignandoutsourcing.com

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Dexcom chairman, president & CEO Kevin Sayer believes the company is well-placed to continue its growth in a post-pandemic world.

LEADING THE COMPANY FORWARD

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The past year threw the same hurdles in the way of Dexcom that it did every other major company. CEO Kevin Sayer told us how it responded.

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ike most companies in 2020, diabetes tech giant Dexcom faced a number of challenges brought on by COVID-19, public unrest and more. Dexcom chairman, president & CEO Kevin Sayer had to prioritize the health of his employees over all else, while also keeping patients safe and somehow managing to keep the company rolling as a business. “Anybody who says they’re prepared for something like this, they’re better than me,” Sayer told Medical Design & Outsourcing. “I think we’re just learning as we go.” As the majority of businesses around the country did, Dexcom sent as many employees home as possible to keep them safe. For those who still had to work in-person, the San Diego-based company devised safer ways to do so. www.medicaldesignandoutsourcing.com

While many across the world sought to cut costs and save money, the insulin-delivery technology developer went in the opposite direction, increasing compensation over an extended period of time to make sure employees who had to make, for example, daycare payments so they could come into work, had additional funds for that. “People who choose to work at Dexcom are some of the most creative people in the universe. They figured out ways to get their jobs done,” Sayer said. “We have to take care of our people if we’re going to ask our people to do extraordinary things. We need to compensate them for that and we did. We asked them to come in and not miss a beat on the manufacturing side because our patients can’t live without this product.”

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The focus on making sure employees were taken care of was followed by a turn to keeping Dexcom’s patients safe during the pandemic. The company shifted some strategies as Sayer saw telehealth coming to the fore — and he doesn’t see it going away. Remote physician visits will remain a part of Dexcom’s plan, while Sayer intends to develop tools to grow that aspect of the business. The pandemic also enabled Dexcom to help some patients it normally wouldn’t have access to. Because COVID-19 can severely affect those with diabetes, the FDA did not object to hospitals using Dexcom’s G6 continuous glucose monitoring system, which is indicated for at-home use. Sayer said nearly 250 U.S. hospitals contacted Dexcom, with more than 100 using the G6 CGM to manage patients’ glucose values so staff can respond to other health issues.

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Seeking to serve everyone According to the American Diabetes Association’s most recent data, in 2018, 34.2 million Americans, or 10.5% of the population, had diabetes. The percentage of Americans age 65 and older with diabetes— seen as the highest-risk population for COVID-19 — remains high, at 26.8%, or 14.3 million seniors (diagnosed and undiagnosed). Underserved communities and ethnic minorities (Black and Hispanic, predominantly) have also been hit hard by the pandemic, and the diabetes numbers are unfavorable for those groups as well. The rates of diagnosed diabetes in adults are 12.5% in Hispanics and 11.7% in nonHispanic Black people. 78

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KEVIN SAYER

The Dexcom G6, as shown worn on the abdomen, is water-resistant in a slim and easy-to-wear form for those with diabetes who are monitoring glucose levels. Image courtesy of Dexcom

The volume of at-risk populations across the board whose diabetes makes them more vulnerable to the virus only puts further pressure on Dexcom to do all it can to keep its patients safe, according to Sayer. “We’ll just keep chugging along,” he said. “One of my own credos is, ‘You don’t ever ask anybody to do what you won’t do.’ And I think my leadership team has just been great at this as far as being engaged on calls day and night, as available as we can possibly be, and we’ll continue to do stuff.” While working to protect employees and patients alike, Dexcom also had to react to the growing unrest across the globe following the police killing of George Floyd in Minneapolis in May. “When, when this all started, the ﬁrst thing I did was picked up the phone and called some friends, board members and other people at Dexcom saying, ‘OK, what am I missing here?’ Sayer said. “Because I need to understand this and have a better perspective. I think we can all learn and have better perspectives.” Sayer said a company the size of Dexcom — with 3,900 full-time employees listed on its annual report at the end of 2019 and continuing to grow — means it has added responsibility for social issues like the ones raised by Floyd’s death. The company has what

Sayer calls a “high-powered” diversity and inclusion council and several employee resource groups that meet regularly to determine how Dexcom can improve its diversity and inclusion efforts. Sayer added that he is always open to suggestions on how he and Dexcom can continue to improve. “What could come out of this on our side is more individual development and more thought going into hiring,” Sayer said. “As we’re in remote locations around the U.S., let’s make sure that we reﬂect the population we’re serving. … We’re getting better and we’re going to be better.” Continuing to grow And while Dexcom puts its energy into handling the effects of the COVID-19 pandemic and the civil unrest resulting from Floyd’s killing, the business is doing as Sayer hoped it would — chugging along. The company began the year with revenue guidance of approximately $1.7 billion, having ﬁnished 2019 with sales of nearly $1.5 billion. At its investor day on Dec. 9, Sayer announced that Dexcom’s guidance for 2020 is now $1.9 billion. At the start of 2018, Dexcom projected revenues of $2.3 billion by 2023, and as 2020 came to a close, the company was just $400 million away from that with time on its side. “We can’t ask for much more www.medicaldesignandoutsourcing.com

than that,” Sayer said of the revenues. William Blair analyst Margaret Kaczor listed Dexcom as one of her firm’s “bestsounding names” coming out of Q3 2020 and highlighted potential growth of 20% or more through 2022. “We expect share momentum can be supported by near- and long-term commercial and product catalysts as well as an increasingly profitable business model,” Kaczor’s analysis said. “Further, while still early, we expect Dexcom will continue to execute on expensing its [total available market] into new opportunities such as hospital use and gestational diabetes, which could support durable long-term growth.” Sayer joined Dexcom as president and COO in 2011, having previously served as CFO of Biosensors International and before that, as CFO of MiniMed from 1994 until its acquisition by Medtronic in 2001. He holds master’s and bachelor’s degrees in accounting and information systems from Brigham Young University. He remains confident that Dexcom is growing, not only in its efforts to create a safe and healthy environment but in its plans to move forward with its insulin- and CGM-monitoring technologies. Bumps in the road are inevitable, but the executive only sees success ahead. “The company’s never been in a better place,” Sayer said. “Where we’ll have hiccups due to COVID like everybody else [in 2021] — I probably don’t know what they are, but we have a great group and we know our mission. We will manage through it and we’ll always be upfront with everybody about where we are.” The Dexcom G7, yet to be released, is the latest version of the company's CGM technology and is being developed as a sleeker, more effective model. Image courtesy of Dexcom

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he National Society of Black Engineers (NSBE) is a U.S.-based, student-governed organization founded in 1975 to promote engineering and technology among Black collegiate and pre-collegiate students — as well as technical professionals. Mechanical engineering is the most common major of its members, followed by computer sciences, electrical engineering, chemical engineering, computer engineering and civil engineering. NSBE has more than 790 chapters and over 20,000 active members in the U.S. Its Healthcare Innovation Special Interest Group (HISIG) has over 3,300 members across all healthcare sectors, with 300 members in the medical device www.medicaldesignandoutsourcing.com

industry. Theodore Nicholson, treasurer and board member of the NSBE healthcare group, is manager of research technology development at the Marcus Autism Center of Children’s Healthcare of Atlanta. He specializes in medical device diagnostics that use cloud-based architecture and is a strong proponent of STEM education and inclusivity initiatives for underrepresented individuals. He has more than 10 years of experience, postPh.D., in chemistry, chemical polymers, software development, medical device development and biomedical engineering for commercial applications. Nicholson recently told Medical Design & Outsourcing how NSBE intends to expand its inﬂuence in medtech. 1 • 2021

Medical Design & Outsourcing

NATIONAL SOCIETY OF BLACK ENGINEERS

MDO: What opportunities is NSBE looking for in the medical device industry? Theodore Nicholson: NSBE, through its Healthcare Innovation Special Interest Group (HISIG), is looking for industry, academic and government partners who are working to eliminate healthcare disparities and close gaps in care delivery to Black communities. We seek to collaborate on programs that increase technology development and improve outcomes. We welcome partners who want to co-create innovation ecosystems within healthcare hubs to engage with the Black community directly. NSBE is seeking organizations that are ready to initiate or continue to foster change in creating more equitable, diverse and inclusive environments. These organizations should seek to improve technology, train future engineers and broaden their available opportunities.

MDO: How can the medical device industry begin to diversify its leadership? Nicholson: The medical device industry should identify gaps within its leadership. Which skills is it looking for in the individuals in those roles? After determining those needs, ﬁll them by seeking candidates from areas that have larger groups of diverse engineering leaders. This can be done by partnering with professional associations, working with historically Black colleges and universities (HBCUs) and going directly to communities that are typically underrepresented. To NSBE’s HISIG, the solution is straightforward, but unless the industry expands and shifts to think beyond what has been done in the past, change will be slow and arduous. It is up to the medical device industry to prioritize inclusion and diversity within its leadership, to add board members from

underrepresented communities and to stay engaged with capital investment in the battle against systemic racism. MDO: What kinds of things are you doing to promote diversity and what are your plans for the future? Nicholson: NSBE was founded in 1975 by six African American engineering undergraduates and their faculty advisor at Purdue University, who saw the need for a national organization to address the low retention rate of Black engineering students across the country. Now an international organization, NSBE, in the U.S., remains committed to increasing engineering diversity, strengthening Black communities and expanding economic prosperity by ending the underrepresentation of Blacks/ African Americans in our ﬁeld. NSBE’s main 10-year strategic goal is to lead the U.S. to produce 10,000 new Black engineers annually by 2025, up from only 3,501 in

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NATIONAL SOCIETY OF BLACK ENGINEERS

2014. Our programs and events are aligned with this goal. They target students and professionals of all ages to boost their interest, proﬁciency and expertise in STEM to enhance their academic excellence, professional success and positive impact on the community. NSBE’s work has contributed to the recent upward trend in engineering education of African Americans. More than 5,600 Black students obtained bachelor’s degrees in engineering last year. A sample of current NSBE programs and initiatives follows:

school students from groups underrepresented in STEM; a free, three-week program, SEEK provides students in grades 3–5 with handson, team-based engineering design activities led by engineering role models, many of whom are collegiate members of NSBE. • NSBE Special Interest Groups (SIGs) — Signature programs presented by the NSBE Professionals organization to promote technical excellence among graduate student and technical professional members. SIGs provide a platform for members to explore and discuss particular areas of focus and interest: aerospace, energy, entrepreneurship, environmental engineering, healthcare innovation, information technology, intellectual property, process improvement, public policy, transportation, and women in science and engineering.

• Integrated Pipeline Programs (IPPs) — Initiatives developed with NSBE organizational partners to significantly increase the number of Black students who are qualified and available to fill technical positions. IPPs increase STEM awareness, access, engagement and inclusion through internships, scholarships, mentoring and professional development seminars; provide grants to universities to scaleup successful academic support programs; engage with and support pre-collegiate students to encourage their interest in engineering careers; and support technical professional programming for NSBE professionals. • NSBE Student Retention Program — An umbrella covering three different programs designed to support NSBE undergraduates: skill development workshops, study halls and academic mentorship. The program, based on proven educational research, is designed to increase the number of Black students who remain in STEM majors for their sophomore year and go on to earn their degrees. • NSBE Jr. — A program that gives students in grades 3 through 12 the opportunity to join one of more than 270 chapters in the U.S. and abroad; bond, learn and compete with their peers; and experience programming designed to help them discover firsthand the excitement of STEM and how engineering and technology relate to the world around them. • NSBE Summer Engineering Experience for Kids (SEEK) — The nation’s largest summer engineering program geared toward African American and other elementary www.medicaldesignandoutsourcing.com

1 • 2021

Medical Design & Outsourcing

CoraVie Medical founder Aimee Garza Image courtesy of CoraVie Medical

Taking the guesswork out of tracking high blood pressure Startup CoraVie Medical aims to give patients and their physicians better control over hypertension with a tiny implantable device.

imee Garza wants to do for high blood pressure what continuous glucose monitors are doing for diabetes. The veteran medtech engineer and marketing maven brings 25 years of experience at two of medtech’s biggest companies — Medtronic and Integer — to a problem she’s wanted to solve for years: the suffering caused by cardiovascular disease. High blood pressure, or hypertension, increases the risk of heart attack and stroke, the leading causes of death in the United States, according to the Centers for Disease Control and Prevention. But relying on a once-a-year blood pressure measurement in a doctor’s ofﬁce is not enough to track what is known as the silent killer. Even periodic measurements taken at home are just that — periodic. Garza’s idea is to create an implantable, continuous blood pressure monitor equipped

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with sensors and wireless communication capability to notify physicians of abnormal readings. The doctor could then summon the patient for a visit or adjust medication and then monitor the patient’s progress on the new med. “Our device is prescribed by a physician for a clinical need, and then it is inserted under the skin in the upper arm,” Garza said. “This should not be any more difficult than getting a flu shot at your doctor's office.” Garza’s journey Garza started at Medtronic as an electrical engineer and spent many years in cardiac rhythm technical sales. She went back to school, earned an MBA and started working in marketing business strategy, working closely with scientists and researchers. Before leaving Medtronic after 20 years, Garza had become senior manager of strategy and planning for the connected care and diagnostics monitoring group. www.medicaldesignandoutsourcing.com

1 • 2021

Medical Design & Outsourcing

CORAVIE MEDICAL

At Integer, she led marketing for cardiac rhythm and neuromodulation devices, rebuilding relationships with customers after Greatbatch’s 2015 acquisition of Lake Region Medical. The companies rebranded as Integer the following year. Garza left Integer in early 2020 and launched CoraVie Medical in Edina, Minn., in April, pursuing an entrepreneurial goal and a desire to be closer to patients. The decision to leave Integer was not an easy one, Garza told Medical Design & Outsourcing in an interview. She deeply values the leadership of Integer CEO Joe Dziedzic. “I saw an unmet need and an opportunity to address it,” she explained, “and at the same time, tackle the spiraling costs of healthcare.” Garza described going from billion-dollar companies to being a first-time founder as simultaneously

empowering and scary. “I’ve grown 200+% since founding CoraVie Medical and have more conviction, conﬁdence and determination to lead CoraVie Medical to achieve its goals,” she said. “Each month brings new successes that move us forward to our ultimate goal — improving the health outcomes of people with high blood pressure.”

testing will kick off in the ﬁrst quarter of 2021 at the University of Minnesota, she added. Garza has recruited business partners from the clinical and business sides of medtech. “I've been very fortunate to recruit an amazing group of

I've grown 200+% since founding CoraVie Medical and have more conviction, confidence and determination to lead CoraVie Medical to achieve its goals.

The technology The CoraVie device under development is smaller than a dime and designed to be implanted alongside the brachial artery, Garza said. The sensor technology was developed through a collaboration with the University of California at Berkeley and is undergoing bench tests that are looking very promising, according to Garza. Preclinical

teammates and advisors around me that bring years of expertise and leadership,” she said. “They've really helped push me, push CoraVie Medical, forward. They ﬁll in my gaps, they

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advocate for me and CoraVie Medical and ultimately ensure that we're successful.” That team includes retired Integer COO/CFO Jeremy Friedman, now CoraVie CFO, with whom Garza worked for about five years. When she contacted him about her new business idea, Friedman thought it was great — a unique device that would fill a significant market need. “I have a lot of confidence in Aimee,” Friedman said. “She’s an incredibly hard worker. She is very capable. She has a good mix of engineering background and skill and knowledge along with a real understanding of the medical device world per her experience at Integer and Medtronic. We’re just perfectly aligned with starting up this kind of business.” Garza is also developing her product at a perfect time, Friedman added. “There’s been a lot of advances over the years in miniaturization and the ability to do something like this,” he said. “There’s always been a desire for some kind of continuous blood pressure monitor, but I don’t think it was so easy to do before. We’re leveraging a concept that has been around for decades but hasn’t been applicable in this way until recently.” The clinical team An advisor with ties to Medtronic is Dr. Michael A. Weber, a professor of medicine at State University of New York Downstate College of Medicine in Brooklyn and former editor-in-chief of the Journal of Clinical Hypertension. Weber’s career has focused largely on hypertension and preventive cardiology, including the development of ambulatory blood pressure monitoring. “Aimee is very structured and wellorganized, and seemingly a very good engineer and a very good designer,” Weber said. “I was impressed right from the beginning that this wasn’t some wild idea that needed some genius to make it work. In Aimee, we already had a topnotch researcher to make it work.” Physicians have come to understand that the most important blood pressure measurements take place outside their offices, including overnight when patients are asleep, Weber said. And while several companies make ambulatory blood pressure monitors, their ability to deliver reliable data depends on a few important 90

Medical Design & Outsourcing

1 • 2021

factors, such as patients’ daytime activity levels. Also, Weber added, there are several home blood pressure monitors available on the market, but many patients grow bored with the task of measuring their blood pressure carefully, so their technique slacks off and the measurements suffer. “The device that CoraVie has gets around all of these problems because it’s working 24 hours a day to provde accurate readings during time periods of interest to the patients’ medical advisors,” Weber said. Like other connected medical implants, CoraVie’s device would generate reams of data, which could overwhelm healthcare providers if not managed and analyzed properly. Company ofﬁcials have plans to include experienced medical advisors to determine the best way to inform and present not reams of data, but actionable insights. “The sheer volume of readings and the ability to analyze them through a computer system would probably give the most robust possible interpretations,” Weber said. In addition to measuring blood pressure, the device might also be able to signal arterial stiffness and endothelial function, or the workings of the lining of the artery’s inner wall, another measure of cardiovascular health, Weber added. Filling a need A third advisor has recently retired from Medtronic. Dr. Marshall Stanton, a former Mayo Clinic cardiologist, spent 21 years at the medtech giant, working in cardiac rhythm management, remote disease management, clinical research and implantable deﬁbrillators. When he left, Stanton was SVP and president of the pain therapies business. Stanton said he believes CoraVie’s technology is “very much needed,” given that one-third of Americans have high blood pressure, but most don’t appreciate www.medicaldesignandoutsourcing.com

the health implications. The device may have a built-in target market, though. “Somebody who has had a stroke is highly motivated to not have another stroke, particularly people who have not had a devastating stroke. They’ve been scared — appropriately so — by what has happened,” Stanton said. “You do everything you can to prevent having a recurrence.” Garza and her partners have set a goal of 2023 for ﬁrst-in-human use. They have raised about $800,000 in seed money from angel investors and are on target to meet initial investment goals. CoraVie Medical is also pursuing non-dilutive funding from the National Institutes of Health and will seek further funding from angel investors and from venture capital ﬁrms interested in earlystage companies, according to Friedman. CoraVie will also consider strategic alliances with other manufacturers and hospitals that have R&D capabilities. “I think that we’ve gotten good traction quickly,” Friedman said. “There’s a lot of medical device companies that start and disappear… but this certainly has the ability to be very successful.” Added Stanton: “If anyone can pull this off, she can.”

The CoraVie Medical device is designed for implantation in the upper arm to continuously measure blood pressure. Image courtesy of CoraVie Medical

DEVICETALKS Medtronic CEO Geoff Martha Image courtesy of Medtronic

Medtronic CEO Geoff Martha explains the importance of competition

To m S a l e m i | D e v i c e Ta l k s E d i t o r i a l Director |

A major reorganization will position the world’s large medtech company for higher growth. But employees will be asked to hold on tighter to market share to help drive innovation.

MEDTRONIC CEO MARTHA EXPLAINS THE WHY OF COMPETING, THE REORG, AND THE IMPORTANCE OF INSTITUTIONS

devicetalks.com/ category/podcasts/

In the Dec. 3, 2020 episode of the DeviceTalks Weekly Podcast, Medtronic CEO Geoff Martha brought us on the inside of Medtronic’s ongoing reorganization. Martha explains how the new company will be structured to work with outside vendors. He also explains why the company’s push to instill more competitive juice is aligned with its overarching mission of innovation.

Medical Design & Outsourcing

1 • 2021

hether they’re running a startup or the largest medical device company in the world, CEOs must be competitive. Their job requires a desire to win that’s strong enough to lift and inspire an entire organization. New Medtronic CEO Geoff Martha has put his competitive ﬁre more front-and-center than most other CEOs after taking over the reins from his friend and mentor Omar Ishrak — who joined as CEO in 2011, the same year he convinced Martha to join him. Martha may have been with Medtronic for nearly a decade, but he came to the corner ofﬁce in April 2020 with an outsider’s zeal. In a bid to accelerate growth, Medtronic is splitting into 20 operating units. Kaila Krum, managing director at Truist Securities, said that the arrangement — if executed correctly — could motivate leaders of those 20 new units. “It pushes those business leaders to really look and understand the markets they go after,” she said. But Martha is also asking Medtronic employees to move forward with a new competitive spirit. In an interview with the DeviceTalks Weekly podcast, Martha said he’s seeking to create a culture that is “ultra-competitive outside the company, but in an appropriate way because [medtech companies are] all in healthcare together, and then inside the company, a little bit of a friendly competition.” The following is a transcript from the interview. It’s been edited for clarity.

www.medicaldesignandoutsourcing.com

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DEVICETALKS

DTW: Why is competition important to you? GM: Well, the first point I want to explain is the `why’ behind the competitiveness. Why is it important for Medtronic? We’re a mission-driven company. We talk about putting patients first. We talk about creating new healthcare markets. The `why’ is important because the markets that we play in have gotten so much more competitive over the years. If we want to carry out our mission, which is to create these new, wonderful therapies and globalize them, once we do that, we’ve got to be able to hold onto our share. DTW: What does market share have to do with innovation? GM: We create these new markets and historically, we’ve let competition come in behind us and take big chunks of the new markets too quickly. If that happens, we don’t get the full financial return for our shareholders and we don’t get the capital we need to keep funding innovation. That market share is a source of fuel. It fuels our invention and market development, which is really the mission-driven nature of Medtronic. You have to make that connection. It’s superimportant because this innovation doesn’t come free, right? Clinical innovation, technical innovation is very expensive. So we have to do a better job at holding onto this share.

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Medical Design & Outsourcing

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DTW: Salespeople can easily measure success, but how can other employees — say, engineers or clinical trial managers —show their competitiveness? GM: This is not just about sales. This is about everybody in the company. You mentioned engineers. The best way to hold onto your market share is to innovate, right? Let me give you an example. In the cardiac rhythm space, we have Link. It’s inserted just below the skin and it monitors cardiac arrhythmias, and it monitors atrial fibrillations that could cause stroke. Our new Link2 device has a four-and-a-half-year battery life with lowenergy Bluetooth. This means we see all this data in the cloud and can do all kinds of analytics. We created this market and it’s been wonderful for patients and wonderful for us. It’s a $700 million, $800 million business for us. Now Abbott and Boston Scientific came into the market. Despite that, we have held onto over 80% share because we are constantly innovating. We are on our fourth-generation device while they’re coming out with their first-generation device. It doesn’t effectively compete. DTW: How does this compare to the past? GM: In businesses that I took over that wasn’t the case. New competition came in and our 100% share position went down to like, 30%. People would think, `Well, there’s three of us. Let’s split it – one, two, three.” Well, no. That’s not the way it’s supposed to work. We’ve got to hold onto that share. That economics is what’s funding other parts of our business. Things like renal denervation, that’ll be one of the biggest things to happen in public health in a long time. Things like the soft-tissue robot, they cost money. These other businesses need to be more competitive to hold onto their share to help fund the fuel for our mission. DTW: You’re splitting Medtronic into 20 semiindependent operating units. Do you want them to compete with each other? GM: Not really, no. We talk about that internally. One question being asked was, `Well, can you still be competitive and be mission-driven?’ I went through that whole explanation that I just gave you and the answer is, ‘Yes’ and ‘Yes.’ And then someone asks, Ìs this going to drive internal competition?’ I talked about this with our leadership team, our top 200 leaders just last week, and I’m okay with a little friendly competition inside the company. We don’t have overlapping markets where we’re competing. We don’t want to be competing in front of the customer, but I think it’s okay for businesses within Medtronic to strive to be the highergrowth businesses or the business that produces the most cashflow. We need the whole package to work together. DTW: What does a healthy balance look like? GM: We have some businesses that are like rocket ships that are growing really fast and generate less cash, and we have others that are mid- to single-digit growth that are throwing off much more cash that we can reinvest in innovation and M&A. Everybody has their role. Internally, we have our Peak Performance Awards that businesses can win for growth or new product launches. That kind of friendly competition is good, but what I really hope to see is everyone sharing best practices and sharing technology platforms that will make Medtronic better.

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ISO 9001:2015 | AS9100D ITAR Compliant - DDTC Registered DFARS Compliant NIST SP 800-171 Compliant

We deliver precision gears, high-quality machined parts, and molded components for thousands of applications. • Prototype • High-Volume Production • Custom Design • Engineering Support • Precision Manufacturing • Assembly

CNC Swiss Turning l CNC Milling & Turning l Gear Cutting | Bevel Gear Cutting Rapid Tooth Cutting Only Capability As an online engineering resource, SDP/SI provides: Engineered Mechanical Solutions Design Tools and Calculations Product Specifications 3D CAD Models

Shop with us 24 / 7 87,000 Component Choices Gears, Timing Belts, Pulleys, Couplings, and More

DIAGNOSTIC EQUIPMENT

We look forward to working with you! Send an RFQ – we can quote from a 3D model or drawing

SURGICAL EQUIPMENT

MEDICAL ROBOTICS

250 Duffy Avenue, Hicksville NY

www.sdp-si.com • (516) 328-3300

PRODUCT WORLD

Covestro tests plastics against high-strength hospital disinfectants Covestro recently teamed with disinfectant manufacturer Metrex to test five different Covestro polycarbonate materials against three of Metrex’s products, which are widely used throughout the healthcare industry. As is customary for rapidly assessing the compatibility of plastics to disinfectants, test specimens were prestrained and underwent several wipe-and-dry cycles with Metrex disinfectants to simulate actual usage. They were then evaluated by how well they retained their tensile strength, according to a news release. Covestro materials developed to withstand the use of strong disinfectants performed well and retained their tensile properties in testing, the company said. Makrolon M6011 FR polycarbonate, Makroblend M4000 FR and Makroblend M5005 FR (both PC+PBT blends) are all flame-retardant

Image courtesy of Covestro

housing materials with skin-contact biocompatibility. Makrolon M6011 FR polycarbonate and Makroblend M5005 FR PC+PBT will launch in 2021 and are now available for sampling, according to Pittsburghbased Covestro. – NC

Traco Power expands power supply line for portable medical equipment Traco Power announced that it has expanded its TPP 450 high-density 3×5 power supply series. The series now offers Protection Class II models (TPP 450BA-M Open-Frame Models and TPP 450B-M Enclosed with Fan Models), designed for non-stationary requirements where connection to ground is not possible. Key approvals on the original series remain on the expanded class II versions, including medical IEC/ EN/ES 60601-1 and industrial IEC/EN/UL 62368-1 safety approval. Features for the medical market include a double, reinforced 4000 VAC I/O isolation system with low leakage current (<100µA) for a 2 x MOPP rating and BF compliance. High efficiency up to 94% supports a convection-cooled operation up to 320W at +50°C and 450W operation at +65°C with 20cfm airflow. – NC

Image courtesy of Traco Power

Medical Design & Outsourcing

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BETTER PARTS | BETTER PROCESS Additive Manufacturing Experts

FAST DELIVERY Turn 6-8 week lead times into days

REMOVE RISK

QUALITY DRIVEN

Just-in-time manufacturing

Manufacturing parts to a blueprint everytime

MANUFACTURING TO BLUEPRINT

Connect today for a free analysis of your parts and learn more about how we can be

your partner in manufacturing innovation. Better match materials for your design and come out ahead in delivery times and overall quality improvement.

Specializing in manufacturing complex functional parts that demand a quality-driven process.

www.azoth3d.com Manufacturing On-Demand

PRODUCT WORLD

Sharp Fluidics launches port site closure device Sharp Fluidics has launched the NeoClose AnchorGuard, designed to enable clinicians to close laparoscopic and robotic port sites without insuﬄation. This is the ﬁrst port site technology that can be used with any brand trocar that meets the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) recommended guidelines for safe closure of laparoscopic and robotic port sites, according to the company. NeoClose uses bio-absorbable anchors with a pre-attached suture. It is designed to work faster and safer and to provide less port-site pain than the standard practice of closing port sites. – NC Image courtesy of Sharp Fluidics

Forefront Medical debuts nasal swab globally

Image courtesy of Forefront Medical

Contract manufacturer Forefront Medical Technology announced the global launch of a uniquely designed nasopharyngeal COVID-19 test swab. The EzySwab was originally developed to support the need for COVID-19 test swabs in Forefront Medical’s home country of Singapore. “We worked with a team at the National University of Singapore to develop and manufacture a product that addressed a critical testing need in Singapore. We are now tooled at suﬃcient volume to support needs around the world,” said company president Walter Tarca in a news release. – NC

Medical Design & Outsourcing

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Interpower® North American & International Hospital-Grade Cords With 1-Week U.S. manufacturing Lead-Times on non-stock Interpower products, and Same Day Shipping on in-stock products, reliable power is readily available to critical medical facility patients, families and staff. Whether a city hospital or a country clinic, Interpower manufactures hospital-grade power cords and cord sets to hospital-grade specifications and ships them on time! When designing, building, and maintaining hospital-grade products to be used worldwide, it is important to know the medical

requirements of the country of export. In addition, select hospitals have proprietary requirements. Special consideration is needed for products used in Australia, Canada, Denmark, Japan, and the United States. Questions? Interpower offers free customer support to both novice and expert to help you find exactly what you need.

• Quantity price breaks available with blanket or scheduled orders • No minimum order or dollar requirements • Value-added options, e.g., colors, lengths, packaging and labeling

Order Online! www.interpower.com Business Hours: 7 a.m.–6 p.m. Central Time

L E A D E R S H I P

I N

M E D I CA L T E C H N O LO GY

Nominate the company you think has provided leadership in the medical technology industry.

The medical device industry successfully weathered a tumultuous year as it provided life-saving technologies against COVID-19. This level of success wouldn’t be possible without the innovation, ingenuity and determination of the people who drive it: leaders. These individuals and companies are working for the growth of the entire medical device industry. The future of medtech will build on the foundation of today’s efforts. Medical Design & Outsourcing would like to acknowledge such achievements on the following pages. We think they deserve recognition from you, too. Vote online for one or more of the companies listed through October.

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QUALITY, EXPERTISE AND INNOVATION As the largest electropolishing specialist in the United States, Able Electropolishing has spent six decades at the forefront of innovation in metal improvement technologies, including passivation, laser marking and contract cleaning. In close collaboration with clients in the aerospace, medical, laboratory, pharmaceutical and food processing industries - among others - Able has developed highly

Prototyping Collaboration Puts Finishing Expertise to Work at the Start

customized processes that produce the most precise, consistent and reliable results for a wide array of critical metal parts, with beneﬁts

The Able Difference

And while we play a vital role as the “last step” in the process for many critical metal parts, we also use our metal finishing expertise to improve parts from the start by consulting in the design and prototyping stage. Our “Finish First” methodology helps clients avoid design flaws that can trap debris and liquids and impede the ability to create the highest quality surface finish.

that include: • Deburring • Ultracleaning • Resistance to Bacterial Growth • Microﬁnishing • Fatigue Life Improvement

We’ve earned the trust of engineers and manufacturers in some of the most challenging industries in the world. That takes more than innovation and state-of-theart processes. It also means an attention to deadlines, efﬁciency, reliability and a tradition of continuous improvement. Our clients depend on us for jobs with no room for error. You can too.

• Improved Corrosion Resistance

Commitment to Our Customers

Our commitment to our clients’ success drives our work toward continuous innovation, down to the customization of our processes for each part, including on-site tooling, custom racking, custom chemical formulation and prototyping runs conducted on full production equipment. We treat every single job as the critically important step that it is and our roster of clients worldwide shows the level of trust that we have earned over six decades of providing state-of-the-art solutions and unmatched customer service.

www.ableelectropolishing.com

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Accumold began in a rented garage in 1985. Our primary focus was and still is on very small micro-sized plastic parts and components that other companies can’t produce. The original Micro-Molder® was designed to help manufacture parts with minimal waste and short cycle times for electronic component manufacturing. Although there have been many innovations

Micro-Mold®

These minute parts are often measured in microns and are no bigger than 0.5 cubic inches; they typically weigh less than a gram. In addition to their size, these parts have very tight tolerances and must be molded efﬁciently and precisely — time and time again. Accumold builds specialized molding machines for this unique capability. The machines are engineered to handle volumes from prototypes to millions per year while maintaining consistent, precise tolerances that are unique in the industry. The specialized tooling and molding for micro-sized components are only available at Accumold.

over the years the basic principals have remained the same and so has our commitment to micro-injection molding technologies. Today the company now focuses on industries that require fast turn around and complex parts for high tech industries such as Micro Electronics, Micro Optics, and Medical, as well as new emerging markets and technologies.

Small Parts

Not every micro-molded application requires microscopic parts, but many require demanding geometry and tight tolerances on a slightly larger scale. Micro-features — incorporating very small features on a normal-sized part up to about 3 inches in diameter — are another of Accumold’s capabilities.

Lead Frame / Insert Molding

Insert micro-molding involves molding in or around a wide variety of materials such as plastic, ceramic, glass, fabrics, ﬁlm or foil. This type of over-molding can be achieved on either the Micro-Mold® or Small Mold platforms with the same high-precision output. The process can be operator loaded or our Automation Team can build a custom loading system for high-volume applications.

Accumold 1711 S.E. Oralabor Road Ankeny, IA 50021

Facilities

P: 1.515.964.5741

Accumold is an ISO 13485, 9001 and 14001 certiﬁed company with a state of-the-art, 130,000 square foot production plant. The Accumold facilities are located near Des Moines, IA, in the heart of the Midwest. The building is climate controlled and includes six 100K clean rooms and three 10K clean rooms for micro-electronics and medical applications.

F: 1.515.964.5742 accu-mold.com

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74 YEARS OF MANUFACTURING EXCELLENCE

Acme Monaco, a family-owned advanced global custom manufacturer, services the medical device industry in over two dozen countries. As your one stop for custom guidewires, wireforms, springs, and stampings for all medical applications, we offer the highest quality products that are priced to compete. From crucial low-run prototypes to lean mass production, we offer 74 years of experience working with our customers to develop high-quality tailored solutions to ensure a smooth transition to market. With a commitment to quality, R&D and engineering, we aim to exceed customer expectations by consistently delivering exceptional components.

Custom Stainless Steel and NiTi Guidewires

Medical Springs, Stampings and Wireforms

Our stainless steel and NiTi guidewires set the standard for quality, performing with high reliability during insertion and withdrawal. Our corewire technologies, including our proprietary stainless steel “KTC” core, provides the strength and ﬂexibility to resist prolapse or kinking and facilitate accurate placement.

Our CNC spring, stamping and wireforming equipment provide consistent high-quality at cost effective productivity levels.

• Diameters from 0.012” - 0.080”

Acme Monaco

• Lengths from 20cm - 500cm

75 Winchell Road

• Straight, “J”, angle, radius, and custom tip conﬁgurations

New Britain, CT 06052 Tel: (860) 224-1349

• PTFE and Hydrophilic coatings along with polymer jacketing

acmecorp@acmemonaco.com

• Various ﬂex and taper lengths

www.customguidewires.com

• Laser welding, gluing, product speciﬁc custom equipment Regulatory and Design Assistance

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Acme Monaco’s multi-faceted quality team offers full regulatory, validation, qualiﬁcation, and documentation services. Experienced engineers can provide the necessary design assistance and routinely offer classes for your engineering staff to aid in the ﬁner elements of guidewire and spring design.

www.medicaldesignandoutsourcing.com

• Spring wire sizes from .002” - .098” • Flat stock thickness up to .080”, strip widths up to 8” • NiTi heat setting and coiling • In-house EDM and Tooling Department to support progressive die and fourslide tooling 75,000 Sq. Ft. of Manufacturing Ingenuity Product is produced in three facilities New Britain, CT (HQ), Presque Isle, ME, and Singapore. Modern cleanrooms for assembly and packaging. FDA registered. EN ISO 13485 certiﬁed. Expert Operators Acme Monaco employs skilled craftsmen with years of experience. We are committed to training and workforce development while ensuring well-qualiﬁed in-house staff to maintain quality and delivery.

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AllMotion Inc. develops and manu-factures miniature high-performance stepper and servo drives for the medical, scientiﬁc, optical and general automation markets. Their mission is to create superior, ultra-compact motion control solutions that reduce costs and readily integrate into OEM instrumentation designs across a wide range of industries. R&D efforts are centered on core competencies of small form factor components that deliver precise positioning control and ease of use. AllMotion provides off-the-shelf motion control devices and custom solutions based on their EZStepper and EZServo motor driver technology. Their servo motor controllers and brushless DC motor controllers feature quadrature encoder feedback, and are programmable to allow standalone operation. Based in Union City, California, the company has proven leadership in miniature motion control, with a full line of intelligent driver/controllers.

AllMotion introduces the next generation of Servo Drive and Control for 2021. The drive circuit is now Torque Vector controlled for smooth motor operation. The control side still provides ease of operation allowing the rapid implementation of servo motor solutions in products requiring automation. Big Power in a Small Package The Drive measures just 2.25” square and is 0.9” high. The fully intelligent servo motor Driver + Controller can deliver better than 20 amps of current into a 3 phase servo motor. Voltage input can range from 12 to 50 Volts. Four inputs for home and limits as well as general purpose inputs are standard. There is also a high power output for solenoids or brakes. No hall sensors are required and encoder feedback has options for single ended or differential inputs. New ways to Communicate The new Servo Drive also has CAN and Ethernet hardware interfaces to allow the integration of the drives into applications requiring these types of communications. Protocols such as CAN-OPEN and EtherCATTM can be run on the high speed processor expanding the possible applications of this next generation Driver + Controller.

All Motion, Inc. 30097 Ahern Avenue Union City, California 94587 Sales Ofﬁce - 510.471.4000

Tried and True For users already familiar with the AllMotion product line, the drive also incorporates the tried and true communications protocol that allows users to be up and running in no time.

Technical Support - 408.460.1345 Fax - 408.358.4781 Email - support@allmotion.com www.allmotion.com

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AllMotion Vector Servo Driver Controller with Ethernet Communications

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The Commands are intuitive and simple. For example, the command A10000 will move the servo motor to Absolute position 10000. (This communications protocol is compatible with devices that use the Cavro DT or OEM protocol.) The Servo is also capable of standalone operation with no connection to a PC. It can be set to execute a preset string of commands upon power up (i.e., only power is required in this mode). The Commands include nested loops and execution halt pending a switch closure, which is useful in stand-alone applications. The Servo Motor Controller will typically work with any motor that is 4” or smaller (size 34 or smaller). Starter Kits enable a ﬁrst time user to make Servo Motors move intelligently in less than half an hour. For more information, contact Sales@ AllMotion.com or call us at 510-471-4000.

ALTECH - COMPONENTS FOR MEDICAL DEVICE DESIGNS Serving automation and control industries

Altech Corporation is an established USA supplier of components and devices used in industrial control, instrumentation and automation. It is an ISO 9001:2000 certiﬁed manufacturer and distributor of electrical, electronic and electromechanical components.

since 1984, Altech’s products meet UL and international standards and all are RoHS and REACH compliant. Altech’s commitment to quality has been recognized since May 27, 1999 when they were awarded the prestigious honor of ISO 9001 certiﬁcation

Altech provides many services. This begins with its product managers, providing technical support and partner with customers in design assistance, ensuring the best solutions. The Customer Service Department ensures that customers are informed with complete order information. The versatile assembly department provides manufacturing, value added or customization services to expedite delivery. The marketing department has been highly recognized for its catalogs, advertising and website, while the sales department motivates over 25 manufacturer representative companies throughout North America, ensuring product information is complete.

and maintains a ISO 9001:2000 certiﬁcation today. Product lines include miniature circuit breakers, busbars, DC-UPS devices, digital panel meters, terminal blocks, enclosures, contactors, many types of relays including safety relays, motor disconnect switches, strain reliefs, receptacles, foot switches, push buttons and pilot lights. Many other products are also available.

The product line includes miniature circuit breakers, busbars, DC-UPS devices, panel meters, terminal blocks, contactors, motor discon¬nect switches, pin & sleeves, receptacles, foot switches, many types of relays, push buttons & pilot lights. Also available are metal detection systems, ferrules, marking & engraving systems, fuses, power distribution blocks, tubing, liquid tight strain reliefs, timers, test & measurement, LED panel lights, thermostats, panel ﬁlters, tower lights & wire ducts. Altech’s products meet UL and many international standards and all are RoHS compliant.

Altech 35 Royal Rd. Flemington, NJ 08822 www.altechcorp.com

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Asahi Intecc High Performance Components Asahi Intecc is a ISO9001/13485 certified manufacturer of precision medical components, extruded tubing, PTFE Liners, sub-assemblies, and guidewires. We supply our products to over 100 countries around the world. We have five R&D facilities located in Japan and the USA as will as production facilities in Japan, Thailand, Vietnam, and the Philippines. Our ACTONE flexible cable tube (1 to 1 torque response), motor driven drive cables, and multi-layered torque coils, miniature coils, braid-reinforced catheter tubing are all high quality and high performing products that can be used in you delivery system, catheter, or device. High-Volume manufacturing capabilities are available. Device assemblies and subassemblies are offered.

Asahi Intecc is an industry leader due to our Torque Processing which is one of our four core technologies along with Wire drawing, Forming, and Coating Technology. Asahi is industry leader in 1 to 1 torque performance of our components and guidewires. Our experience in many medical applications makes Asahi Intecc unique as we can offer many components along with value-add options like subassembly, coatings, laser welding, PTFE Liners, and much more. We also offer OEM/ODM service. Our products are used in many medical applications such as cardiovascular catheters, microcatheters, sheaths, guidewires, delivery systems, retrieval systems, imaging devices, surgical tools, and orthopedic devices. Our components are intended for use in applications requiring torque response, ﬂexibility, kink resistance, and maneuverability within a small proﬁle or tortuous path.

Asahi Intecc USA, Inc. 22 Executive Park Irvine, California 92614 http://www.asahi-inteccusa.com

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Atlas Vac is the industry standard recognized for technical excellence in the design and manufacture of medical device tray sealers used in cleanroom production. Their knowledgeable staff is comprised totally of engineers and technicians who know their product and your issues when it comes to tray sealing. Atlas Vac is the only manufacturer

Atlas Vac Machine’s core expertise is the design

worldwide offering an All Electric Tray

and manufacture of tray sealing equipment for medical device packaging clean room applications.

sealer for extreme accuracy, Light Curtain Safety Systems, UDI barcode input and

Whether you require a tray sealer, tooling nests or ﬁeld service, the engineers and technicians at Atlas Vac Machine are considered some of the most knowledgeable in the industry.

audit trail data, Direct Force Sensing for digital down-force readings, Electric Shuttle Technology for ultra-smooth

Atlas Vac sealers are available with: Direct Down-Force Measurement, Auto Electric Shuttle technology for ultrasmooth movement; calibration ports for all parameter readings; heaviest cross section heater design for even heat distribution; and anodized single-piece CNC precision tooling nests with molded gaskets. All Atlas Vac sealers are PLC controlled for correct validation of processes.

movement as well as the heaviest cross section heater design for even heat distribution and anodized single piece CNC precision tooling nests.

An option for increasing production while reducing repetitive motion issues, Category 3 Light Curtains (OSHA or ISO13849-1 Cat 3 compliant) are available across the entire product line for hands free sealer operation and included standard on the Model 18:30S All Electric Sealer. In addition to standard pneumatic units, Atlas Vac offers an All Electric Model medical device tray sealer. The All Electric Model 1830S provides supreme downforce control unmatched by any other pneumatic sealer. Precision sealing forces are repeatable to the tightest tolerance of any tray sealer available.

Atlas Vac Machine, LLC 9150 Reading Rd. Cincinnati, OH 45215 www.atlasvac.com

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Atlas Vac recently included, as a standard feature, Data Logging for a complete Audit Trail of not only the dynamic sealing cycle data but also Operator ID’s & PW, sign-ins, PW changes, recipe changes, alarms, date, time and odometer reading all on a standard 10” color touch screen. Entry by bar code of recipe input, tool ID matching and UDI input for lot tracking is also a standard feature. New for 2020, an optional Enterprise Integration Solution (EIS) was created as a simpliﬁed interface between corporate ERP systems and the tray sealer for bi-directional exchange of set-ups and resulting production sealing performance.

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SMALL METAL PARTS EXPERTS Azoth is a vertically integrated additive manufacturing company driven by quality. Focused on innovation and technology, Azoth has developed the TOMO business model to transform physical inventory into digital inventory that is printed on demand. With world class technology in metal AM, deep knowledge in plastics and composites printing, and leading manufacturing engineers, Azoth can generate new manufacturing solutions with their customers. Azoth aims to be the continued technology experts of a rapidly changing ﬁeld, and help customers implement the best solution for their manufacturing needs.

More than a service bureau, Azoth is manufacturing to blueprints on demand. Whether the customer is searching for complex prototypes or high volumes of end-use components, Azoth’s customer focused and quality driven approach is up to the task. Azoth is backed by a successful parent company, Ewie Group of Companies (EGC), which services 300+ fortune 500 manufacturing facilities across 12 countries. This, in combination with deep technical partnerships, has positioned Azoth to be an industry leader in delivering end-use metal and polymer components.

Azoth 1099 Highland Drive Ann Arbor, MI 48108 www.azoth3d.com

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Azoth combines the quality systems of traditional manufacturing with the speed and efﬁciencies of the Rapid Prototyping industry. Azoth has a deep understanding of the entire Additive Manufacturing (AM) landscape and applies the best technology for each customer’s parts. With Azoth, customers only need an idea or blueprint, which Azoth can then transform into the exact physical part the customer desires.

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If you need a trusted outsourcing partner for medical device and pharmaceutical contract manufacturing, turn to B. Braun’s OEM Division — a division of one of the world’s leading health care companies. Whether you are looking for a solution, medical device, ﬂuid administration set, custom kit or individual components, we can provide the products and capabilities to meet your needs. Our dedicated project management teams have the expertise to turn your ideas into reality.

B. Braun’s OEM Division B. Braun Medical Inc. 861 Marcon Boulevard Allentown, PA 18109

For more than 175 years, B. Braun has worked to protect and improve the health of people around the world. With thousands of pioneering achievements in medical device and pharmaceuticals, the family owned company remains at the forefront of innovation. The OEM Division operation has been part of B. Braun for over 30 years.

1.866.8.BBRAUN (1.866.822.7286) us.bbraunoem.com

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Propelled by our philosophy of Sharing Expertise®, B. Braun Medical Inc. is a leader in infusion therapy, pain mangement technology, and support services that meet the highest standards for quality, safety, sustainability, and efﬁciency.

Every day, over 64,000 B. Braun employees worldwide share their expertise with colleagues and customers to enhance safety for patients, doctors, and nurses, and to improve working processes in hospitals and medical practices. The B. Braun Group of Companies has global headquarters in Melsungen, Germany and operations in 64 countries. In the U.S., B. Braun Medical’s corporate headquarters is located in Bethlehem, Pennsylvania with manufacturing facilities in Allentown, Pennsylvania, Irvine, California, Daytona Beach, Florida, and the Dominican Republic.

Voting for this company will identify it as a leader in the medical technology industry.

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Our slogan is our mission! The pursuit of Perfection in Automation has inspired and guided B&R for over 40 years. To us, perfection means more than developing the best solutions in industrial automation. It also means developing the best relationships – with our customers and partners as well as our employees and suppliers. An intuitive sense of market dynamics and emerging trends has established us as a pioneer, leading the way with the most innovative technology on the market. Our role as the ABB Group’s global center for machine and factory automation strengthens our position of leadership and adds new moment to our impressive record of sustained growth.

Leaders in medical device assembly are creating solutions with the unprecedented ability to produce multiple product types simultaneously – enabling small-batch flexibility without compromising productivity. This is a new generation of adaptive machines, uniquely efficient at automating dynamic changes. The secret: a synergy of key technology breakthroughs integrated into a single system. B&R Industrial Automation, a member of the ABB Group, demonstrated their ACOPOStrak intelligent track technology, which seamlessly integrates with robots to enable an adaptive machine that automates tasks requiring high variability, precision and mass customization. The adaptive machine brings a new level or flexibility to product handling, assembly and packaging in the healthcare industry and beyond. B&R has been developing innovative hardware and software solutions for more than 40 years. Our automation know-how, customer experience and culture of innovation make us the perfect technology partner for adaptive machinery in the medical and pharmaceutical industries.

B&R Industrial Automation 1250 Northmeadow Parkway Suite 100 Roswell, GA 30076 https://www.br-automation.com/en-us

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BAYCABLE Interconnect Solutions Our specialty is working with clients to design application speciﬁc solutions to complex interconnection problems that are solved by our capability to manufacture custom cable, coil cords, molded cable assemblies and electromechanical sub-assemblies in Fremont, California and Sonora, Mexico. SPECIALTIES: •

Silicone and Thermoplastic Molding &

BAYCABLE is vertically integrated and can offer a wide range of manufacturing capabilities including custom cable constructions, full turnkey cable assembly and molding services, component customization, specialized testing, and in house mold tool manufacturing.

Extrusion •

In House Cable Manufacturing

•

In House Mold Tooling

•

Very Fine Wire Termination

•

Custom Connector Design

BAYCABLE delivers unparalleled engineering expertise “an integrated solutions partner” that can help skillfully create the optimal interconnect system for your application.

MARKETS: •

Medical

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Industrial

•

Automotive

•

Audio

•

Defense

Early design collaboration with our Silicon Valley based engineering group takes you from concept through pre-production into the initial production runs quickly, and we provide medium to higher volume production by transferring production to our plant in Sonora, Mexico. Both manufacturing locations are ISO Registered. BAYCABLE has a long legacy of delivering high performance reliable interconnect solutions to our customers.

Bay Associates Wire Technologies 46840 Lakeview Blvd Fremont, CA 94538 510-933-3800 bayinfo@baycable.com www.baycable.com

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As technology continues to demand precision and smaller tolerances, engineers are turning to Bird Precision micro-drilled inserts, fittings and filter components. We offer a high value solution in nozzle, restrictor and orifice applications, all designed with Bird Precision accuracy. If you’re involved in product design and production, you’re always on the lookout for ways to improve manufacture, performance and quality in your products. Now is the time to investigate the wide range of accuracy and workmanship Bird Precision continues to supply for micro miniature components and assemblies. Bird’s early experience in aircraft instrument bearings & micro assembly techniques for timing mechanisms has prepared us well for the critically demanding needs of modern instrumentation.

Bird sapphire and ruby orifices are scientifically designed to insure repeatable flow control of both liquids and gas. Ruby and sapphire materials are used exclusively because of their durable material characteristics. This economical man made crystal has amazing credentials: 1. Extreme hardness, 9 mohs scale, next to diamond 2. Practically chemically inert, highly resistant to most alkalis and acids

3. Extreme abrasion resistance, 5 x that of tungsten carbides. 4. Does not outgas, zero porosity 5. Non-thrombogenic, for medical applications 6. Excellent insulator 7. High temperature material, 2000 degree C melting point. 8. No ﬂash points, extensively used in oxygen environments. With such impressive material characteristics, the designer can design with conﬁdence in even the harsh environmental applications.

With the development of new laser drilling and wire lapping techniques, we have transitioned into micro miniature oriﬁces, nozzles, ﬁlters, and connectors. We offer a whole line of micron level standard products ranging in size from 10 microns (.0004”) up through .080”. Flow rates from under 1cc/min are available. Bird Precision maintains an impeccable reputation for precision component fabrications. A full complement of Swiss CNC, production assembly and specialized secondary machines provide a vertical in house capability, enabling fast prototype and production delivery. Join us as one of our valued customers. We will work together to improve your product through a mutual exchange of ideas, service and quality.

Bird’s unique manufacturing process Bird Precision offers a unique series of laser drilled, wire lapped Ruby and Sapphire orifices. This unique wire lapping method insures that our orifices are round and highly polished. . This method also removes all possibilities of burrs or loose particles in the orifice area. The orifices are all lapped both sides to impart a very uniform sharp edge to our orifices. It is this edge along with the roundness and high polish that yields a highly repeatable Cd value (Coefficient of Discharge).

One Spruce Street Waltham, MA 02454 800.454.7369 Fax: 800.370.6308 sales@birdprecision.com birdprecision.com

Further the wire lapping method guarantees hole tolerance .0002” or less as standard. Bird Precision has recently introduced our new

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Golden Orifices with .0001” total spread for those most demanding applications. It is this precise methodology and attention to detail that distinguishes us from all other manufacturing methods, yielding production quantities of highly precise flows at reasonable prices. Our orifices and micron level filters are conveniently packaged in a huge variety of stainless, plastic and brass fittings, inserts and connectors. Bird Precision continues to focus on putting orifices and filters where you need them. We also offer a host of standard Swagelok, Smc, Parker and Value Plastics, retrofits.

Bishop-Wisecarver makes designing and delivering complex linear and rotary assemblies easy while reducing labor, costs and inventory requirements. Through the integration of mechanical, electrical, software, control and systems design engineering expertise, we continue to provide a single point of service that results in: custom designs, increased efficiencies and accelerated time to market. Bishop-Wisecarver develops innovative motion solutions that are expertly designed and delivered to perform from a company you can trust. Leveraging nearly 70 years of experience, we’ve earned the reputation of providing unmatched quality, reliability, service and engineering support for every stage of a customer’s design cycle. No matter your application, volume shipment requirements or extreme environmental conditions, Bishop-Wisecarver listens to your specific needs. Then we design innovative solutions enabling you to finalize projects from concept to completion quickly, easily, and cost effectively. Our customers consider us a valued partner that helps solve even their toughest problems with unmatched commitment. How can we help you today?

BISHOP-WISECARVER:

Expertly Designed, Delivered to Perform Founded as a custom machine builder 69 years ago, Bishop-Wisecarver as a second generation family owned company has never been more relevant to innovative customers requiring highly specialized automation solutions. Our Signature Experience™ process promises our customers: 1. That our technology and designs will be the right ﬁt for your application 2. That you will receive a documented needs assessment to guarantee alignment with your deﬁnition of success for your project. 3. We will customize a solution for you - even for one unit.

See the difference our unique Signature Experience program brings to customers.

4. Proactively communicate with you through all stages of your order from beginning to after installation. 5. Guarantee we have met or exceeded your deﬁnition of success on your project through post installation follow meeting. We have you rate us. What else sets us apart? Customers regularly score us not just better, but much better than other companies in technical & engineering support, product and

Bishop-Wisecarver

solution reliability, service and parts support, responsiveness of customer service,

2104 Martin Way

and that we appreciate our customers’ business. This commitment to customers

Pittsburg, CA 94565

through our Signature Experience process helps us maintain some of the

Tel: (888) 580-8272

longest-lasting partnerships in the industry.

www.bwc.com

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BMP Medical provides plastic contract

manufacturing services to leading medical device and diagnostic OEMs in need of injection molding, injection blow molding, two-shot (2-shot), and insert molding contract manufacturing services. We help customers in the Medical & Diagnostic markets bridge their capability gaps and accelerate their go-to-market success. We foster strong trust-driven relationships to develop inventive solutions tailored to customers and end-user needs. From concept through commercialization, BMP offers in-depth problem solving backed by deep industry knowledge and

A culture that promotes continuous improvement, respect for humanity, and an optimal results-driven approach—all of which benefit leading medical device and diagnostic OEMs, the employees, and the company. Our continuous improvement approach can be seen in our expanded capabilities within our 80,000-square-foot manufacturing facility and in our commitment to implementing internal training programs with an eye to benefiting our valued customers. BMP proudly became the first plastic injection-molding company to receive MedAccred accreditation. MedAccred is quickly becoming the new standard for quality control and risk mitigation.

operational excellences. https://www.bmpmedical.com/

16 Chocksett Road Sterling, MA 01564 Phone: 978-632-2555; toll-free: 800-253-3684 Fax: 978-632-2524 E-mail: sales@bmpmedical.com Web: www.bmpmedical.com

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Markets Served: BMP Medical is a global contract manufacturer servicing the Medical Device and Medical Diagnostic markets in all areas, including, but not limited to, IVD, IV access, sample-preparation devices, and lateral-ﬂow technologies. Headquartered in Sterling, MA, and with global manufacturing capabilities in both Massachusetts and Asia, BMP Medical can service partner requirements on a worldwide basis.

Quality Systems: • ISO 13485:2016 • FDA 21CFR820 • MedAccred Accredited

Services:

BMP Medical

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What makes BMP Medical different from other companies?

• Custom Injection Molding • Custom Injection Blow Molding (IBM) • Custom 2-Shot Molding • Custom Insert Molding • Clean Room Manufacturing (Class 8) • Clean Room Packaging and Assembly (Class8) • Product Design & Development Services • Sterilization Services • Custom Packaging • Pad Printing • DNase- and RNase-free manufacturing • FDA Registered Facility • Class 7 Assembly

Capabilities: • Design Consultation • Engineering Consultation • R&D Tooling • CAD Design • Statistical Process Control

www.medicaldesignandoutsourcing.com

Cadence, Inc. is a single source contract manufacturing partner for medical device and diagnostics companies worldwide. Cadence provides end-to-end product realization solutions focused on best-in-class total value. Cadence employs 500 people with headquarters in Staunton, VA and other locations in Connecticut, Pennsylvania, Rhode Island, and Wisconsin. Major Markets Served: Analytical Science Cardiology Drug Delivery Point of Care IVD Fluid Delivery Interventional Therapy Neurology Biopsy Dianostics Endoscopy Pharmaceutical Orthopedics General Surgery Minimally Invasive Surgery Opthalmology

What makes Cadence different from other companies? Cadence is all about improving product performance and economics. We help develop new products that other cannot, build processes that other will not, and deliver outcomes that simply make the world work better. We use integrated and advanced technologies to make ﬁnished devices as a single, turnkey manufacturing partner for medical OEMs. Cadence offers complete services that range from initial design through manufacturing and full supply chain management for single use and disposable medical devices.

Cadence, Inc.

sales@cadenceinc.com

• Laser Welding, Drilling, Cutting, & Marking • Tube Fabrication including LaserSwiss • Sharps – Specialty Blades & Needles • Precision Metal Stamping • Microstamping & Multi-slide Stamping

• Rapid Prototyping

• EDM – Wire, Ram, & Sink

• Certiﬁed Cleanroom Manufacturing

• Nitinol Shape Setting

• Finished Device Assembly

• Custom Automation

• Complete Supply Chain Management

• IncisionLab™

• Sterilization Management

Staunton, VA 24401

• Micro Machining & Swiss Machining

• Design Services

• Final Packaging and Labeling

9 Technology Drive

Metals Expertise: • Advanced Welding Lab™

We also provide a very broad set of core

Tel: 540.248.2200

capabilities that are competitive and

Fax: 540.248.4400

differentiated in the marketplace. Unlike

cadenceinc.com

most contract manufacturers, we also have signiﬁcant metals and plastics expertise; making new products a reality.

Plastics Expertise: • 3D Printing • PEEK Machining • Cleanroom Molding • Engineered Resins Expertise • Sharps Molding & Handling • Reel-to-Reel Molding • Plastic Injection Molding • Insert Molding

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• Micro Molding

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LARGEST MINIATURE-GUIDES SUPPLIER IN THE WORLD Chieftek Precision USA of Chieftek Precision Co. Ltd. (cpc) is a manufacturer of complete linear-motion mechatronic solutions, including profile linear guides, linear motors, compact linear stages, servo drivers, XYZ tables, and gantry systems for automation machine tools and robotic industries. With distribution centers in California, cpc provides rapid and first-rate service to American customers — offering German quality with Taiwanese flexibility, prompt delivery, and competitive pricing.

Chieftek Precision USA of Chieftek Precision Co. Ltd. (cpc) supplies linear guides, directdrive tables, linear motors, feedback components, and servo drives backed by a team of managers, engineers, and technicians dedicated to the R&D and manufacture of top-quality linear-motion components. Chieftek MR Series linear guides excel in precision measurement and inspection applications; ARC guides are widely used in machine tools; HRC and ERC guides complete heavily loaded axes; and RR linear guides with roller bearings deliver top performance in general motion designs. Chieftek P Series ironless linear motors have the highest thrust density and efﬁciency of their kind. C Series iron-core linear motors deliver high thrust with low cogging. For users familiar with belt and ballscrew-driven systems, Chieftek packages its linear motors into CLS/ CLMS compact linear stages that integrate linear motor, guide, and positioning. Engineers can also source servo drives from Chieftek. The Will1 Series features high power density, easy-to-use autotuning, and advanced features to let machine builders create breakthrough products. The low-voltage Chieftek Will1-D accepts 48-Vdc input to 30 A continuous. It features an ultra-small size and high power density — and is suitable for AGVs, drones, and robot applications; Will1-B drives support all standard encoder formats.

Chieftek Precision Co., Ltd (cpc) www.chieftek.com

Most recently, Chieftek introduced the UF-30-09 ultra miniature linear-motor stage. With thickness to 9 mm and acceleration to 3.5 g, the stage excels in electronics assembly (SMT), medical pipetting, and other multi-head applications where space is limited.

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Watch our linear motor in high density liquid handling video.

www.medicaldesignandoutsourcing.com

For more than 50 years, CGI has enabled design excellence in motion control across a range of industrial applications. The people at CGI have demonstrated a deep commitment to providing the latest technology, innovative product, and unrivaled customer service to earn the reputation as one of the most trusted experts in the business. CGI’s engineering footprint is seen in a range of industries including medical, aerospace, robotic, semiconductor, machine tool, packaging, food/beverage, textile, material handling, telecommunications and specialty machine design.

Advanced Products for Medical Applications Our core business is manufacturing precision motion control solutions. CGI’s diverse customer base and wide range of applications have earned us a reputation for quality, reliability, and ﬂexibility. Our leadership in the market features a careful blend of cutting edge technology and renowned reliability. With CGI you can count on us to provide the highest levels of manufacturing acumen and expertise while delivering it with the customer service you deserve. Our goal is to be the most trusted partner in your supply chain. Whether it’s an improvement on a current design or groundbreaking new designs, CGI has the know-how and team to enable design excellence.

You will ﬁnd CGI components integrated into industrial robotics and machine automation systems including applications for artiﬁcial hearts, robotic surgical systems, laser eye surgical equipment, drills and attachments used for orthopedic surgery. CGI components have played a role in the repair of the Hubble telescope. Astronauts used a CGI precision-crafted wrench to repair the telescope that allows scientist to peer into the deepest recesses of space. CGI technology is also used on the spectacular Bellagio Resort dancing fountains and other hotels in Dubai and China also use CGI technology in their fountains.

Our team is renowned for being able to provide complex precision machined component parts of high quality and hold tolerances as tight as 2.5 microns (.0001”). These parts are machined from diverse metals, and involve a variety of hardness, surface treatment, heat-treating and plating requirements. One of the distinct competitive advantages we are able to provide our customers with is an engineering team that is knowledgeable and easy to work with. CGI, Inc.

When comparing the manufacturing capabilities offered by CGI with those of our competitors the clear difference is in the commitment have to exceeding expectations. This commitment can be seen by our customers each day through our investment in technology, our attention to precision and the high level of service we provide.

3400 Arrowhead Drive Carson City, NV 89706 775.882.3422 Toll free: 1.800.568.GEAR (4327) F: 775-882-9599 cgimotion.com

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CLIPPARD PRECISION FLUID CONTROL PRODUCTS & SOLUTIONS

Clippard provides thousands of standard and special precision flow control products to design engineers and manufacturers around the world. Clippard’s expertise is not limited to providing over 5,000 standard products, but also offers a unique advantage by providing custom products and value added assemblies for hundreds of applications. Products include: • Electronic Pressure Controls • Electronic valves, standard and proportional isolation • PTFE Isolation valves and pneumatic or electronic pinch valves • Precision flow controls • 7, 8, 10 and 15 mm electronic valves • Cylinders and fittings • Value-added custom assemblies • Special components and systems designed for customer’s OEM applications For over 75 years Clippard has been manufacturing and providing products and solutions to design engineers and manufacturers in a wide variety of industries including drug dispensing, laboratory equipment, medical devices, material handling, analytical, chemical analysis, sampling, life science/biotech, genetic research, gas chromatography, spectrometry, DNA synthesizing, blood analyzing, printing, diagnostic equipment, fermentation, packaging, water treatment and more.

Miniature Pneumatic Products & Solutions Web

Visit www.clippard.com to find complete product information, engineering drawings, technical specifications, full color photos, CAD files, order information, literature downloads, helpful calculators, technical assistance, distributor information and more.

Quality

Quality remains a primary feature of every product Clippard produces. This is achieved through the excellence in manufacturing practices and craftsmanship that has continued throughout the years. The high standards set by Leonard Clippard, in company relationships with customers, distributors, suppliers and employees continue to be upheld. The company motto, “Quality People, Quality Products”, emphasizes the important role every employee plays in maintaining the company’s reputation.

Catalog

Clippard offers a full-line catalog which contains over 5,000 standard products. Call today for a free copy.

Applications

Today, Clippard pneumatic control devices are used virtually everywhere for control, interface, sensing, logic and actuation functions. For medical, analytical, laboratory, diagnostic and other related applications, Clippard manufacturers precision components including oxygen clean, analytical and proportional valves, PTFE isolation and pinch valves, precision regulators, manifolds and more. Custom products and assemblies for speciﬁc applications are also welcomed.

Distributors

Clippard products are sold through a worldwide distributor network that offers products plus design engineering expertise.

Clippard 7390 Colerain Avenue Cincinnati, Ohio 45239 877-245-6247 www.clippard.com

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Components Corporation is the global leader in the design, manufacture and engineering of precision printed circuit test points, wireform interconnect and testing solutions, printed circuit card edge connectors, preform jumpers and hardware, and battery contacts. We remain committed to solving the industry’s most demanding wireform interconnect and testing challenges with

Components Corporation: Your Trusted Leader in Innovative Interconnect Solutions

high-quality and innovative products for the broadest range of mission-critical

At Components Corporation, throughout our years we’ve focused on providing innovative, essential solutions to the most challenging problems faced by board designers, builders and technicians worldwide. Much of our skill in board-level product improvement and application technology can be traced to our strong history in successful research and development.

applications. Our industrial, military, commercial and consumer customer base have come to rely on Components Corporation to ensure the excellence and economy of products regardless of

Now concentrating strictly on boardlevel hardware, our early challenges in developing solutions in space ﬂight, aviation, medical and ﬂedging electronics applications have given Components Corporation a talent for anticipating that every new product has to be smaller, faster, less costly and more functional on rapidly shrinking board real estate.

the quantity required. Our products are marketed through a worldwide network of sales representatives and distributors.

CC ®

COMPONENTS CORPORATION

With a dedicated “no failure” policy, Components Corporation remains the leading manufacturer in Printed Circuit Wireform Interconnect Products. We’ve earned our reputation as being the driving, innovative force in the development of circuit board hardware technology

Components Corporation

COMPONENTS C C 866-426-6726 ®

CORPORATION

www.componentscorp.com

And at Components Corporation, custom manufacturing is our standard. Given basic requirements or dimensions, Components Corporation is able to deliver an economical, perfectly functioning part from prototype to production run. A unique feature of both our custom wireform and standard products is their ability to function in extremely harsh conditions. All of our products are RoHS and REACH compliant (Directive 2015/863/EU RoHS and EU Regulation EC 1907/2006).

www.componentscorp.com / (888) 401 7490

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Our in-house capabilities allow us to partner with each customer to design and develop the best custom products for any PCB design requirement, incorporating compliant materials to stringently meet industry directives.

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COMSOL is a global provider of simulation software for product design and research

Fluid-structure interaction analysis of an idealized heart valve, including contact modeling and nonlinear material modeling. Deformation, von Mises stress, and velocity magnitude are shown.

to technical enterprises, research labs, and universities. Its COMSOL Multiphysics® product is an integrated software environment for creating physics-based models and simulation applications. A particular strength is its ability to account for coupled or multiphysics phenomena. Add-on products expand the simulation platform for electromagnetics, structural, acoustics, ﬂuid ﬂow, heat transfer, and chemical applications. Interfacing tools enable the integration of COMSOL Multiphysics® simulations with all major technical computing and CAD tools on the CAE market. Simulation experts rely on COMSOL Compiler™ and COMSOL Server™ to deploy applications to their design teams, manufacturing departments, test laboratories, and customers throughout the world.

COMSOL, Inc. 100 District Avenue Burlington, MA 01803 Phone: +1 781 273 3322 Fax: +1 781 273 6603 E-mail: info@comsol.com www.comsol.com

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The COMSOL Multiphysics® software is widely used for medical device design and bioengineering. Applications include modeling and simulation of ablation systems, hearing aids, stents, hematology analysis, MRI, implantable devices, glucose sensors, ultrasound imaging products, peristaltic pumps, electrical sensors, piezoelectric valves, and more. Simulation specialists can turn their multiphysics models into simulation applications with the Application Builder tool available in COMSOL Multiphysics®. This provides a new way for teams of engineers and scientists to bring the use of simulation to non-specialists. With COMSOL Server™ simulation applications can be deployed and administrated via a web interface. With COMSOL Compiler™ simulation specialists can compile an application into a single executable ﬁle for unlimited use and distribution. Standalone executable applications provide simulation specialists with an unprecedented level of freedom in distributing their work to their design teams, manufacturing departments, test laboratories, and customers throughout the world. www.comsol.com

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Visualization of the motion of bacteria particles in a room with a displacement ventilation system.

EXPERTS FOR PHARMA AND MEDICAL DEVICE TESTING DDL is a full-service ISO/IEC 17025:2017 accredited testing lab that provides package, medical device and combination products testing to the medical device, pharmaceutical, biotech and consumer products markets. DDL’s team of engineers, technical and quality experts is devoted to helping customers worldwide succeed by taking an independent, involved and informed approach to ensuring regulatory compliance. DDL’s commitment to customer service is supported by an upfront approach, DDL has provided package, product and materials testing for the medical device, pharmaceutical, and consumer goods industry since 1990.

unmatched technical expertise, a robust quality system, fast turn-around, and

DDL’s package testing services evaluate the strength and integrity of packaging systems before and after simulating the anticipated distribution and storage conditions that the systems may undergo. DDL offers full service package testing in Eden Prairie, MN and Irvine, CA, and select package testing capabilities in Edison, NJ.

scalable capacity. All of our testing services are delivered with integrity, professionalism and a commitment to meeting the timing needs of our customers.

DDL offers testing of medical devices such as luer ﬁttings, syringes, needles, catheters, guidewires, surgical sutures, cannulae and tracheal tubes. DDL also specializes in mechanical and performance testing for pre-ﬁlled syringes (ISO 11040) and needle-based injection systems (ISO 11608).

DDL, Inc. 10200 Valley View Road Eden Prairie, MN 55344 • 9400 Toledo Way Irvine, CA 92618 • 551 Raritan Center Parkway Edison, NJ 08837

DDL provides stability storage space for products requiring environmental conditions based on ICH Q1A guidelines as well as customizable storage conditions. Our laboratories house over 38,000 cubic feet of validated storage space providing accelerated aging, real time aging, stability testing, thermal shock, thermal performance and environmental testing services. Temperature ranges from -65C to 120C and humidity ranges from 5% to 95% RH are available.

1-800-229-4235 email: ddlinforequests@ddltesting.com www.ddltesting.com

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DDL now also offers the latest deterministic capabilities for container closure integrity (CCI) testing as outlined in USP <1207> at its Irvine, CA location. We can provide tailored expertise to design and execute a CCI study based on your system, providing the support you need. DDL works one on one with all clients providing technical expertise, readily available capacity and easy to understand quotes. Contact us today for a quote or to talk to one of our testing experts.

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We make your medical device promise a reality Donatelle provides component and medical device manufacturing worldwide. We operate under ISO-9001:2015 and ISO13485:2016 certiﬁed systems and are FDA compliant. Capabilities include: complete engineering services, rapid prototyping, in-house tooling design and fabrication, processing capabilities for the entire range of engineered resins, micromolding, insert molding, over-molding, white room and clean room molding and assembly, liquid silicone injection molding, as well as precision machining for metal and plastic components.

Donatelle is focused exclusively on medical device design, development and manufacturing, especially for intricate applications - like high-risk, long-term implants and disposables - where precision, tolerances, validation and timelines are critical. For over 50 years, the best, most recognized names in the medical industry have relied on Donatelle.. Donatelle employs a team of over 40 highly specialized engineers, designers, machinists and toolmakers. Our staff is available to supplement your team, and they come with specialty certiﬁcations, including: IOPP Packaging, Process Validation, Medical Device Compliance, and Quality System Regulation Compliance. Our vertically integrated capabilities provide exactly the level of support you need, from a single manufacturing process to a complete solution. We’ll save you time while reducing risk across each manufacturing phase. Plus, we’ve earned - and maintain - an impeccable track record of meeting product development deadlines and more than 99% on-time delivery rate.

501 County Road E2 Extension New Brighton, MN 55112 Phone: (651) 633-4200 www.Donatellemedical.com

Donatelle provides the highest achievable quality of products and services. We accomplish this through rigorous processes, continual improvement and maintaining effectiveness at all levels.

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Delivering stainless steel, high nickel alloy and titanium components to customers in medical, aerospace and high tech manufacturing. Since its inception in1982, Eagle Stainless has a sterling record of on-time delivery, fair pricing, product quality and highly skilled employees dedicated to continuous improvement and training. Eagle has earned its reputation as a supplier of choice for off-the-shelf stainless

Laser welding/cutting - Eagle’s computer controlled laser welding equipment (laser center shown above) enables us to produce extremely close-tolerance cutting, notching, etching and welding operations.

steel products and fabricated stainless steel products. With “Eagle Eye Quality” you are assured:

CNC / Swiss machining Specializing in CNC machining for more than two decades, Eagle Stainless has been delivering some of the most intricately machined part imaginable. Working in diameters ranging from .030” to 2”, we’re ready to meet the requirements of your most demanding application!

100% parts made to your speciﬁcations. 100% Cut-to-length tubing - Eagle’s facilities enable us to cut and deburr any diameter tubing in quantities from a single piece to millions of pieces or more…and from lengths of .010” and longer with standard tolerances (see cutting tolerances below). Closer tolerances are certainly possible, simply request a quote with the details of your application, and we’ll be glad to help.

on time delivery. 100% traceable certiﬁed material.

Bending / Coiling - The ability to bend tubes without excessive distortion, wrinkling or fracturing is an art born of experience. Eagle craftsmen working with state-of-the-art machinery supply uniformly smooth bends - meeting the tightest customer speciﬁcations.

Eagle Stainless Tube & Fabrication, Inc.

Flaring and reductions Flaring and end reduction of tubing is an every day precision process at Eagle. Special tools and procedures have been developed to insure repeatability for proper mating of ﬂared and end-reduced tubes.

Call us. We are ready to help with any of your metal needs! Phone: 800.528.8650 Fax: 800.520.1954 www.eagletube.com

Custom shaped tubing in sizes from .040” to 1.00” to lengths to 17 ft.

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• Round • Triangular • and more!

• Oval • Rectangular

• Square • Hexagonal

With a complete in-house tool and die facility, experienced toolmakers will develop a custom extrusion die to yield tubing that will meet or exceed your expectations.

medicaldesignandoutsourcing.com/leadership

State-of-the-art tube bending

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ElectroCraft, Inc. is a global provider of dependable, application-engineered fractional-horsepower motor and motion products. The ElectroCraft Powering Innovation custom manufacturing services cover the following products: AC motors, PMDC motors, brushless DC motors, stepper motors, servo motors, gearboxes, gearmotors, linear actuators, drives, servo drives and integrated motor drives. Our products are found in thousands of different applications within industrial, commercial and consumer product markets. While ElectroCraft provides a wide array of standard products with many configurable options, we have built our brand on custom OEM solutions that meet the precise performance, cost and quality our customers require. For OEM Customers who are unsatisfied with having to design around inflexible off-theshelf products, our technical knowledge and cusomizable product families provide for a design experience which results in motor and motion systems that provide superior reliability and performance at the lowest possible cost.

ElectroCraft LRPX Series Brushless Planetary Gear Motor

ElectroCraft MP MobilePower™ Geared Mobility Motor

Compact, powerful performance enables innovative medical devices

Dependable Fractional-HP Motion, Globally

For medical equipment OEMs, frustrated with the requirement to design around off-the-shelf products from inﬂexible suppliers, ElectroCraft offers customizable product families and access For medical equipment OEMs, frustrated with the requirement to design to our deep engineering resources. We pride ourselves in providing a best-in-class design experience, resulting in motor and motion systems from that provide superior quality, reliability and around off-the-shelf products inflexible suppliers, ElectroCraft performance at the lowest possible cost-of ownership. offers customizable product families and access to our deep engineering

resources. We pride ourselves in providing a best-in-class design experience,

ElectroCraft custom medical motion control services are driven by our engineering innovation resulting in motor and medical motion equipment systems that provide superior quality, coupled with our long history in serving needs. The company’s productsreliability and performance lowest applications possible cost-of ownership. are found in a variety at of the life science ranging from medical equipment, lab equipment, labcustom automation, diagnostic andcontrol surgicalsolutions equipment, ultra-quiet power wheelchair ElectroCraft medical motion aretodriven by our engineering transmissions.

innovation coupled with our long history in serving medical equipment needs. The company’s products are found in a variety of life science applications ranging from medical LRPX Features: Mobility Product Features: equipment, lab automation, diagnostic and surgical equipment, to ultra-quiet power • wheelchair High torquetransmissions. density, small form factor • Very energy efﬁcient, long battery life

ElectroCraft, Inc. 844.338.8114 www.electrocraft.com

• LRPX High load capacity Features

• Smooth andProduct quiet operation Mobility Features

• High torque density, small form factor • High load capacity • Wide range of voltages and ratios • Low noise, Low heat generation Wide range of voltages and ratios available • • Up to IP65 • Up to IP65

• Very energy efficient, Long battery life • Smooth and quiet operation • Controllable variable speed available • High starting torque • Controllable • Wide range of IPvariable options speed • Wide Range of IP Options

• Low noise, low heat generation

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ElectroCraft, Inc. 1 Progress Drive Dover, NH 03820

Phone: (844) 338-8114 Fax: (603) 742-9080 www.electrocraft.com

www.medicaldesignandoutsourcing.com

• High starting torque

Euroﬁns Medical Device Testing Your Global Testing Partner From our testing lab...to the operating room. It’s where experience, quality and accuracy matter the most. With a strategic focus on quality and personal service, we help our clients ensure From implants and instruments, to single-use and combination products, as well as active electronic devices, Euroﬁns Medical Device Testing provides the optimal strategy for all types of medical devices and delivers rapid turnaround times with the highest level of service and most advanced technologies.

the safety and efﬁcacy of their products by delivering unparalleled testing services with complete, compliant and accurate data.

With extensive knowledge of the commercialization process, regulatory requirements and scientiﬁc trends in the Medical Device Industry, our scientists and engineers have been assisting companies, large and small, with developmental testing and regulatory submissions for more than 40 years.

As a trusted partner for over 40 years, let our experience and global reach work for you.

Our >20 state-of-the-art facilities throughout North America, Europe and Asia Paciﬁc offer extensive capacity and the highest level of instrument technology, enabling us to provide the full scope of testing services required by the Medical Device Industry, including:

Euroﬁns Medical Device Testing 2425 New Holland Pike Lancaster, PA 17601 717-656-2300

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Analytical Chemistry - Our chemistry laboratories are equipped with nearly 400 HPLCs and 100 GCs with more than 600 detectors.

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Microbiology - We offer validations for terminal sterilization, as well as for reprocessing of reusable devices and environmental monitoring to support your clean manufacturing facilities.

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Biocompatibility - Our global biocompatibility team includes a vast group of certiﬁed veterinarians, pathologists and toxicologists.

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Electrical & Mechanical - We perform testing of active medical devices for compliance to electrical requirements of ISO 60601.

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Package Testing - We provide the full range of testing required to assess every aspect of product packaging, from sterile seal integrity through pallet-level transit testing, as well as label durability and UDI compliance.

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Stability Testing & Storage - Over 187,000 cubic feet of environmental chamber space for accelerated and real-time stability and aging studies.

medical-device@euroﬁns.com www.Euroﬁns.com/medical-device

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Euroﬁns Medical Device Testing can help develop and execute your test plans and navigate the regulatory pathway to market anywhere in the world. Our laboratories maintain quality systems compliant with cGMP, GLP, and ISO 17025, and conducts testing in accordance with ISO, ASTM, ANSI, AAMI standards, as well as custom test methodologies to meet the unique needs of our customers.

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As the exclusive provider of FAULHABER products for North America, FAULHABER MICROMO creates value through advanced design and engineering services. We’re proud to offer the broadest range of high precision, high performance products for micro motion applications in the medical market. FAULHABER MICROMO brings together the highest quality motion technologies and value-added services in North America plus global engineering, sourcing, and manufacturing to deliver the best micro motion solutions. FAULHABER partners with customers to deliver quality, innovative solutions faster and better every time. FAULHABER MICROMO is your full service, value added outsourcing partner: • ISO 9001 and 13485 certiﬁcation • Custom design and complete clean room subassembly • Express prototyping • Machining center • State-of-the-art testing laboratory • Energy-efﬁcient solutions and enhanced product life FAULHABER’s benchmark motion solutions are part of numerous medical devices and applications, such as medical pumps, surgical robotics & end effectors, laboratory automation, point-of-care diagnostic systems, haptics systems, medical imaging, bionic prosthetics and more.

FAULHABER MICROMO 14881 Evergreen Ave. Clearwater, FL 33762 T: (800) 807-9166 www.faulhaber.com

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Medical Design & Outsourcing

Since 1961, FAULHABER MICROMO is the trusted partner of OEMs for micro motion solutions and subassemblies. As the industry leader with micro motor, encoder technology as well as design customization, we bring together value-added services and cutting-edge technologies from around the world through high efﬁciency, high performance rotary and linear offerings, such as brushed, brushless, stepper, ﬂat DC motors, piezoelectric & linear motors.

YOUR SOLUTION, OPTIMIZED

FAULHABER MICROMO creates value through advanced design and engineering services: • • • •

Precision Actuation Systems Design and Integration Components Drive and Control Integration Performance and Cost Optimization

QUALITY LEADERSHIP

FAULHABER MICROMO is ISO 9001 and ISO 13485 certiﬁed as well as RoHS compliant. With the FAULHABER Group’s ISO 14001 certiﬁcation, FAULHABER MICROMO provides the highest quality standards for the design, development and manufacturing of fractional horsepower drive systems for diverse markets.

TECHNOLOGY LEADERSHIP - IT ALL STARTED DECADES AGO WITH THE “FAULHABER COIL.”

Decades ago, Dr. Faulhaber patented the ﬁrst selfsupporting, ironless, skew-wound rotor coil, and the FAULHABER Drive Systems product portfolio evolved from this innovative motor technology, based on utilizing hollow, coreless, low-inertia rotor coils for maximum power and efﬁciency in the absolute smallest physical spaces. FAULHABER is the premier provider of micro motion control systems. FAULHABER’s product line includes fractional horsepower DC coreless motors, brushless DC motors, stepper motors, piezo motors, linear servo motors, precision gearboxes, high resolution encoders, fail-safe brakes, speed and motion controllers, micromechanical systems, and custom subassemblies that incorporate these products for integration into OEM devices.

IT’S ALL HERE IN NORTH AMERICA

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EXCELLENCE IN MICRO MOTION SOLUTIONS

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From concept to delivery, FAULHABER MICROMO (Clearwater, FL) provides it all. With on-site machining and assembly facilities, a versatile standard product line, an Advanced Engineering Group, and over 5,000 special executions, customization is our strength. FAULHABER MICROMO’s operations include a state-of-the-art CNC machining center, a 12,000 ft² clean room assembly operation (class 100,000 capable), and a design, R & D and engineering testing center. All application work is carried out by in-house engineering staff. FAULHABER MICROMO’s engineering team partners with customers for the design, speciﬁcation and after sales support of industry leading motion control products. Advanced online tools, such as the FDST (FAULHABER Drive Selection Tool) used for evaluating and selecting a variety of product conﬁgurations and performance options, combined with our easy online store, OEM engineers can easily and quickly purchase compact motion systems day or night. Plus, with our localized inventory, many products can be delivered in three days or less to meet immediate design and testing requirements.

Contact FAULHABER, and let’s get your application in motion, today! www.medicaldesignandoutsourcing.com

Reimagining Connectivity, Together. For more than 60 years, the people of Fischer Connectors have been reimagining connectivity. Every day, over 500 employees in 10 countries work to create innovative connectivity solutions that help design engineers around the world turn ambitious ideas into success stories. From the first push-pull connector in 1954 to our current range of five product series, we draw on our history of innovation to help shape the solutions of the future. We partner with customers in a variety of industries, including medical, solving their connectivity challenges to co-create reliable, high-performance devices. Our global headquarters are in Saint-Prex, Switzerland, along with our R&D center and modern manufacturing facilities. Our North American headquarters is located near Atlanta, GA, and is home to our assembled solutions engineering team, cable assembly teams, customer support, and services. It is ISO 13485 certified and ITAR registered. We also have cable assembly sites in EMEA and Asia, eight local subsidiaries and a wide network of distributors and agents all over the world.

The ﬁve series of rugged connectors from disposables to up to 10,000 mating cycles. Our products are manufactured according to rigorous and controlled processes - ensuring the highest standards of quality, every single time.

Here at Fischer Connectors, we believe that even a connector company can change the world. It may sound ambitious. But together with our customers, we’re already pushing the boundaries of connectivity. Our vision, mission and values put into words who we are, what we do, and why and how we do it. They’re a map for our future, as well as a reﬂection of our history. They are the way we see the world and the change we want to make in it. We believe that to make a difference, we mjust see things differently. We know from experience that the best ideas begin with asking, “What if?”

Our vision is to reimagine connectivity, helping turn ambitious ideas into solutions that shape the future. Our mission is to make our customers’ lives easier with a collaborative approach, tailored connectivity solutions and passionate employees who turn challenges into success. The values are a behavioral compass, guiding the way we work, the decisions we make and the way we treat others. Collaboration. Longevity. Entrepreneurial Spirit. Innovation. Respect. Excellence. They aren’t just words, they’re instructions for action. As a family company, we put human relationships at the heart of everything we do. Our experts around the world are passionate about making our customers’ lives easier through close collaboration, both internally and externally.

Fischer Connectors, Inc. 1735 Founders Parkway Alpharetta, GA 30009 678.393.5400

800.551.0121

mail@ﬁsherconnectors.com ﬁscherconnectors.com

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Freudenberg Medical is a global CMO / CDMO with 11 manufacturing operations and more than 1,500 associates worldwide. Manufacturing capabilities range from high precision molded components and medical tubing to drug coatings, ﬁnished devices, catheter shafts and hypotubes for minimally invasive, handheld, and catheter-based devices. ISO 13485 certiﬁed quality systems and FDA registered sites are located throughout the Americas, Europe, and Asia.

Freudenberg Medical has the experience and expertise to simplify your supply chain and get product to market faster. A global network of R&D and manufacturing facilities supports customers from material selection and design optimization to prototyping and mass production of components and ﬁnished devices. Freudenberg Medical has introduced a number of pioneering process and product innovations over the past year. These include: A groundbreaking extrusion technology, Helix iMC™ continuously measures the inner geometry of silicone tubes. Unique to the industry, it increases product quality for critical applications and dramatically reduces material waste and process time. HelixTwist™ multi-lumen tubing is designed to provide an equal balance of stress across the inner and outer lumens as the tube bends. Ideal for pacemakers, breathing tubes, and other applications which require navigation through tortuous pathways within the body.

Freudenberg Medical California • Indiana • Massachusetts Minnesota • Costa Rica • Germany Ireland • China info@freudenbergmedical.com www.freudenbergmedical.com

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As a materials specialist, Freudenberg Medical has developed a proprietary conductive silicone compound used for smart therapeutic devices that deliver electrical currents also to shield sensitive electronics. Freudenberg Medical holds 5 patents for minimally invasive technologies, these include the Composer® Catheter Handle Platform, hemostasis valves with variable diameter seals, and expandable introducer sheaths. Three next generation Product Solutions were just added to the portfolio – Composer® EPIC and Composer® Toccata Catheter Handle Platforms, and the HyperSeal® Mini hemostasis valve. Designed for medical device companies looking to accelerate time to market with commercialization-ready solutions. And announcing the latest in needle devices from Cambus Medical, Velona Custom & Specialty Needles for ﬁne needle aspiration, ﬁne needle biopsy, minimally invasive delivery systems, and structural heart applications.

www.medicaldesignandoutsourcing.com

WE MAKE INNOVATION POSSIBLE FUTEK specializes in creating inventive custom solutions for today’s leading tech innovators. Our sensing and testmeasurement instruments have been to Mars and below the sea, they save people’s lives and even help read their minds.

We have a fearless approach to new projects because we have the expertise to back it up. Our unique combination of innovation, honesty, quality, hard work and great people make it possible. FUTEK is helping progress the emerging technologies by providing advanced standard and custom load, force, torque, and pressure measurement solution along with the signal conditioning electronics. The application environment of these solutions can be standard to extremely demanding in terms of very low to very high temperature and pressure, as well as non-magnetic, corrosive, and autoclavability requirement. The secret to our success has been in establishing a quality culture. With high quality comes meticulous attention to all details. This quality standard drives every stage of design, development, and production. We are so passionate about our quality assurance that we guarantee our products meet and exceed the quality clauses outlined by the International Organization of Standardization (ISO). We proudly carry certiﬁcations in the following ISO standards: 9001, 13485, and 17025. We aim to provide the most precise sensor solution for your speciﬁc project. Part of the FUTEK experience is having a thorough support team available to our customers, including pre-application R&D consultations, as well as post-sales technical support.

FUTEK Advanced Sensor Technology Inc. 10 Thomas Irvine, CA 92618

If you have a test-measurement application or control feedback need, please don’t hesitate to contact us for support. Again, we are in the business of creating solution.

Tel: (949) 465-0900 http://www.futek.com/

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Custom Hard Cases designed from the inside out. Gemstar® Custom Hard Cases is an engineering-based solutions provider with over 50 years of manufacturing experience and protective packaging knowledge. We are a US-based, family-owned business with a history rooted in custom manufacturing to meet the containment, portability and protection demands of rugged applications ranging from aerospace, communications, electronics, industrial, military, medical and instrumentation. With three distinct hard case technology platforms, hundreds of standard sizes, and comprehensive capabilities for full custom development, Gemstar cases are designed, made-toorder and tested to meet a host of stringent industry and military speciﬁcations for durability, such as IP67 and MIL-STD 810.

Gemstar® Custom Hard Cases 103 Mensing Way Cannon Falls, MN 55009 Phone 507-263-4770 Fax 507-263-3129 Toll Free 800-533-3631

Gemstar has deep experience designing transportable and protective medical cases for applications ranging from AEDs to telemedicine to ﬁeld-based units for ﬁrst responder care. Our customer applications have been designed to accommodate protective, transportable instrument containment, to complete integration of PCs, electronics and medical diagnostic equipment intended for diverse deployments in emergency care, mobile health clinics and disaster response sites. For custom medical cases, ease of use can be just as important as device protection. Gemstar’s intuitive design approach focuses on the user, allowing us to help determine the best layout where quick access to equipment is vital. Custom-designed panels can be manufactured for mounted electronics, as well as hinged storage compartments, external digital ports and integrated security measures. Our engineering and testing teams also understand product and instrument fragility and can help design the optimal shock-absorbing system to protect your equipment and meet the demands of real-world and mobile applications. Gemstar’s manufacturing capabilities include:

International +1-507-263-4770 gemstarmfg.com

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Custom Hard Cases for Demanding Medical Applications.

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Exclusive Robotic Rotational Molding Technology

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Rotational Molding

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Injection Molding

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Thermoforming

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Foam Fabrication

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3 Axis, 5 Axis, and Robotic Machining

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Comprehensive Secondary Fabrication and Assembly

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CAD Support and 3D Rapid Prototyping

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Testing to ASTM, MIL-STD, ISTA, ATA and other critical standards

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Extensive lab capabilities for testing and certiﬁcation

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www.medicaldesignandoutsourcing.com

Halkey-Roberts is a leading supplier of plastic components and subassemblies used for fluid and gas management in disposable medical devices. We supply all of the major OEM medical device and Life Science companies worldwide. We are ISO 13485 certified and manufacture to GMP standards. Our standard and customized medical valves include those used as substitutes for needle ports in IV and drug delivery applications, catheter balloon inflation valves, tubing clamps, tubing flanges, fill and drain closures, hand pumps and pressure relief valves. Halkey-Roberts has supplied high quality products for over 75 years. We pioneered the use of plastics in the medical device industry when we introduced the Roberts’ tubing clamp decades ago. We continue to provide innovative solutions to the Medical Device and Life Science markets worldwide.

Our comprehensive line of high ﬂow, split septum swabable valves feature a unique and innovative patented design that allow the valves to be used in a wide variety of

We have the technical and ﬁnancial resources to invest in new product development and the automation it takes to produce high-quality products at the lowest possible price point. We understand the value of providing an economical solution that solves a problem and addresses a need in the market.

demanding applications where high ﬂow and a closed system are a must.

Our design and manufacturing groups work hand-in-hand utilizing concurrent engineering methodologies to minimize the product development cycle. Our vertical integration, meaning we mold and assemble most everything in the same facility, demonstrates our expertise in the vast array of engineering disciplines from mold building, automation, machine vision and materials.

Halkey Roberts Corporation 2700 Halkey Roberts Place North St. Petersburg, Florida 33716 www.halkeyroberts.com

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We also understand the concept of mass customization. We combine your idea with our in-depth product knowledge and expertise in ﬂexible automation to provide a custom product at a low unit production cost. This helps our customers differentiate their end products and provide their clients with truly custom solutions.

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Precision Metal Components for Medical Devices Hobson & Motzer’s world-class facilities offer the most advanced technology in metal transformation and assembly. With more than 100 years of precision manufacturing experience, we have the capabilities and infrastructure to deliver on critical projects. Our commitment to lean and continuous improvement results in superior quality, as well as exceptional supply chain performance and customer satisfaction. Our extensive tool design and engineering expertise drives repeatability and efﬁcient production. We offer precision rapid prototyping and projectbased support, from concept to completion. Medical device components include endomechanical, electro-surgical, pharmaceutical, ophthalmic blade blanks, custom electrical contacts, and more.

Improving Lives. Advancing Technology. Transforming Metal. Performance When It Counts As a trusted supplier to OEMs, we drive the latest thinking in manufacturing through innovation and technology. We are often relied upon to make the impossible possible—or pick up where others have failed.

Hobson & Motzer 30 Airline Road Durham, CT 06422 1-860-349-1756 www.hobsonmotzer.com

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Our company is vertically integrated with key competencies in metal stamping, and 3-, 4-, and 5-axis high-speed CNC machining, PECM, laser cutting, welding, and assembly services. We also perform a wide range of secondary operations, all in house: pad printing, PTFE coating, metal ﬁnishing, electro polishing, and more. We have an extensive team of toolmakers and a highly equipped tool room—all supported by industry-leading design engineers and skilled project managers. Our plants are highly automated, featuring robotic automation technology that is engineered, designed, built, and supported in house. Vertical integration is a solid strategy—but listening to the needs of our customers has truly been the driving force behind our manufacturing depth. We invest in the right equipment, resources, and people to successfully develop in-house expertise. This ensures the highest quality end-to-end, so medical device OEMs can have conﬁdence in our precision, our consistent quality, and a robust supply chain. www.medicaldesignandoutsourcing.com

Kicking off an NPD project?

Get your project off on the right foot with First Step, a new program from Hobson & Motzer developed with your needs in mind.

1-800-476-5111

Driven by innovation and expertise. Proven by manufacturing excellence and quality. Integer® is a world leader in advanced medical device outsourcing, bringing unparalleled expertise and comprehensive solutions in innovation and manufacturing to customers. We have a rich, 80-year history of innovation shaped from the legacy of Greatbatch Medical® and Lake Region Medical® that serves our customers with an unmatched breadth and depth of capabilities. We leverage our global presence, vertical integration, and extensive design and manufacturing

Integer’s global workforce brings a depth of knowledge to every step of the product development process. We are a trusted partner to many of the world’s leading medical device companies who depend on our 600+ engineers, along with thousands of skilled machinists, toolmakers, and quality and regulatory professionals, to create the right solution for your products. Our 15 manufacturing sites, located in seven countries, operate under multiple ISO certiﬁed systems and are committed to ensuring the products we produce meet or exceed the highest standards set by the FDA, the European Community and other internationally recognized agencies. Additionally, with full control of the product’s supply chain and dual-site manufacturing capabilities, our partners receive unparalleled service.

know-how to partner in the development of quality components to complete systems.

From concept to completion, our stable supply chain, world-class manufacturing facilities and delivery performance are focused on providing customers the high-quality devices they rely on. A full-service technology partner, Integer is uniquely equipped to support critical steps across the product lifecycle. We aspire to be our customers’ partner of choice.

Integer 5830 Granite Parkway Ste 1150 Plano, TX 75024

Our broad capabilities and expertise include:

www.integer.net

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Research Design & Development Testing & Certiﬁcation Expertise Rapid Prototyping Quality & Regulatory Expertise Commercialization Global Medical Device Manufacturing Vertical Integration Strategic Sourcing Supply Chain Management

Visit integer.net to learn more.

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We Create High-Impact Med Devices & Diagnostics Integrated Computer Solutions (ICS) helps medical device and life science innovators create transformative products that advance patient care and help in the fight against COVID-19. We offer compliant medical platforms, services and full product realization focused around embedded, desktop and companion mobile where usability, precision and validation are safetycritical. Companies like MilliporeSigma, Thermo Fisher, Johnson & Johnson, Boston Scientific and Breas Medical are among those that look to ICS to help create gamechanging products with modern UIs, such as defibrillators, radiation therapy systems, infusion pumps, respiratory and intelligent ventilation devices, and complex scientific software applications.

ICS offers deep domain expertise, specialized tools and a tightly coupled suite of services to accelerate development and testing of your medtech solution. Our dedicated medtech practice comprises user experience (UX) designers, software engineers, human factors engineering (HFE) specialists and regulatory experts developing with processes that are ISO 13485-compliant. ICS’ work spans modern user interfaces, connected products and touchscreen-enabled applications — everything from high-performance medical devices, in vitro diagnostic instruments and scientific software. We offer end-to-end product design and development, including HFE, UX design, custom software development, cloud connectivity and analytics, proprietary codegeneration tools, software and hardware architecture assessment, and verification and validation testing. By partnering with our team, you’ll benefit from accelerated time to market, decreased development inefficiencies, cost savings from enhanced usability/ reduced use error, and lowered development risk.

Integrated Computer Solutions 230 2nd Avenue Waltham, Massachusetts 02451 https://www.ics.com/medical

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www.medicaldesignandoutsourcing.com

International Polymer Engineering (IPE) provides high-quality design, engineering, and manufacturing services for many different industries through custom proﬁle extrusions made from FluoroFlex™ ePTFE and a variety of melt thermoplastic materials. We also manufacture a variety of other products such as sutures, biopsy channels, light guide covers, and CO2 sensor covers. The mission of IPE is to provide our customers with innovative, consistent, high-quality products and services that consistently exceed the expectations of our customers. This is accomplished through continually examining and reviewing our existing products and researching and developing new materials

International Polymer Engineering

and technologies. IPE is your total solution provider!

International Polymer Engineering, Inc. (IPE) 2445 West Medtronic Way Tempe, Arizona 8528 Toll Free Phone: (877) 410-3265 Phone: (480) 967-3265 Fax: (480) 929-9799 www.ipeweb.com

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(IPE) is one of the only companies worldwide that engineers custom FluoroFlex™ ePTFE and thermoplastic extrusion solutions for the most demanding applications. IPE utilizes advanced engineering solutions, creativity, and experience to provide the best possible solutions to our customer’s specific requirements and specifications across a wide variety of industries. We accurately control the function and form of ePTFE to meet almost any porosity, density, barrier, instrument delivery, and bending section for applications such as filtration, medical device covers, implants, and dental components, among others. We also specialize in the bonding of ePTFE to other materials (metal, plastic, etc). We are experts in providing the best solutions for lubricity, caustic chemical resistance, flexibility, low profiles, and the shift away from ferrous materials. We use the latest in polymer technology, equipment, and technique to offer a wide range of fabricating capabilities, reduce costs, and shorten lead times for the manufacture of all of our tubing, rods, and sheets. IPE is an ISO 13485:2016 certified company. Our testing and analysis procedures ensure that all of our products meet the stringent quality standards that our customers require. We constantly inspect for any particulate matter that may limit performance in your application. Our Class 10,000 clean rooms assure you of our attention to detail and minimizing particulate contamination.

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Interpower® is the premier supplier of

power system components offering a full line of North American and international products, including hospital-grade products, power cords and cord sets, IEC 60320 inlets and outlets, accessory power strips, power entry modules, cable, plugs and sockets, the Interpower International Power Source, plus more. There are no minimum order or dollar requirements, same day shipping on in-stock Interpower products, and a 1-week U.S. manufacturing lead-time on non-stock Interpower products. All Interpower manufactured products are made in Iowa and 100% tested.

Design. Easy. Fast. We at Interpower® want to make it easy for you to design,

build, and maintain products for North American and global markets—that’s our mission. We strive to provide our customers with quality products that delight— FAST. Designing products with the global customer in mind can give a company a competitive advantage and may increase customer relations. It’s imperative that companies know that their products will function properly in the areas they are meant to be used. As the premier supplier of AC power system components, Interpower hospitalgrade products are designed for use in medical settings throughout the world. We have an extensive range of clear, black, and gray plugs along with IEC 60320 C13 and C19 connectors available in ﬁve different conﬁgurations (straight plus four angles). Connector locks can help prevent accidental removal or interruption. For those products that will be used in North America, they are UL and CSA approved and carry the green dot.

Interpower® Group of Companies P.O. Box 115, Oskaloosa, IA 52577-0115 (800) 662-2290

Interpower offers a 1-week U.S. manufacturing lead-time on non-stock Interpower products. We have same day shipments on in-stock Interpower products and no minimum order or dollar requirements. Interpower manufactured products are made in Iowa and 100% tested. Free technical support at Interpower is available. Please check our website at www.interpower.com, e-mail us at sales@interpower.com or contact Customer Service at (800) 662-2290.

sales@interpower.com www.interpower.com

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Additionally, we carry power cords and cord sets, accessory power strips, cable, IEC 60320 inlets and outlets, power entry modules, and more! We offer valueadded options such as specialized packaging, labeling, cord lengths, and colors.

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INTROTEK INT’L designs, manufactures and markets non-invasive ultrasonic air bubble and liquid level detection systems Beginning operations in 1981, we became a wholly-owned subsidiary of Magnetrol International—a worldwide leader in industrial level and flow instrumentation in 1986. Since then the companies have engaged in collaborative R&D efforts for the enrichment of both firm’s product lines. Introtek’s production operations represent the leadingedge in manufacturing. Our manufacturing practices conform to the identical standards as those of medical device manufacturers. An ISO certified company, our quality system is also TUV certified to meet the established requirements for the development, production and distribution of our complete product line. Introtek stands behind the quality of every product with a three-year product warranty. Whether you require standard or custom designed sensors and electronics, our comprehensive design and manufacturing capabilities—along with our solid record of O.E.M. service proficiency—will provide you with the most reliable ultrasonic-based detection products available today.

INTROTEK, the Global leader for over 40 years, has produced non-invasive, ultrasonic air bubble detectors, continuous liquid and point level sensors, and optical blood component detectors for companies in industries such as medical device manufacturing, chemical processing, pharmaceutical development, clinical laboratories and food & beverage manufacturers. Since it’s early conception, Introtek has maintained its commitment in providing safe, reliable products to ensure customer satisfaction. Our products lead the way in meeting O.E.M. customers’ needs for sensors and electronics that are compact, accurate, highly reliable and reasonably priced. Introtek’s standard sensors attach at the desired point of detection to the outside of stainless steel, or rigid and ﬂexible plastic Introtek’s Engineering Design Team specializes in taking custom requirements from concept to completion using highly innovative ideas, while working closely with the customer in order to obtain maximum results. Introtek’s AD8 / AD9 / ADU Integral Ultrasonic Air-In-Line, Air Bubble Sensors incorporate Introtek’s latest generation “MEC” pulse-type ultrasonic circuitry. The microcontroller based circuitry is located integrally in the sensor assembly. AD9 ADU Custom algorithms to control functionality, such as response times, time delays and more can be designed at Introtek based on customer requirements. ADU Series Sensor for nonstandard soft tube sizes between 1/8”- 3/18” where standard AD9 housings are not available and can eliminate tooling costs for low volume requirements for some odd sized tubes.

Introtek International 150 Executive Drive Edgewood, New York 11717 Phone: 631-242-5425 Fax: 631-242-5260 General E-Mail: info@introtek.com Sales: sales@introtek.com https://introtek.com/ https://introtek.com/intropro-occlusiondetector/ https://introtek.com/productslist/

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INTROTEK® Drip Chamber and Drip Level Detect Sensors are custom designed for use with a variety of drip chambers or larger OD tubing to overcome conditions such Point Level Sensor as relaxation, slippage or vibration, which would normally cause false air alarms. These sensors are designed to meet OEM form, ﬁt and functional speciﬁcations. Sensors are available with integral or remote circuitry and panel mount or Drip Detect Sensor self-standing designs.

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Introtek’s line of Non-invasive Liquid Level Detectors provide the ultimate solution for almost any liquid level detection application.

PLD

CLD

Introtek’s PLD – Point Liquid Level Detector is extremely user-friendly with a sleek compact, non-invasive design, incorporating integral electronics that never require calibration. The PLD is the most advanced pulse wave, ultrasonic sensor available for liquid level detection, emphasizing reliability, accuracy and repeatability. Introtek’s CLD – Continuous Liquid Level Detector is a pulsed ultrasonic, continuous level sensor, scalable for small to large vials, containers and tanks for industrial, laboratory, pharmaceutical medical & beverage applications. Our unique, non-invasive design enables the liquid level from the bottom of vessel to be monitored quickly, accurately and dependably. Introtek’s IntroPro non-invasive occlusion free-entry detection devices accurately monitors tubing IntroPro occlusion in soft tubing. When tubing within an application becomes blocked (occluded), the result is a change in pressure within the tube. These variations in tubing pressure is detected using a passive device output non-invasively with the freeentry IntroPro Occlusion Detector. This type of detection is considered critical in improving processes for various applications.

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Custom Automation Machinery Solutions CELEBRATING OUR 100TH ANNIVERSARY.

Kahle is the only automation company in the world that focuses exclusively on custom automated assembly equipment for medical and pharmaceutical devices. Dedicated to providing custom automation solutions for the Medical Device, Pharmaceutical and Healthcare Industries. For nearly a century, Kahle has shaped the industry through the use of innovative technologies and we bring this experience to your project. Today, we create systems that handle, assemble, inspect, test and package every medical device imaginable – from syringes, tubing sets and catheters and needle products to diagnostic, pre-ﬁlled and pharmaceutical devices.

Kahle Automation 89 Headquarter Plaza North 3rd Floor Morristown, NJ 07960

Successful automation requires an automation partner who truly understands the process of manufacturing medical devices. Regardless of whether you’re looking for a system that assembles thousands of devices per minute, improves the quality and consistency of your manufacturing process or whether you’re simply trying to maximize the space in your clean room, Kahle has the technical solutions to meet your goals. Every year, Kahle dedicates over 182,500 man-hours to designing automation systems that manufacture medical devices. This effort has resulted in the largest portfolio of proprietary automation technology in the entire industry. From this portfolio, you can choose from continuous, indexing and asynchronous motion assembly platforms that feature the latest innovations in mechanical, pneumatic and robotic assembly with premium inspection and process control operations. This flexibility allows us to create cost efficient, effective systems for projects of every size. Beyond creating the ideal assembly system for your project, your Kahle team is also focused on getting your machine validated promptly and transitioned efficiently into production. Further, we want to make it easy for your employees to be trained to operate and maintain the equipment. In addition your Kahle machine arrives with the best quality and validation documentation in the industry.

www.KahleAutomation.com

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HELPING ENGINEERS SUCCEED

JW Winco, Inc., A Ganter Company, is a leading supplier of Standard Industrial Machine Components and Assembly Hardware that also specializes in offering value-added services to engineers. Standard parts are extremely versatile in their application and therefore can offer great opportunities. An increased use of standard parts greatly reduces the costs of product development and in turn, provides the engineer with more time to devote on larger project requirements. The engineers can concentrate on the actual machine or equipment design, as standard parts can costeffectively be procured externally. The wheel does not have to be reinvented, and the creativity in developing can be the focus again.

GN 8170 Hygienic Design Indexing Plungers

GN 8170 stainless steel indexing plungers are intended for use in hygienic areas. The seals keep the part protected from bacteria entering into the mechanism or assembly. The HNBR seal and the high surface quality aid in preventing dirt and bacteria from adhering to the part and facilitates cleaning. They are available in lock-out or non lock-out types with a sealing lock nut that creates a totally hygienic version. Find out more at www.jwwinco.com.

GN 44 / 45 Stainless Steel AISI 316L Leveling Feet GN 44 / 45 leveling feet are intended for use in aggressive environments. The wide range of possible combinations of the base and the adjusting spindle variations make these leveling feet universally applicable. The base with the rubber pad/cap protects sensitive surfaces and reduces lateral slippage. The GN 45 leveling feet can be screwed to the mounting surface using the lag bolt hole, which prevents lateral slippage. These leveling feet are supplied fully assembled and cannot be disassembled. Find out more at www.jwwinco.com.

JW Winco offers catalogs or digital part libraries that users can access quickly. Along with an extensive selection of high-quality parts, JW Winco strives to make an engineer’s job easier. The company’s mobile-responsive website at www.jwwinco.com is dedicated to providing the customer with modern navigation and usability that also allows visitors to see product availability. Features include ﬁltering capabilities to ﬁnd products faster and easier, the ability to build and price parts to easily create the standard part required for the design, and free CAD download in all common 2D and 3D CAD formats. Customers can not only check product availability and pricing online, they can set up an account or make a purchase easily 24/7 with a credit card. JW Winco prides itself on its knowledgeable technical sales associates who provide assistance with products and applications. Customer service is a top priority. To provide customers with complete solutions, JW Winco also offers secondary machining, special kit packaging, and bar coding.

EN 628.1 Antibacterial Ergostyle® Bridge Handle

EN 628.1 Ergostyle® Bridge Handles are manufactured from a new antibacterial plastic. Adding a silver-based substance has created a natural active agent that helps to prevent the growth of bacteria. Even after repeated cleaning with soap or solvent, the antibacterial effect of this additive will not diminish. Sterilizing at temperatures below 130 °C (266 °F) will also have no effect on the antibacterial property. With these properties, the handles are the perfect choice for use in medical engineering, in the food and the pharmaceutical industry, and in general wherever hygiene is of great importance. Resistant to solvents, oils, grease, and other chemical agents. Cover caps are supplied but not assembled (press-ﬁt, removable with screwdriver). Find out more at www.jwwinco.com.

For more information, visit www.jwwinco.com, call 800-877-8351, fax 800-472-0670, or email sales@jwwinco.com.

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Our custom design and precision manufacturing capability are supported by a complete machine shop staffed by a professional crew of toolmakers who utilize Dessault Systemes Solid works for design, and Charmilles EDMs for tool and die production. This allows us to build, maintain, and repair all tools utilized in our production areas. We design and build many of our own high speed, automated, spring manufacturing machines. This “on-site” capability further reduces cost and lead time for our customers.

Spring Design & Manufacturing Excellence John Evans’ Sons, is the international leader in the design and manufacturing of constant force springs, constant force spring assemblies and precision specialty springs for the medical device industry.

We have been recognized for outstanding design, quality and on-time delivery by major medical device manufacturers. Some examples of products that have utilized our design and engineering include:

We are a trusted medical device industry

• World class surgical robots

spring supplier, as evident by our

• Surgical staplers

commitment to manufacturing excellence.

• A wide range of various medical device assemblies and support equipment

All of our products align with strict quality standards. We are ISO 9001 and ISO 13485 certiﬁed.

With respect to the medical device industry, we offer several counterbalance options to assist/enhance articulated instruments and assemblies, many medical equipment designers utilize constant force springs, constant force spring motors, spiral torsion springs or spring reels. The capabilities of these products have signiﬁcant beneﬁts compared with traditional helical springs and gas springs.

Constant Force Springs • Constant load • Smooth range of motion • Minimal starting force

Spiral Torsion Springs • Develops high torque • Rotation in two directions • Compact, easily mounts in many designs

Spring Powered Reels • Wide range of forces, cable lengths, & travel

John Evans’ Sons, Inc.

• Mounts quickly & easily

1 Spring Ave.

• Metal and plastic available

Lansdale, PA 19446 www.springcompany.com

We provide impeccable service from start to ﬁnish and set the standard for world-class precision spring products.

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INSPIRING SCIENCE, ENHANCING LIFE As a global leader in sustainable technologies, we apply our cutting-edge science to create solutions with our customers that make a real difference to the world around us. We’ve been leaders in our field for more than 200 years, applying unrivalled scientific expertise to enable cleaner air, improved health and the more efficient use of our planet’s natural resources. Johnson Matthey Medical Device

Johnson Matthey is a world leader in manufacturing of components for the medical device industry. We combine expertise in material science, mechanical engineering, and precision manufacturing to deliver a broad portfolio of Precious Metal alloys and Nitinol components to medical device manufacturers. Johnson Matthey partners with leading medical device manufacturers to support their demanding needs of a competitive, fast paced healthcare marketplace.

Components provides Precious Metal Alloy and Nitinol components for use in a broad range of medical markets including but not limited to; Cardiac Rhythm Management, Neuromodulation, Structural Heart, and Neurovascular. All of our medical components manufacturing sites operate

Johnson Matthey is an expert in all areas of precious metal alloys beginning with the PGM sourcing and providing our customers with risk management strategies including reﬁning, recycling services of their scrap. Additional PGM capabilities include: Seamless Tube Drawing, Bulk Fine Wire Drawing Machining Rod, Sheet & Foil Rolling, Advanced Tube Cutting Methods, Laser Cutting Capabilities, CNC Machining, and our Center for Coating & Surface Solutions. JM Nitinol capabilities include Seamless Nitinol Tube Drawing, Nitinol Sheet/Foil Rolling, Nitinol Shape Setting, and Laser cutting.

under ISO-9001:2015 and ISO-14001:2015 certiﬁcations.

Johnson Matthey, Inc. 1401 King Rd West Chester, PA 19380 http://www.matthey.com/medical

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Johnson Matthey provides the highest achievable quality of products and services. We accomplish this through rigorous processes, continual improvement and maintaining effectiveness at all times. We offer a global presence, ﬁnancial stability and advanced manufacturing in today’s medical markets, in addition to investing in emerging technologies to support our vision of a cleaner, healthier world today and for future generations.

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Quality Interconnect Components and Electronic Hardware Leading–edge technology and precision manufacturing have defined Keystone’s performance as a world-class manufacturer of precision, electronic interconnect components and hardware since 1950. Keystone Manufactures precision stampings and specializes in progressive dies, four slides, wire forming, in-die tapping, and high-speed blanking. Assembly procedures include eyeleting, riveting, staking, swaging, inserting, crimping and screw insertion to assemble components into finished products. Our Product Design Guide M70 features products for OEM Designers and Engineers who create/develop state-of-the-art electronic products/instruments/systems. Our Custom Manufacturing Division provides modifications and custom fabrications and is fully integrated with in-house, precision tool and die shop that utilizes the latest CAD/CAM and 3D modeling software to provide close tolerance Stamping, Machining and Assembly services. Keystone is ISO 9001:2015 certified and RoHS/ REACH compliant with USA headquarters and offices in Canada, Europe, Australia and Asia. Visit our website for our Dynamic Catalog of Products or to request our Product Design Guide M70.

Battery Clips, Contacts, Holders & Retainers

Advances in portable electronics and LithiumIon battery technology demand dependable battery connections. Keystone leads the way with a vast range of reliable, high-quality, costeffective products for most battery types.

Test Points & Terminals

Low profile and limited board space drive today’s PCB connectivity designs. Keystone is the right fit with UL Recognized Quick-fit Male and Female PCB terminals, Snap-on, Snap-Fit and PCB Screw Terminals as well as SMT and THM Test points and Jumpers and more.

Fuse Clips & Holders

Fuse connectivity products for Electronics, Datacom, Telecom, Automotive and Solar use. Keystone offers Surface Mount, Thru-Hole and Rivet Mount products for Cylindrical, Automotive and Subminiature fuses.

Spacers, Standoffs/Supports

Diverse insulated and non-insulated spacers and standoffs are available in a wide range of lengths, thread sizes, hole sizes, mounting styles & materials. Choose from English or Metric type products for your PCB, panel and mounting applications.

55 South Denton Avenue New Hyde Park, NY 11040 800.221.5510 or 516.328.7500 www.keyelco.com

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Pins, Plugs, Jacks & Sockets

Keystone’s USB 2.0, 3.0 & 3.1 Jacks & Plugs, Micro Pins/Jacks, Banana and Phono Plugs & Jacks are designed for use in the latest Mobile & Computer Electronics, Home Theatre, Test Gear and Industrial Interconnects.

www.medicaldesignandoutsourcing.com

Multipurpose and Panel Hardware

Check out the diverse selection of Panel and Mounting hardware Keystone is well known for. Fan Filters & Guards, LED Lens Caps, Holders & Spacer Mounts, Jack Screws and Connector Hardware, Instrumentation Handles, Cable Clamps, Knobs and more.

Founded in 1918, Lee Spring is

Lee Spring manufactures and distributes mechanical springs, wire forms, stampings and fourslide parts worldwide. Our extensive print and online catalog offers over 25,000 inventoried products in a variety of materials. From 10 springs to 10 million springs, Lee Spring is a premier global source for stock catalog and custom designed mechanical springs and related products.

headquartered in New York, with multiple locations in the United States, Mexico, Europe, India and China. The Lee Spring brand sets the standard for excellence

Lee Spring continues to respond to the voice of the customer with advanced Custom capabilities and unique Stock products such as LeeP™ Plastic Springs, Bantam™ Mini Springs, Lite™ Pressure Springs and our latest expansion of Stainless Steel 316 springs. All stock products are available through our website or our print catalog.

through bold product innovations, quality manufacturing and responsive customer care. Lee Spring takes pride in creating solutiondriven responses. The Lee Spring Sales Team,

•

We make it easy - exceptional personal attention

Engineering Team and Manufacturing Team

•

We have it - over 25,000 catalog products

collaborate to develop application speciﬁc

•

We can design it - engineering expertise

resolutions.

•

We can make it - extensive custom manufacturing capabilities

Lee Spring understands the value of our customers for well qualiﬁed engineering support. Lee Spring engineers can offer assistance from design conception through project completion. Extensive expertise in spring design and mechanical engineering complement our customers’ design teams. Lee Spring’s expanding global presence and in-depth knowledge of the worldwide

CUSTOM SPRINGS

Online CAD Downloads

Prototypes to Production Runs

Free Ground Shipping Options Available

Turning Ideas Into Reality

Over 25,000 Stock Springs

marketplace puts Lee Spring at the leading edge of creating market speciﬁc solutions for customers’ needs.

www.leespring.com

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Over 25,000 Stock Imperial and Metric Designs

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Free CAD Downloads

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Wire Forms, Stampings and Springs

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Pull/Kanban Capabilities

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CAD Assisted Product Design, Drawing & Modeling

Live Engineering Support

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Live Engineering Support

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Free Ground Shipping in Continental U.S.

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Free Passivation on Stainless Steel Springs

In-House Prototype Production Services

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Free Plating on Music Wire Springs

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Free Material & Chemical Certiﬁcation

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Free Grinding on Standard Compression Springs

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Free Certiﬁcates of Compliance

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In-House Tooling Production Including EDM

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Governmental and Industrial Regulatory Expertise

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Global Supply Chain Network

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Long or Short Runs

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Proprietary Quality Control System

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Free Certiﬁcates of Compliance

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Guaranteed RoHS & Reach Compliance

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Online or Phone Ordering

•

Inch and Metric Designs

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LEMO®, founded in Switzerland in 1946, took its name from the company founder, engineer Léon Mouttet. Originally a manufacturer of contacts in noble and rare metals, the company took a major step forward in 1957 with the introduction of the push-pull self-latching connector. REDEL, LEMO’s plastic connector solutions for medical device interconnect companies, are one of LEMO’s top selling product lines due to their high-quality and reliability. These connectors can be found in wearable electronics, catheters, scopes, surgical robotic navigation, x-ray equipment and dental equipment. LEMO purchased Northwire, Inc., a wire and cable manufacturer, in the Summer of 2014, for the ability to offer a complete solution.

LEMO USA, INC. 635 Park Court, Rohnert Park, CA 94928 USA 707-206-3700 info-us@lemo.com

The Original Push-Pull Connector

www.lemo.com

LEMO is the acknowledged leader in the design and manufacture of precision custom connection and cable solutions. LEMO’s high quality push-pull connectors are found in a variety of challenging application environments including medical, industrial control, test and measurement, military/aerospace/aviation, audio-video, and telecommunications.

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LEMO has been designing precision connectors for seventy five years. Offering more than 75,000 combinations of product that continues to grow through custom specific designs. LEMO, and it’s affiliated sister companies REDEL, NORTHWIRE and COELVER, currently serve more than 100,000 customers in over 80 countries around the world. LEMO USA recently acquired ISO13485:2003 Certification for the medical cable assembly

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Optimized Step Motors and Motion Control Products for Your Speciﬁc Application

Lin Engineering will grow with your needs.

Lin Engineering designs and manufactures BLDC, Stepper, Frameless, and Slotless

Lin Engineering is capable of producing step motors and motion control components that will ﬁt your speciﬁc requirements. They will also scale with your needs--from small bath volume to OEM quantities. Their line of standard products and specialty products will meet your exact requirements. They will deliver optimum torque, high precision, reduced resonance, or provide a product that can operate in various environments such as vacuum, hot/cold environment, or even submersion.

motors as well as provides motion control components. Their motors and products are routinely used in medical, aerospace, automation, and many other applications because their products can be optimized for each speciﬁc application. This is why thousands of Engineers from around the world trust the accuracy, reliability, and consistency of their products and their top-notch support.

For high-volume orders, they can works directly with your engineering team throughout the design phase of your project to ensure the best overall system optimization and motor ﬁt while avoiding over-engineering. Their experienced engineers can help you eliminate costly complexities and overdesigning while keeping in mind future developments and improvements.

LIN ENGINEERING

Their Northern California manufacturing facility doubles as their prototyping facility, which means their engineers work within the premises of the manufacturing facility, and have access to the same tools that will be used to produce your motor in volume.

MOTOR SPECIALISTS IN MOTION A

COMPANY

Lin Engineering 16245 Vineyard Blvd Morgan Hill, CA 95037

This gives them a much higher ﬂexibility to try out different components and windings to ensure the motor will perform at its best. This also ensures that prototypes operate the same as the manufactured parts. Plus, they test each motor in real time. Best of all, they can grow with your needs. The beneﬁt of having multiple manufacturing facilities—within the United States and in Asia— allows them to maintain whatever volume you need, as well as handle spikes with minimal concern.

www.LinEngineering.com

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Marshall is a Medical Device Contract Manufacturer Marshall Manufacturing Company is a contract manufacturer serving medical device OEM’s throughout the world. We’re located in the heart of “Medical Alley”. We are 13485 registered since 2010.

Marshall Manufacturing Company is a World Leader in the art of

CNC Swiss & Mirco-Swiss: We provide our customers micro-parts by utilizing CNC microSwiss machines.

CNC 3D Bending. Our capabilities

Laser & EDM: Other methods of precision material removal at Marshall include CNC Laser Tube Cutting and CNC Wire EDM.

OEM’s in the manufacturing of their

Wire & Tube Bending: CNC 3D Bending of pre-machined small diameter wire and tubing remains one of Marshall’s specialty services. Laser Welding: For the permanent assembly of small machined and laser cut components, Marshall offers CNC Laser Welding.

in bending small diameter premachined wire and pre-laser cut tubing serve many medical device medical products. Marshall provides Swiss machining, micro-Swiss machining, laser tube cutting and 3D-bending services to customers throughout the United States, Europe and Asia. Supplying our customers with medium to high volume production quantities, Marshall offers solutions

Automation: Marshall is constantly automating processes.

to complex bending of precision machined wire and tubing. Utilizing laser alignment, proximity sensors or probes, we have the ability to orient speciﬁc bend radiuses to machined and laser cut features. The robotic arm of our CNC bending machine can then orient these features into

Marshall Manufacturing Company

their appropriate position within the bending operation.

3820 Chandler Dr Minneapolis, MN 55421 612-788-9621 www.marshallmfg.com

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Master Bond is celebrating 40 years of formulating cutting edge adhesives, sealants, coatings and potting/encapsulation systems for challenging medical device applications. High Performance Adhesives, Sealants & Coatings Our expansive line of epoxies, silicones, UV curable and LED curable compounds can be customized to meet a myriad of property requirements including: • • • • • • •

High/low temperature resistance Electrical conductivity/insulation Thermal conductivity Sterilization resistance High/low viscosity Flexibility and toughness Optical clarity

Developed to withstand harsh environmental conditions, our products feature superior longterm durability. They are used in a variety of industries and are designed to meet stringent industry standards and are certiﬁed for: • • • • •

USP Class VI ISO 10993-5 NASA low outgassing FDA CFR 175.300 & FDA CFR 175.105 UL 94V-0 & UL 94V-1

Outstanding Customer Support Master Bond makes customer support a fundamental priority in the adhesive selection process. Our technical specialists have decades of experience and will work with you, one-on-one, throughout the design, prototyping and manufacturing stages of your application.

MasterSil 912Med: Biocompatible Silicone Passes USP Class VI Testing

MasterSil 912Med is a single component silicone with a paste viscosity offering a non-corrosive, neutral cure. Complying with USP Class VI and ISO 10993-5 speciﬁcations, it resists many kinds of sterilization including gamma radiation, EtO and some types of liquid sterilants. MasterSil 912Med withstands rigorous thermal cycling as well as thermal and mechanical shock.

UV15DC80Med: Features Superior Sterilization Resistance

Master Bond UV15DC80Med is a special dual cure epoxy based system that offers a primary cure using UV light along with a secondary heat curing mechanism. This enables the adhesive to cure areas on parts that do not allow UV light curing because of “shadowing” issues. It also meets USP Class VI speciﬁcations and passes ISO 10993-5 cytotoxicity testing.

Master Bond 154 Hobart Street Hackensack, NJ 07601

See how Master Bond began in a video that celebrates our 40 year history as an adhesives formulator.

Tel: 201-343-8983 Fax: 201-343-2132 www.masterbond.com technical@masterbond.com

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maxon drives set the world in motion. maxon combines electric motors, gears and DC motor controls into high-precision, intelligent drive systems that can be

Offering solutions that ﬁt your customized needs At maxon, we focus on comprehensive solutions optimized through a diversiﬁed product range and client consultation.

custom-made to ﬁt the speciﬁc needs of customer applications. maxon helps provide innovative solutions at competitive prices for numerous applications in various markets, such as industrial automation, medical, robotics and aerospace.

maxon manufactures small, high-quality brush and brushless DC motors ranging in size from 4 mm to 90 mm. maxon’s rhombic wound ironless rotor motors provide exceptionally high efﬁciency, low EMI emissions, fast acceleration, no preferred rotor position, torque constants and long service life. The drive components are assembled and designed according to your individual needs. Our modular system includes planetary, spur and special gearheads as well as encoders and control electronics.

maxon X drives Extremely powerful drives that are easily configured online. Customers can fit the drives with specific mechanical and electrical components specific to their application needs. It is possible to customize the shaft lengths, winding types, ball bearings and much more. When combined together with maxon encoders and planetary gearheads, you form a high-precision, robust drive system ideal for any application requiring a compact, powerful, quiet and strong drive system. In addition, detailed product data may be viewed immediately online and 3D CAD data for the configuration is available for downloading. Visit xdrives.maxongroup.us

With over 50 years of experience, hightech innovations and superior product quality, maxon is the reliable partner in drive technology. Individual, customized drive solutions are our greatest strength.

maxon precision motors, inc. 125 Dever Drive Taunton, MA 02780 508.677.0520 info.us@maxongroup.com maxongroup.us

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On our website, you can ﬁnd the latest information on our products and services as well as an integrated online catalog, the selection program and the maxon online conﬁgurator. Go to www.maxongroup.us

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Full Service Contract Manufacturer • ISO 13485:2016 Certiﬁed • FDA registered • Clean Room Molding • Clean Room Assembly

Medbio

• Clean Room Packaging

Medbio is an ISO 13485:2016 certiﬁed contract manufacturer offering innovative manufacturing solutions for the medical and biotechnology industries. We specialize in precision injection molding, assembly, packaging, project management, and design support.

• Precision Injection Molding • Thermoplastic & Silicone • Insert & Over Molding • Micro Molding

Our facilities contain certified ISO Class 8 clean rooms for molding, along with certified ISO Class 7 clean rooms for assembly and the molding of implants. We have flexible capacity to handle major projects or small custom orders. We mold most medical grade thermoplastics and silicone. We currently mold products for OEMs in Orthopedics, Cardiovascular, Ophthalmology, Neurological Surgery, General Surgery, Wound Care, Biotech (diagnostics & cell growth), and Dental.

• Two-shot Molding • Prototype • 6 Facilities in Michigan and New York

Members of our leadership team average over 30 years of medical device industry experience, so we know what it takes to get a new product to market. Supported by a large staff of Engineers, Medbio is able to help our customers through all phases of their project. A commitment to delivering quality service and value to every customer is a priority at Medbio. We’ve earned a reputation of excellence and strive to exceed those expectations. Please contact John Woodhouse, Director of Sales & Marketing, to begin your next project with Medbio and become one of the customers we so greatly value.

Medbio - Headquarters 5346 36th St SE Grand Rapids, MI 49512 P: 616.245.0214 medbioinc.com

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Complete Medical Devices & Assemblies MICRO is a full-service contract manufacturer of complete medical devices, insert/ plastic moldings and custom fabricated tube assemblies. This includes product development & design assistance—from prototyping and validation to full-scale production. Our own tube mill for raw material, combined with our laser cutting technology and automated work cells, allow us to drastically reduce tubing costs on high volume, single-use disposable instruments. Tubing capabilities include: flaring, flanging, expansions & reductions, piercing, slotting, sharpening, electropolishing and laser welding, cutting & marking. Our modern facilities are cGMP-QSR compliant and ISO9001, ISO-13485 & ISO-14001 certified and we maintain an ISO Class 8 clean room for surgical instrument assembly.

MICRO is a full-service contract manufacturer that draws on over 75 years of experience in medical device assembly, precision metal stamping, insert/injection molding, machining, sharpening, and ﬁnishing—delivering the highest quality products to customers in the medical device industry. Utilizing modern manufacturing techniques and innovative engineering solutions, we manufacture and distribute our products to customers all around the world.

MICRO 140 Belmont Drive Somerset, NJ 08873 732-302-0800 sales@micro-co.com www.micro-co.com

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We are the world’s largest manufacturer of titanium and stainless steel ligation clips – class-critical implant devices shipped directly to inventory. We also produce a wide variety of blades, scissors, stapling and biopsy devices, as well as laparoscopic, endoscopic and arthroscopic minimally invasive surgical instruments.

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We strive to develop and manufacture the best possible products at the best possible price, while providing a supply-and-distribution chain that allows our customers to operate at optimum efﬁciency and ease. www.medicaldesignandoutsourcing.com

To achieve these ends, we offer full-service project and supply-chain management platforms consisting of cost containment/ quality-enhancement programs, inventory consignment, just-in-time delivery, and local warehousing.

Design Engineering At its heart, MICRO is an engineering company, staffed by experienced, innovative design engineers driven to help customers achieve their goals in a timely, cost-effective manner. Critical to our success is our ability to design, produce and maintain the dies, molds and associated tooling used to produce customer parts. From prototyping to mass production, we are eminently capable of generating engineering designs that take advantage of our team’s unique ability to translate our customers’ needs into practical, reliable solutions.

Microlumen has been a leading manufacturer of high performance medical products since 1987. Our high performance medical tubing is used in a wide range of minimally invasive, critical OEM applications such as cardiovascular catheters, stent delivery systems, urological retrieval devices and drug delivery.

Exceptional Products & Customer Service

Primary materials include Polyimide, PTFE, Pebax®, Nylon, Polyurethane and various polymers speciﬁcally designed to provide exceptional mechanical, thermal and chemical properties. Our proprietary process delivers signiﬁcantly tighter tolerances for our medical and surgical tubing than conventionally extruded products.

MicroLumen is committed to providing high performance medical and surgical tubing of unparalleled quality and function. Our dedication to technical excellence ensures that our surgical tubing products will always be at the cutting edge of what’s possible, while maintaining the highest standards of consistency and quality. Our goals are simple. To help you, our client: • • •

Improve patient care Reduce recovery times Reduce the overall cost of health care

We invite you to experience the best in high performance medical tubing products. Our products include polyimide tubing, braid reinforced tubing, PTFE/composite tubes, and laser machined medical tubing.

MicroLumen offers innovative solutions and aids engineers in the design of extremely specialized medical devices. Our diversiﬁed medical product line and secondary operations include; custom laser machining, etching, composite constructions, assembly, braid / coil reinforced shafts - all that solve speciﬁc tasks. Contact our engineering team for possibilities. MicroLumen, Inc., is registered to ISO 13485:2003.

Capabilities

We design and produce the highest quality medical and surgical tubing available, on time and at a competitive price. Our cutting-edge processes ensure exceptional consistency and product performance, while also providing the ﬂexibility to create new solutions that meet your speciﬁc needs. In our state-of-the-art manufacturing plant, our tubing is manufactured with tighter tolerances than conventionally extruded plastic tubing.

Microlumen One Microlumen Way Oldsmar, FL 34677 T: 813-886-1200 www.microlumen.com

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High Performance Medical Tubing

MicroLumen provides tubing with exceptional mechanical, thermal and chemical properties for use in a wide range of minimally invasive, critical OEM applications such as cardiovascular catheters, stent delivery systems, urological retrieval devices and drug delivery. Our innovative manufacturing process allows us to deliver signiﬁcantly tighter tolerances than conventionally extruded tubing. We offer Polyimide, PTFE, Nylon, Pebax®, Polyurethane, and various polymer products. Our secondary operations, including custom laser machining, etching, composite constructions, assembly, and braid/coil reinforced shafts enable us to develop customized solutions for your exact requirements.

www.medicaldesignandoutsourcing.com

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Total solution for steel strip spring application Ming Tai Industrial Co., Ltd. is one of leading manufacturer of steel strip springs for medical device application, including Constant Force Spring, Constant Torque Spring, Power Spring and Pre-stressed Power Spring, Variable Force Torque Spring, Variable Torque Spring and SpringStrip Tube. With ISO 9001: 2015 and RoHs certiﬁcated, Ming Tai is capable of serving customer from the technical support in develop procedure, prototype, to trial run, mass production, spring mounting and assembly. Each manufacturing procedure, including steel strip slitting, heat treatment, edge trimming, forming process is consistent production and completed in-house to ensure highest quality requirement.

Ming Tai Industrial Company expects to be your best engineering consultant for steel strip spring application with enthusiasm. Recently Ming Tai has been helping lots of customers to develop medical devices which apply steel strip spring successfully. All innovative products include pen-type drug injector, high adjustable monitor and keyboard integrated medical workstation, high adjustable trapeze for patient bed, and patient bedside table, Bowden cable for endoscope, draw wire encoder for MRT machine. Both performance of Ming Tai’s steel strip springs and manufacturing service are gain lots of praise and appreciation from customers. Attached figure 1, it explain that variable force torque spring exerts constant force to keep injecting drug with fixed flow, to prevent patient from feeling uncomfortable. Variable force torque spring also features stretch force in the end the stroke that ensure pen type drug injector dose drug entirely. Figures 3, you can find constant force spring features counterbalance. These can be applied to high adjustment application, such as patient bedside table.

FIGURE 1

Since there are a number of different spring design possibilities for a given application, you are welcome to contact us in the early design phase to create an optimized spring solution for your demand. Along with high quality production, prompt delivery and competitive pricing. Ming Tai is your best partner to win the market.

FIGURE 3

Ming Tai Industrial Co., Ltd. No. 250, Sing Jhong Road, Tamsui New Taipei City, Taiwan 251 Taiwan 886(2)26228651 www.powerspring.com.tw

FIGURE 2

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MTD Micro Molding is a micro medical manufacturer of ultra- precision molded components that meet the exact requirements of the medical device industry. While many companies dabble in micromolding components for the medical market, MTD focuses 100% on medical micromolding. MTD is an ISO 13485 certiﬁed and FDA registered micro molding contract manufacturer with in-house tooling,

MTD Micro Molding is built for high performance in one area: the micro molding of advanced medical implants and products. Every part of the manufacturing process, from design through packaging, is carried out by people whose sole focus is medical micromolding. Our team of designers and engineers work together under one roof to solve complex challenges to help our partners bring higher quality medical devices components to market before their competitors. Key medical markets for bioabsorbable micromolding include Orthopedic and Drug Delivery. Other markets served include: Biomed Pharma, Bronchoscopy, Diabetes Care, Endoscopy, ENT, Gastrointestinal, Gynecology, Interventional Cardiology, Neuromodulation, Oncology, Peripheral Medicine, Urology, Vascular, and other areas to help improve life.

unparalleled bioabsorbable molding expertise, assembly services and state-ofthe-art equipment—all under one roof. Our focus on problem solving for medical devices ensures successful delivery of complex custom products that nobody else can produce.

BIOABSORBABLE EXPERTISE: As a globally recognized leader in bioabsorbable polymer molding, MTD achieves bioabsorbable micromolding success with tools like runner optimization, robust validation, and in-house testing. MTD utilizes a proven process that results in bioabsorbable products with superior post-mold mechanical and functional properties, consistent and minimal post-mold IV loss, and highly capable critical dimensions. SPEED TO MARKET: From mold fabrication to manufacturing to testing and inspection, all micro molding processes take place at our headquarters, which means faster turnaround times and better quality control.

MTD Micro Molding 15 Trolley Crossing Road Charlton, MA 01507

SUPERIOR TECHNOLOGY: Our breakthrough micro molding technology permits sharper edges and tighter feature tolerances. In a ﬁeld where precision is paramount, MTD Micro Molding delivers the highest quality solutions possible, which leads to more efﬁcient, reliable, and betterfunctioning products, less invasive implants, and healthier patients.

1-800-998-5549 info@mtdmicromolding.com mtdmicromolding.com

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FASTER, BETTER PROBLEM SOLVERS: By reﬁning a micro design for improved manufacturability and consulting on materials, our specialized team of engineers helps bring your new cutting-edge micro products to market faster. A staggering 20% of new projects come to us as “rescues”— failed attempts by others. Our success rate? 100%.

www.medicaldesignandoutsourcing.com

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Leadership in Healthcare Packaging Technology With facilities in Cranston, RI; Whitehall, PA; Phoenix, AZ; Venray, the Netherlands; Galway, Ireland; Clara, Ireland; Derry, Northern Ireland; Elsham, United Kingdom; Humacao, Puerto Rico; and San Jose, Costa Rica, Nelipak® Healthcare Packaging designs, develops and manufactures custom packaging products that provide superior protection for medical devices and pharmaceuticals. With over 1,400 employees worldwide, Nelipak® is focused on delivering superior quality and customer experience through world class manufacturing at each of its locations. The company offers medical trays and blisters, surgical procedure trays, pharmaceutical handling trays, custom built sealing machines, ﬂexible packaging materials and other value-added services.

Nelipak Healthcare Packaging 21 Amﬂex Drive

Nelipak Healthcare Packaging has cultivated a global team of first-rate, 100% healthcare-focused engineers and designers that apply extensive expertise to develop custom packaging solutions to meet customers’ unique and specific needs for pack performance, functionality and product protection – all while adhering to the stringent considerations of surgical environments. Nelipak is a true partner that adds value to customers’ packaging products from the earliest design phase through to manufacturing and validation. Nelipak’s development process starts with an experienced team providing sketches or digital images followed up with detailed CAD drawings and prototypes. As the project progresses, pre-production items will be made and then tooling is created, tested and put into production once approved. Throughout this process, Nelipak has an ongoing dialogue with customers about the design, progress and potential modifications to ensure satisfaction.

Design Expertise and Technology

Cranston, Rhode Island 02921

Nelipak understands that modern software and technology is critical to successful outcomes and keeps abreast of the latest developments to maintain our leadership position through regular investments in new and upgraded systems.

https://www.nelipak.com

Waste and Cost Reduction through Design

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Nelipak engineers and designers always keep in mind that the package should ﬁt all your requirements and provide the most cost-effective solution while minimizing waste.

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Fostering Innovation, Expanding Opportunities, Building a Community

2.4.21 2.11.21 2.25.21 3.4.21 3.18.21

robobusinessdirect.com

Sponsorship opportunities are available for future ROBOBusinessDirect programs.

For more information, contact

COURTNEY NAGLE

cseel@wtwhmedia.com | 440.523.1685

Custom Medical Extrusions Incorporated in 2001, New England Tubing Technologies occupies a 14,000 square foot state-of-the-art controlled environment manufacturing facility in the beautiful White Mountains of New Hampshire. Partnering directly with the world’s leading medical electronics and device manufacturers, we design custom braid or spiral reinforced tubing, lined catheter shafts, and hybrid tubing built to exacting speciﬁcations.

NEW ENGLAND TUBING T E C H N O LO G I E S

Working directly with clients in the medical electronics and device industries, as well as with other custom industrial and commercial projects, we design and manufacture custom braid or spiral reinforced tubing, lined catheter shafts, multi-durometer and multi-lumen tubing, hybrid tubing configurations, as well as medical braid. Building on the decades of extrusion and wire-processing experience of our parent company, New England Wire Technologies, New England Tubing is advancing innovation in thin-wall, tight tolerance tubing, reinforcing, bonding layers of thermoplastic to fluoropolymer, and braiding all types of round and flat wire.

New England Tubing Technologies

Our team of design engineers work personally with each customer to develop innovative, one-of-a-kind tubing solutions and custom OEM components from their speciﬁcations or to meet unique performance characteristic requirements.

132 North Main Street Lisbon, NH 03585 United States www.newenglandtubing.com

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We also offer a wide range of value-added and post-processing services—tipping, hubbing, ﬂaring, Parylene coating, centerless grinding, and cut to length options. Through true vertical integration of manufacturing processes, New England Tubing Technologies is able to offer customers everything from rapid prototyping services and small quantity orders to full production and value-added services. Let us help you dream beyond today’s technology and achieve the impossible!

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New England Wire Technologies is a privately held company with an employee

Founded in 1898 in response to the birth of the communication age, today New England Wire is advancing innovation in several industries including medical device and electronics, aerospace, defense, robotics/automation, power generation, and alternative energy. Our capabilities include custom Litz wire, miniature, microminiature, single and multiconductor cables, low-noise, high temperature, coaxial and hybrid cables. Since the 1960’s, we have provided cabling and insulating services to the superconductor industry where our products are integrated into most of the major accelerator projects, ore separator magnets, NMR magnets, and superconducting magnetic energy storage (SMES) magnets.

stock ownership program. For over 115 years, we have manufactured the most technologically advanced wire and cable in the industry. Our 400,000 square foot, state-of-the-art facility, located in Lisbon, NH, houses manufacturing, R&D, quality/ testing, tooling/machine fabrication and ofﬁce space. With almost 400 employees, we operate 3 shifts per day, ﬁve days a week. As an ISO9001 registered company, we specialize in technical cable solutions, short lead times, and unparalleled customer service.

NEW ENGLAND WIRE T E C H N O LO G I E S

New England Wire Technologies 130 North Main Street Lisbon, NH 03585

Through our creative design and development expertise, our engineering staff specializes in product development, concurrent engineering, design for manufacturability, and quick-turn prototyping. Our on-site manufacturing processes include wire drawing, plating, braiding, insulating, and extrusion services. And, since all of our proprietary equipment and tooling is designed and built in-house, we have complete control while also offering quick modiﬁcations when needed. Through true vertical integration of the manufacturing processes, our customers’ design-to-market curve is the shortest in the industry!

603.838.6624 www.newenglandwire.com

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New England Wire Technologies is committed to being the premier custom cable manufacturer of choice for customers in existing and emerging worldwide specialty cable markets. We help our customers dream beyond today’s technology and achieve the impossible!

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Nitto Kohki USA Nitto Kohki USA, Inc. designs, develops, engineers, and continuously improves high quality air compressors and vacuum pumps for applications like medical devices, laboratory equipment, applied robotics and environmental sensing equipment. Nitto Kohki’s unique linear free piston design has one moving part per pump— the piston. The result is a pump with exceptionally reliable performance in tough medical applications. The linear free piston concept enables Nitto Kohki pumps to be smaller and lighter than conventional aerators, allowing designers greater ﬂexibility in system design.

Nitto Kohki USA, Inc. 46 Chancellor Drive

Nitto Kohki leads through exceptional product design and execution, with pumps that meet the rigorous demands of today's medical device industry.

WHY DESIGNERS CHOOSE NITTO KOHKI

Nitto Kohki pumps feature a unique, patent-awarded linear-motor-driven free piston system that is globally proven in the medical device, instrumentation, and other critical industries. This unique design theory eliminates the wear components typically found in conventional air compressors and vacuum pumps, such as crank shafts, connecting rods and ball bearings. The only moving part is the piston! Also eliminated is the need for any lubrication. Fewer parts translate into fewer problems.

• World class manufacturing expertise ensures consistent product quality

Roselle, IL 60172 www.nittokohki.com

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• Exceptionally reliable performance for critical applications

• Clean, simple design maximizes performance, minimizes maintenance — adding value over the integrated product lifecycle.

Nordson MEDICAL (Nasdaq: NDSN) is a global expert in the design, development, and manufacturing of complex medical devices and component technologies. As a single-source partner, we enable our customers to save costs, speed time to market, and simplify supply chain management. We work with companies at any point in the product lifecycle, from

Medical Balloons

concept to launch and beyond. With

We are the market leader in complex medical balloon design, development, and manufacturing. All extrusion, tooling, design, manufacturing, & testing is performed in-house, enabling us to produce high quality balloons in less time, accelerating time to market.

our ﬂexible business model, we can provide a solution that meets the scope and scale of any project to bring innovative ideas to life.

Catheters and Cannulae

Nitinol Components

Fluid Management

Biomaterial Delivery

We offer a complete, one-source solution to your catheter and cannulae device needs. We can partner with you in all phases of development, from design & development through manufacturing & assembly.

Looking for prototypes or partner that can scale to production volumes? We are the experts in complex manual nitinol wire braiding and forming with over 1 million components deployed.

Nordson MEDICAL 805 W 71st St Loveland, CO 80538 http://nordsonmedical.com

Medical Tubing

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We are pioneers and innovators in the design, development, & manufacturing of medical tubing. From simple medical tubing to complex, tight-tolerance extruded tubing in a wide range of materials.

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www.medicaldesignandoutsourcing.com

We offer costeffective solutions that connect fluid management systems. Process management components, like quick connect fittings, luers, stopcocks, check valves, and tube-totube fittings, effortlessly & securely connect different elements of fluid administration devices.

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We provide proven solutions for accurate and precise delivery of tissue sealants, hemostatics, adhesion barriers, & other autologous or synthetic biomaterials for surgical applications.

Medical Design & Outsourcing

159

Novotechnik is a manufacturer and global supplier of linear and rotary position sensors based on innovative potentiometric, Halleffect, magnetostrictive and inductive measurement principles. The company was founded in 1949 and is part of the Siedle Group. Customers routinely beneﬁt from our experience gained from our long-term focus on position sensing products. Our application-proven sensors include premium position sensing solutions for customer applications requiring high precision and time-proven reliability under harsh conditions. Novotechnik develops a wide spectrum of state-of-the-art position sensors with numerous standard options and custom enhancements. All sensors are rigorously tested tomeet customers’ needs and application requirements while adhering to international standards. Novotechnik is certiﬁed to ISO 9001:2015 and IATF 16949:2016. Dedicated local engineers provide technical support to assist with the seamless and costeffective integration of position sensor systems into a wide variety of automation, agriculture, automotive, marine, robotics, medical and other applications.

Novotechnik U.S., Inc. 155 Northboro Road Southborough, MA 01772

Many Novotechnik angle and position sensor are integral parts of complex industrial feedback loop controls. To meet rising safety demands selected Novotechnik sensors are available in redundant versions, have diagnostics built in and are suitable for safetyrelevant applications according to ISO 13849. Non-contact rotary angle sensors utilize the NovoHall™ Hall-Effect for measurements without shafts or couplings to measure without mechanical wear and through solid or nonsolid materials. A magnetic marker attaches to an application´s rotating part and a sensing part with NovoHall technology detects the field orientation and converts the detected angle into an analog or digital output signal. One of six product families this technology is used in is the RFC4800 Series and enables up to 14-bit resolution and repeatability of 0.1° or better. The high temperature rating of -40°C to +120°C and high seal rating of IP69 are key specifications that express the long-term robustness of this low profile sensor.

Toll free: 800-667-7492 Ph: 508-485-2244 www.novotechnik.com

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Award-Winning Electronic Enclosures

OKW manufactures advanced enclosures for today’s electronics equipment.

OKW Enclosures, Inc. is a specialist manufacturer of enclosures for OEM electronics. The company’s extensive and award winning program includes pocket-size,

The enclosures can be supplied fully customized to customer speciﬁcations.

handheld, desktop, portable, wall mount and

The range includes the following popular versions:

DIN rail enclosures, plus accessories and a

Handheld Enclosures

large range of tuning knobs. OKW also offers a comprehensive customizing service which can supply the enclosures fully ﬁnished with all the modiﬁcations necessary for mounting the customer’s components. Options include CNC machining, custom colors and materials, digital printing and much more.

Modern and ergonomically designed enclosures for mobile electronics used both indoors and outside. Standard features include recessed tops for locating membrane keypads, battery compartments for AAA, AA and 9V cells, integrated cable glands, infra-red versions, sealing kits up to IP 65, desk stations for charging and wall holders for storing. Many of these enclosures can also be used as wearable devices with the optional wrist/hand straps, belt/pocket clips and lanyards.

Instrument Enclosures

Free samples are available for evaluation.

Stylish high quality enclosures for table-top and portable electronic instruments. Large range of designs in plastic or aluminum with removable front panels or sloping front sections. Options include aluminum or plastic front panels recessed for membrane keypads, ventilation slots, battery compartments, bail arms or integrated handles and non-slip feet.

Wall Mount Enclosures

Advanced wall mount enclosures for indoor and outdoor electronics equipment. Stylish and modern design sets these enclosures apart from the norm. Standard features include hidden ﬁxing screws for a clean and tamper-proof assembly, recessed top for a membrane keypad, standard ingress protection up to IP 67 ( NEMA 4X) and hinged solid or transparent lids.

OKW Enclosures, Inc. Abele Business Park 3000 Old Pond Road Bridgeville, PA 15017 United States Tel: (800) 965-9872

www.okwenclosures.com

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Leader in orthopedic medical device outsourcing Orchid is a worldwide leader of orthopedic medical device outsourcing, providing contract design and manufacturing services. We are a strategic sourcing partner that can handle an entire project or provide services at a Single Point in the process. We have the broadest portfolio in the industry, ranging from design and development through ﬁnished goods manufacturing and packaging, and we Orchid is driven to success through our customer-focused team, living out our core purpose and values and striving for continuous improvement.

improve our customers’ supply chains through our supply chain solutions.

We are a complete value stream partner for our customers. As the market changes, so do our customers’ needs, and we are deliberate in adapting to be the best partner we can be.

Orchid’s culture of continuous improvement continues to produce innovative products and solutions that better meet the needs of our customers. Orchid specializes in delivering the highest levels of quality, efﬁciency, and compliance on a local, federal, and international scale.

We offer the most orthopedic solutions under one roof. We partner with our customers to provide value-added solutions, including managing supply chains, ensuring risk mitigation, tying value streams together and providing a complete and ﬁnished product already in the package. Orchid Orthopedic Solutions 1489 Cedar St. Holt, Michigan 48842 United States www.orchid-ortho.com

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Enhance product development realization through Orchid’s expertise in product design, regulatory submission and design transfer process. Generating new ideas and developing solutions to challenging design problems is at the core of Orchid Design’s capabilities. Whether it is an idea, a partially developed product, or even a clinical problem, we can provide a full range of design and development services from initial ideation to final Design for Manufacturing (DFM) and verification testing to help deliver innovative products to the market. Orchid Design helps customers overcome complex and challenging processes related to product design and development. And, by utilizing Orchid’s design-to-manufacturing, customers get the benefit of leveraging Orchid’s manufacturing expertise across our global network.

Voting for this company will identify it as a leader in the medical technology industry.

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Major Markets Served:

Orchid specializes in implants, instruments and innovative technologies for the following markets: •

Hip Reconstruction

•

Knee Reconstruction

•

Spine

•

Extremities

•

Trauma

•

Sports Medicine

Leading Manufacturer of Geared Motor Solutions Parvalux Electric Motors is a leading global manufacturer of geared motor solutions, chosen by manufacturers to power hundreds of diverse applications. We have over 70 years’ experience designing and manufacturing the perfect combination of motor and gearbox to match our customers’ applications and we offer thousands of

Delivering gearmotors solutions for a range of applications in the healthcare Industry

standard AC, PMDC and BLDC electric motor options. Parvalux products are found in hundreds of applications, globally but

We’re trusted by the leading manufacturers healthcare product suppliers, to provide the reliable power inside their products. From mobility scooters and wheelchairs to stairlifts and patient hoists, our design engineers can meet the requirements of every type of application. Parvalux invests heavily in the design of innovative geared electric motor solutions to meet the demands of the ever-changing patientcare and mobility industries.

we are particularly recognized for our work within the healthcare, leisure, mobility, transport and a diverse range of industrial applications.

While our huge range of standard products will allow you to prototype quickly, we also offer semi-custom or fully customized solutions that sets us apart in the market. We can make an array of customization changes to ensure your medical motor meets the exact needs of your application. Our design team can help you choose, customize or design from scratch, geared motor solutions, ensuring you gain a competitive advantage in your market. For more information about Parvalux electric motors and how we can help with your next project, get in touch with our team of qualiﬁed, knowledgeable engineers today at sales.us@parvalux.com

Parvalux Electric Motors, Ltd. 125 Dever Drive Taunton, MA 02780 https://www.parvalux.com/

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50 years of Excellence Our 700+ employee owners continually

MAJOR MARKETS

strive for excellence providing services

• Medical

to our customer partners. We focus on

• Connectivity

precision metal tooling and components

• Energy

including:

• Oil & Gas • Aerospace & Defense

• Design for manufacturing and component

• Automotive

simulation services.

• Fluid Handling

• Precision tooling, gauges, and ﬁxtures.

• Parker Majestic CNC Grinding Machines • Precision Components & Tooling

• Metal additive manufacturing. • Precision metal stamping, laser cutting, and laser welding. • Secondary processes including part cleaning, heat-treating, coatings, and precision assembly

Established in 1971, three founding entrepreneurs took a small precision grinding shop and turned it into a multifaceted, 700 person employee owned company. Through honesty, integrity, and a clear vision we constantly strive to be a company by which our employee owners, our community, and other businesses measure excellence. That excellence is not just deﬁned by how we make components but how we treat our employee owners, vendors, and customers on a daily basis.

Penn United Technologies, Inc. 799 N. Pike Road Cabot, PA 16023 724-352-1507 https://www.pennunited.com

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For nearly 50 years the employee owners of Penn United have continued to push the barriers of technology to remain at the forefront of precision tooling and metal component manufacturing. We continue to invest in our employee owners and machinery combining the experience of our engineers and journeyman with state of the art manufacturing technology. The advancement of manufacturing knowledge through our education and accredited journeyman programs encourages our employee owners to creatively combine hands on craftsmanship with the effectiveness of the latest machine tool technology and automation.

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We serve diverse markets and vital customers that require high levels of quality and performance, and we support companies delivering products that impact the lives of healthcare workers and patients all over the world. We are committed to the safety of our employee owners throughout our facilities, and the continued manufacturing and delivery of components for life sustaining products.

About PTC (NASDAQ: PTC) PTC helps

companies around the world reinvent the way they design, manufacture, operate, and service products in and for a smart, connected world. In 1986 we

The COVID-19 pandemic has impacted the entire medical sector. For medical device manufacturers, it has become even more critical to service equipment while offsite; whether due to a hospital lock-down or an internal concern over technician safety. And now, more than ever, medical equipment downtime is beyond an inconvenience—it can directly compromise medical outcomes during a time of extreme stress on healthcare systems.

revolutionized digital 3D design, and in 1998 were ﬁrst to market with Internetbased product lifecycle management. Today, our leading industrial innovation platform and ﬁeld-proven solutions enable you to unlock value at the convergence of the physical and digital worlds. With PTC, manufacturers and an ecosystem of partners and developers can capitalize on the promise of the Internet of Things and

PTC’s Internet of Medical Things

augmented reality technology today and

(IoMT) solutions are providing essential support for medical device makers as they shift to remote-enhanced service models that were nice-tohave before the pandemic—and have since become business critical. With remote condition monitoring providing real-time insights, technicians are able to reduce medical equipment downtime, improve ﬁrst-time-ﬁx rates, and support medical leaders who are under unprecedented pressure. Service parts planning made possible through off-site data connectivity helps ensure the right parts are available at the right location, for the right problem, at the right time. And augmented remote assistance provides the just-in-time instructions and coaching needed to keep equipment running seamlessly, even if service teams can’t get to it for hands-on repairs.

drive the future of innovation.

PTC 121 Seaport Blvd Boston, MA 02210

PTC’s IoMT service solutions provide crucial protection for both technicians and patients—ensuring that medical device service teams can support medical practitioners by safeguarding the equipment that saves lives.

www.ptc.com/medical-device

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PTI Engineered Plastics is a custom injection molder and manufacturer of plastic components and assemblies. As a diverse plastic injection molding company, PTI services the medical, automotive, defense/aerospace, consumer products, and electronics industries. Whether it’s low or high volume, simple or complex, prototype or production, PTI can deliver. Our 160,000 sq. ft. facility in Macomb, Michigan offers 4,000 square feet of ISO Class 8 Cleanroom, an array of secondary services and is fully versed in IQ/OQ/PQ validation protocol. Our facility was purposely designed and technically equipped to deliver our customers a comprehensive experience. Certiﬁcations PTI is FDA, UL, and ITAR registered and ISO 13485, ISO 9001, ISO 16949, and MedAccred AC8160 certiﬁed.

Design PTI can take you from mind to manufacturing® starting with an in-house industrial design and development studio. PTI Design can optimize your design or take your idea through a ﬁvephase process to ensure your product has a competitive edge in the market.

Tooling The PTI Tool Room is comprised of 40 highly skilled mold makers and utilizes a fully integrated network of 25 CNC machining centers. In addition to seven Makino high-speed vertical machining centers, PTI has a 4-axis horizontal Makino and two 5-axis machines offering the latest in high-speed machining technology: a GROB 550 and a Hermle C400. Each of the ten high-speed CNC machining centers utilizes thermal shrink collet tooling for precision and accuracy. Within the EDM department are four high-speed graphite robotic-fed machining centers with spindle speeds up to 54,000 RPM. PTI has a total of four CNC carousel-fed sinker EDM machines as well as wire EDM capabilities. In terms of tooling, PTI incorporates many materials based on the needs of the program. These materials include aluminum, P-20, NAK 55, hardened steels and varying grades of stainless. Different types of injection molds include unit-mold insert, free-standing, and shuttle bases; all are available in single cavity and multiple cavity options. PTI’s P3™ Proprietary Process can create production-ready prototypes.

Production PTI’s Production ﬂoor currently hosts 57 injection molding machines ranging from 38-750 tons of clamping force, with 0.09-98 oz. shot capacity. Manufacturing capabilities include low and high volume production, insert/overmolding, high-temperature molding, contract manufacturing, assembly and packaging.

Smart Factory Technology PTI has 12 Arburg presses that are all equipped with a host computer system. These “smart machines” provide numerous beneﬁts from improved efﬁciency, safety, security, cost reduction and performance.

Cleanroom Manufacturing Services within ISO Class 8 Cleanroom include injection molding, assembly, secondary operations and packaging.

PTI Engineered Plastics 50900 Corporate Drive

Secondary Services

Macomb, MI 48044

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586.263.5100

PTI offers an array of secondary services such as plastic joining, laser marking, and assembly.

teampti.com

Color Lab

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PTI has added a color management lab to its list of capabilities. With this software, we can achieve the perfect match. This system will reduce lead time, allow for on-site adjustments, and reduce cost with its demand-based system. It’s simple, clean, and fast. This added service will increase speed to market for our customers.

Validation PTI is fully versed and staffed in the IQ/OQ/PQ validation processes.

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Qosina is a leading global supplier of more

Qosina helps medical device engineers get their products to market faster and more efﬁciently by offering free samples of our products; downloadable 3D CAD models and technical product documentation; modiﬁcation of existing molds; and new product design and development.

than 5,000 OEM single-use components to the medical and pharmaceutical industries. Our mission is to provide the best customer

Purchase from Qosina to eliminate the cost of tooling your own components. If you need an item that is not a stock product in our inventory, we will work to develop the part to your exact speciﬁcations. We’re committed to providing you with high quality products that meet your expectations and comply with industry standards. Download a pdf of our vast product catalog, which includes full-scale images on a one-centimeter grid.

experience possible by helping our customers ﬁnd, order and receive quality medical components quickly and accurately. We provide practical solutions to meet the changing needs of today’s engineer through innovation, technology and continuous improvement. Qosina is ISO 13485, ISO 9001, ISO 22301

Our Extensive Component Inventory

and ISO 14001 certiﬁed and operates in a 95,000 square-foot, climate-controlled facility that includes an ISO Class 8 Clean Room.

Qosina 2002-Q Orville Drive North Ronkonkoma, New York 11779 631.242.3000 www.qosina.com

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Adhesives Applicators, Swabs & Brushes Bags Caps Chambers Clamps & Clips Containers Connectors Dilators & Introducer Sheaths Dispensers Drapes, Towels & Bandages ENFit® Extension Lines Filters Guide Wire & Catheter Accessories Injection & Sampling Ports Needles NRFit™ O-Rings Ports & Flanges Scoops & Spoons Spikes Sterilization Supplies Stopcocks Syringes Tools Tubing Valves Visit qosina.com today and discover countless solutions to get your project off the ground and into production. We look forward to being your partner in growth, innovation and success.

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Applications and Advancements for the Medical Device Industry

Resonetics is the leader in micro manufacturing for life sciences. Core capabilities include laser processing, centerless grinding, nitinol processing, thin wall stainless steel tubing fabrication, precious metal forming, and other critical machining services. Our industry-leading teams, resources and passion for innovation puts our broad capabilities and absolute customer satisfaction in your hands. Our speed and best in class customer service enables us to develop strategic R&D teams all while keeping an eye on your manufacturing costs - ensuring delivery of great value on volume production. Resonetics has claim to many of the industry’s ﬁrsts and puts innovation at the forefront of our focus; we heavily invest in internal R&D

There’s no better partner to help you develop and manufacture your medical device than the one leading the way in micro manufacturing – for over 30 years. At Resonetics, our technical team takes great pride in not only solving difﬁcult problems, but in ﬁnding a way to make your device a reality – faster. These 3 key capabilities enable us to bring your product or device to the next level.

PRIME Laser Cut™ is a disruptive process, creating new design options for advanced delivery systems requiring a better backbone. Laser cutting enables the precise engineering of catheter hypotubes to match a device’s speciﬁc path through the body. Resonetics has developed proprietary equipment and algorithms to enable cost-effective use of spiral and interrupted spiral cut tubing in advanced catheter delivery systems for neurovascular, peripheral vascular, structural heart and other challenging applications.

initiatives each year, resulting in many process

Our electromechanical sensors have a small footprint making them ideal for minimally invasive surgeries. Resonetics continuously invests in novel technologies to further our expertise. By combining technical expertise in sputtering, plating, and photochemical machining, we can deliver leading edge sensors to the medical device industry. Our enhanced capabilities and innovative thinking combined with our advanced sensor assemblies can elevate your product into a superior device.

patents and novel applications for next generation medical device applications. The company is ISO 13485:2016 certiﬁed with facilities in the U.S., Costa Rica, Israel and Switzerland.

26 Whipple Street

MICRABLATE™ 3D Laser Machining picks up where traditional machining and injection molding leave off to create miniaturized three-dimensional medical components. Using advanced laser processing techniques, we remove material on a micro scale to create complex geometries in a single machine setup, achieving tolerance down to ± 0.00025” (± 0.00635mm).

Nashua, NH 03060 800.759.3330 sales@resonetics.com resonetics.com

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Present your complex product to Resonetics. There is no challenge too big, or in the micro medical industry, nor too small.

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INNOVATION EVERY DAY: ROTOR CLIP

Rotor Clip is a globally recognized

We not only manufacture quality products, but offer a wide range of parts in different sizes, ﬁnishes and styles. Our products are made in the USA and EU including retaining rings, spiral rings, wave springs and hose clamps.

manufacturer of high-quality retaining rings, spiral rings, wave springs and hose clamps. Companies across a broad range of industries rely on Rotor Clip products, value-added services and expertise to build reliable and safe equipment for virtually any application. Rotor Clip operates in the US, UK, Germany, China, and the Czech Republic - providing worldwide service to its customers. Recognized worldwide, Rotor Clip has received numerous quality awards from major OEMs, automotive

Wave Springs - Rotor Clip manufactures the largest range of Wave Springs in the market. We have the capability to make Wave Springs from .188” to 25” O.D.

manufacturers, and distributors. Rotor Clip also produces its products under IATF 16949, ISO 9001, AS 9100C, and ISO 14001 standards.

Spiral Rings - Spiral Rings are axially installed into machined grooves in housings/bores or on shafts to retain assemblies. They provide 360° contact with the groove and offer more clearance than a tapered section ring. Made from .188” to 25” O.D. Tapered Section Retaining Rings – inch, DIN, ANSI metric, and JIS retaining rings to world standards. We make over 50 different styles, and well over 1000 part numbers. Hose Clamps - Perfect ﬁt every time, uniform hose pressure, and a lower cost and weight leaving more budget room.

Rotor Clip 187 Davidson Ave

Custom Material and Finish Options - We can produce these parts in Carbon Steel, Stainless Steels Alloys, Beryllium Copper, Phosphor Bronze, and Specialty Steel Alloys. We also have several ﬁnishing options to withstand almost any condition: including many RoHS and REACH compliant options.

Somerset, New Jersey 08873 www.rotorclip.com

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Established 1950, SDP/SI provides engineering development and manufacturing for many of the most recognized companies in medical, aerospace and robotics today. The state-of-the-art Hicksville, NY facility

Facing a design challenge?

houses the latest manufacturing, industrial

SDP/SI partners with many Fortune 500

automation, and inspection equipment

companies in new and exciting projects.

available. Employing skilled machinists, CNC

Applying years of experience, product

programmers, inspectors, engineers, and

knowledge, and design acumen our

customer service personnel, we meet and

engineering and manufacturing teams

surpass expectations. Standard catalog

provide innovative solutions through

components can be found and purchased

part selection, modiﬁcations, or

online where free 3D CAD models and part

custom design.

speciﬁcations can be easily downloaded. Sometimes the best solution is the simplest. Standard components are a cost-effective Manufacturing capabilities include precision

option and with 87,000 machined and molded components offered, SDP/SI is the

gear cutting, 5-axis milling, 9-axis Swiss turning,

engineer’s preferred source.

and world class quality. •

Timing Belts and Pulleys

ISO 9001:2015 + AS9100D certiﬁed, ITAR,

•

Precision Gears

Reach, and RoHS compliant.

•

Precision Gearboxes

•

Bearings

•

Couplings

•

Hardware

•

Precision Machined Components

•

Molded Components

Stock Drive Products/

•

Mechanical Assemblies

Sterling Instrument

•

Contract Manufacturing

250 Duffy Avenue Hicksville, NY 11801 USA

SDP/SI’s ability to fully support projects from the

Web: www.sdp-si.com

development and prototype stage through the entire

Email: sdp-sisupport@sdp-si.com

life cycle of a product has built a strong and loyal

Phone: 516-328-3300

customer base. Our precision gears, machined parts,

Toll Free: 800-819-8900

molded components, and drive assemblies can be

Fax: 516-326-8827

found in high-tech operating rooms, movie sets, military operations, space exploration, and even on Mars. Partnering with OEMs around the world we manufacture and manage supply chain of precision

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components required for medical, surgical robotics, aviation, satellites, defense, automation, and commercial industries. We look forward to working with you.

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Vacuum Heat Treating for the Medical Industry Solar Atmospheres is one of the world’s largest providers of commercial vacuum heat treating services, serving over 18 metal working industries including aerospace, medical, and power generation. Solar’s thermal processing produces bright, scale-free parts with minimal distortion. With over 60 furnaces ranging from lab sized to 48 feet long with a 150,000 pound workload capacity, Solar can efﬁciently handle any size job. Solar operates plants in Eastern and Western Pennsylvania, California, and South Carolina. Nadcap, ISO 9001:2015/

Lives depend on your medical components, so partner with a heat treater that you can depend on. Solar’s state-of-the-art services include vacuum heat treating, brazing, carburizing, nitriding and advanced processing of raw materials. From annealing to case hardening, we’ll help assure that your parts perform reliably in critical situations.

AS9100D, ITAR, and MedAccred Certiﬁed.

At Solar Atmospheres, your stringent medical specs get the specialized expertise they deserve. Harness our leading-edge vacuum technology for clean, bright, safe parts. Our world-class equipment and expertise give you precise process control and repeatability for uncompromised quality. Solar Atmospheres

Solar Atmospheres operates a MedAccred accredited metallurgical testing services laboratory, utilizing Struers Microhardness testers which can read both Knoop and Vickers scales without recalibration. Computerized stage control and indentation measuring systems signiﬁcantly improve test accuracy, precision, and repeatability.

1969 Clearview Road Souderton, PA 18964 https://solaratm.com

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Solve your toughest thermal processing challenges with innovative, custom process solutions from our brain-trust of metallurgists, chemists and engineers. Our commitment to taking on the challenge of new types of work is evidenced by the R&D we perform for universities and national laboratories.

ONLINE

Get results that exceed your expectations and the responsive service you deserve at Solar Atmospheres.

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Proven Shock, Vibration & Noise Reducing Solutions Sorbothane, Inc. serves widely varied market segments with Standard and Custom Engineered components. MARKETS SERVED TRANSPORTATION SHIPPING & LOGISTICS • Sorbothane® Safeguards Precious Cargo PRECISION LABORATORY EQUIPMENT • Sorbothane® Isolates Disruptive Vibration MOBILE ELECTRONIC DEVICES • Sorbothane® Attenuates Impact Shock & Isolates Vibration CONSUMER & COMMERCIAL PRODUCTS • Sorbothane® Damps Unwanted Vibration & Noise INDUSTRIAL & MANUFACTURING EQUIPMENT • Sorbothane® Extends Equipment Life AEROSPACE & AERONAUTICAL • Sorbothane® Protects Critical Components MEDICAL EQUIPMENT • Sorbothane® Protects Performance SPORTING GOODS & FITNESS • Sorbothane® Protects, Cushions & Comforts Sorbothane, Inc. is located in Kent, Ohio and operates 10 specialized pouring machines. With 64,000 square feet of manufacturing space and supply support systems in place, the Sorbothane team stands ready to meet any production need. Sorbothane, Inc. has an engineering design staff that specializes in shock and vibration solutions plus an in-house testing and quality assurance lab. 2144 State Route 59

Sorbothane® is a proprietary viscoelastic material that has been specified by engineers worldwide for over three decades. Sorbothane® is a highly damped polymeric solid that “flows” like a liquid under load. Its superior damping and isolation properties have been scientifically and real-world proven. Sorbothane® is ideal for engineering design applications requiring shock absorption, vibration isolation and acoustic damping. Produced in a durometer range from 25 to 85 - Shore 00 scale Sorbothane® is considered a super soft polyurethane. Unique applications call for innovative solutions. Standard Sorbothane® parts and custom engineered solutions are available to meet individual product objectives. STANDARD Sorbothane® PRODUCTS Sorbothane, Inc. offers an extensive line of standard Sorbothane parts.

Phone: 800.838.3906

For over 37 years Sorbothane, Inc. has been - and will continue to be - the innovative and trusted choice of engineers worldwide for developing materials and components that isolate vibration, attenuate shock and damp unwanted noise.

Sorbothane Passes the Egg Smash Test https://youtu.be/RVE5b3BzSWQ PROVEN SHOCK, VIBRATION & NOISE REDUCING SOLUTIONS

MATER

ONLINE

IAL

INNOVATING SHOCK & VIBRATION SOLUTIONS Online Design Guide Calculators for working with Sorbothane

medicaldesignandoutsourcing.com/leadership

800.838.3906

sorbothane.com

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Medical Design & Outsourcing

Sorbothane, Inc. - Innovating Shock & Vibration Solutions

These standard products have been developed over 30 years and are selected for their speciﬁc shock absorbing and vibration isolating applications.

www.sorbothane.com

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Our goal is to protect the performance and integrity of your product.

The Sorbothane® Standard Products Guide is available at www.sorbothane.com or by contacting Sorbothane, Inc. directly.

Kent, Ohio 44240

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CUSTOM Sorbothane® SOLUTIONS Unique applications call for very innovative solutions. Our engineering team will help design the custom Sorbothane® component perfect for your individual product speciﬁcations. Since 1982, Sorbothane, Inc. has engineered individualized shock and vibration solutions for numerous and diverse markets.

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Sorbothane_DesignWorldAd_8-2020_A.indd 1

SORBOTHANE® MADE IN THE U.S.A.

8/18/20 11:25 AM

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APVS 04, 06, 08, 15 (Air Piloted, Isolation Valves)

Spartan Scientiﬁc, an American manufacturing facility located in Northeast Ohio, was formed in 1987, with a mission to redeﬁne industrial solenoid valves and related products.

The recently released APVS series is comprised of four different sized valves and provides many versatile options for handling caustic media, all while allowing safe operation in volatile areas.

Spartan Scientiﬁc continues to evolve by expanding their product range and developing key components in today’s medical and analytical technology markets.

APVS 04

The series includes inert gas/spring-operated valves to control high-purity, aggressive, and corrosive liquid chemicals while allowing a ﬂow rate superior to other similar valves on the market.

Fluid Power has remained a fundamental principal of the medical world, and Spartan has recently introduced new products and new solutions speciﬁcally focused on meeting critical requirements, exceeding expectations, and creating value for medical providers, practitioners, and patients.

Each APVS Valve can be conﬁgured to meet critical user requirements with ordering options that include various port sizes, seal materials, pilot options, and valve function. In addition, an optional magnetic piston is available for end-of-stroke position sensing and can be combined with a magnetic position sensor to maintain positive feedback.

Spartan specializes in building isolation valves, diaphragm valves, and dispensing pumps used for controlling medical medias such as water, oxygen, CO2, blood, plasma, dialysate ﬂuid, steam, and disinfectant ﬂuid.

SSDP 15

SSDP 60

Spartan Scientiﬁc 8510 Foxwood Court

SSDP 15, 30, 60 (Dosing Pumps) Another recently developed product, the SSDP Series includes 3 different sized electro-fluidic, solenoid dosing pumps. They feature an environmentally resistant, fully encapsulated solenoid coil design and offer high-precision, fixed volume and finite control of fluids, making it ideal for controlling liquids in medical, analytical and scientific applications, such as in vitro diagnostics, dialysis and biotechnology. In addition, they can be used for dispensing and mixing fluids, cleaning and sterilizing processes. The SSDP dosing pumps are also useful in agricultural, chemical and other non-medical applications, such as for dosing of insecticides, herbicides and other nutrients, as well as dispensing of beverages and flavors or color additives and more.

Stepper 12 (Proportional Flow Control)

Youngstown, Ohio 44514

The Stepper 12 brings an entirely new perspective to controlling liquids and gasses. With more than 1,500 different positions, it precisely regulates ﬂow output and requires minimal power to maintain a desired position, maximizing energy savings.

Phone: 330-758-8446 Toll Free: 855-629-4648 Email: customerservice@spartanscientiﬁc.com Website: www.spartanscientiﬁc.com

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The Stepper 12 is self-contained with control circuitry (including an innovative M12 connector) for both the motor and valve embedded into the unit. This eliminates needing to purchase a separate control device, which can compromise performance. In addition, control can be tailored to increase resolution, enhancing reliable and repeatable ﬂows.

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SERVICES OFFERED

Spectrum Plastics Group is a full-service partner to the Medical Device Industry

CATHETER DESIGN, DEVELOPMENT, AND ASSEMBLY

providing comprehensive and precision-engineered medical device solutions, that enable health-restoring therapies for patients globally. The company’s global footprint across the United States, Mexico, Costa Rica, Ireland, and Malaysia supply thermoplastic and silicone tubing, catheters and catheter sub-assemblies, medical balloons, injection molded components and implantable devices,

Spectrum Plastics Group specializes in providing advanced catheter solutions through the combination of various technologies, including tight tolerance, precision extrusion, coil/braid reinforced shafts, steerable catheters, complex balloons, and secondary operations. Spectrum Plastic engineers have designed and built some of the most sophisticated catheter sets for the most advanced companies in the medical device world.

INJECTION MOLDING

medical ﬁlm &packaging, and a variety of value-added and device-ﬁnishing services.

Our injection molded product solutions consist of both premium, high quality components and fully assembled devices. Products include micro-, insert-, and multi-shot molded components and assemblies. We are a major supplier to orthopedic, dental, sports medicine, surgical and medical device market customers. Spectrum Plastics Group is a recognized leader in manufacturing and converting engineered, high temperature and performance medical plastics, including implantable and bioresorbable materials.

VALUE-ADDED ASSEMBLIES & FINISHING SERVICES Offering expert capabilities at every step of the manufacturing process — from concept to full scale production, and sterilization management — Spectrum Plastics is your trusted partner for medical device components and value-added assemblies. We deliver results to leading medical device companies around the globe.

Spectrum Plastic Group 2500 Northwinds Pkwy, Suite #472 Alpharetta, GA 30009 Phone: 404-564-8560 Fax: 404-564-8579 E-mail: marketing@spectrumplastics.com

OFFERINGS INCLUDE: • • • •

Web: www.spectrumplastics.com; webstore.spectrumplastics.com

•

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• • • • •

Design & Prototyping Development Material Selection Fabrication/Secondary Ops Solvents, UV Adhesives, Radio Frequency, and Ultrasonic welding and Plastic Bonding Automated, and Manual Assembly and Sterile Packaging Product Testing and Sterilization Management Services Quality Controls Manufacturing Transfers 510K & Regulatory Services Scalable Manufacturing

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Medical Design & Outsourcing

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Robotic solutions for the advancement of medicine The 128-year-old family-owned Swiss company’s unique robot portfolio, decades of industry experience and strong customer focus, make Stäubli a valued partner for renowned medical companies around the globe. Stäubli’s high-precision medical robots not only impress by virtue of their operation room compatibility but also in terms of high rigidity, safety, hygienic design and maximum reliability. Stäubli Robotics is a leading global player in robotics, consistently delivering engineering as effective and reliable as our service and support. In order to position itself as a complete solution provider for digitally networked production, Stäubli offers a broad range of standard kinematics of 4-axis and 6-axis robotic arms for all kind of sensitive environments, autonomous mobile robotics, driverless transport systems (AGVs) as well as POWER cobots for human-robot collaboration.

Stäubli is the manufacturer with the most comprehensive expertise, and broadest range of robots designed for life science applications. In fact, the world’s ﬁrst robot-assisted surgical procedure was a brain biopsy in 1985 that used Staubli’s Puma 560 Unimation robot. What constituted a niche application 35 years ago has become one of the most important markets for Stäubli. Its robots are used in 10,000-plus operations per year, ranging from hip replacements, liver cancer operations, spinal surgeries, hair transplants, brain intervention services and more. Stäubli’s medical robotics experts work in close collaboration every day with specialized medical technology manufacturers around the world to develop innovative robotic solutions. Stäubli provides clean, highly precise, and reliable operating room 6-axis robots that meet all the criteria for the use under sterile surgical conditions, including a design that facilitates decontamination between interventions. Stäubli surgical robot advantages include: accelerating the intervention by limiting risk of contamination, minimizing trauma and improving patient recovery times; making surgical interventions safer by reducing human error risk and providing higher levels of accuracy; optimizing surgical scheduling while improving hospital productivity and efﬁciency.

Stäubli Robotics 201 Parkway West Duncan, South Carolina 29334 www.staubli.com

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Stäubli’s unique robot portfolio, decades of industry experience and strong customer focus make it a valued partner for renowned life science companies around the globe. Stäubli currently operates in 29 countries, with agents in 50 countries, to provide comprehensive solutions with long-term patient care.

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STEUTE has specialized in designing and

manufacturing off-the-shelf-custom built (with no tooling or NRE costs) and fully-custom cabled and wireless, medical-grade foot switches expressly for medical device OEM’s for more than 60 years. Our staff of 300 employees understands your need to demonstrate your medical devices’ superiority with an easy-to-use foot control that is ergonomically-designed for operator comfort and optimum functionality. With ofﬁces in 30 countries, our worldwide team is ready to share our ideas for realizing a human interface that optimizes your device’s performance and market appeal.

STEUTE has been designing and manufacturing medical-grade foot switches expressly for medical device OEMs worldwide since 1952. During that period we have tooled a wide range of platforms/consoles, actuators, detents, carrying handles, and analog and digital output devices. These components, coupled with the wide array of connectors, cables, strain reliefs and our in-house graphics capabilities, has enabled us to address an inﬁnite number of medical device OEM foot switch needs with our unique “off-the-shelf-custom” program. Within this program we can satisfy a wide variety of performance requirements, with a fullycustom designed and built foot switch that requires no tooling investment or NRE costs to the medical device OEM. Each unit is developed with the following key objectives: • Optimum medical device functionality • Operator comfort and ease-of-use • Aesthetically complimentary to the OEMs device design • Full compliance with IEC, UL, CSA and FCC requirements In addition, STEUTE has pioneered the use of wireless foot switch technology expressly for use in medical environments. Now into our fourth generation, we offer our proprietary 2.4 GHz frequency-hopping system featuring: • Safe, noise immune operation • Encrypted communication protocols • Low power consumption • Real-time battery charge status • Optional “sleep-mode” • Fast wake-up time • Worldwide acceptance Today we have thousands of safe, reliable cabled and wireless foot switches installed in diagnostic and therapeutic applications worldwide.

STEUTE Meditech, Inc. 901 Ethan Allen Highway, Suite 102

Call for a no-obligation design consultation, or a complimentary evaluation sample.

Ridgeﬁeld, CT 06877 203.244.6302 Email: info@steutemeditech.com www.steutemeditech.com

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Sunrise Labs specializes in product development for Medical Devices and Life Science Instrumentation. With over 85 dedicated employees in a high-performance culture based on engineering excellence, mutual respect, ethics and integrity, we are known for solving tough engineering problems and turning novel ideas into commercially viable products. For over 28 years we’ve been making a difference in people’s lives through technology and design. Our portfolio includes products for cardiology, radiology, neurology, diabetes, oncology, pulmonary,

IMPROVING HEALTHCARE OUTCOMES THROUGH INNOVATIVE PRODUCT DESIGN

robotics, drug delivery, and dermatology.

Sunrise Labs applies a Systems Approach and extensive expertise in core enabling technologies to tailor a program to your speciﬁc needs. With a sharp focus on enduser and client needs, and leveraging transparent project management techniques, state-of-the art tools, and fast prototyping methods we can accelerate time to market to turn your vision into a successful product.

ISO 13485:2016 certiﬁed

Meet our Executive Team

Device design inspired by passion and delivered with excellence • • • • • • • • • • • •

Sunrise Labs 25 Constitution Drive Bedford, NH 03110 www.sunriselabs.com info@sunriselabs.com

User Centered Design Software Electronics Mechanical Optics Systems Quality & Test Project Management DHF Creation Low Volume manufacturing Contract manufacturer management Lifecycle Support

Learn more about our Expertise

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Second generation controller: Class III device that pumps an artiﬁcial heart

SynCardia Systems manufacturers the total artificial heart (TAH-t) used by end stage heart failure patients waiting for a transplant. Sunrise Labs was engaged to develop the next generation driver for the implanted TAH-t. The Driver is worn as a backpack by the patient to deliver a specific cyclic pressurized air profile through a cannula to drive the TAH-t. The TAH-t then pumps blood through a patient’s circulatory system. Read the full Case Study

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Tegra Medical makes products used in a variety of markets including: • Orthopaedics • Cardiac care • Women’s health • Neurology • Ophthalmology • Radiology • Pain management • Diabetes and other medical specialties

Tegra Medical provides true end-to-end contract manufacturing solutions, handling all the steps of creating your complete device or component from prototyping to full production. Our customers look to us to manufacture everything from complex components to ﬁnished devices – from the sharp “business end” to the molded plastic handle – including assembly, sterilization and packaging. We are headquartered near Boston and have manufacturing facilities in several U.S., Costa Rica, Europe, and Asia locations.

The types of procedures often include

Manufacturing Capabilities Tegra Medical has the expertise to manufacture complete, ﬁnished medical devices, particularly those with intricate tolerances or that require combining nontraditional with common technologies. We are renowned for keeping devices sharp throughout the entire manufacturing process. Our vast range of manufacturing technologies includes CNC milling/ turning, Swiss machining, gundrilling, wire and sinker EDM, laser processing, CNC grinding, electrochemical cutting and grinding, injection molding of various materials, metal forming, and Nitinol shape setting, as well as cleanroom molding and assembly.

arthroscopy, endoscopy, joint reconstruction, biopsies, and drug delivery using a wide range of devices such as implants, needles, cannulas, ﬁxation systems, probes, wires, catheters, stylets, mandrels and many more. See our website for details.

Product Development

Tegra Medical

Our dedicated GENESIS Tech Center® resources are focused 100-percent on prototyping, development and pilot production to help launch your products smoothly and costeffectively.

9 Forge Park Franklin, MA 02038 info@tegramedical.com T: 508.541.4200

Quick Wire and Tubing Store Over two million feet of in-stock wire and hypotubing inventory available for shipping within 24 hours. Secondary processes are also available.

www.tegramedical.com

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Where medical devices come to life, Tegra Medical, and GENESIS Tech Center are registered trademarks of Tegra Medical. Tegra Medical is a member of SFS.

www.medicaldesignandoutsourcing.com

TRACO Electronic AG, is a Swiss

Global Leader in Medical Certiﬁed Power Solutions

company with headquarters in Baar,

Setting the Standard for Small Footprints & High Efﬁciencies

Switzerland. TRACO markets its products worldwide under the registered trademark

TRACO POWER medical products are suitable for B and BF rated equipment. Our safety critical products are globally certiﬁed to current Medical regulations and standards and approved to the requirements for applied parts applications with a 2xMOPP rating and are BF compliant. TRACO POWERS’s global manufacturing facilities are certiﬁed to ISO 9001/14000.

TRACO POWER. As a leading power supply specialist with more than 35 years’ experience we are dedicated to the design and manufacturing of high quality DC/DC and AC/DC power conversion products with an emphasis in medical approved solutions.

Our commitment to quality is supported by a full 5 year warranty on our medical products and every standard model has fully regulated output voltages, a reinforced insulation system and a low leakage current.

The standard product offering in medical grade power solutions includes 15~850 watt AC/DC power supplies in open frame,

1 Watt DC/DC - 0.77 x 0.33 x 0.49”

MEDICAL DC/DC: 1 ~ 60 Watt MEDICAL AC/DC: 15 ~ 850 Watt

fully enclosed or encapsulated models and 1~60 watt DC/DC converters with PCB mounting.

Additional features include: • IEC/EN/ES 60601-1 3rd edition for 2xMOPP • IEC 60601-1-2 4th Edition Compliance for EMC • Risk management process according to ISO 14971 • IPC-A-610 Level 3 for electronic assemblies • Design and production to ISO 13485 quality system • 5-year product warranty Traco Power North America 2025 Gateway Place, Suite 330 San Jose, CA 95110

300 Watt AC/DC - 4.00 x 2.00 x 1.44”

P: (408) 916-4570 F: (408) 916-4571 Email: salesusa@tracpower.com www.tracopower.com

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www.medicaldesignandoutsourcing.com

1 • 2021

Medical Design & Outsourcing

179

Your Language Resource With over 35 years of experience, United Language Group (ULG) has become a trusted industry leader for translation and localization solutions in the medical device industry. Our clients rely on ULG for accurate translations and beneﬁt from value-added solutions that decrease costs and time to market. ULG approaches every project with a focus on fully understanding the needs of our clients. With ULG’s quality assurance, industry expertise, and commitment to customer service, our clients achieve global success.

We know that medical device manufacturers operate in a highly regulated space, and quickly reaching your global audience to capture market share before your competitors is critical. This means that effective localization services should be a key piece of your global marketing plan. Our proven localization solutions will meet your regulatory needs for the industry in an array of languages to apply to consumers worldwide.

Specialized Language Solutions: Every client at ULG is supported by quality processes, expert linguists, and comprehensive project management. Our specialty language solutions include: • MDR and IVDR consulting • Training manuals, protocols, and eLearning • Packaging and product labels • Surgical techniques, IFUs, and user guides • Technical ﬁles and SOPs

United Language Group

• Software and website localization

1600 Utica Avenue South

• GUI testing

Minneapolis, MN 55416

• Marketing, advertising, and promotional materials

https://www.unitedlanguagegroup.com

• Interpreting services

Our Quality Commitment: ULG’s translation approach for medical device clients centers on managing risk, emphasized through ISO-certiﬁed processes. We tailor our approach by testing and adapting quality procedures that respond to the regulatory needs of the industry.

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180

Medical Design & Outsourcing

1 • 2021

www.medicaldesignandoutsourcing.com

Viant is a design and manufacturing

services provider to the medical device

Expertise You Can Count On

industry, who partners and innovates with

Viant is one of the few manufacturing partners in the industry with true end-to-end solutions, from design and development through manufacturing and packaging.

customers to provide the highest quality, life enhancing medical devices in the world. We do this through our depth and breadth of capabilities, end-to-end integration,

At Viant, we’re 100% focused on medical technology. Our engineers bring both deep medical device expertise and an understanding of clinical applications. The result is clinically effective, innovative solutions for customers serving these markets:

technical expertise and relentless focus on customer and operational excellence. With nearly 6,000 associates across 24 locations worldwide, Viant offers a unique combination of small-company service and

• • • • •

attention with big company resources.

Surgical Technologies Orthopedics Cardiac & Interventional Bioelectronics Drug Delivery, Diagnostics & Patient Care

Our end-to-end solutions begin with comprehensive design and development (D&D) services. Our team of almost 100 dedicated D&D engineers work with our customers to design products for optimal performance as well as optimal manufacturability. Our materials engineers offer unparalleled breadth of expertise, including polymers, metals, and industry-leading UHMWPE. With a broad understanding of clinical applications and manufacturing processes, they help customers select materials with the characteristics needed to meet performance and cost requirements. Our production engineers use Lean Product Launch techniques, including 3P, to design and develop manufacturing processes and successfully launch products while minimizing risk, reducing waste, and compressing timelines.

For more information, visit www.viantmedical.com.

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Our team of degreed packaging engineers offers comprehensive services including packaging design and development, process validation, and testing. Developing packaging solutions allows our customers to streamline their supply chains and optimize product launches.

ONLINE

At Viant, we’re in it for life. The strength of our global engineering teams is integral to our success in partnering with customers to bring to market medical devices that positively impact lives.

medicaldesignandoutsourcing.com/leadership Voting for this company will identify it as a leader in the medical technology industry.

www.medicaldesignandoutsourcing.com

1 • 2021

Medical Design & Outsourcing

181

The Smarter Choice for R&D and Manufacturing The Weiss-Aug Group is your partner for the design support, development, engineering and manufacturing of medical devices, drug delivery components and sub-assemblies. With specialized knowledge and state-ofthe-art equipment, we deliver the latest technologies for disposable safety, drugdelivery, orthodontic, ophthalmic, and electrosurgical products. Our customers are supported with a full range of services from prototype development to highly sophisticated tooling and manufacturing. 6 world class facilities with expansion projects in process totaling over a half million square feet under roof are available to customers for a variety of capabilities.

Develop Smarter

How can we reduce friction of these components in our design? Our design requires high strength, but can we still have these features? My current design is too expensive and has too many steps, how can we make it more cost effective? Every day, customers like you come to us with design challenges for new products, material, and manufacturability concerns and of course how to make designs more cost effective. From in-house talent that can perform full DFMs to our specialized divisions 100% focused on R&D and prototyping, we can help you develop smarter. Our experienced engineers and scientists will work with you from the start on material selection, geometry, and processing. We focus on quickly delivering functional prototypes and iterations to help you determine the best design.

Manufacture Smarter

From micro highspeed stamping on our Bruderer press lines to larger metal parts accommodated on our 100- 350 Ton Minster press lines, we can stamp a variety of sizes and volumes. Additionally, we have EDM, P-ECM and extensive laser cutting, etching and reel to reel capability to deliver almost any type of metal part. We also offer complex insert, reel to reel and multi-component molding. Our metal and plastics teams work hand in hand to ensure a robust and repeatable design.

The Weiss-Aug Group 220 Merry Lane East Hanover, NJ 07936

At the root of our culture is the concept of Quality Begins With Me. We focus on quality in everything we do, in appreciation that we are part of global life-saving and patient-healing health initiatives every day.

http://www.weiss-aug.com

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182

Medical Design & Outsourcing

1 â&#x20AC;˘ 2021

www.medicaldesignandoutsourcing.com

WATCH

TUESDAYS

ENGINEERING BETTER DEVICES.

DeviceTalks Tuesdays is a weekly virtual event that brings the insights and energy of our in-person events to your desktop. Each DeviceTalks Tuesday will kick off with a quick brieﬁng from the editors of MassDevice and Medical Design and Outsourcing. These presentations will give attendees insights on what trends will be moving medtech in the days to come

BUILDING BETTER COMPANIES.

Topics include:

• Keynote interviews

• • • • •

• Panel discussions • Interactive presentations • Guided Q&A for attendees

Innovation & Finance Manufacturing & Sourcing Medtech People New Tools & Technology Prototype & Product Development • Regulatory/Reimbursement

UPCOMING SESSIONS: FEB 2 @ 4pm – Virtual User Centered Design – a new dawn? FEB 9 @ 4pm – From the Artiﬁcial Heart to Artiﬁcial Intelligence: Protecting Your Technology Before It Is Gone