Medical Design & Outsourcing – JANUARY 2022 by WTWH Media LLC

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www.medicaldesignandoutsourcing.com JANUARY 2022

INSIDE: 5 THE TOEPCH MEDT ORIES NEWSFS2T021 O

HOW ABBOTT SEEKS TO IMPROVE CARE, HEALTH INEQUITIES FOR PEOPLE WITH CARDIOVASCULAR DISEASE MEDTECH’S BIGGEST PERSONNEL CHANGES IN 2021

The pandemic tested

Medtronic’s Its CFO, Karen Parkhill, explains how

mettle:

T H E

L E A D E R S H I P

I N

M E D I C A L

T E C H N O L O G Y

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www.medicaldesignandoutsourcing.com JANUARY 2022

INSIDE: 5 THE TOEPCH MEDT ORIES NEWSFS2T021 O

HOW ABBOTT SEEKS TO IMPROVE CARE, HEALTH INEQUITIES FOR PEOPLE WITH CARDIOVASCULAR DISEASE MEDTECH’S BIGGEST PERSONNEL CHANGES IN 2021

The pandemic tested

Medtronic’s Its CFO, Karen Parkhill, explains how

mettle:

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Medical Design & OUTSOURCING EDITORIAL S TA F F

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medicaldesignandoutsourcing.com January 2022 ∞ Vol8 No1

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Medical Design & Outsourcing

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Some thoughts for medtech leaders in 2022

tarting our third year of the COVID-19 pandemic, I wonder when it will ever end. Four words stick in my head: “This stuff is hard.” (That’s the G-rated version.) It’s tough when things don’t go your way, but you must learn to accept the situation and persevere. Keep on working at it, and it will eventually get better. As Dylan Thomas wrote in a poem I memorized when I was young: “Do not go gentle into that good night.” The past year was a lot about aspirations colliding with hard truths. We thought vaccines and masks would beat COVID. The vaccines have saved countless lives, but they didn’t prevent new variants — and too many people have refused to be vaccinated, anyway. Masks help, but humans are social animals and can’t wear masks indefinitely without losing something. So we must carry on and dare to hope. All plagues end, and this one will, too. COVID-19 has been medtech’s moment as the industry supplied the products needed to protect people and save their lives. It’s also been an exciting time for pharma, with its COVID vaccines and new coronavirus treatment drugs. Life sciences companies will continue to play an essential role in what I’m hoping is the beginning of the end of this pandemic. Innovations such as mRNA vaccines, better personal protective equipment, digital health and telehealth advances, and more could prove to be the pandemic’s silver lining, enabling us to live happier and healthier lives. I’ve written about medical devices for nearly a decade, and one of the things that I love about medtech is that it can be so ambitious. Abbott CEO Robert Ford exuded optimism during his recent CES 2022 keynote, the first ever given by a life sciences leader: “Technology gives us the power to digitize, decentralize and democratize healthcare, create a shared language between you and your doctor — and put more control of your health in your hands. We’re Chris Newmarker creating a future that will bring you and your loved Executive Editor ones care that’s more personal and precise. It’s Medical Design & happening right now. And its potential is no less Outsourcing than incredible.” cnewm a rk e r@ wtwh m e di a .c o m But medtech has faced its realities. COVID tests, for example, have continually been in short supply in the U.S. Leaders need to have answers in these times. Medtronic CFO Karen Parkhill, who is on this issue’s cover, had some of those answers for her company in early 2020. “When the pandemic hit, we didn’t know how bad, how long it was going to affect us,” she told Managing Editor Jim Hammerand. “We needed to quickly decide whether we were going to cut back on R&D, on manufacturing, on our employee base. I took the lessons learned from stress tests in the financial services sector and quickly showed that Medtronic had the financial stability to withstand very severe stress from COVID.” Medtronic CEO Geoff Martha described Parkhill as a steadyhanded and compassionate leader, and a BTIG analyst credited her with clearly communicating expectations to investors. >> 8

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The world’s largest medical device company, however, is working through its share of challenges. Medtronic has had supply chain and manufacturing problems hindering the development of its Hugo surgical robot, delays in renal denervation clinical trial results, and FDA warnings about issues at the diabetes business. Other major companies are grappling with their own supply chain snarls, recalls and the like. Martha displayed humility bundled with conﬁdence at this month’s J.P. Morgan Healthcare Conference. “I feel a mix of disappointment and anger. And, I feel deeply accountable for this. … But, it’s important to reiterate that, while these programs are delayed, they are still expected to be meaningful growth drivers going forward.” That pretty much sums up the traits I’d like to see more of in leaders this year, qualities I will try to embody more as a manager and human being: optimism, decision-making based on facts, steadiness, empathy and compassion, a willingness to admit mistakes, and the courage to persevere and win. Here’s to 2022 being everything we hoped 2021 would be — and more.

CONTRIBUTORS

VINCE ARNEJA is chief product ofﬁcer for GrammaTech (Bethesda, Maryland), a provider of application security testing solutions including static analysis (SAST) and software composition (SCA) products. Arneja has over 20 years of management experience in product strategy spanning application, cloud, mobile, endpoint and network security. TODD C. BASILE is a registered patent attorney at Greenberg Traurig in Dallas with more than 15 years of combined experience in the tech and legal industries. He helps technology companies protect and commercialize their innovations and brands across various industries including medtech, robotics, and software. Basile also represents technology investors in M&A deals, negotiates technology transactions, and assists clients in navigating IP disputes. He can be reached at basilet@gtlaw. com or (214) 665-3640. BILL BETTEN is director of solutions, medtech at S3 Connected Health.

BETTEN 10

Medical Design & Outsourcing

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DAVID J. DYKEMAN is a registered patent attorney with 25 years of experience in patent and intellectual property law, and co-chair of Greenberg Traurig’s global Life Sciences & Medical Technology Group. Dykeman’s practice focuses on securing worldwide intellectual property protection and related business strategy for high-tech clients, with particular experience in medical devices, robotics, wearables, life sciences and information technology. He can be reached at dykemand@gtlaw. com or (617) 310-6009. ROMAN FAYERBERG is a registered patent attorney with over 15 years of experience in patent and intellectual property law at Greenberg Traurig in Boston. He advises clients on procurement and enforcement of IP rights, including domestic and international patents, with the focus on medtech and life science technologies. Fayerberg’s patent practice builds on seven years of experience gained as a research and development engineer at C.R. Bard (now Beckton Dickinson) and Boston Scientiﬁc. He can be reached at fayerbergr@gtlaw.com or (617) 310-5206.

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CONTENTS

medicaldesignandoutsourcing.com ∞ January 2022 ∞ Vol8 No1

COLUMNS 8

HERE’S WHAT WE SEE:

CONTRIBUTORS

DRUG DELIVERY:

• • • • • THE LEADERSHIP IN MEDTECH ISSUE

ON THE COVER THE PANDEMIC TESTED MEDTRONIC’S METTLE: ITS CFO EXPLAINS HOW

Some thoughts for medtech leaders in 2022

How medical device companies can beneﬁt from digital therapeutics

Medtronic CFO Karen Parkhill discusses leadership, innovation and restructuring at the largest organization in medtech.

20 IP ISSUES:

Design patents can provide extra protection for medical robots

28 ORTHOPEDICS:

Stryker CEO Kevin Lobo talks Wright Medical merger, surgical robotics

FEATURES

34 PHARMA:

Inside Genoskin’s quest to use human skin scraps to accelerate drug research

38 SOFTWARE:

How to protect medical devices from hidden cybersecurity risks

42 TUBING TALKS:

Abbott sees the delivery system as a differentiator for its TAVR

74 DEVICETALKS:

The top 5 medtech news stories of 2021

80 PRODUCT WORLD

58 HOW ABBOTT SEEKS TO IMPROVE CARE AND HEALTH INEQUITIES FOR PEOPLE WITH CARDIOVASCULAR DISEASE

Abbott is on a mission to grasp the scope of the patient journey through cardiovascular disease diagnosis and treatment.

66 MEDTECH’S BIGGEST PERSONNEL CHANGES

160 AD INDEX

Here are some of the biggest personnel moves in the medtech space in 2021.

PAGE 85

Medical Design & Outsourcing

1 • 2022

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How medical device companies can benefit from digital therapeutics

Bill Betten | S3 Connected Health |

There are growing opportunities when it comes to creating digital therapeutics that combine software and medical devices. Here’s what traditional device companies stand to gain.

ith so many types of digital health solutions available, device developers could be wondering where the key distinctions lie and which will drive business value for their offerings. Digital Therapeutics (DTx), however, are one subset of digital health products that device developers should keep their eye on. According to the Digital Therapeutics Alliance (DTA), DTx delivers medical interventions using evidence-based, clinically evaluated software to treat a series of conditions. The most notable DTx to date have been software products only, but growing opportunities exist for medical device vendors to create DTx that combine a software element and a device. These combination DTx offer traditional device-based companies the chance to further their capabilities in digital health and provide a more appealing, competitive product while retaining value 14

Medical Design & Outsourcing

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around their core devices. In addition, Philips has recently joined the DTA, which had, up until that point, been made up of pharma and standalone DTx companies. This marks an interesting development for the organization and for the industry; it is a clear sign that DTx — and combination DTx, in particular — are not just for pharma companies. But what can device vendors who embrace and develop combination DTx stand to gain? Boosting competitiveness In an increasingly competitive industry, device manufacturers can differentiate themselves by offering peripheral services on top of core device functionalities. Combination DTx do exactly that. They turn “standalone” medical devices into tools that can gather, analyze and share data to manage, treat or perhaps even prevent certain medical conditions. >>

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They also can generate new revenue streams, expand existing product portfolios, or even enter new therapy areas. While combination DTx retain the value of the device, developing software capabilities will enrich a company’s portfolio and enable a more diverse offering into the future. The key feature of DTx, as opposed to other digital health solutions, is they are clinically validated. As a result, they offer the potential for greater adoption among clinicians, who can be assured the product does what it claims to and can prescribe them in the several markets where reimbursement pathways are available. Allin-all, devices packaged in a combination DTx will stand out against competitors’ standalone products and ensure patients receive better, more personalized care.

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Facilitating reimbursement Several markets have already introduced legislation to permit doctors to prescribe DTx solutions and provide reimbursement options for patients. Even in regions where DTx pathways haven’t been specified, the assurance of clinical efficacy will strengthen chances of reimbursement in a wider market. >>

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In Germany, the DiGA legislation allows doctors to prescribe apps, and costs can be reimbursed through health insurance. The DiGA Fast Track process is available to all countries in the European Union; however, this is subject to strict regulatory approval and data protection laws. Meanwhile, in Belgium, the National Institute for Health and Disability Insurance announced its health app reimbursement scheme last year, allowing medical apps to be reimbursed under insurance schemes. While progress may be slow, the tide is turning. In the U.S., the new Remote Therapeutic Monitoring (RTM) codes, set to go live in January 2022, demonstrate a growing acceptance of the use of connected medical devices and digital health. Even though there is not yet a clear path to reimbursement for DTx, the fact that DTx are clinically validated certainly strengthens the case for reimbursement in that region.

Augmenting traditional strengths with new capabilities Their clinically validated nature separates DTx from other digital health solutions. While this comes with a regulatory burden that can be challenging for those used to low-impact, non-regulated solutions, it will be nothing new for device developers familiar with the pathways, quality management systems, and processes used to certify medical devices. Embracing DTx can allow device vendors to diversify their offerings and expand the value of core devices into the future. While it might appear difﬁcult to enter new territory, device vendors don’t need to develop companion DTx independently. They can augment their traditional capabilities by engaging a specialist digital health partner to get ahead of the competition.

their core, they deliver better healthcare through clinically validated software interventions. While that’s the overall goal we’re seeking, they can provide a multitude of beneﬁts for vendors to make their offerings more appealing, for healthcare professionals to have more conﬁdence in prescribing these solutions and devices, and for patients to have more personalized healthcare. Crucially, combination DTx can enable new ways of looking at data, unlocking actionable insights, and, ultimately, driving better outcomes for patients.

A step on the path to better patient care DTx are an, as yet, relatively untapped resource for medical device developers. At

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Medical Design & Outsourcing

IP ISSUES

Design patents can provide extra protection for medical robots

Roman Fayerberg | G r e e n b e r g Tr a u r i g |

Image courtesy of Adobe Stock

Filing design patents can protect a medical robot’s overall aesthetic and the software user interface.

To d d C . B a s i l e | G r e e n b e r g Tr a u r i g |

David J. Dykeman | G r e e n b e r g Tr a u r i g |

edical robotics companies often emphasize utility patents when building strategic patent portfolios, given the complex nature of robotics technology. However, don’t overlook design patents, which provide another layer of protection by covering elements of robotics beyond the scope of utility patents. A robust patent portfolio is an important indicator of a successful medical robotics company. As the medical robotics industry continues to grow and more and 20

Medical Design & Outsourcing

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more companies enter the increasingly competitive market, a medical robotics company needs a comprehensive and strategic patent portfolio around its technology to compete. A strategic patent portfolio attracts investors, keeps competitors at bay, and provides necessary ammunition in litigation. Utility patents vs. design patents Both utility and design patents have the same patentability requirements: novelty, non-obviousness, and utility. >>

www.medicaldesignandoutsourcing.com

IP ISSUES

Both grant the owner the right to exclude others from making, using, selling, offering for sale or importing the claimed invention in the U.S. However, this is where the similarities end and the differences begin. Coverage Utility patents protect the operational or functional features of a product or how the product works. In contrast, design patents protect the ornamental or nonfunctional features of a product or how the product looks. Utility patents include a complex and lengthy speciﬁcation with a thorough written description of the invention and its use and detailed drawings of various embodiments of the product. Most importantly, utility patents include multiple claims of varying scope deﬁning the invention, which may provide patent coverage for various embodiments of the invention and may be different (broader or narrower) than

the exact product shown in the drawings. In contrast, design patents have no written description and are limited to one claim covering only the exact product shown in the design patent drawings However, continuation design applications are available and can have a different scope than the parent design patent by either adding or disclaiming portions of the original drawings. Duration of protection The term of utility patents (20 years) and design patents (15 years) is also different. Utility patents generally last 20 years from the effective ﬁling date (or the priority date) of a patent application. The term of utility patents is sometimes extended for more than 20 years due to delays by the USPTO, but typically the term of continuation and divisional utility patents will expire (or be disclaimed) at the same time as the parent utility patent or 20 years from the ﬁling date of the parent application. For design

patents, the term is 15 years from the patent issuance date. How the term is calculated is an important difference and can be used strategically. Because the term of the design patent is counted from the issuance date rather than from the priority date as for utility patents, continuation or divisional design patents filed after the parent application can stay in force for years after the parent design patent expires. They can stay in effect longer than 20 years from the parent application’s filing date. A design patent family can thus outlast a utility patent family with the same priority date. Timing of public disclosure Another important difference is that design patent applications do not become public unless and until they issue as patents. Generally, all utility patent applications are published 18 months from the earliest priority date. The USPTO allows applicants to request non-publication, but only if the applicant foregoes foreign protection. In contrast, design patent applications remain confidential even if there is a foreign counterpart. As a result, competitors will not be able to obtain information about the company’s technology under development before the technology is commercialized or a patent issues. Design patents for medical robots Factors like aesthetics and approachability often play into consumer purchasing decisions, especially when it comes to robotics. Many expect cutting-edge medical robots to look “cool,” “smooth” and “user-friendly.” As such, the overall look and feel of a surgical robot, and associated tools and its software user interface, can influence buyer perceptions and the user experience. With this comes value worth protecting. Accordingly, many smart medical robotics companies consider supplementing their utility patents with design patents to provide additional protection covering the appearance or ornamental features of their product platforms. Robot design features It’s possible to use design patents to protect the overall design of the robotic system and tools that the users may find appealing. For example, aggressive lines can give robots a high-tech feel that complements new and innovative >>

Medical Design & Outsourcing

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IP ISSUES

Software user interfaces Design patents can also be used to protect graphical user interfaces (GUI), which are important for robots. A welldesigned GUI provides many benefits to users. For example, the use of the robotic system can be simplified if the GUI provides intuitive controls or easyto-understand feedback, not unlike innovative icon-based interfaces first employed with smartphones. Design patents can be used to protect these features of the GUI. The overall screen design and individual icons can be protected by design patents. Moreover, animated icons that go through a series of transformations can also be protected. A strategic design patent portfolio protects GUI elements desired by users, thus providing another competitive advantage to design patents.

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Enforcing design patents For all their merits, the scope of protection offered by design patents is generally more limited than that of utility patents. >> 1 • 2022

Medical Design & Outsourcing

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procedures. Smoother, more sweeping lines can convey approachability desired by patients undergoing more routine, inpatient procedures. Some lines are better than others for invoking emotions and responses in purchasers and users of surgical robots. Thus, competitors may be inclined to copy or impersonate successful designs to increase sales. Design patents can deter copying or knock-offs and help an innovator maintain its edge over less creative competitors. Companies often include certain ornamental elements to signal to the user that they originate from the same company and are speciﬁcally designed for use together. Think how consumer shaving razors often include handles and heads with lines that complement an overall design theme where they are joined. It’s possible to design detachable components of a surgical robot with similar interfaces that convey to a user that this particular component goes with this particular robot without even having to read the label. Design patents can be a particularly effective way of protecting such “trade dress” without the challenges of proving that the particular design theme is so distinct that it has taken on “secondary meaning” in the eyes of consumers, which is typically required to win traditional trade dress lawsuits.

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IP ISSUES

Simply stated, utility patents can cover a variety of aesthetic embodiments so long as each includes the claimed functionality, while design patents generally require that the accused design have a very similar “look and feel” as the drawings in the design patent. More specifically, courts will find design patent infringement if the accused design is so similar to the design patent drawings that a purchaser would be deceived by the similarity between the claimed and accused designs. The similarity, the reasoning goes, would induce the purchaser to buy one, supposing it to be the other product. In other words, the accused design is compared to the drawings of the design patent rather than more mechanically oriented claims of a utility patent. Competitors may thus be able to “design around” a design patent by making small changes to the patented design to avoid infringement, especially in a crowded field with similar prior art. Consequently, the

appearance and selection of the drawings is critical in design patents. Enforcing design patents offers some unique benefits. If infringement is found, an owner of a design patent has two options when seeking damages. The first option is to seek damages under the standard patent damages statute available for both design and utility patents, which is a reasonable royalty. The second option, which is typically not available for the infringement of utility patents, is to recover the infringer’s total profits. In other words, it may be possible for the design patent owner to collect total profits on the entire product, even when the patented design constitutes only a portion of the product. Moreover, as discussed above, continuation practice is useful to obtain design patents of varying scope of protection. Accordingly, even though design patents provide a somewhat limited coverage, design patents can still serve as a strong deterrent to infringement.

Conclusion When building a strategic patent portfolio, medical robotics companies should consider ﬁling for design patents. Design patents are typically easier and less expensive to obtain than utility patents. Although generally having a more limited scope of protection, design patents can still deter potential infringers in the U.S. and foreign countries. Due to the differences between the two patent types, design patents can supplement protection provided by utility patents, creating comprehensive patent coverage. This article reﬂects the opinions of the authors, and not of Greenberg Traurig or Medical Design & Outsourcing. The article is presented for informational purposes only and it is not intended to be construed or used as general legal advice nor as a solicitation of any type.

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Stryker's CEO talks success of Wright Medical merger, increasing competitiveness of surgical robotics Kevin Lobo has a lot to be excited about at Stryker, the world’s largest orthopedic device company.

evin Lobo has seen many successful acquisitions at Stryker’s helm in the last 10 years. The Kalamazoo, Michigan medtech giant’s recent acquisition of Wright Medical has positioned the company to expand its orthopedics range – adding upper extremities to its vast portfolio of orthopedic devices and robotics. Stryker announced the $4.7 billion acquisition of Wright Medical in November 2019 but didn’t fully acquire the company until November 2020 because of concerns raised by U.S. and U.K. regulators. The company added Wright’s upper extremities (shoulder, elbow, wrist and hand), lower extremities (foot and ankle) and biologics devices to its portfolio. It then separated and reorganized its businesses into three separate business units within Stryker: upper extremities, core trauma and lower extremities. Stryker CEO “I’ve been extremely pleased with this integration. It’s been one of the best we’ve Kevin Lobo done in the time I’ve been at Stryker,” Lobo told DeviceTalks host Tom Salemi in the DeviceTalks Weekly Podcast that aired Dec. 3, 2021. “It’s very exciting that this integration [with Wright Medical] has not disrupted the new product engine and has not disrupted anything in the ﬁeld. We continue to enjoy very good growth rates. Foot and ankle are affected by the pandemic.” Lobo explained that people and culture are the most signiﬁcant part of any integration. Before any acquisition, it’s important to consider culture. The bigger the company, the more two different cultures will have to change. Through the melding of the two companies, Stryker appointed a Wright Medical person to lead upper extremities and lower extremities and a Stryker person leading core trauma and the Danielle Kirsh | overall business. >> Senior Editor | 28

Medical Design & Outsourcing

1 • 2022

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LOBO AND PIERCE TALK WRIGHT, COOL TECH, ROBOTICS AND THE NOT-SO-SECRET PLANS TO KEEP STRYKER GROWING Stryker CEO Kevin Lobo discusses plans to keep building on its market leader status, the Wright Medical integration, what makes a good acquisition, and how the rise of surgical robotics is helping Stryker build out its Mako product. PLUS: MedSurg and Neurotechnology Group President Andy Pierce updates us on his group’s wide-ranging portfolio.

www.devicetalks.com/ podcast

ORTHOPEDICS

Said Lobo: “We knew their culture would be a good match for ours, and it’s proven to be the case.” Growing orthopedic robotics Another big part of Stryker’s orthopedic portfolio is the Mako robotic-assisted surgery platform that it acquired in 2013. Mako’s SmartRobotics technology combines 3D CT-based planning, haptic technology and data analytics for better outcomes in total knee, total hip and partial knee procedures. The company has grown its net sales exponentially since buying Mako Surgical for $1.6 billion in 2013. Stryker made $9 billion in sales that year and has risen quickly to $14.4 billion in 2020. >>

"I've been extremely pleased with this integration. It's been one of the best we've done in the time I've been at Stryker."

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ORTHOPEDICS

Its orthopedics business grew from $3.9 billion in 2013 to just under $5 billion in 2020. It made $14.9 billion in sales and $5.3 billion in orthopedic sales in 2019 — the year before the COVID-19 pandemic hit. One out of two Stryker knee implants in the U.S. are implanted using the Mako system. Lobo said that Stryker also sells Mako into a competitive implant market 60% of the time. The company has sold more than 1,300 units globally and over 1,000 units in the U.S. “It’s a spectacular growth that we’ve had. Far faster than I expected,” Lobo said. “I really believed this would be compelling and we would have a strong adoption, but it’s been faster than I expected. We only launched the total knee application about four years ago.” The surgical robot market is seemingly having its moment with Intuitive Surgical’s da Vinci surgical robot dominating and Medtronic’s Hugo RAS being in trials (not to mention Johnson & Johnson’s much-anticipated but recently delayed Ottava). In the ortho surgical robotics space, Mako now has competition from Zimmer Biomet’s Rosa, Smith+Nephew’s Cori and J&J’s Velys systems. Lobo welcomes the competition and wants to see interest in robotics to keep rising. “More players that come into the market creates more interest,” he said. “We love our chance to side-by-side compete with any of the systems on the market.”

1 • 2022

Medical Design & Outsourcing 33

PHARMACEUTICALS

Inside Genoskin's quest to use human skin scraps to accelerate drug research Surgically removed skin could prove a treasure for Salem, Massachusetts–based Genoskin.

"H Brian Buntz | Pharma Editor |

The MANTIS spatial biology imaging platform for skin immunology Image courtesy of Genoskin

Medical Design & Outsourcing

ow do you maintain human skin alive so that you can generate data from what would otherwise be trash?” asked Eric Merle, chief business innovation ofﬁcer of Genoskin. “We work with surgical discards.” Founded a decade ago, Genoskin collects human skin that would otherwise be waste from cosmetic surgeries such as face-lifts and abdominal surgeries to foster research on new drugs and cosmetics. “Many people worldwide are undergoing plastic surgery, yielding tissue,” Merle said. Keeping the skin preserved requires “pretty tight logistics,” Merle said. “We have the logistics of an organ transplant company.”

function of in vivo human skin. Another of its products is the InflammaSkin model, an ex vivo human psoriasis model T cell-driven with a Th17/Th1 phenotype. Genoskin also offers an injectable site reactions platform. Rounding out its products is its latest offering, MANTIS, which offers an automated analysis of more than 12 markers in a single acquisition, coupled with deep learning-based computational imaging. Named after the mantis shrimp, MANTIS is also an abbreviation for Multiplex ANnotated Tissue Imaging System. MANTIS supports 3D imaging of skin and immune cells. Genoskin counts companies such as GSK, Sanofi, Leo Pharma and Pfizer as customers.

The resultant skin models preserve the characteristics of real human skin. The company has a variety of product types. One is HypoSkin, an alternative to animal testing for subcutaneous injections. “We can maintain human skin in an immunocompetent survival state with the ability to inject into it,” he said. In addition, its NativeSkin human skin models preserve normal skin barrier

The FDA recently invited the company to demonstrate how its skinbased models could determine the toxicity of compounds. The company’s offerings remain unique in the marketplace, Merle said. “We’ve had a very strong IP effort,” Merle said. “Last year, we filed a patent on a biofluidic platform that connects tissue to microfluidics.” >>

1 • 2022

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Still, there is indirect competition from companies specializing in bioprinting, virtual clinical trials and animal testing. “But there are not that many actors in skin itself, actually,” Merle said. “Yet skin is our largest organ. It’s the biggest indicator of what’s happening in your body.” Genoskin also hopes to play an instrumental role in the pharmaceutical industry’s gradual transition from animal testing. In 2019, the EPA signaled its intent to eliminate mammal testing by 2035. Last year, Senators Rand Paul (R-Kentucky) and Corey Booker (D-New Jersey) introduced a bill known as the FDA Modernization Act that would end FDA’s animal testing mandates. Large pharmaceutical companies are making similar long-term plans. Genoskin has had “very advanced discussions with big pharmaceutical partners,” Merle said. “Animal testing dates back to the 1950s. It is not a very old part of the drug development process,” Merle said. “As better solutions for drug development and prediction of efficacy in humans come up, people will adopt those.”

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SOFTWARE

How to protect medical devices from hidden cybersecurity risks Your software supply chain could be a cybersecurity risk. Here’s what you can do.

Vince Arneja | G r a m m a Te c h |

Medical Design & Outsourcing

he healthcare industry has been fighting a war on two fronts during the COVID-19 pandemic against the virus and an outbreak of cyberattacks. The Department of Health and Human Services says the sector reported a 9,851% increase in cyberattacks in 2020 compared to 2019. Cybercriminals see healthcare organizations as “soft targets” that are not as well defended; they need to be accessible to users and have heavy traffic of files and records, which leave multiple attack vectors open for criminals. In addition, healthcare is in the midst of a technology expansion, with explosive growth in Internet of Things (IoT) connections, patient portals and telehealth. All these new medical technology applications run on software. MarketsandMarkets Research says healthcare IT spending will grow more than 20% every year through 2026, and most of that growth will come from enterprise software. The software development process — both for custom and off-the1 • 2022

shelf programs — often relies on what’s known as “Software of Unknown Pedigree/ Provenance (SOUP),” or code from opensource libraries or other sources that developers use to save time and money by copying the programming of common functions. The practice lets them develop and update software at speed and scale, but can also expose vulnerabilities that attackers can use to steal patient and PII data or install malicious code such as spyware or ransomware that can disrupt critical healthcare services. In this environment, protecting medical devices from security vulnerabilities in open source and third-party code is imperative. Supply chain attacks are a growing concern among all industry sectors, and medical devices present a large attack surface for this type of threat. Protecting medical devices from supplychain poisoning The FDA already requires risk management of third-party software and other SOUP for pre-market approval of medical devices. >>

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SOFTWARE

Still, comprehensive software risk management, augmented with automated analysis, can also help analyze and ﬁx vulnerabilities in software at speed and scale. For example, software composition analysis can help software supply chain risk management by providing insight into open source and third-party code. A software bill of materials (SBOM) should be a basic part of risk management efforts. You can’t secure what you don’t see. These outside sources of software can often ﬂy under the radar of security; analyzing them requires specialized skills and can be costly and timeconsuming. Automated tools can be key to understanding and managing risk and documenting, tracking, and communicating the risks associated with SOUP. So how to protect medical devices to avoid landing in the SOUP? Some best practices to reassess your approach to software security can lower the risk and liability from third-party software:

•

Adopt new guidelines for software development. The techniques and methodology for developing both software and critical devices are evolving. Any organization will beneﬁt from reviewing software risk management, development and security best practices. Including software as part of supply chain management is critical, as is evaluating software for safety, quality, and security. Combine risk management with security threat analysis and assessments. Security should be a part of medical device risk management at all stages of development. A safety analysis may focus on the device’s medical function and overlook its cybersecurity, but a device open to hacking is not a safe device. The assessment must include the software supply chain, including any off-theshelf software and SOUP.

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Manage the software supply chain. Most software development will continue to reuse code or leverage existing open-source or commercial programs. Creating an SBOM to understand the make-up of the software enables your organization to detect vulnerabilities that may be hiding in open source and third-party code. Reducing this risk will require continuous assessments of the quality and security of SOUP and other code, internal or external to the company. Integrate automated development and testing tools. As software approaches evolve, an automated toolbox is critical to leverage increased security, quality, and safety opportunities. Static application security testing (SAST) is required to find and fix defects through the software development life cycle (SDLC). Additionally, software composition analysis to parse out the SBOM needs to play an important role in automating the vetting of software. Integrate security and safety audits continuously. Automation allows security staff to continually monitor the security of software under development when it’s part of a continuous integration and deployment pipeline. Confirming that software meets the auditing standards complies with the FDA requirement for pre-market approval, and doing so continuously avoids any unexpected shocks later in the development process.

Forrester found that 85% of healthcare organizations claim to be very or extremely concerned about the security risks of IoT devices, and 95% are spending more to secure their devices in the next two years. Tighter management of supply-chain risk throughout the SDLC should be a key part of the effort to deliver medical devices with a securityﬁrst mindset.

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TUBING TALKS

Abbott sees the delivery system as a differentiator for its TAVR A top Abbott executive explains how the company’s FlexNav delivery system could make the Portico TAVR competitive.

The Portico with FlexNav TAVR system

Image courtesy of Abbott

Chris Newmarker | Executive Editor |

Medical Design & Outsourcing

bbott is aiming to claw market share away from transcatheter aortic valve replacement pioneers Edwards Lifesciences and Medtronic. The Abbott Park, Illinois–based medtech company in September announced FDA approval of its Portico with FlexNav TAVR system, more than a year after it secured CE mark approval in Europe. For now, the approval covers symptomatic, severe aortic stenosis associated with a high or extreme risk for open-heart surgery. The Portico valve boasts a self-expanding design with intra-annular (within the native valve) leaﬂets. The Portico’s creators designed its structure to provide optimal blood ﬂow 1 • 2022

when placed inside a patient’s natural valve. It also preserves access to the critical coronary arteries for future interventions. But Santosh Prabhu — divisional VP, product development of Abbott Structural Heart — says the FlexNav delivery system is where the real ingenuity lies. “I think it’s a major innovation in how the valve is delivered, based on the innovation that has gone into the design of that delivery system,” Prabhu said during an interview that originally ran in November on our DeviceTalks Weekly podcast. Abbott wanted to create a TAVR delivery system that was ﬂexible, safe, able to get through tough anatomies, and easy to use. >>

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TUBING TALKS

“The smoother the delivery is, the better it is. The more accurately the doctor is able to place the valve, the better outcomes he gets, the better for the patients,” Prabhu said. Here are ﬁve advances that Abbott incorporated into FlexNav: 1. Strategic use of hydrophilic coatings Prabhu and his team took a hydrophilic coating and used it on speciﬁc areas of the catheter to provide lubricity through tough-to-navigate vasculature. He described the coating as a common material used infrequently in TAVR delivery systems. The coating, Prabhu said, “allows us to reduce the friction as we navigate through that tortuous anatomy.” The coating placement had to be well thought out because some parts of the delivery system that are interacting with human anatomy need the reduced friction — but others don’t because they need to anchor.

"I think it's a major innovation in how the valve is delivered, based on the innovation that has gone into the design of that delivery system."

2. A low profile The Abbott engineers and designers were able to drive the size of the FlexNav catheter down to 14 Fr, which Prabhu said is the lowest profile in the industry. “The low profile is what improves the deliverability of the catheter, but to get to the low profile, there’s a lot of engineering.”

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“We have to make sure that we pick the right components, the right tolerances, the right blend of materials,” Prabhu said. “Catheter design is more of an art than a science in many ways.” Abbott innovated in how it used standard catheter materials, giving close scrutiny to their size and braiding conﬁguration. “The team had to work through several different iterations,” Prabhu said. “Not all of them were right. But as we progressed, we got closer and closer to the design goals.” 3. An integrated sheath Prabhu and his colleagues also created an integrated sheath that could accommodate the catheter’s size; Doctors can go sheathless or use the sheath integrated into the FlexNav system. “Instead of using a secondary sheath, it’s built into our product, which is one of the reasons we were able to drive down the proﬁle,” Prabhu said.

TAVR-TALKS PART II: WHERE DOES ABBOTT SEE OPPORTUNITY? 4. A stability layer The stability layer in the catheter, according to Prabhu, helps take the guesswork out of TAVR deployment. In a TAVR procedure, a doctor maneuvers the catheter when placing the valve to ensure it is at the right location. “Now, with the stability layer that we have incorporated, he necessarily doesn’t have to do that,” Prabhu said.“Wherever you decide the valve needs to go, you start the deployment process, and the valve deploys in that location. He doesn’t have to maneuver or rotate the catheter or move the catheter front and backward.”

In the follow-up to our first episode focused on transcatheter aortic valve replacement (TAVR), we hear from the new competitor on the block, Abbott, which recently earned FDA approval for its valve. Santosh Prabhu, PhD, introduces the new entry and explains why this work is so important to him personally.

5. Better benchtop testing Clinically relevant benchtop models — including 3D printed and silicone — also played an important role. “There was a lot of innovation in how we tested these products on the bench,” Prabhu said. “We tried to simulate the anatomy. We take the actual patient scans and develop these models. >>

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Medical Design & Outsourcing

TUBING TALKS

We look for those clinically, worst-case situations where we can test these products.” A large amount of data from the original Portico delivery system also informed the FlexNav system, which Prabhu thinks could someday go into delivery systems for transcatheter mitral and tricuspid valves. Luckily, the manufacturing technology for catheters has evolved enough over the past 10 to 15 years that it was possible to achieve the smaller, tighter tolerances and other enabling technologies needed to make the improvements a reality. “We are very committed to this space,” Prabhu said. “There will be more to come.”

"We have to make sure that we pick the right components, the right tolerances, the right blend of materials. Catheter design is more of an art than a science in many ways."

Divisional VP, Product Development of Abbott Structural Heart Santosh Prabhu

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Medtronic’s mettle:

Its CFO explains how J I M HAMMERAN D MAN AGI N G EDI TOR

aren Parkhill drew on her experience in the banking industry to offer Medtronic a prognosis as the COVID-19 pandemic started rippling across the globe. Parkhill, Medtronic’s CFO and EVP, was CFO of JPMorgan Chase’s commercial banking business during and after the 20072008 financial crisis, and then served as CFO at Comerica before joining Medtronic in 2016 under former CEO Omar Ishrak. “When the pandemic hit, we didn’t know how bad, how long it was going to affect us,” Parkhill said in an interview with Medical Design & Outsourcing. “We needed to quickly decide whether we were going to cut back on R&D, on manufacturing, on our employee base. I took the lessons learned from stress tests in the financial services sector and quickly showed that Medtronic had the financial stability to withstand very severe stress from COVID.” She said Medtronic kept its plants operating at full capacity, kept personnel in place without cutting pay, and worked Photo courtesy of Medtronic

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with suppliers and customers to help them through the crisis. “We built great credibility and a stronger long-term relationship with our suppliers, our customers and our employees as a result,” Parkhill said. “I look back on the very early stages of the pandemic with a lot of pride that Medtronic was able to handle it the way we did.” Jason Weidman, Medtronic SVP and president of its coronary and renal denervation business, said Parkhill complements her financial smarts with compassionate and caring leadership. “When something difficult is going on or there’s a really tough situation we’re dealing with, one of her first questions is always going to be, ‘How is the team doing?’ ” CEO Geoff Martha described her as a steady-handed and compassionate leader in a statement shared with MDO. “Throughout her tenure, Karen has led by example and enabled teams to innovate and share ideas, feel understood, and achieve results,” Martha said. >>

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Medical Design & Outsourcing

KAREN PARKHILL, MEDTRONIC CFO

“I have been consistently impressed by Karen’s commitment to the Medtronic Mission and dedication to achieve excellence — and doing so while embracing the highest ethical and quality standards.” Parkhill also played an important role in communicating with The Street, according to Ryan Zimmerman, managing director, equity research – medical technology at BTIG. “We think that Karen has done a strong job of communicating clear expectations to The Street in an ever-changing environment. Many of Medtronic’s markets are ﬂuid quarter to quarter as a result of the elective nature of surgery, so it does present a challenge in terms of forecasting,” Zimmerman said. Parkhill, who is leading Medtronic’s restructuring initiatives, discussed leadership, culture and innovation with MDO in the conversation below, which we’ve edited for brevity and clarity.

MDO: Can you explain Medtronic’s two big reorganization projects and offer any updates? Parkhill: Enterprise Excellence was a program that we started under Omar to have our functions be more cost-effective (and) plant consolidation to enable more cost-effectiveness in our general operations — and ultimately use that savings to reinvest and help ensure that we delivered our bottom-line commitments. We’re not completely ﬁnished. We’ve got another year to go, but we’re nearing the end. On top of that, we put Simpliﬁcation, a new program under Geoff’s leadership around driving the operating model changes and simplifying our org structure. It was really about enabling our business units — we call them operating units — to be at the center of the new organization. It’s been very powerful for Medtronic to get rid of the old group structure because we had many companies operating within Medtronic,

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and they each had their own infrastructure. Every group president had their CFO, their head of HR, their legal person, their quality person, all these functions around them. We’ve simpliﬁed that whole structure, put what we needed at the operating units, and got rid of the overhead. MDO: What does that do for you as CFO? Parkhill: I have much greater transparency and insight into what’s going on down in our businesses rather than that being clouded through the group structure. It enables me to be more effective as a CFO and in our capital allocation process, ensuring that we truly are driving our capital to our highest and best use, and that we’re driving it toward the greatest growth opportunity and holding our leaders accountable when we’re investing in these great growth opportunities to ensure we ultimately achieve them. I think it’s done wonders for the organization and particularly in my role. The CFO role is supposed to be a highly strategic role, and there’s no other role in the company that has the purview of the CFO. And with that purview, the role can and should be wide and strategic because you understand the past and you’re looking forward to the future and you’re helping to shape the future as we plan and forecast and budget. MDO: How does the reorg affect R&D and innovation? Parkhill: It encourages innovation and greater accountability around that innovation. We have driven the amount of dollars that we put toward R&D higher in this new structure. We now have about 8% of our revenue in R&D, a little bit higher than before. From a dollar perspective, we had the highest dollar increase in R&D than we’ve ever had. Much of that R&D is innovation yet to come. But our pipeline is super strong. And if we talk about just two key things in our pipeline that the external world likes to focus on a lot, it’s both RDN [renal denervation to treat hypertension] and the Hugo robot. MDO: What kind of cultural changes have come from the reorg, and how has leadership made that happen? Parkhill: We have a new Medtronic Mindset. It’s about being bold, moving with speed and decisiveness, focusing on greater competitiveness where we’re >> 50

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driving a focus on not just performance against our internal plans, but performance against the external market and driving increased market share. Those are underlying the big cultural changes. We’re talking about it all the time: We’re talking about boldness, we’re talking about making decisions quickly, and simplifying the org structure has helped us do that. We’re tracking and monitoring and talking about market share all the time now, which we didn’t do before. That helps drive the cultural shift as well.

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MDO: Is market share the biggest metric to determine whether this is successful? Parkhill: It’s an important factor, but we’re also measuring things like our organization health through surveys. We want to make sure that we’re at best-in-class levels in org health, and since we put this new operating model in place, we’ve had the highest org health scores we’ve ever had, and in many categories have achieved worldclass status. So market share, org health, ensuring that we’re delivering on our external commitments, and most importantly, driving our revenue growth higher and sustaining it. We had historically been delivering 4% to 5% annual revenue growth, and our external commitment is ﬁve plus. I would put great emphasis on that plus because with the pipeline and the focus on market share, our key focus is to drive it much higher than 5%.

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MDO: What does this cultural shift and reorganization mean for suppliers and vendors? Parkhill: They’re going to grow with us, which is important. We have a new head of operations, and I think he’s going to bring even greater discipline and move us — from an operations perspective — to best in class. In our industry, I would say our operations have never been the best-in-class kind of operations that happen in other industries, and we’re focused on moving to that. So our suppliers and our vendors will grow with us, but we’ll also want to make sure that they’re innovating with us. And those that are innovating with us are the ones that will have greater business from us as we probably work to consolidate some of our vendors. MDO: Martha has said the reorg could open the door for more contract manufacturers if your business leaders can make the cost-beneﬁt case up the chain. Have you seen much of that yet? Parkhill: Not yet. We have a decent number of contract manufacturers today, and that could grow in the future. I think we’ll always have a mix of contract manufacturing in our own manufacturing, so as we grow, both grow. MDO: What are you looking for in external partners? Parkhill: We like partners that innovate as fast or faster than we do, that focus on a partnership with us. It’s a relationship. It’s not a service that they provide and they get a fee. It’s a long-term relationship where they understand Medtronic on a deeper level, understand where we’re heading and are a part of helping us get >> 52

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MDO: How do you think about making sure you have the right people in the right places, from recruiting and retention to turnover and succession? Parkhill: We have a very robust talent management process that includes knowing each individual’s aspirations and making sure that we’re helping them achieve their aspirations within Medtronic. We do that really well. We also have very robust succession planning, as you can expect from a company of our size and stature, and not just at the very top echelons of the company. It goes all the way down into the company. From a talent recruitment perspective, we are constantly scouting talent. When we ﬁnd great talent, sometimes we don’t have the exact role to slot them in, but we’ll create roles and take risks with that external talent so we’re constantly building that pipeline of both internal and external talent.

"We have a new Medtronic Mindset. It's about being bold, moving with speed and decisiveness, focusing on greater competitiveness where we're driving a focus on not just performance against our internal plans, but performance against the external market and driving increased market share." there, and also part of understanding problems and issues that we face and helping us solve them. MDO: We’ve seen a lot of executive departures during the reorganization. How much turnover was expected, and how much was unrelated? Parkhill: Whenever you do a major reorganization like we’ve done, you just expect some turnover. The percentage of turnover that we had was deﬁnitely expected. On an individual basis, some of it was the right turnover, and then some of it was regrettable, but you’re always going to have that when you’re a strong company like Medtronic and you breed talent and the external world sometimes wants to poach that talent. From a retention perspective, we do a really nice job. We retain a lot of our strong talent, and they are incredibly motivated under this new operating model because they have greater responsibility and accountability. www.medicaldesignandoutsourcing.com

MDO: You’ve supported Medtronic’s early career rotation program. What do you hope to achieve, and what advice can help other companies launch their own? Parkhill: Early career is so important to build your culture and your talent pipeline from the ground up. Medtronic had — when I first joined — not as robust of an early career program. Now it’s much more robust. We’re doing early career hiring outside of colleges and putting people through rotational training programs, and they’re ultimately feeding our open positions once they finish that program. We’re seeing great success. The talent you can get from colleges and universities today is tremendous, and we’re really focused on driving a diversity of talent. We’ve got a new partnership with the Thurgood Marshall College Fund where we recruit at colleges that we may not have gone to in the past, and we also help support the educational expense of that diverse talent. We’re seeing good success, and every good company should have a good early career strategy. MDO: It can’t be that expensive to fund, can it? Parkhill: That’s where finance comes in. Oftentimes, our early career programs were not funded because the businesses thought it was too expensive. They wanted to put their dollars in R&D. >>

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Medical Design & Outsourcing

KAREN PARKHILL, MEDTRONIC CFO

But the reality is we have open positions all the time and we’re hiring headhunters to do the external recruiting to fill beyond early career positions, when if we just reallocated that dollar to fund an early career program, it can easily happen. We had finance work with each of the businesses to prove that out and ultimately ended finding the dollars without needing to add extra dollars to start this program.

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"Early career is so important to build your culture and your talent pipeline from the ground up." MDO: What have you learned about yourself and about Medtronic while leading the reorganization over the last few years? Parkhill: We did this reorg in the midst of the pandemic, and we were all on Zoom calls together. Ex-com (the executive committee) spent endless hours on Zoom calls designing the new operating model. What I learned in that process is never underestimate the power of what we can do even under extreme circumstances. That’s what I personally take away, and I think the organization takes it away too. We not only designed this new operating model via Zoom, but we implemented the whole thing via Zoom, and the new operating model meant that we put people in brand-new positions according to our new structure, all the way down the organization. And we did all that via Zoom. For more from Karen Parkhill on Medtronic’s M&A strategy, go to medicaldesignandoutsourcing. com/medtronic-acquisitions.

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Executive Editor Chris Newmarker contributed to this report. 56

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How Abbott seeks to improve care and health inequities for people with cardiovascular disease Abbott is on a mission to grasp the scope of the patient journey through cardiovascular disease diagnosis and treatment. SEAN WHOOLEY ASSOCI AT E EDI TOR Image courtesy of Adobe Stock

bbott’s Beyond Intervention Initiative kicked off a few years ago to improve patient care and quality of life. The company found there is plenty of ground to make up. “That’s what all these life-changing technologies that we developed are about,” CMO and Divisional VP of Medical Affairs for Abbott’s Vascular Business Dr. Nick West told Medical Design & Outsourcing. “If we’re not going to improve the quality of life and, indeed, the number of patients, the amount of life and improve patient care, then what are we doing?” Year one data from the initiative — with feedback from more than 1,800 patients with cardiovascular disease, physicians and healthcare leaders — highlighted disruption within the patient care continuum. It found care divided among different providers without collaborative thinking. 58

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Abbott’s research identiﬁed several inconsistencies in patient care delivery and access to technology that supports accurate diagnosis. The company observed inadequate care for underserved communities, highlighting another barrier in managing cardiovascular disease. The ﬁndings also revealed major discrepancies in how patients and healthcare providers perceive the effectiveness of the care delivered. Technology, powered by data-driven techniques, could be key to closing the gaps appearing across the care continuum, West said, with Beyond Intervention aiming to raise awareness and start a conversation about it. “The industry needs to do what it can to improve the holistic patient experience,” West said. “We need to move away from just product and tech to a more patient-centric and serviceangled offering which is going to help patients, doctors and healthcare providers.” >>

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CARDIO HEALTH INEQUITIES

Image courtesy of Abbott

Abbott’s research found that healthcare administrators are more likely to rate the patient experience for patients with cardiovascular disease as more positive (65% consider it ideal) than the patients themselves (38%) for those with peripheral artery disease (PAD). Similar numbers (64% and 44%, respectively) were observed for coronary artery disease (CAD). A significant source of patient frustration stems from the lack of electronic medical record (EMR) interoperability, with more than one-third of patients with peripheral artery disease (PAD) stating that they “constantly” have to provide medical history and information to physicians. Healthcare providers and hospital leaders (35% in the research effort) also believe a lack of medical record integration among providers results in a limited exchange of patient history and information. That creates inefficiencies and barriers for early and accurate diagnosis of CAD and PAD, the professionals say. “We’re looking at about a third of patients that say [treatment] was ideal, and the rest of them were saying, ‘No, it’s not.’ And so I think that is a stopping moment to say, I wonder what’s going on,” Abbott Divisional VP of Global Clinical Affairs Jennifer Jones-McMeans said. “I think if you uncover even more, some of the findings that were identified is that patients, especially with PAD, can have a lack of awareness of the symptoms that they have.” Jones-McMeans said anyone with pain in their leg likely wouldn’t leap to peripheral artery disease as the cause and, even if symptoms persist, they might not perceive it as problematic. Among the many challenges related to diagnosis and treatment for these diseases is the issue of the heightened impact on underserved communities, putting patients 60

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who carry the burden of disease at a disadvantage to the type of care they will get and when they will receive that care. Health inequities brought on by socioeconomic status, education and healthcare access are massively affecting certain patient populations, Jones-McMeans said. Misdiagnoses can happen without support from the system and the proper education and awareness. Someone seeking a diagnosis who doesn’t have good access to care is more likely to report the use of multiple physicians. As that person seeks to solve their problem with different people offering different opinions, they can be made overwhelmed or anxious and afraid of hospitals and doctors because of social determinants of health in an inequitable system. “We have these communities and populations that are disproportionately

impacted,” Jones-McMeans said. “People of color are being disproportionately impacted, and there is a lack of awareness. This can be even more problematic because, by the time they get to care, it’s sometimes too late.” Abbott is focusing its clinical trials on including underserved communities

such as women and people of color who are disproportionately affected, as shown by Beyond Intervention. For example, Jones-McMeans noted that the company’s LIFEBTK trial for a treatment for critical limb ischemia (CLI) is looking at the barriers to certain populations,

"We're looking at about a third of patients that say [treatment] was ideal, and the rest of them were saying, 'No, it's not.' And so I think that is a stopping moment to say, I wonder what's going on. I think if you uncover even more, some of the findings that were identified is that patients, especially with PAD, can have a lack of awareness of the symptoms that they have."

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including African American and Native American women, who can have the highest risk of such disease as their age increases. Overall, Jones-McMeans said the study operates with the knowledge that the African American, Latino and Native American populations are all disproportionately impacted. Rather than just hoping the trial can include certain populations, the company aims to make trials include underserved communities, with clinical sites in affected communities and new investigators that Jones-McMeans said are diverse themselves. She said that on top of improved access, the moves increase trust, with patients more likely to participate with physicians and nurses who “look like them and speak the same language.” “COVID has really shown that studies need to be representative of the patient populations we’re trying to impact,” West said. “This is not a problem statement that we’re not doing something about. We are actively looking into ways that we can impact to better understand what this space is and make sure our clinical trials are really representative of the patients that are out there.”

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Medtech’s Biggest Personnel Changes A

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s medtech companies continued to drive innovation throughout the past 12 months, a number of high-level executives led the way. Some of those companies and executives opted for major changes over the course of 2021, though, with some high-profile moves from medtech giant to medtech giant. Here are some of the biggest personnel moves in the medtech space in 2021:

Medical Design & Outsourcing

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1. Medtronic’s internal shufﬂe causes movement in every direction At the end of 2020, Medtronic conﬁrmed that it would reorganize its corporate structure, creating 20 operating units and expecting annual savings of up to $475 million in connection with the changes. Amid all the change, a number of personnel moved in and out of the company over the course of 2021. Among the changes was the big move of former Medtronic President of Pelvic Health and Gastric Therapies Brooke Story, who departed to become the worldwide president of BD’s Integrated Diagnostic Solutions. Other departures included former VP of Investor Relations Francesca DeMartino heading to BD, former SVP of Strategy Mike Weinstein leaving for Caris Life Sciences, >> www.medicaldesignandoutsourcing.com

2021

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former SVP and President of Medtronic’s Cranial and Spinal Technologies segment Jacob Paul departing for Corin, and former VP and GM of Medtronic’s Aortic business John Farquhar leaving for Heartflow. Medtronic didn’t only see outgoing moves, though, as the company appointed Walmart’s former EVP of U.S. supply chain, Greg Smith, as its EVP of global operations and supply chain. The company also announced that Jennifer Kirk would be its new principal accounting officer, global controller and chief accounting officer. Late in the year, on Dec. 16., Medtronic also confirmed changes to its executive committee, with General Counsel and Secretary Brad Lerman and CMO and CSO Dr. Rick Kuntz both set to retire in 2022. Lerman will retire at the end of January and Kuntz intends to retire in April upon the conclusion of Medtronic’s fiscal year. Succeeding Lerman will be new EVP, General Counsel and Secretary Ivan Fong.

Chair of the Board Paul Cataford as interim president and CEO. Anthony J. Giovinazzo will assume the role of lead independent director of the board. The Titan board plans to begin a search process in early 2022 to identify a permanent replacement for McNally. In July, the company also appointed a new CFO — Stephen Lemieux — after Monique Delorme left the position. Delorme left the company, effective immediately, but remains on in an advisory capacity through March 2022 to aid with the transition process. >>

Greg Smith

Alex Gorsky

2. Johnson & Johnson CEO steps down Alex Gorsky cited family health reasons when he announced in August 2021 that he would step down from his position as CEO of Johnson & Johnson, having led the medtech giant since 2012. Gorsky continues to serve as executive chairman. In January 2022, Gorsky was replaced as CEO by 30-year J&J veteran and former vice chair of the executive committee, Joaquin Duato, who also joined the board of directors. 3. Abbott’s former CEO retires from board chair spot Abbott Executive Chair and former CEO Miles D. White stepped down from the company’s board of directors on Dec. 13, 2021, bringing an end to his 38-year run at the Abbott Park, Illinois-based medtech company. Following White’s retirement, CEO Robert B. Ford was elected as the new chair of the board of directors.

Joaquin Duato

Miles D. White

4. Titan Medical’s CEO resigns On Dec. 1, 2021, Titan Medical announced that its president and CEO, David McNally, stepped down from those leadership roles, effective that day. The surgical robotics company’s former president and CEO also resigned from Titan’s board of directors. No reason was provided for his departure. Toronto-based Titan Medical appointed www.medicaldesignandoutsourcing.com

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Medical Design & Outsourcing

PERSONNEL CHANGES

Timothy Scannell

5. Stryker president and COO retires Stryker President and COO Timothy Scannell announced his planned retirement in August 2021, with plans to transition into a role as advisor to Stryker Chair and CEO Kevin Lobo. The effective date of Scannell’s transition to advisor was Oct. 1, 2021, with Lobo taking on the title of president that day. Scannell’s ofﬁcial retirement date from the company is currently set for March 31, 2023. Stryker has spread Scannell’s previous duties between Group Presidents J. Andrew Pierce and Spencer S. Stiles. Scannell has been with Stryker since 1990, working through a number of roles before he was appointed as president and COO in July 2018. 6. A slew of leadership changes at BD Among the biggest news at BD in 2021 was the conﬁrmation that the company

intends to spin off its Diabetes Care business as an independent, publiclytraded company during the ﬁrst half of 2022. BD expects that spinoff to close in the second quarter of the 2022 calendar year. That major change brought personnel moves, with Devdatt Kurdikar, the current worldwide president of BD Diabetes Care, set to become CEO of the recently named company — Embecta — upon the completion of the spinoff. Operating under Kurdikar, Embecta’s leadership team will include Ginny Blocki as SVP of product management and global marketing, Tom Blount as SVP and president of North America, Shaun Curtis as SVP of global manufacturing and supply chain, Jake Elguicze as SVP and CFO, Ajay Kumar as SVP and chief human resources ofﬁcer, Jeff Mann as SVP, general counsel and head of corporate development, >>

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PERSONNEL CHANGES

Slobodan Radumilo as SVP and president of international, and Colleen Riley as SVP and CTO. BD made other moves, too, appointing Dr. Joseph M. Smith as its new SVP and CSO and naming Francesca DeMartino — formerly VP of investor relations at Medtronic — as BD’s SVP of investor relations. 7. Zimmer Biomet expands executive team In June 2021, Zimmer Biomet confirmed the appointments of Wilfred van Zuilen as president of Europe, Middle East, Africa, and Dr. Nitin Goyal as chief science, technology and innovation officer. Goyal previously served as CMO and SVP of innovation and digital care delivery at Rally Health, part of UnitedHealth Group’s Optum business, while van Zuilen was the regional VP to Northwestern Europe at Medtronic. He has also held leadership roles at Medtronic, Covidien, Novartis and Edwards Lifesciences. The company had a major outgoing move near the end of 2021, when Chief Accounting Ofﬁcer Carrie Nichol left to join agriculture giant Cargill. 8. iRhythm CEO steps down iRhythm Technologies announced that President and CEO Mike Coyle resigned due to personal matters in early June 2021, departing just about six months after he left Medtronic in December 2020 to lead the AI-powered heart monitor developer in January. CFO Douglas Devine took over as interim CEO while the search for a permanent replacement for Coyle was conducted. In September, the company announced that it had appointed former Dexcom COO Quentin Blackford as its new president and CEO. Blackford joined Dexcom as CFO in 2017, moving to the COO position less than six months before leaving for iRhythm. 9. GE Healthcare taps Integra chief as new CEO In June 2021, Integra LifeSciences conﬁrmed that Peter Arduini would step down as CEO to accept a new role leading GE Healthcare as its CEO. According to Integra, Arduini was stepping down at the end of

2021 to assume his position at GE Healthcare. Current president and CEO of GE Healthcare, Kieran P. Murphy, expressed his intention to retire in the same week that Integra announced Arduini’s departure for GE Healthcare. Arduini will lead the company as it becomes a standalone entity from General Electric in 2023. In October, Integra conﬁrmed the appointment of former Barco CEO Jan D. De Witte to take over from Arduini by the end of the year. De Witte left Barco effective Sept. 1.

Peter Arduini

10. Dexcom promotes Sylvain to CFO In March 2021, Dexcom announced that it promoted Jereme Sylvain to become a new EVP and CFO at the continuous glucose monitoring company, taking the title of CFO from Quentin Blackford, who until then served as CFO and COO. As previously mentioned, Blackford left Dexcom in September to become CEO at iRhythm. Sylvain joined San Diego-based Dexcom in 2018 and served as SVP of finance and chief accounting officer. 11. Varian executives change gears as Siemens Healthineers acquisition goes through Varian Medical Systems CEO Dow Wilson announced at the beginning of March 2021 that he would retire following the $16.4 billion acquisition of the company, completed by Siemens Healthineers in April. On the back of Wilson’s retirement announcement, CFO J. Michael Bruff decided to resign from the company to pursue other opportunities. SVP, Chief Accounting Officer and Corporate Controller Magnus Momsen took on the role on an interim basis following Bruff’s departure. 12. Butterfly Network picks new CEO ahead of going public At the beginning of 2021, Butterfly Network confirmed that CEO Laurent Faracci would step down ahead of the company’s $859 million SPAC merger that took the company public. After Faracci stepped down, Dr. Todd Fruchterman took over as the handheld ultrasound technology developer’s president and CEO, effective Feb. 1. www.medicaldesignandoutsourcing.com

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DEVICETALKS

The top 5 medtech news stories of 2021 The past year saw signiﬁcant changes in the medtech space. Our editorial team picked their top stories.

Chris Newmarker | Executive Editor |

he lingering COVID-19 pandemic was top of mind in 2021, but there was much more going on in the medical device industry. The Life Sciences editorial team here at WTWH Media discussed their top picks during the December 17 episode of our DeviceTalks Weekly podcast. Tom Salemi, DeviceTalks Editorial Director:

Vicarious Surgical goes public Back in 2020, Vicarious Surgical seemed like the little surgical robotics company that could — seeking to succeed in a space dominated by Intuitive, with giants including Medtronic and Johnson & Johnson seeking to enter the market. Fast forward to 2021, and Vicarious was going public through a $1.1 billion special purpose acquisition company (SPAC) deal. “We’ve got these smaller companies carving a niche for themselves,” Tom said of the surgical robotics space. He also noted that the deal was a great sign for medtech exiting-wise. SPACs in medtech and many other industries have become a popular tool

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to take young companies public. Other notable medtech-related SPAC deals announced in 2021 included prescription digital therapeutics platform company Better Therapeutics, point of care diagnostic testing company LumiraDx, robotic surgery company Memic Innovative Surgery, genomic and diagnostic testing company Prenetics, and prescription digital therapeutics pioneer Pear Therapeutics. Chris Newmarker, Executive Editor:

Supply chain problems aren't going away Pandemic-related supply chain problems dogged medical device companies in 2021. ResMed cited them as a reason why it wasn’t able to better take advantage of competitor Philips’ major recall in the sleep and respiratory care products space. Both Medtronic and Johnson & Johnson mentioned supply chain when announcing delays related to their efforts to take on Intuitive in the surgical robotics space. And GE Healthcare’s business “largely is a supply chain story right now,” GE Chair and CEO Larry Culp said in September. >>

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Culp speciﬁcally cited semiconductors, resin and logistics as supply chain barriers to meeting “strong, if not robust” demand. Don’t expect the supply chain problem to go away post-pandemic, either. As MDO Managing Editor Jim Hammerand detailed in a feature story in November, climate change is increasingly causing problems: “Superstorms, ﬁres, droughts and other extreme events driven by climate change are already straining the industry’s supply chain — and it could get a lot worse.” Pharma Editor Brian Buntz thinks medical device companies and manufacturers in general may need to rethink their supply chain paradigm: “The old model of supply chain was based on lean. … You have a national disaster, you have COVID — and that takes a nosedive.” Brian Buntz, Pharma Editor:

FDA approval of the Pfizer/ BioNTech vaccine Pfizer/BioNTech, Moderna and Johnson & Johnson all have COVID-19 vaccines available in the U.S. But the shot made by Pfizer and its German partner BioNTech is the only one with official FDA approval — popular in the U.S. and around the world. Brian thinks that the Pfizer/BioNTech COVID vaccine, along with Moderna’s vaccine, helped catalyze interest in mRNA therapeutics by years, maybe even decades. It helped change the dynamics of mRNA research. “Before the pandemic, you had mRNA-based companies, but they were mainly focused on novel indications. … COVID-19 happened, and that all changed.” There’s now inspiration for mRNA vaccines for other viruses, cancer and potentially heart indications. “Odds are, we’ll see more than just vaccines in the future,” Brian said. Interest in mRNA could also fuel research in related platforms, such as cell and gene therapy.

self-expanding, wire mesh device that is inserted through a small incision in the leg and guided through vessels to the heart to treat one of the most common congenital birth defects. It’s the size of a small pea and fits into the heart of a premature baby. Physicians and surgeons often have to use products that aren’t approved for use in children. Sometimes they use a liver stent made for adults as a heart valve in kids. Abbott isn’t alone in building medical devices specifically for kids and pediatric diseases rather than miniaturizing an adult product for a child. The National Capital Consortium for Pediatric Device Innovation announced in early December five electrophysiology devices that could monitor and treat congenital heart disease and arrhythmia in pediatric patients. The devices include: PeriCor’s TeriTorq, Inkspace Imaging’s MRI Coils, Karios Technologies’ Tissue Shield, Sibel’s Anne One and the Starlight Cardiovascular Project Lifeline. The FDA has done a lot of work to make it easier for companies with pediatric >>

EXPLORING HEARTMATE, CARDIOMEMS AND THE REST OF ABBOTT’S TOOLBOX TO HELP HEART FAILURE PATIENTS The entire editorial staff joins the podcast to share their personal top stories of 2021. News includes mentions of Vicarious Surgical, ResMed, Philips, Pﬁzer, BioNTech, Abbott, Dexcom and Insulet. www.devicetalks.com/podcast

DEVICETALKS

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A pediatric device renaissance The pediatric heart device market had a handful of innovations throughout 2021. One of those devices is Abbott’s Amplatzer Piccolo that the company designed to treat patent ductus arteriosus (PDA) in the hearts of premature babies. Abbott’s Piccolo is a catheterdelivered device that was originally approved for FDA use in 2019. It is a

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Medical Design & Outsourcing

DEVICETALKS

products to enter the medical device space. It has created a nationwide funding program and sponsors several pediatric medical device consortiums across the U.S. The FDA also connects industry professionals and people who know how to commercialize a device to help inventors bring their own devices to market. “I just think we’re going to see a lot of innovation in pediatrics soon. There’s going to be a pediatric device renaissance happening. That’s what I’m going to be looking forward to over the next ﬁve to 10 years,” Danielle said. Sean Whooley, Associate Editor:

Next-gen diabetes treatment tech on the way A number of new innovations in the diabetes management space are set to make their way to the market soon, led by Dexcom’s G7 continuous glucose monitor (CGM). Dexcom CEO Kevin Sayer told MDO that enthusiasm

for the next-generation CGM — roughly 60% smaller than the previous G6 version — is “at an all-time high.” Sean said, “It’s clear to see they’re excited, and it’s really interesting to see what everyone is looking for in diabetes management. It’s a smaller insulin sensor.” Dexcom’s G7 isn’t the only nextgeneration innovation set to enter the diabetes market, with Insulet’s Omnipod 5 wearable insulin pump expected to launch in early 2022 once it receives FDA clearance. Medtronic expects its MiniMed 780G insulin pump system with the Guardian 4 sensor for continuous glucose monitoring to drive growth once approved, with the company currently in talks with the FDA. Senseonics also anticipates major regulatory steps in 2022, with hopes that the FDA will reach an approval decision in the coming months for its Eversense 180-day CGM. With those four companies planning for a big 2022, plus plenty more

For updates on speakers, agendas and more, go to DeviceTalks.com. If you have programming ideas, reach out to tsalemi@wtwhmedia.com.

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innovations across the diabetes care space, there is a lot to be excited for in the coming 12 months. Runners up:

Smart knee implants and telehealth Zimmer Biomet scored an important ﬁrst in the orthopedic device space with the launch of its Persona IQ smart knee implant, created in partnership with the startup Canary Medical. Expect more smart implants from the two companies in the future. Meanwhile, the U.S. Department of Health and Human Services reported an astonishing statistic near the end of 2021: a 63-fold increase in Medicare telehealth use during the COVID-19 pandemic. It’s hard to think that telehealth will ever return to pre-pandemic levels. Senior Editor Danielle Kirsh and Associate Editor Sean Whooley contributed to this story.

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PRODUCT WORLD

Traco Power launches new ac/dc power supplies

Traco Power (Baar, Switzerland) announced its newest high efﬁciency, miniaturized ac/dc power supplies: the TPP 180 series for medical and industrial and TPI 180 for industrial. The power supplies measure only 2-by-3-by-1.24 inches in the open frame version — with global safety approvals for medical or industrial markets. They come in 16 standard models with single outputs of 12 / 15 / 18 / 24 / 36 / 48 / 53 V and either open-frame or enclosed packaging. The small footprint and performance characteristics of the power supplies makes them suitable for a variety of requirements. The TPP 180 power supplies are 2xMOPP compliant and BF rated for applied parts applications — and come with a ﬁve-year product warranty. Traco Power’s North American headquarters are in San Jose, California. –CN Traco Power www.tracopower.com

Nitto Kohki introduces vacuum pump for pick-and-place applications Nitto Kohki USA announced the introduction of a standalone vacuum pump device that it says is ideal for pickand-place applications. The LV-125A (Linicon) vacuum pump is particularly useful when house air is not available, according to the company. The pump is compact, lightweight, and features an oil-less design so that it can ﬁt into cleanroom assembly operations. It has a noise proﬁle of <40dB. It’s possible to purchase the LV125A with a vacuum pen, needles, tubing and a pen stand. Nitto Kohki USA (formerly Medo USA) designs, develops and engineers air compressors and vacuum pumps for challenging applications, including medical devices, laboratory equipment and applied robotics. –CN 80

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Nitto Kohki www.nittokohki.com

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The LV-125A (Linicon) vacuum pump Image courtesy of Nitto Kohki USA

PRODUCT WORLD

Varta launches online battery monitoring feature Pulse Technologies laser tech could promote electrode innovation Pulse Technologies used its MD&M Minneapolis booth to show off various surfaces treated with its hierarchical surface restructuring (HSR) tech. Photo by Executive Editor Chris Newmarker

Varta’s Cloud Monitoring Dashboard Image courtesy of Varta

Battery maker Varta has launched a cloud computing feature to let customers remotely monitor battery charging, health and the temperature of the battery management system. While Varta makes microbatteries for medical devices such as hearing aids, the new online monitoring dashboard is meant for its “Easy Block” and “Easy Blade” modular smart batteries. The smart batteries go into forklifts, driverless transport systems and other small or medium vehicles at manufacturers and distributors. Users of Varta’s customerspeciﬁc batteries will also have access to the remote monitoring feature, and Varta said it plans to expand its cloud services in the future. The rechargeable “Easy Block” and “Easy Blade” lithium batteries are modular and expandable. They’re adaptable for applications in industries such as logistics, agriculture and mobility. API interfaces support integration 82

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between the front-end and back-end software layers. “With the help of the data, it will be possible in the future to recognize patterns and errors even faster or identify anomalies in the operation of the batteries before they occur. This leads to an increase in the life expectancy of the battery and a reduction in operating costs,” Varta Solutions GM Gordon Clements said in a news release. “Another advantage of cloud service is that there is a better understanding of the beneﬁts of the battery, which will lead to more cost-effective solutions for certain user groups in the long run. And it opens up opportunities for new business models, such as a rental system in which the customer only pays for the energy that the battery delivers in a certain period of time.” –JH

Pulse Technologies used MD&M Minneapolis last November to show off its new hierarchical surface restructuring (HSR) tech, promoting its ability to modify the surface of implantable electrodes and microelectrode arrays. Ofﬁcials at Quakertown, Pennsylvania– based Pulse Technologies think the offering is well-suited for the neuromodulation and cardiac rhythm management space — as well as other medtech applications. The tunable process uses ultrashort pulse lasers to engineer the surface of an electrode versus using specialized coatings. HSR, according to Pulse Technologies, can enable smaller electrodes with enhanced electrochemical performance, durability, sensitivity and resolution. –CN

Varta www.varta-ag.com

Pulse Technologies www.pulsetechnologies.com

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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 another 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 electropolishing to eliminate defects and improve the surface ﬁnish of critical metal parts, with microscopically precise and consistent results. In close collaboration with clients in the aerospace, medical, laboratory, pharmaceutical and food processing industries - among others - Able has developed highly

Nitinol wire

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

Prototyping Collaboration Puts Finishing Expertise to Work at the Start

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.

• Deburring • Ultracleaning • Resistance to Bacterial Growth • Microﬁnishing • Fatigue Life Improvement • Improved Corrosion Resistance

Commitment to Our Customers

www.ableelectropolishing.com

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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.

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

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The Able Difference

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-ofthe-art 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.

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

Accumold 1711 S.E. Oralabor Road Ankeny, IA 50021 P: 1.515.964.5741 F: 1.515.964.5742 accu-mold.com

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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.

Facilities

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.

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Medical Design & Outsourcing

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 San Jose, California, the company has proven leadership in miniature motion control, with a full line of intelligent driver/controllers.

The EZQuad Servo was designed to allow the rapid implementation of multiaxis stepper motor solutions in products requiring automation. Measuring only 2.25” x 2.25” X 1.0” (57mm x 57mm X 25mm), the fully intelligent servo motor Controller + Drivers runs 4 fully independent Brushed or BLDC servo motors. Operating from a 7V to 40V supply, the controller regulates to any motor voltage via software command (e.g., 3V motor can be run with 24V supply). Commands can be issued from any serial terminal program (such as HyperTerminal) or from the EZStepper Windows application. The EZQuad Servo will drive 4 motors at 2.5 Amps each with a setting of move current m=50 %. However, with careful selection of motors and/or improved cooling and/ or low move time duty cycle, it is possible to run motors at 5 Amps at m=100%. See Command Set for details.

Command Set for details.

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.)

All Motion, Inc. 30097 Ahern Avenue Union City, California 94587 Sales Ofﬁce - 510.471.4000 Technical Support - 408.460.1345 Fax - 408.358.4781 Email - support@allmotion.com www.allmotion.com

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The EZQuad 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 EZQuad Servo Motor Controller will typically work with any motor that is 3” or smaller (size23 or smaller). Starter Kits enable a ﬁrst time user to make Servo Motors move intelligently in less than half an hour.

ALTECH - COMPONENTS FOR MEDICAL DEVICE DESIGNS Serving automation and control industries since 1984, Altech’s products meet UL and international standards and all are RoHS and REACH compliant. Altech’s commitment to quality have been recognized since May 27, 1999 when they were awarded the prestigious honor of ISO 9001 certiﬁcation 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.

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

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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. 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.

Circuit Breakers

Foot Switches

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.

Custom Assemblies

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Medical Design & Outsourcing

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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Medical Design & Outsourcing

1 • 2022

www.medicaldesignandoutsourcing.com

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 worldwide offering an All Electric Tray sealer for extreme accuracy, Light Curtain Safety Systems, UDI barcode input and audit trail data, Direct Force Sensing for digital down-force readings, Electric Shuttle Technology for ultra-smooth movement as well as the heaviest cross section heater design for even heat distribution and anodized single piece CNC precision tooling nests.

Atlas Vac Machine’s core expertise is the design and manufacture of tray sealing equipment for medical device packaging clean room applications. 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. 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. 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.

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

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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 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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1 • 2022

Medical Design & Outsourcing

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 1.866.8.BBRAUN (1.866.822.7286) us.bbraunoem.com

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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. 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.

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Medical Design & Outsourcing

1 • 2022

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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.

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 & Extrusion

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In House Cable Manufacturing

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In House Mold Tooling

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Very Fine Wire Termination

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Custom Connector Design

MARKETS: •

Medical

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Industrial

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Automotive

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Audio

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Defense

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. BAYCABLE delivers unparalleled engineering expertise “an integrated solutions partner” that can help skillfully create the optimal interconnect system for your application. 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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1 • 2022

Medical Design & Outsourcing

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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Medical Design & Outsourcing

1 • 2022

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

Bishop-Wisecarver 2104 Martin Way Pittsburg, CA 94565 Tel: (925) 439-8272 www.bwc.com

BISHOP-WISECARVER:

Expertly Designed, Delivered to Perform Founded as a custom machine builder 71 years ago and built through two generations of family ownership, Bishop-Wisecarver has maintained some of the longest-lasting partnerships in the medical automation space. Equipment manufacturers in the medical industry stand behind our front line doctors, nurses, and technicians… and BishopWisecarver stands behind you. Each customer we partner with knows they can trust the reliability of our motion systems - but the trust doesn’t end there. OEMs turn to the motion experts at Bishop-Wisecarver for custom products, subassemblies, kits, and design support. What’s more, our customer service is rated among the best in the automation industry. The result? Collaborative R&D efforts and innovative, differentiated medical and laboratory products that set our customers apart from the competition. You may be designing an automated product transfer system in a cleanroom, moving scanners for lab equipment, a sliding patient bed, or any number of projects requiring smooth guided motion. Bishop-Wisecarver can help! Our Signature Experience™ process promises our customers:

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1. That our technology and designs will be the right fit for your application. 2. We assess and document your specific needs, to guarantee alignment with how you define project success. 3. We can customize your solution - even for a single unit.

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4. We communicate through all stages of your order, from beginning to after installation. 5. We have met or exceeded your deﬁnition of success on your project through a post installation follow-up meeting.

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1 • 2022

Medical Design & Outsourcing

BMP Medical provides plastic contract

manufacturing services to leading medical device and diagnostic OEMs in need of injection molding, and injection blow 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 operational excellences.

What makes BMP Medical different from other companies? 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.

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

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

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Medical Design & Outsourcing

1 • 2022

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

Markets Served:

www.medicaldesignandoutsourcing.com

Boker’s, Inc., is a woman-owned, AS 9100:2016 and ISO 9001:2015 certiﬁed manufacturer of precision stampings, washers, spacers and shims. To request a complimentary copy of the company’s 2022 Stampings & Washers Catalog and a 2022 Scheduling Calendar with Metric Conversion Chart, contact Boker’s at: bokers.com

With over 100 years of experience, Boker’s has earned the reputation as a stamping leader. They deliver precision stampings in a complete range of sizes: flat blanking and piercings up to 12” x 12” (flat) with thicknesses from .005” to .190” (varies by material) and draws up to 3” deep and 8” in diameter. With numerous inside diameters, thicknesses and over 2,000 commonly specified and hard-to-find material options— including various types of steel, aluminum, brass, copper, nickel silver, plus non-metallic materials such as PTFE, polyester, fiber and nylon—whatever your requirements, if it can be stamped, Boker’s can turn it into the part you need. Boker’s, Inc. 3104 Snelling Avenue Minneapolis, MN 55406-1937 Phone: 612-729-9365 TOLL-FREE: 800-927-4377 (in the US & Canada) bokers.com

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Boker’s also delivers a wide selection of standard and non-standard washers, spacers and shims. With over 32,000 stock tools, and outside diameters of .080” to 5.140” along with a variety of inside diameters, you have millions of ﬂat washer possibilities. All stampings, washers, spacers and shims are available in short, medium and long runs with a 100-piece minimum. Boker’s also offers 3D printing for prototyping, complete Statistical Process Control (S.P.C.) capability, in-house tooling, and “Dock-to-Stock” and “Just-in-Time” programs.

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1 • 2022

Medical Design & Outsourcing

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-inclass total value. Cadence employs over 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

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.

Point of Care IVD Fluid Delivery Interventional Therapy Neurology Biopsy Dianostics Endoscopy Pharmaceutical Orthopedics General Surgery Minimally Invasive Surgery Opthalmology

Cadence offers complete services that range from initial design through manufacturing and full supply chain management for single use and disposable medical devices.

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

• Design Services

• EDM – Wire, Ram, & Sink

• Rapid Prototyping

• Nitinol Shape Setting

• Innovative Custom Automation

• Combination Technologies

• Certiﬁed Cleanroom Manufacturing

• IncisionLab™

• Finished Device Assembly • Complete Supply Chain Management

9 Technology Drive

• Final Packaging and Labeling

Staunton, VA 24401

• Sterilization Management

sales@cadenceinc.com Tel: 540.248.2200

We also provide a very broad set of core

Fax: 540.248.4400

capabilities that are competitive and

cadenceinc.com

differentiated in the marketplace. Unlike most contract manufacturers, we also have signiﬁcant metals and plastics expertise; making new products a reality.

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Medical Design & Outsourcing

1 • 2022

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

medicaldesignandoutsourcing.com/leadership

• Machining - CNC, Swiss, Screw and Micro

• Microstamping & Multi-slide Stamping

Cadence, Inc.

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Metals Expertise: • Advanced Welding Lab™

www.medicaldesignandoutsourcing.com

Precision Designs “MOVE” Canon started cultivating our core technology for DC micro motors in 1962. Today, Canon USA uses that advanced technology to propose customized solutions to meet all kinds of customer needs. Our ﬂexibility in design, allows us to work closely with each customer to provide the exact solution required, be it simple or complex. “M”otion control solution We combine technology, production, and response to create leading edge motion solutions. “O”ptimum solution We study your requirements and promptly propose the optimum solutions to meet your needs. “V”alue added solution We provide gears, encoders, even custom actuators, as well as other value added solutions. “E”cological solution

Canon U.S.A., Inc.

Our compact DC motors, developed for use in Canon 8-mm movie cameras, have been further refined for use in audiovisual devices, single-lens reflex cameras, office equipment, and other applications. The scope of application for these motors has continued to expand, and they can now be found in product categories subject to high demand, including polygon mirror drives for laser printers, information peripherals, industrial machinery, appliances, cash machines and medical devices. Our product lines include iron-core, coreless and brushless motors as well as optional equipment for gears and encoders. In addition, our simulation technologies enable us to offer actuator units and other essential parts to meet the needs of a wide range of customers. Energy-efficient small motors have the advantage of consuming little power, which makes them the popular choice of industries worldwide. By offering the unique ability to customize our products, we remain committed to meeting customer needs. Linear Piezo Motors: Canon’s linear ultra sonic piezo motors are compact, quiet and accurate for linear positioning applications. Canon has been using this technology for driving focus lens in camera products. Applications include Medical, Robots, Surgical, Scanning electron microscope(SEM), Semiconductors. Brushless DC Servo Motors: Achieves Best-in-Class torque and compactness BLDC, compared with other Canon motors. Applications include Gantry Robots, SCARA Robots, Surgical Robots etc.

3300 North First Street San Jose, CA 95134 United States www.usa.canon.com

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1 • 2022

Medical Design & Outsourcing

We’re more than medical device manufacturing Canon Virginia works with companies to bring together innovative technologies, ideas, and processes to make meaningful impacts in medical manufacturing, device development, and beyond. Whether device development, manufacturing & engineering services, or support services, we’re uniquely equipped to be an outsourcing partner. Canon Virginia is ISO 13485:2016 and MDSAP certified as well as FDA cGMP compliant for medical manufacturing. We have the skills and facility to support Class I, II, III medical device manufacturing. In addition, Canon Virginia is ISO 9001, 14001 certified, and EAR/ITAR compliant. As the manufacturing and engineering center for Canon in the Americas, Canon Virginia can tap into processes and insights from the global Canon network and apply them to customer challenges. With hundreds of engineers and a broad range of skill sets, we’re able to produce everything from single parts to complex products for medical image/optics and microfluidics manufacturers.

Canon Virginia, Inc.

Canon offers an extraordinary range of services, including: Product Design, Prototyping, Design for manufacturing, Injection mold making, Design transfer, Manufacturing process development and validation, Risk management, Medical molding, Quality management systems, Component and subassembly manufacturing, Logistics, Financial Services, and Service & support.

12000 Canon Blvd Newport News, VA 23606 United States www.cvi.canon.com/mfg

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Medical Design & Outsourcing

1 • 2022

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Mechanical Cable for Surgical Applications The world trusts Sava’s mechanical cable to power tomorrow’s surgical robots and endoscopic instruments. That’s a fact. For over 50 years, Carl Stahl Sava Industries has been a staple in the manufacture of world-class surgical robotic, endoscopic device, implantable and wearable mechanical cable and assemblies. Using materials such as tungsten, stainless steel, nitinol, titanium and more, Sava has taken the time and invested greatly in perfecting the ultraﬁne cables powering the motion systems of the world’s most advanced surgical marvels. Working alongside the most trusted names in contract manufacturing and surgical instrumentation innovation, Sava has a deep bench of experts with decades of collaborative experience.

Carl Stahl Sava Industries makes the most sophisticated surgical mechanical cable and assemblies on Earth. What make Sava a special maker of ultraﬁne mechanical cable assemblies is our commitment to meeting the complex needs of surgical robotics and medical devices makers. Sava has invested millions deploying the talent and technology required to satisfy the most discerning surgical device makers. Combined with our deep bench and state-of-the-art equipment, Sava also applies the most modern lean and cellular manufacturing processes, and honors 5S practices across all facets of production. What’s more, Sava’s quality experts ensure customers receive products that meet and often exceed rigorous regulatory, tolerance, strength and lifecycle requirements. But even with the right people and tools, the right attitude is what differentiates Sava from alternatives. Sava understands the engineers that design tomorrow’s next surgical innovation. After all, we talk to them all day, every day. With Sava, device makers have a partner that understands the often-protracted R&D exercise undertaken. That’s why Sava has developed manufacturing processes that allow us to move in lockstep with our customers through every phase of production. Any revision, big or small, frequent or rare, as well as course corrections like a change in cable material, testing parameters or even scheduling are all managed with an eye on ensuring goto-market planning goes uninterrupted.

Carl Stahl Sava Industries 4 North Corporate Drive Riverdale, New Jersey 07457 www.savacable.com

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1 • 2022

Medical Design & Outsourcing

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One Online Store to Replace Them All Chamfr is a marketplace where engineers and buyers can access 3000+ components for their medical device innovations from 30+ suppliers including Johnson Matthey, Integer, Viant and more. The one stop shop offers balloons, braided structures, catheters, connectors & ﬁttings, electrodes, heat shrink tubing, mandrels & wire, metal pins, metal tubing, nitinol components, polymer tubing, thin ﬁlms and much, much, more. All components are in-stock and ready to ship in 24

Chamfr Chamfr is a female-owned medical device component marketplace founded 5 years ago by 3 co-founders who saw an unmet need in the industry. Engineers needed fast access to components for early stage development but were frustrated by long lead times and lack of accessibility to medicalgrade components for early stage development.

hours. Learn more at Chamfr.com.

At Chamfr, we are not a single company trying to push our products. Instead, we give medical device engineers access to a wide range of in-stock components and technologies for prototyping to spur the development of innovative medical devices. This allows design engineers to launch their products faster by being able to iterate without long lead times and high-cost minimum orders. With 3000+ components, from over 30 different suppliers, all in-stock and ready to ship, Chamfr is kind of like an Amazon for medical device components.

Chamfr 6114 La Salle Avenue Suite 485 Oakland, CA 94611

One of the biggest advantages of buying on Chamfr is transparency. You see who you are buying from so when it’s time to source long term supply, you know exactly where to go and can be conﬁdent that you have medical-grade supplier and traceability for your DHF.

chamfr.com

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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

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.

competitive pricing.

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)

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.

www.chieftek.com

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1 • 2022

Medical Design & Outsourcing

103

Outsourcing Solutions for Complex Medical Devices As a vertically integrated, full-service outsource partner, Cirtec specializes in today’s most innovative product technologies. We bring over three decades of expertise to every phase of the product development lifecycle including state-of-the-art product design, development, and manufacturing capabilities. From active implantables to interventional devices and delivery systems, Cirtec can assist with pilot/ clinical builds to full scale production. Our systems are ISO 13485 certiﬁed to ensure consistent quality management for your components and ﬁnished devices.

More than just another design shop or contract manufacturer, Cirtec offers a uniquely comprehensive range of vertically integrated capabilities. We have the expertise needed to design innovative devices, solve complex design challenges, and help bring devices to market. Cirtec specializes in complex, difficult to produce components and devices in today’s most advanced product technologies including, neuromodulation, implantable drug delivery, cardiac rhythm management, ventricular assist and interventional devices and delivery systems. We have the capabilities needed to bring your product to full production, including assembly, packaging and testing, and in-house sterilization. Our core competencies include: • Active Implantables o EE, SW, Firmware design o IPG manufacturing, assembly o Leads manufacturing, assembly • Catheters & Delivery Systems o Balloons, balloon catheters o Braiding, braided shafts o Coiling, coiled shafts o Tubing extrusions • Circuits & Sensors o Application Specific Integrated Circuits (ASICs) o Surface mount technology o Thin-film circuits

Cirtec Medical 9200 Xylon Avenue North Minneapolis, Minnesota 55445 United States

• Nitinol Tubing & Processing o Implant quality tubing o Peripheral vascular tubing o Laser cutting, heat setting, electropolishing

www.cirtecmed.com

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• Precision Machining o Coil winding o Laser welding o Machining and Swiss turning o Precision metal stamping o Wire EDM Cirtec is committed to being the preferred outsourcing partner for providing innovative solutions for your life-enhancing therapies.

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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.

Miniature Pneumatic Products & Solutions Web

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.

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 high-quality and innovative products for the broadest range of mission-critical 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 the quantity required. Our products are marketed through a worldwide network of sales representatives and distributors.

CC ®

COMPONENTS CORPORATION

Components Corporation

COMPONENTS C C 866-426-6726 ®

CORPORATION

www.componentscorp.com

www.componentscorp.com / (888) 401 7490

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Components Corporation: Your Trusted Leader in Innovative Interconnect Solutions 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. 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. 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 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). 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

Simulation of a rapid test strip showing how the sample ﬂow develops.

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

Highly accurate simulation of the human body and its interaction with medical devices is driving a shift toward in silico device trials of new therapeutics in the medtech industry. The COMSOL Multiphysics® software is critically important to understand and predict the performance of a device through the software’s multiphysics capabilities for the modeling of physiology, different physics of processes in the human body, and their complex interactions. Applications include the 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.

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

Simpliﬁed human head and brain model created with COMSOL Multiphysics® for the calculation of speciﬁc absorption rate (SAR)

E-mail: info@comsol.com www.comsol.com

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Contract Manufacturing & Engineering Services

Making It Easier to Get Your Products to Patients

Cretex Medical provides contract manufacturing and engineering services

Major Markets

to medical device OEMs. Our family of companies consists of rms Company, rms Surgical, Meier Tool & Engineering, JunoPaciﬁc, Spectralytics and QTS. We offer a complete range of endto-end manufacturing capabilities, the latest technologies, and the

• Orthopaedic

• Neuromodulation

• Spine

• Robotics

• Sports Medicine

• Ablation Therapies

• Cardiology

• Laparoscopy/Endoscopy

• Vascular

• Diagnostic Devices

talent to match any engineering or manufacturing challenge. You have a partner in us who can grow with your business, backed by a strong ﬁnancial portfolio and long-term perspective.

Services Offered

Cretex Medical Multiple locations. HQ in Minnesota. Email: info@cretexmedical.com www.cretexmedical.com

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• Design for Manufacturability (DFM)

• Insert & Implantable Molding

• Prototyping

• Silicone Molding

• Machining

• Laser Welding, Drilling & Ablation

• Direct Metal Printing

• Laser Cutting

• Subassembly & Assembly

• In-house Tool Design

• Cleaning & Passivation

• Progressive Metal Stamping

• Sterilization Case & Tray Design

• Bufﬁng & Deburring

• Press Brake Forming

• Cleanroom Assembly, Packaging & Labeling

• Silk Screening & Laser Marking

• Sterilization & Lab Testing Coordination

• Electropolishing & Anodization

• Engineering Validations

• Micro- & Multi-shot Injection Molding

• Supply Chain Management

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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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Global leader in engineering & manufacturing The Eberhard Manufacturing Company is a global leader in the engineering and manufacturing of access & security hardware. We have a standard product line of rotary latches, compression latches, draw latches, hinges, camlocks, key switches, padlocks, and handles to name a few. We also offer full development and program management services for custom electromechanical and mechanical systems designed for speciﬁc OEM’s and customer applications. Our products are found in an expansive range of applications and products globally, virtually unnoticed in our everyday lives. Developing new products to meet our customer’s design challenges is our main objective. Innovative design with special attention given to haptics and functionality allows Eberhard to support our customer’s brand equity while increasing the value of their end products. With over 125 years of excellence in manufacturing of access and security hardware, we are now looking to the future by investing in the electrical and Bluetooth sectors, allowing us to create a suite of electromechanical solutions for our customers’ evolving needs. A strong attention to detail and an dedication to emerging technology set Eberhard ahead of the pack when it comes to serving our customers with both standard and custom built solutions.

Eberhard 21944 Drake Rd Strongsville, OH 44149 www.eberhard.com

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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

ElectroCraft LRPX Series Brushless Planetary Gear Motor

customers require. For OEM Customers who are unsatisﬁed with

ElectroCraft MP MobilePower™ Geared Mobility Motor

Compact, powerful performance enables innovative medical devices

Dependable Fractional-HP Motion, Globally

having to design around inﬂexible off-theshelf products, our technical knowledge and cusomizable product families provide for a

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

design experience which results in motor and motion systems that provide superior reliability and performance at the lowest possible cost.

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 and quiet operation Mobility Product Features

• High torque density, small form factor • High starting • Verytorque energy efficient, Long battery life • High load capacity • Smooth and quiet operation • Wide range of voltages and ratios • Controllable variable speed available • Low noise, Low heat generation • High starting torque Wide range of voltages and ratios available • Controllable • • Up to IP65 • Wide range of IP optionsvariable speed • Up to IP65 • 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

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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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Design Develop and Deliver Flexan is a global strategic contract

Our experience goes back more than 75 years, which allows us to provide our clients with a greater perspective, a better process and improved overall medical device manufacturing experience.

manufacturer of custom high-quality silicone and thermoplastic components, sub-assemblies and devices designed to meet the critical requirements of our customer’s medical devices.

Combined, our leadership team has more than 120 years of experience in this industry. We have the pedigree a medical device company is looking for when they seek a custom contract manufacturer.

Flexan 500 Bond Street Lincolnshire, IL 60069 Phone: (224) 543-0003

www.ﬂexan.com

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Freudenberg Medical is a global CMO / CDMO with 11 manufacturing operations and more than 2,000 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 tubing 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 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

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. 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.

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

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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

Do you have a challenging project that you need to deliver on? Your odds for success improve with a call to HOBSON & MOTZER

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 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

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Creating High-Impact Med Devices, SaMD and Scientific Applications Integrated Computer Solutions (ICS) helps medical device and life science innovators create disruptive 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 applications where usability, precision and validation are safety critical. Companies like Quidel, MilliporeSigma, Thermo Fisher, Johnson & Johnson, Breas and Boston Scientific are among those that rely on ICS to help create transformational products, such as defibrillators, radiation therapy systems, infusion pumps, respiratory and intelligent ventilation devices, and complex scientific software applications.

Integrated Computer Solutions, Inc. (ICS) expedites design, development and testing of connected and touchscreen-enabled medtech solutions via deep domain expertise, specialized tools and suite of targeted services. Our dedicated medtech practice comprises user experience (UX) designers, software engineers, HFE specialists and regulatory experts developing with ISO13485compliant processes. 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 reduced development risk. We offer end-to-end product design and development for precision medical devices, SaMD, in vitro diagnostic instruments, and robust scientific software. Our services include human factors engineering, UX design, custom software development, cloud connectivity and analytics including fleet management and OTA, device cybersecurity and verification testing.

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

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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

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

in-stock Interpower products, and a

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.

1-week U.S. manufacturing lead-time on non-stock Interpower products. All Interpower manufactured products are made in Iowa and 100% tested.

As the premier supplier of AC power system components, Interpower hospital-grade 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. Additionally, we carry power cords and cord sets, accessory power strips, cable, IEC 60320 inlets and outlets, power entry modules, and more! We offer value-added options such as specialized packaging, labeling, cord lengths, and colors.

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.

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

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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CRITICAL-TO-FUNCTION ELASTOMERIC SOLUTIONS •

CUSTOM SILICONE AND RUBBER MOLDING

•

LIQUID SILICONE MOLDING

•

FLASHLESS TRANSFER, COMPRESSION & TRANSFER MOLDING

•

HIGH CONSISTENCY SILICONE MOLDING

•

ORGANIC & POLYISOPRENE RUBBER MOLDING

Since 1980, IRP Medical has been dedicated to a singular focus; molding Critical-To-Function (CTF) engineered components for the Medical Device Industry. With ISO 13485 certiﬁcation and FDA registration, we offer scalable solutions using tested and proven molding and processing technology. Our experienced engineering and tooling group gives us the advantage to go from prototype to millions of parts, allowing our customers to achieve their quality and volume targets.

IRP Medical 1035 Calle Amanecer San Clemente, CA 92673 Tel: 949.373.4511 Cell: 714.272.2473 Corey Wentz cwentz@irpi.com

IRP Medical is a part of the INTEGRATED POLYMER SOLUTIONS company.

www.IRPMedical.com

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Founded in 1990, Isometric’s success begins and ends with our people. Isometric is ISO 13485 certiﬁed with two adjacent facilities, Class 7 cleanrooms, and over 95 employees.

From Small to Micro, Success Starts Here.

With unparalleled micro manufacturing capabilities, Isometric provides 100% in-house: • Micro 3D Printing • Micro Tooling • Micro Molding • Micro Automated Assembly • CT Scanning

For over 30 years, Isometric Micro Molding, Inc., has been a strategic and trusted partner in micro injection molding and micro automated assemblies with unparalleled micro manufacturing capabilities. Today, we are the largest and fastest growing medical-focused micro molder in North America.

A global micro solutions leader, Isometric serves high precision medical market segments such as diabetes, ENT, ophthalmic, cardiovascular, neurovascular, orthopedic, drug delivery–and more. Isometric’s numerous micro solutions include micro ﬂuidics, molded needles, catheter tips, sensors, transdermal patches, life science disposables, and neurovascular implant devices. Driven by ambition for innovation, Isometric’s team of experts use our internally developed Microns Matter® risk mitigation process to successfully meet tolerances and bring your micro parts to validation faster.

Since we work in microns every day, we serve high precision medical markets such as diabetes, ENT, ophthalmic, cardiovascular, neurovascular, orthopedic, drug delivery–and more.

At Isometric, our team of experts make the impossible, possible, through 100% in-house processes: Micro 3D Printing, Micro Tooling, Micro Molding, Micro Automated Assembly and CT Scanning. In addition, we mold all thermoplastics, long-term implantable, bioresorbable, ﬂuoropolymers, and API resins. From small parts with micro features to micro-sized parts, we provide unique, creative, and robust miniaturization solutions. We successfully create components through extreme thin wall molding, tight tolerances, complex geometries, insert molding, overmolding, and 2-shot molding. Your micro solution is completed all inhouse and under our control. We are committed to strategic partnerships through transparent and honest customer collaboration. Coupled with our Microns Matter® proven risk mitigation process, we account for all variables that contribute to the successful validation of your project. Our ambition for innovation means your project can achieve success faster. When you partner with Isometric, you can unleash your FULL design potential, usually thought impossible, to achieve incredible micro solutions.

Isometric Micro Molding, Inc. 240 Wisconsin Drive New Richmond, WI 54017 sales@isomicro.com www.isomicro.com

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Isometric Micro Molding’s small part molding (3 inch or 76.2 mm with 175 micro features of 30 microns or 0.00118 inch); human hair as a size reference

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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. 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.

Sanline

Handles and operating parts can act as vectors for many pathogens. The antibacterial standard parts of the Sanline product family by JW Winco can prevent bacteria and germs from propagating on an operating part, actively reducing their spread and preventing bacterial illnesses. https://www.jwwinco.com/en-us/antibacterial-parts-sanline

Stainless Steel Latches GN 1150 in Hygienic Design Stainless steel latches GN 1150 are intended for use in hygienic areas and meet hygienic requirements on the operating side (front hygiene) or on the operating and latch arm side (full hygiene). The locking mechanism is protected by multiple seals. At the same time, the high surface quality (Ra < 0.8 µm) and dead space-free mounting prevent dirt from adhering and facilitate cleaning. https://www.jwwinco.com/en-us/products/quick-ﬁnder?q=1150

GN 1582 Stainless Steel Screws in Hygienic Design

Captive stainless steel screws GN 1582 with recessed shoulder for loss protection expand the product family Hygienic Design. The sealed mounting surface enables components to be mounted without dead spaces. Due to the recessed shoulder, they are easily secured against loss, such as in a cover. https://www.jwwinco.com/en-us/products/3.2-Mountingpositioning-levelling-with-screws-clamping-and-supportingelements/Swing-bolts-Shoulder-screws-Thrust-bolts/ GN-1582-Stainless-Steel-Hexagon-Head-Screws-HygienicDesign-Low-Proﬁle-Head-with-Recessed-Stud-for-LossProtection

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

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fax 800-472-0670 sales@jwwinco.com jwwinco.com

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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

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.

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

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.

sets and catheters and needle products to diagnostic, pre-ﬁlled and pharmaceutical devices.

Kahle Automation 89 Headquarter Plaza North 3rd Floor Morristown, NJ 07960 www.KahleAutomation.com

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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.

KNF Neuberger is an independent familyowned company comprised of 17 global locations dedicated to providing tailor-made solutions with diaphragm, solenoid, swing

KNF is a technology leader with over 300 patents and a solid reputation for providing innovative, high performance, reliable pumps. Drawing on our expertise in various fields of engineering, from mechanics, materials, and fluidics to electronics and software, KNF strives to find the smartest solutions for every application – not just for today but innovated over time to continuously serve evolving needs.

piston and boxer pump technologies. We have solved thousands of design challenges for a variety of application tasks, including: ﬂuid supply, liquid waste handling, washing, recirculation, and metering/dosing; aspiration, degassing/debubbling, chamber evacuation, and vacuum roughing/backing; gas transfer and pneumatics.

One size doesn’t fit all. We collaborate closely with our customers throughout the entire development process – from the initial idea to the final result – to create the best solution for each specific application while balancing required performance, product lifetime, and cost.

KNF’s broad applications and systems experience stretches across a diverse set of industries, including medical device and diagnostics, environmental/ industrial hygiene, laboratory equipment,

By understanding customers’ applications and speciﬁcations, KNF engineers strive to optimize not only our pump, but to also assist customers in optimizing their overall system. Our job is to ﬁt the pump to your application – not the application to a pump. In fact, customers often send us problematic systems for testing. Whether the issue is related to the pump or other system components, we’ll provide a full report with analysis and recommendations.

reprographics, security and defense, semiconductor, energy, various process industries, and more.

Whatever the challenge, KNF is ready to bring a deep bench of engineering, ﬂuidics, and applications expertise to your next project.

KNF Neuberger Phone: 609-890-8600 Email: knfusa@knf.com Web: www.knf.com

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Founded in 1918, Lee Spring is 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 through bold product innovations, quality manufacturing and responsive customer care. Lee Spring takes pride in creating solution-

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. 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.

driven responses. The Lee Spring Sales Team,

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We make it easy - exceptional personal attention

Engineering Team and Manufacturing Team

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We have it - over 25,000 catalog products

collaborate to develop application speciﬁc

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We can design it - engineering expertise

resolutions.

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

www.leespring.com

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STOCK SPRINGS

CUSTOM SPRINGS

Online CAD Downloads

Prototypes to Production Runs

Free Ground Shipping Options Available

Turning Ideas Into Reality

Over 25,000 Stock Springs

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Over 25,000 Stock Imperial and Metric Designs

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Free CAD Downloads

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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

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Inch and Metric Designs

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Wire Forms, Stampings and Springs

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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 step motors and motion control components. Their motors and products

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.

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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Master Bond formulates 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:

Outstanding Customer Support

• • • • • •

EP62-1HTMed: Non-Cytotoxic Epoxy Resists Sterilization

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

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. Master Bond EP62-1HTMed is a two part epoxy that meets the requirements of ISO 10993-5 for non-cytotoxicity and can be utilized in many medical device applications. It resists repeated sterilization cycles, including STERRAD® and autoclaving. It is also capable of withstanding exposure to gamma radiation, ethylene oxide, bleach and other aggressive sterilants and chemicals.

LED405Med: Biocompatible, Nanosilica Filled LED Curable Adhesive

LED405Med is a one component, LED curing adhesive system that meets ISO 10993-5 cytotoxicity requirements for use in medical device assembly. It does not need a UV light for curing, is optically clear, and offers excellent light transmission properties.It has a nanosilica ﬁller resulting in both lower shrinkage upon cure, as well as greater dimensional stability.

Master Bond 154 Hobart Street Hackensack, NJ 07601 Tel: 201-343-8983

Master Bond offers USP Class VI approved one and two component adhesives, sealants and coatings formulated for the assembly of medical devices.

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 custom-made to ﬁt the speciﬁc needs of customer applications. maxon helps provide innovative solutions at competitive prices for numerous applications in various

At maxon, we focus on comprehensive solutions optimized through a diversiﬁed product range and client consultation.

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. 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.

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

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

Visit us online and discover the digital maxon world.

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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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Precision Injection Molding for the Life Sciences Medbio is an ISO 1348:2016 certiﬁed, FDA registered contract manufacturer offering innovative solutions for the medical and biotechnology industries. We specialize

Members of our leadership team average over 25 years of medical device industry experience, so we know what it takes to get a new product to market.

in precision injection molding, assembly, packaging, project management, and design support. We have numerous certiﬁed ISO Class 7 & 8 cleanrooms and white rooms for molding and assembly. With six manufacturing facilities around the country, we have the expertise and passion to solve your most complex problems. We have ﬂexible capacity to handle major projects or small custom orders. We currently mold products for OEMs in Orthopedics, Cardiovascular, Ophthalmology, Neurological Surgery, General Surgery, Wound Care, Biotech

We leverage the latest technologies including robot, end-of-arm tooling, cavity separation, and automated packing to improve efﬁciency and quality. 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.

(diagnostics & cell growth), and Dental. Full Service Contract Manufacturer • ISO 13485:2016 Certiﬁed • FDA registered • Clean Room Molding • Clean Room Assembly • Clean Room Packaging

Medbio 5346 36th St SE

• Precision Injection Molding

Grand Rapids, MI 49512

• Insert & Over Molding

P: 616.245.0214

• Micro Molding

medbioinc.com

• Two-shot Molding • Silicone

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• In-house tooling

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A Flexible Approach To Meet Your Goals Meddux Development Corporation is a

MARKETS

premier engineering design, development

Interventional Devices: Interventional Cardiology, Interventional Radiology, Electrophysiology Peripheral Vascular, and Neurovascular

and manufacturing ﬁrm for complex medical devices, life sciences, and consumer healthcare products. Meddux has the ability to take you from concept to product launch

Minimally Invasive Surgical Devices: Laparoscopic Devices, Energy-based Therapeutics (RFA, MWA, Cryo, U/S), Biopsy, Interventional Spine, and GI Endoscopic

or help support task speciﬁc projects to meet your goals.

Integrated Smart Devices: Advanced Wearables, Electromechanical Devices, and Integrated Sensors and Circuits Sterile Product Manufacturing: Clinical Builds, Batch Release, and Sterile Packaging Technical Expertise & Capabilities: Energy-Based Devices (RF, MW, Cryo), Balloon Catheters, Braided Catheter Shafts and Delivery Systems, Complex Hand-Held Mechanical Assemblies, Silicone Components and Materials Expertise, Rapid Prototyping and 3-D Printing (make “Rapid Prototyping, 3-D Printing & Testing”), Nitinol Forming, DFM/DFA, Plastics Processing (Molding, Extrusion, Materials), and Precision Metal Components (CNC, Stamping, Wire-EDM, MIM) We also off er sustained engineering and support manufacturing transfer to highervolume commercial manufacturing needs. We are experienced in supply-chain management and the identiﬁcation and successful implementation of critical-tofunction (CTF) process controls.

Meddux Development Corporation 14826 Sterling Drive, Boulder, CO 80301 USA Phone: + 1 (720) 675-7154 E-mail: sales@meddux.com meddux.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 ISO-9001, ISO-13485 & ISO-14001 certified and we maintain an ISO Class 8 clean room for surgical instrument assembly. MICRO will expand its global footprint in 2022 with a 32,000 sq. ft. facility in Costa Rica featuring clean room assembly and light

A Tradition of Manufacturing Excellence

manufacturing.

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

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:

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.

• • •

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.

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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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80 Sextillion Configurations with MISUMI MISUMI is the most comprehensive and user-friendly resource for factory automation, press die, and plastic mold components. Our 80 Sextillion part configurations fit a wide scope for many of today’s advanced manufacturing technologies in such industries as automotive assembly, aerospace, medical manufacturing, 3D printing, semiconductor production, and warehouse automation MISUMI offers a vast selection of standard

MISUMI is a leader in the medical industry by manufacturing configurable components. Configurability allows the engineer to select the material, surface treatment, and dimensions of the component they need, with some dimensions up to 1 micron on our website. A unique and globally accepted part number is generated along with a CAD model for easy importing into their assembly. This model creates over 80 Sextillion configurations! Configurable components provide easy, fast, and flexible solutions for every phase of the medical design process from concept to build.

and customized parts, which make us an unmatched, one-stop-shop to meet customer speciﬁcations. Our products make us an ideal resource for many of today’s engineering teams and we are committed to empowering customers to do incredible

Not only is MISUMI a manufacturer but also a distributor and continues to expand its product offering by onboarding a variety of brands. MISUMI offers a wide range of components to medical markets including lab automation, surgical robotics, capital equipment, and contract design & manufacturing. Whether it’s actuators for a robotic system, bushings for lab automation instruments, or aluminum extrusions for automation machines, MISUMI has it covered. MISUMI is a one-stop-shop for all medical design needs.

design-work, incredibly fast, at the lowest possible cost.

The benefits of configurable components are not only the flexibility but the time savings. A part that could take weeks to create with an in-house machine shop can now take just a few days with MISUMI. Our mission is Quality, Cost, and Time – QCT – to provide quality components, at competitive pricing, and with reliable lead times. The design possibilities are endless with MISUMI configurable components.

MISUMI 1475 E Woodﬁeld Rd Suite 1300 Schaumburg, IL 60173 misumi.info/discover

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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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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.

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 T E C H N O LO G I E S

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.

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!

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 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

• Exceptionally reliable performance for critical applications

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

Roselle, IL 60172 www.nittokohki.com

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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.

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.

www.medicaldesignandoutsourcing.com

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

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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Medical power leader P-DUKE technology P-DUKE was founded in 1992, manufacturing based in Taiwan, is fully devoted in research & development, production that provides complete sales, technical service of DC/DC converters and AC/DC power supply also custom power solution. Specializes in particular sectors such as medical and railway applications where require high standard and attention on safety the most. Main Business is over Europe, America, and paciﬁc Asia. Accumulating abundant experience within 30 years, has opened up product awareness becoming an important role in the global market.

P-DUKE Technology Co.,Ltd.

P-DUKE offer broad range of medical power products. Including 1-60W DC to DC converter for CF type devices and 15-450W AC to DC power supply for B/BF type devices in compact design. The manufacturing facilities are acquired ISO 9001 manufacturing, ISO 13485 quality and 14971 risk Management System certiﬁcation for medical device. Offering high IEC/ EN 60601-1/ ES 60601-1 medical certiﬁcated reliable power supplies.

No.36,22nd Rd.,Taichung Industrial park Taichung 40850 Taiwan www.pduke.com

The products own many design and manufacturing process patents, always bringing the latest technology which won the Innovation Award of TAITRONICS and good reputation in the industry.

P-DUKE USA California (909) 598-5000

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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 125 Dever Drive Taunton, MA 02780 sales.us@parvalux.com www.parvalux.com

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50 years of Excellence Our 700+ employee owners continually strive for excellence providing services to our customer partners. We focus on precision metal tooling and components including: • Design for manufacturing and component simulation services. • Precision tooling, gauges, and ﬁxtures. • Metal additive manufacturing and prototyping. • Precision metal stamping, laser cutting, laser welding, and electro-chemical grinding. • Secondary processes including part cleaning, heat-treating, coatings, and precision assembly

MANUFACTURING SOLUTIONS. ABSOLUTE INTEGRITY. EMPLOYEE OWNED.

Founded in 1971, four entrepreneurs took a small precision grinding shop and turned it into the multi-faceted, 700 person employee-owned company that it is today. 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 www.pennunited.com

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For over 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 a high level of quality and performance as we support those 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.

PTC enables global manufacturers to realize double-digit impact with software solutions that enable them to accelerate product and service innovation, improve operational efﬁciency, and

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

increase workforce productivity. In combination with an extensive partner network, PTC provides customers ﬂexibility in how its technology can be deployed to drive digital transformation – on premises, in the cloud, or via its pure SaaS platform. At PTC, we don’t just imagine a better world, we enable it.

PTC 121 Seaport Blvd Boston, MA 02210 www.ptc.com/medical-device

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PTC’s Internet of Medical Things (IoMT) solutions provide essential support for medical device makers as they shift to remote service models that were nice-to-have before the pandemic—and are now business critical. With remote condition monitoring providing real-time insights and remote service capabilities enabling real-time repair, technicians are able to reduce medical equipment downtime, improve first-time-fix rates, and support healthcare providers who are under unprecedented pressure. Service parts planning made even more effective 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 work instructions and remote assistance provide the just-in-time coaching needed to help factory field teams, 3rd party service organizations, or even users themselves to keep equipment running to specification. 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.

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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, 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 35 mold makers and highly skilled mold build specialists, using 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 productionready 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 14 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 Macomb, MI 48044

Secondary Services

586.263.5100

PTI offers an array of secondary services such as plastic joining, laser marking, part decorating 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 medicaldesignandoutsourcing.com/leadership

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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The Leader in Manufacturing for Life Sciences Founded in 1987, Resonetics is a pioneer in advanced engineering and micromanufacturing solutions for the life sciences industry. Resonetics is a leader in laser processing, centerless grinding, nitinol processing, thin-wall stainless steel and precious metal tubing, photochemical machining, metal fabrication, and ﬁber optic sensors. With nine Lightspeed Application Development Labs located strategically to serve medical device companies around the world, Resonetics is built on a foundation of quality, speed, and innovation to deliver best-in-class value with a customer centric approach. The company is ISO 13485:2016 certiﬁed with facilities in the United States, Canada, Costa Rica, Israel, and Switzerland.

LightSpeed Applications Development Lab: Accelerate Time-to-Market with Unmatched Efficiency and Flexibility Resonetics understands the fast-paced medical device development process and the importance of time-to-market. With seamless customer collaboration, the company can deliver advanced engineering, automation, and micro-manufacturing at blazing speeds, bringing breakthrough medical devices and diagnostics to market faster. 24/7 operations allow Resonetics to meet even the most aggressive development and production schedules, while the proprietary LightSpeed Application Development Lab provides end-to-end service in pre-production and production phases with flexibility and accessibility unique to the industry. Moving with urgency through each stage of development, Resonetics helps companies quickly finalize solutions, saving time and money. The Resonetics Lightspeed Applications Development Lab stands apart in the industry in that it is comprised of a team of dedicated engineers, technicians, and equipment solely focused on helping customers with prototyping and new product development. The team is comprised of leading industry experts who partner with customers early in the development process and use the latest capabilities and advanced micro-manufacturing processes. All projects will also receive detailed feedback on design-for-manufacturability so that the program will be cost effective in production.

26 Whipple Street Nashua, NH 03060 800.759.3330 sales@resonetics.com resonetics.com

Advantages of working with the Lightspeed Applications Development Lab: • Take advantage of the latest advanced micro-manufacturing processes and technology

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• Support for rapid product development with quick turnaround times • 75+ dedicated LightSpeed workstations • Nine global Lightspeed labs located strategically to serve medical device companies around the world • Average quote turnaround time of 1-2 days

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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, AS9100, ISO 14001, ISO 13485, and TISAX 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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SCHURTER Electronic Components SCHURTER is known globally as an innovator, manufacturer and distributor of fuses, connectors, circuit breakers, switches, EMC products, and input systems. Touch screens and touch panels, capacitive sensor keypads, membrane keypads and housing systems are developed in close cooperation with its customers. Within its business unit Solutions, SCHURTER combines all competencies and puts them at the customer’s disposal. SCHURTER products and solutions are developed especially for speciﬁc industry segments – medical, data and communication, automotive, avionics & space, energy and the broader industrial

DG12 THE MOST VERSATILE POWER ENTRY MODULE YET

MSS METAL SLIM SWITCH IS STYLISH & ROBUST

market. SCHURTER considers the quality of its products and services as the key factor to The SCHURTER Group is the world’s leading Swiss technology company providing components and complex solutions that ensure safe power supply and simplified equipment operation. The company’s professional competence, financial independence, innovative strength and distinctive corporate culture, propel the SCHURTER Group, together with its customers and partners, into the digital future. The safe & easy brand claim not only refers to the products, but also the company’s business philosophy, which strives for sustainable success through innovative high-quality products and service, while maintaining flexibility and close proximity to customers.

the company’s lasting success.

SCHURTER 447 Aviation Blvd Santa Rosa, CA 95403 www.schurter.com

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UMT-H SMD FUSE PACKS IN POWER & PERFORMANCE

Setting Ideas Into Motion

Proven Performance for Medical Applications

Stock Drive Products/Sterling Instrument

SDP/SI has over 70 years of experience in engineering development and precision manufacturing for a diverse range of industries, including medical, surgical robotics, and healthcare. Combining our engineering expertise in small power transmission and motion control applications with a state-of-the-artmanufacturing facility ensures our customers receive components and assemblies that meet their speciﬁc needs. SDP/SI is ISO 9001:2015 + AS9100D certiﬁed, ITAR, Reach, and RoHS compliant.

(SDP/SI) makes it easier for OEMs to get their products to market by designing and delivering precision components and complex drive assemblies while managing costs and inventories. Well known as the one-stop-shop, we provide mechanical and electromechanical components, engineering development, precision manufacturing, and problem-solving customized solutions. Established in 1950, we are a proven partner to the most recognized names in medical, aerospace, defense, and robotics industries providing innovative solutions, world-class quality, and engineering support from concept

Medical Applications include:

to completion. We look forward to working

• Minimally invasive & surgical gear drivers

with you!

• Robotic surgery • Pharmaceutical processing & packaging • Drug delivery systems • Therapeutic & assisted living devices Offering a comprehensive selection of mechanical and electromechanical components, SDP/ SI products are available with a wide range of standard features for easy integration intended for precision applications. SDP/SI creates precision gears, timing belt & pulley drive systems, mechanical components, and customized solutions.

Stock Drive Products/ Sterling Instrument 250 Duffy Avenue Hicksville, NY 11801 USA

SDP/SI offers signiﬁcant custom engineering and manufacturing capability. As a trusted partner to companies such as Medtronic, Intuitive Surgical, Abbott Laboratories, Hologic Surgical Products, Siemens Healthcare, and more we develop and manufacture the components and assemblies that ensure success for your device.

Web: www.sdp-si.com Email: sdp-sisupport@sdp-si.com Phone: 516-328-3300 Toll Free: 800-819-8900 Fax: 516-326-8827

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Visit www.sdp-si.com to ﬁnd detailed product speciﬁcations, custom capabilities, 3D CAD models, product literature, and helpful calculations.

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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/ AS9100D, ITAR, and MedAccred Certiﬁed.

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. 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.

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40 Years of 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

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.

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

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. Our goal is to protect the performance and integrity of your product. For 40 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.

Unique applications call for innovative solutions. Standard Sorbothane® parts and custom engineered solutions are available to meet individual product objectives.

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.

STANDARD Sorbothane® PRODUCTS Sorbothane, Inc. offers an extensive line of standard Sorbothane parts. These standard products have been developed over 35 years and are selected for their speciﬁc shock absorbing and vibration isolating applications.

Sorbothane, Inc. 2144 State Route 59 Kent, Ohio 44240 Phone: 800.838.3906 www.sorbothane.com

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

Sorbothane Passes the Egg Smash Test https://youtu.be/RVE5b3BzSWQ

PROVEN SHOCK, VIBRATION & NOISE REDUCING SOLUTIONS

MATER

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

800.838.3906

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IAL

SORBOTHANE® MADE IN THE U.S.A.

Sorbothane_DesignWorldAd_8-2020_A.indd 1

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

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

Media Separated Solenoid Valves Spartan Scientific’s Media Separated product line consists of a variety of different types of isolation valves which have been specifically designed and engineered to control the flow of a particular media without allowing contamination or premature failure to occur. The ability to isolate certain types of media is vital for applications that use ultra-pure media, aggressive chemicals, or corrosive fluids in such environments as: Medical & Analytical technologies, Food & Beverage industries, or Chemical Dispensing & handling

Spartan Scientiﬁc 8510 Foxwood Court

Proportional Control Valve: Stepper 12

Youngstown, Ohio 44514 Phone: 330-758-8446 Toll Free: 855-629-4648 Email: customerservice@spartanscientiﬁc.com Website: www.spartanscientiﬁc.com

Most proportional valves require constant power to maintain their position. However the Stepper 12 saves energy by maintaining it’s position with minimal power and once in it’s correct position, only require 60mA to maintain a steady state. With more than 1,500 different positions, it precisely regulates ﬂow output and requires minimal power to maintain a desired position, maximizing energy savings.

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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. Applications for the Stepper 12 are limited only by your imagination. Aside from general manufacturing, the Stepper 12 can be used in medical, food and drug processing, drinking water, automotive, heavy equipment, agriculture, ﬂuid temperature control, and many more.

www.medicaldesignandoutsourcing.com

Spectrum Plastics Group Based in Alpharetta, Georgia with a global network of plants across the United States, Mexico, Canada, Costa Rica, Ireland and Malaysia; Spectrum Plastics Group is a leader in development through scaled manufacturing of critical polymer-based components and devices for medical and other demanding markets requiring quality, responsiveness,

OUR PRODUCTS AND CAPABILITIES

innovation and technical expertise.

• Medical Device Components & Assemblies and Finished Devices • Extruded Tubing – Microbore & Multilumen Extrusion – Fluid Management Tubings & Fittings – Core Mandrel – Silicone Extrusion • Catheter Technologies – Reinforced Shafts – Dilators/Sheaths – Steerable/Deﬂ ectable Shafts – Silicone Catheter Assemblies – Medical Balloon Catheters – Complex Catheters • Medical Balloons – Thermoplastic Medical Balloons – Silicone Medical Balloons – Medical Balloon Extrusions – Medial Balloon Catheters • Specialty Molding – Implantables & Bioresorbables Molding – Overmolding & Insert Molding – Micromolding – Surgical Components & Systems – Multishot Molding – Silicone Molding – Fluid Management Tubing & Fittings • Flexible Film & Packaging – Performance Films – Converted Bags & Pouches – Sterile Packaging • Laser Processing • Finished Devices

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

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SERVICES OFFERED

• E-commerce store, featuring tubing and components • Design and development – Advanced Additive Manufacturing – Quick-Turn Prototyping • Material selection • Polymer application expertise • Components and secondary operations • Scalable manufacturing – ISO 13485 Certiﬁ ed FDA Registered – 20+ Class 5-9 Cleanrooms • Enterprise Quality Management System – Inventory Management – Product testing and sterilization management services • Manufacturing transfers • 510K and regulatory services

MAJOR MARKETS

Cardiovascular Ear, Nose & Throat Blood Collection & Perfusion Drug Delivery & Infusion Minimally Invasive Surgery Urology / Obstetrics & Gynecology Gastrointestinal / Enteral Feeding General and Advanced Surgical Ophthalmology Sports Medicine Structural Heart Electrophysiology Fluid Management Wound Therapy Peripheral Vascular Respiratory Neurovascular Orthopedics Robotic Surgery Surgical/Wound 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 • MDR compliant, available with MDR documentation package 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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Tegra Medical makes products used in a variety of markets including: • Orthopaedics • Cardiac care

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.

• Women’s health • Neurology • Ophthalmology • Radiology • Pain management • Diabetes and other medical specialties

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.

The types of procedures often include 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.

GENESIS Tech Center® Product Development Services Work with Tegra Medical’s GENESIS Tech Center team to give your product a smooth launch to market. We’ll help you reduce production costs, increase quality, and shorten the development cycle of your medical device. Our product development services include Design For Manufacturing (DFM), prototyping, pilot production, and more.

Tegra Medical 9 Forge Park

Wire and Tubing Shipped Quickly Sometimes you need wire and hypotubing ASAP for your catheter and other medical device development projects. Order in-stock items from our Quick Wire & Tubing store and we’ll ship them within 24 hours. And to make your life easier we also offer a wide variety of custom ﬁnishing and mandrels. Visit our online store and see how our wire and tubing help bring your projects to life.

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

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

Tegra Medical is a member of SFS.

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TRACO Electronic AG, is a Swiss

Global Leader in Medical Certiﬁed Power Solutions

company with headquarters in Baar, Switzerland. TRACO markets its products worldwide under the registered trademark 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. The standard product offering in medical grade power solutions includes 15~850 watt AC/DC power supplies in open frame, fully enclosed or encapsulated models and 1~60 watt DC/DC converters with PCB mounting.

Setting the Standard for Small Footprints & High Efficiencies 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. 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.

60 Watt DC/DC - 2.30 x 1.45 x 0.50”

MEDICAL DC/DC: 1 ~ 60 Watt MEDICAL AC/DC: 15 ~ 850 Watt Additional features include:

180 Watt DC/DC - 3.00 x 2.00 x 1.24”

• 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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Your Partner for Life-Changing Technologies Trelleborg Healthcare & Medical helps pharmaceutical and medical device companies improve patient quality of life by partnering in all stages of development, from concept to serial production to create engineered polymer solutions for demanding applications. Trelleborg’s global footprint is backed by experts with 30+ years of industry experience and a portfolio of capabilities, including micro-molding, process automation, silicone extrusion, drug-eluting solutions, silicone and thermoplastic molding and over-molding, multicomponent molding, device assembly, and silicone dipping and

Our capabilities enable us to provide creative solutions to our customers’ challenges. Combining development work and innovation with customer collaboration, Trelleborg has manufactured critical and complex components for the industry’s leading medical device companies.

coating. Trelleborg’s Rapid Development Center helps medical device companies navigate and accelerate the development process from concept to market launch.

One tool is Trelleborg’s Rapid Development Center, which brings together engineering experts who advise on design, prototyping, and production, with the end goal of optimizing time to market, manufacturability, and functionality of the end product. Our extrusion capabilities include multi-lumen, inside and outside diameter variation, twisted lumen, reinforced tubing, and extremely thin walls. Trelleborg’s GeoTrans technology is used for custom applications and enables

Trelleborg Healthcare & Medical 1550 Utica Ave South Suite 555 Minneapolis, Minnesota 55416 www.trelleborg.com/healthcare

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the cross section of silicone tubing to be changed during the extrusion process while maintaining precision tolerances and eliminating molding and secondary bonding. Our injection molding capabilities with Liquid Silicone Rubber can be automated and result in ﬂashless and consistent dimensions and quality. We’ve manufactured medical device components, including longterm urological, intrauterine, and orthopedics implants, hemostasis seals, and blood glucose monitoring systems. Trelleborg works with pharmaceutical companies to design and manufacture implantable drug-device combination products that control the release of the Active Pharmaceutical Ingredients (API), target delivery of the API, improve patient compliance, and prevent infection.

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

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Able Electropolishing ................................. 27 Accumold .................................................... 31 AllMotion ....................................................... 8 Altech Corporation ................................... 6, 7 Asahi Intecc USA......................................... 30 Atlas Vac LLC............................................... 40 B. Braun ...................................................... BC Bay Associates Wire Technologies, Inc. .... 36 Bird Precision .............................................. 52 Bishop Wisecarver ...................................... 37 BMP Medical ............................................... 75 Boker’s, Inc. ................................................. 65 Cadence ...................................................... 19 Canon U.S.A., Inc. ....................................... 29 Canon Virginia, Inc...................................... 32 Carl Stahl Sava Industries ........................... 21 Chamfr ......................................................... 57 Chieftek Precision ......................................... 4 Cirtec Medical ............................................. 41 Clippard ....................................................... 13 Components Corporation ......................... 26 COMSOL ..................................................... 71 Cretex Medical.............................................. 5

Eagle Stainless Tube................................... 33 Fischer Connectors ..................................... 51 Flexan .......................................................... 79 Freudenberg Medical................................. 67 Halkey | Roberts .......................................... 15 Hobson & Motzer ....................................... 68 Integer ......................................................... 64 Integrated Computer Solutions ................ 61 Interpower ..................................................... 9 IRP Medical ................................................... 2 Isometric Micro Molding ............................ 54 J.W. Winco, Inc. .......................................... 22 Kahle Automation ....................................... 35 Keystone Electronics Corp........................... 1 KNF Neuberger .......................................... 47 Lee Spring Company.................................. 11 Lin Engineering ........................................... 84 Master Bond................................................ 77 maxon .....................................cover/corner, 3 MedBio ........................................................ 63 Meddux ....................................................... 76 MICRO ......................................................... 56 MicroLumen .......................................... 44, 45

Ming Tai Industrial Co., Ltd. ....................... 53 Misumi USA, Inc. ......................................... 24 Nelipak Healthcare Packaging .................. 59 New England Wire & Tubing Technologies ... 43 Nitto Kohki USA .......................................... 16 Nordson MEDICAL ..................................... 81 OKW Enclosures, Inc. ................................. 55 P-DUKE Technology Co., Ltd. .................... 39 Parvalux ....................................................... 83 Penn United ................................................ 17 PTI ................................................................ 72 Qosina ......................................................... 70 Resonetics ................................................. IFC SCHURTER Inc. ........................................... 52 Solar Atmospheres ..................................... 25 Sorbothane.................................................. 50 Spartan Scientiﬁc ........................................ 60 Spectrum Plastics........................................ 46 Steute Meditech, Inc. ................................. 23 Stock Drive Products/Sterling Instrument ..... 62 Tegra Medical ........................................... IBC TRACO POWER North America, Inc. ........ 18

2022 MEDTECH LEADERSHIP

Eberhard .................................................... 110 ElectroCraft, Inc. ....................................... 111 Fischer Connectors ................................... 112 Flexan ........................................................ 113 Freudenberg Medical............................... 114 Halkey Roberts .......................................... 115 Hobson & Motzer ..................................... 116 Integer ....................................................... 117 Integrated Computer Solutions .............. 118 Interpower ................................................. 119 IRP Medical ............................................... 120 Isometric Micro Molding .......................... 121 J.W. Winco, Inc. ........................................ 122 Kahle Automation ..................................... 123 Keystone Electronics Corp....................... 124 KNF Neuberger ........................................ 125 Lee Spring Company................................ 126 Lin Engineering ......................................... 127 Master Bond.............................................. 128 maxon ........................................................ 129 Medbio, Inc. .............................................. 130 Meddux ..................................................... 131 MICRO (Micro Medical)............................ 132 Microlumen ............................................... 133 Ming Tai Industrial Co., Ltd. ..................... 134 Misumi USA ............................................... 135

Nelipak Healthcare Packaging ................ 136 New England Tubing Technologies ........ 137 New England Wire Technologies ............ 138 Nitto Kohki USA ........................................ 139 Nordson MEDICAL ................................... 140 OKW Enclosures, Inc. ............................... 141 P-DUKE Technology Co., Ltd. .................. 142 Parvalux ..................................................... 143 Penn United .............................................. 144 PTC ............................................................ 145 PTI Engineered Plastics ............................ 146 Qosina ....................................................... 147 Resonetics ................................................. 148 Rotor Clip .................................................. 149 SCHURTER Inc. ......................................... 150 SDP/SI-Stock Drive Product ..................... 151 Solar Atmospheres ................................... 152 Sorbothane................................................ 153 Spartan Scientiﬁc ...................................... 154 Spectrum Plastics Group.......................... 155 STEUTE Meditech Inc............................... 156 Tegra Medical ........................................... 157 TRACO POWER North America, Inc. ....... 158 Trelleborg .................................................. 159

Able Electropolishing ................................. 86 Accumold .................................................... 87 AllMotion ..................................................... 88 Altech Corporation ..................................... 89 Asahi Intecc USA......................................... 90 Atlas Vac ...................................................... 91 B.Braun ........................................................ 92 Bay Associates Wire Technologies, Inc........ 93 Bird Precision .............................................. 94 Bishop Wisecarver ...................................... 95 BMP Medical ............................................... 96 Boker’s, Inc. ................................................. 97 Cadence ...................................................... 98 Canon U.S.A, Inc. ........................................ 99 Canon Virginia........................................... 100 Carl Stahl Sava Industries ......................... 101 Chamfr ....................................................... 102 Chieftek Precision ..................................... 103 Cirtec Medical ........................................... 104 Clippard ..................................................... 105 Components Corporation ....................... 106 COMSOL ................................................... 107 Cretex Medical.......................................... 108 Eagle Stainless Tube................................. 109

LEADERSHIP TEAM

SALES

Managing Director Scott McCafferty smccafferty@wtwhmedia.com 310.279.3844 @SMMcCafferty

VP of Sales Mike Emich memich@wtwhmedia.com 508.446.1823 @wtwh_memich

EVP Marshall Matheson mmatheson@wtwhmedia.com 805.895.3609 @mmatheson

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Ryan Ashdown 216.316.6691 rashdown@wtwhmedia.com

Mary Ann Cooke 781.710.4659 mcooke@wtwhmedia.com

Courtney Nagle cseel@wtwhmedia.com 440.523.1685 @wtwh_CSeel

Jami Brownlee 224.760.1055 jbrownlee@wtwhmedia.com

Jim Dempsey 216.387.1916 jdempsey@wtwhmedia.com

Jim Powers jpowers@wtwhmedia.com 312.925.7793 @jpowers_media

Ashley N. Burk 737.615.8452 aburk@wtwhmedia.com

Mike Francesconi mfrancesconi@wtwhmedia.com 630.488.9029

Brian Toole 267.290.2386 btoole@wtwhmedia.com

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Protecting caregivers, treating patients and delivering confidence. It starts with decades of product development expertise. Our vast catalog of standard components can be customized to generate endless possibilities for sets and kits. We put in place processes for ensuring stringent quality levels, managing volumes of documentation and tracking all project details. Add in a full suite of capabilities, and you have a turnkey solution that’s more like a partnership for creating confidence. B. Braun Medical | OEM Division | USA | us.bbraunoem.com | 1-800-359-2439 ©2020 B. Braun Medical Inc. Bethlehem, PA. RX only. All rights reserved. OEM 16-5563 05/20 LMN

MEDICAL DESIGN & OUTSOURCING | 9" X 10.875" | BRN2608