Medical Design & Outsourcing – MAY 2020

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THESE MEDICAL DEVICES ARE READY TO LAUNCH IN 2020

Medtech may never be the same HOW ARE ALTERNATIVE VENTILATORS HELPING DURING THE PANDEMIC?

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I S S U E www.medicaldesignandoutsourcing.com MAY 2020

THESE MEDICAL DEVICES ARE READY TO LAUNCH IN 2020

Medtech may never be the same HOW ARE ALTERNATIVE VENTILATORS HELPING DURING THE PANDEMIC?

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A Lost Year? Let's make 2020 matter

T

he COVID-19 pandemic has entirely changed the world since Medical Design & Outsourcing last published in March.

Our editorial team, our WTWH Media colleagues — we’re all navigating sheltering in place at home as we do the work and crank out the medtech stories that hopefully help people navigate this crisis.

The mounting death toll around the world fills me with sadness, and yet I also marvel at the little moments of courage as people seek to get through their days and still make a difference.

Taking our family on end-of-day walks, my wife and I talk about the swimming and soccer classes cancelled, the concerts and sporting events we’re not going to watch. We wonder if people someday are going to say that 2020 was a “Lost Year.”

•

My colleague Tom Salemi, who is editorial director of our DeviceTalks events, surveys industry insiders and finds a host of medtech trends accelerating — from making hospitals more efficient and effective to digital manufacturing to virtual prototyping. (Tom is being inventive himself, with plans for virtual DeviceTalks events.)

"The need to respond to the coronavirus catastrophe has created opportunity for innovation. In fact, the moment demands that we produce meaningful change."

And yet as I write this editorial, the words of the ancient Romans come to mind: “Fortune favors the brave.”

The need to respond to the coronavirus catastrophe has created opportunity for innovation. In fact, the moment demands that we produce meaningful change. It’s little wonder that the pageviews on our MassDevice and MDO news sites have skyrocketed since the pandemic began: In many ways, this is medtech’s moment.

Our team of editors in this issue provide a glimpse of what is already taking place:

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Chris Newmarker Executive Editor Medical Design & Outsourcing cnewmarker@wtwhmed i a .c o m

www.medicaldesignandoutsourcing.com

| | | |

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Assistant editor Sean Whooley writes of the university research teams who have partnered with industry to cobble together medical ventilator alternatives to help fill shortages of the life-saving devices during the pandemic.

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Managing editor Nancy Crotti latched on to another effort to solve the ventilators dilemma: refurbishing old ventilators. She also covers the heroic efforts of medical device industry suppliers to rapidly shift their operations in response to the crisis.

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Stay tuned, because we’ll have many more exciting things to announce in coming months. In the meantime, stay safe and healthy.

And last but certainly not least, senior editor Danielle Kirsh describes the significant new devices that medtech companies are still planning to launch this year, even as they grapple with COVID-19.

It’s worth noting, too, that we’re engaged in a great deal of innovation within our Life Sciences publications here at WTWH Media.

For example, I’ve enjoyed reaching out to Tom every Thursday to record the new DeviceTalks Weekly podcast he produces (www.devicetalks.com/ podcast). And Danielle helped our tech folks create a MedTech 100 Index (index. medicaldesignandoutsourcing.com) so that our readers can track the average stock performance of the world’s largest medical device companies.

On top of MassDevice and MDO, we also have an expanding roster of news sites: Medical Tubing + Extrusion, Drug Discovery & Development, Pharmaceutical Processing World, and Drug Delivery Business News.

5 • 2020

Medical Design & Outsourcing

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CONTRIBUTORS

DYKEMAN

GAYNOR

HALLADAY

HOOVER

LARSON

DAVID J. DYKEMAN is a registered patent attorney with over 23 years of experience in patent and intellectual property law, and co-chair of Greenberg Traurig’s Global Life Sciences & Medical Technology Group. David's practice focuses on securing worldwide intellectual property protection and related business strategy for high-tech clients, with particular experience in medical devices, robotics, life sciences, wearables and healthcare information technology.

JUSTIN GAYNOR is business development manager for Intrasense in TE Connectivity’s Sensors Solutions Group. He has experience in new product development and in semiconductors. He previously worked at Texas Instruments and Novellus Systems and holds 17 patents.

KRIS GODBEY is an application development specialist at 3M with over 35 years in various 3M divisions, working in product development and technical support roles.

COLIN HALLADAY is the strategic business development manager of test services at Laird Connectivity, a provider of wireless technologies, embedded, pre-certified wireless modules and design services.

TOM HOOVER has been senior medical business development manager — Americas, Assembly Technologies at Emerson in Danbury, Conn. since 2010. He has extensive experience in medical device product development and regulatory compliance.

ROBIN HUNEKE ROSENBERG is a senior clinical research associate at 3M and currently works in the Health Care Business Group, Medical/Clinical affairs group.

SCOTT LARSON is CTO of Medical at TE Connectivity.

With 30 years in medtech, he previously worked for Olympus and Boston Scientific.

PETE SMITH is senior manager of sensor product knowledge and training for TE Connectivity Sensor Solutions. He has worked with sensors since the 1970s and holds four patents.

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SMITH

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CONTENTS

medicaldesignandoutsourcing.com ∞ May 2020 ∞ Vol6 No3

COLUMNS 6

HERE’S WHAT WE SEE:

8

CONTRIBUTORS

12

IP ISSUES:

18

MANUFACTURING & MACHINING:

Let’s make 2020 matter

5 strategies to prevent medtech IP theft

• • • • • THE COVID-19 ISSUE

32

ON THE COVER COVID-19 IS HERE: MEDTECH MAY NEVER BE THE SAME The pandemic could accelerate hospital transformation, endanger medical device startups — and much more. Here’s what industry insiders think.

How to improve ultrasonic weld quality

22 PRODUCT DEVELOPMENT:

7 ways to make the most of clinical trials

24 SENSORS:

Sensor innovation is just getting started in healthcare

26 TESTING:

FEATURES

How to navigate testing for devices that use wireless technology

40 THESE MEDICAL DEVICES ARE READY TO LAUNCH IN 2020

28 TUBING TALKS:

Despite the coronavirus pandemic, medical device companies are still working to gain regulatory approvals and launch new devices this year.

Glass tubing supports Mayo Clinic innovation

46 HOW ARE ALTERNATIVE VENTILATORS HELPING

DURING THE PANDEMIC?

Amid the shortages of vital equipment, ventilators stand out — their presence a matter of life or death for people needing respiratory assistance.

58 DEVICETALKS:

Keeping our medtech community connected

61

50 REFURBISHED VENTILATORS COULD BE A SECRET

WEAPON AGAINST COVID-19

PRODUCT WORLD

Old ventilators will get new life from a nationwide network of engineers and technicians.

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54 MEDTECH CONTRACT MANUFACTURERS MAKE IT WORK

From coping with wild fluctuations in demand to keeping workers safe and customers satisfied, these medical device industry suppliers have found ways to adapt amid COVID-19 and an uncharted business environment.

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IP ISSUES

5 strategies to prevent medtech IP theft Even as they rapidly innovate to fight the coronavirus pandemic, medtech companies need to stop IP theft. Here are the basics.

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

edtech companies are at the forefront of innovation, and that has never been more evident than in the industry’s response to COVID-19. The healthcare research and development (R&D) engine is in high gear to create innovative products for hospitals to treat patients. Medtech companies are bringing new diagnostic tests, ventilators and personal protective equipment (PPE) to market in record time.

The increase in R&D reflects the fast pace of innovation seen across the entire healthcare industry, from digital health, to medical equipment, to diagnostics and drug delivery systems.

Medtech areas poised for growth include medical robotics, artificial intelligence and combination products that combine devices and drugs.

Medtech IP theft In an industry so heavily dependent on costly R&D, medtech companies need to take every precaution to safeguard their innovations against intellectual property (IP) theft. The potential

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losses are far from trivial: The National Bureau of Asian Research, for example, estimates that IP theft costs U.S. companies over $300 billion per year.

IP theft comes in many forms including counterfeiting, patent infringements, piracy, corporate espionage, cyberattacks and the misappropriation of trade secrets, product designs or manufacturing processes. Whether entering a new market, improving existing products or expanding distribution networks, IP theft concerns are ever-present.

The stakes are high. IP theft leads to competitive products that often bypass the costs of R&D. The competing products erode market share and cost the innovator sales and potentially millions in lost revenue.

To combat “IP thieves,” medtech innovators need to think broadly about ways to protect their IP in order to maintain a competitive advantage and prevent inferior medical products from entering the market. This article discusses five strategies to prevent IP theft, including both opportunistic and targeted IP theft.

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1. Develop a strong patent strategy Developing and maintaining a strategic patent portfolio is critical to a medtech company’s growth and survival, and can be effective at discouraging theft of company innovations. The key is to develop a strategic patent portfolio that has comprehensive patent coverage around the company’s inventions. The core technology must have adequate patent protection to provide flexibility and room to operate in the dynamic medtech market. To obtain broad patent protection, medtech companies should file an initial patent application covering the core technology, followed by additional patent applications covering key improvements and methods of treatment. Medtech companies should consider both current and future business objectives and analyze ways that competitors or copycats may attempt to design around its patents.

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2. Protect trade secrets Trade secret protection can provide an option to protect the IP of a medtech innovator when used in conjunction with or as an alternative to patent protection. As the name would imply, one requirement for trade secret protection is that the innovation must truly be kept secret, whereas with patent protection, the invention is disclosed in writing for the world to see. Once a trade secret is divulged, it is no longer protected and becomes part of the public domain.

Therefore, trade secret protection requires continuous diligence, since once the medtech trade secret is revealed, it is no longer protected. To ensure secrecy, it is critical that medtech companies educate employees on keeping information confidential and implement a trade secret protection program to maintain the secrecy of innovations.

Medtech innovators can leave themselves vulnerable to IP theft by inadvertently including trade secret information — such as formulations, algorithms, manufacturing secrets, or mixing and assembly details — in the company’s instructions for use (IFUs), standard operating procedures (SOPs), or marketing materials. Companies should review a product’s IFUs and SOPs and eliminate any information that may reveal trade secrets that could allow a competitor to duplicate the product or device.

With trade secret protection, it can 14

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MEDICAL

be easier to obtain an injunction for misappropriation under trade secret law.

This is because, in the absence of a prior favorable court finding of infringement and validity of a patent, courts may not be as willing to issue preliminary injunctions in relatively complex patent litigation, thus allowing wrongdoers to continue infringing. However, courts generally are more willing to issue a preliminary injunction in trade secret litigation.

3. Don’t forget about trademarks A carefully selected and maintained trademark can be a valuable business asset for medical device innovators.

Among other important benefits, a registered trademark protects against registration of confusingly similar marks, as the USPTO has a duty to cite prior registrations against applications for similar marks and to refuse to register such marks. In essence, trademarks enlist the power of the U.S. government in helping to prevent trademark infringement (at no additional cost to the trademark owner).

The first step in an effective trademark strategy is to conduct a trademark search for a fanciful, arbitrary or suggestive mark. It is important to avoid using a mark that is merely descriptive – or worse, generic. Once the mark is determined, a U.S. trademark application should be filed. Filing early in foreign countries can be even more important, or a manufacturer may later find that another company owns the rights to “its” mark in a foreign country. Manufacturers should also take steps to monitor competitors’ activities, so that action to stop infringement can be taken as soon as possible if a problem is detected.

Finally, manufacturers must ensure all trademarks are properly entered in the FDA’s medical device listing database and the Global Unique Device Identification Database (GUDID).

Founders of early-stage companies often get “married” to a proposed product name before engaging a trademark attorney and conducting a trademark clearance search and then continue to pursue the trademark even in the face of potential red flags. Trademark disputes are expensive and can drain

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valuable time and monetary resources from companies with little or no economic upside. Thus, it is prudent to engage an IP attorney early in the name-selection process to avoid expensive missteps.

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4. Draft strong agreements For medtech companies, a key line of defense to protect IP is using ironclad agreements both internally with employees and externally with third parties.

All employees should sign a confidentiality agreement, sometimes called a non-disclosure agreement (NDA), that contains at least the following provisions: confidentiality, protecting confidential information and trade secrets from disclosure; assignment of all inventions and IP to the company; and non-competes that limit an employee leaving to work for direct competitors.

Exiting employees should also sign separation and/or severance agreements containing a release of claims and reminders to not disclose the company’s confidential information or trade secrets to new employers.

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The stakes are high. IP theft leads to competitive products that often bypass the costs of R&D.

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In dealing with third-party companies and contractors, medtech innovators must be sure to protect their proprietary designs, IP and other proprietary information. The first step is to make sure all third parties sign a strong NDA before any disclosure about the product (even getting a price estimate). Next, draft comprehensive written agreements with all potential partners including: independent contractors; consultants (R&D, regulatory, marketing); contract research organizations (CRO); component suppliers; original equipment manufacturers (OEM); contract manufacturing organizations (CMO); distributors; and marketing firms.

Innovators should ensure the following types of agreements contain strong confidentiality and assignment of IP and improvements clauses: master 5 • 2020

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IP ISSUES

service agreements; development agreements; manufacturing agreements; distribution agreements; license agreements; regulatory and marketing agreements; and independent contractor and consulting agreements.

5. Be prepared for cyberattacks and corporate espionage Sensitive designs and data must be secured physically and electronically to prevent cyberattacks and corporate espionage. IP theft via cyberattacks and hacking has become a real threat for the IP-driven medtech industry. A number of the world’s leading medtech companies have been infiltrated in recent years.

Unauthorized users attempt to break into computer systems to steal, change or destroy information, often by installing dangerous malware which can be accessed later. Computer hackers attempt to find holes in the cybersecurity protocols of medtech companies to

gain access to sensitive information like product schematics and future designs.

Sometimes, hackers try to hijack control of medical devices or extort manufacturers for monetary payments.

Threats can also come from foreign nationals, especially from emerging economies with substantial funding and support from governments.

Internal threats are equally menacing. The risk of disgruntled current or former employees leaking important confidential information to competitors or the public is a universal concern. Personnel screening is critical, and should include performing background checks and credit checks on anyone hired for positions that involve proprietary information, from engineering to marketing and sales.

To combat both internal and external IP theft, medtech companies should create procedures for identifying and securing sensitive data and

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information, especially if they have complex supply chains that could make that information vulnerable at many points. Firewalls, intrusion prevention systems, web security proxies, payload analysis and other prevention-centric products can provide a first line of defense for electronic protection.

In the company’s physical space, measures to prevent IP theft include: keeping critical designs and product information and all tangible trade secrets under lock-and-key; restricting access only to employees with a need to know; using a visitor log with badges to control entry to proprietary areas; limiting electronic access to trade secrets through password-protecting key documents, encryption, and/or storage on a separate computer server with limited access. Implementing steps to prevent a security breach is an ongoing process, as IP thieves try to stay one step ahead of preventative measures.

Conclusion Due to high R&D costs and the expense of clinical trials and marketing, the cost of bringing a medical device to market continues to increase. As each passing year brings new rivals, novel solutions and greater potential for theft, it is imperative that medtech companies develop a multipronged strategy to prevent all types of IP theft.

This article reflects the opinions of the authors, and not of Greenberg Traurig.

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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MANUFACTURING & MACHINING

How to improve ultrasonic weld quality An electromechanical actuation system that delivers downforce with greater precision and responsiveness throughout the ultrasonic welding process can improve the weld and reduce waste.

A To m H o o v e r | Emerson |

Ultrasonic welds strongly bond even small items like the ties on a disposable surgical mask at a fraction of the cost of stitchery or glue.

Image from Emerson

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s medical devices miniaturize, there’s an increased need to weld plastic parts that are smaller, lighter, thinner-walled and often more complex in shape or contour than in the past. The growing presence of parts that contain embedded electronics and sensors that require special care in the ultrasonic welding process only heightens the challenge.

Meeting the medical device industry’s demand for repeatable, strong and consistent welds of these delicate components has required the development of ultrasonic welding technology that provides more precise and responsive force control.

The challenge The ultrasonic welding process requires downforce exerted by the welder’s actuator to maintain horn-to-part contact, ensure the smooth and efficient transmission of ultrasonic energy into the mating parts, and bond the parts together after melt has occurred at the part interface. For decades, actuators have relied on pneumatics to deliver and regulate downforce and pneumatic actuators continue to be an industry standard.

However, to meet the unique challenges posed by increasingly small and delicate parts, the developers of Branson ultrasonic welding technology had to reconsider the capabilities of pneumatic actuators in light of the rapidly advancing capabilities of servo control technology.

They ultimately found an optimal solution in a new electromechanical actuation system that delivers downforce with greater precision and responsiveness throughout the ultrasonic welding process.

Extensive testing of the new actuation systems revealed that rapidly and precisely adjusting downforce during the weld process could significantly improve weld quality.

www.medicaldesignandoutsourcing.com

MANUFACTURING & MACHINING

For users, more responsive actuation and force control mean a higher likelihood of achieving 100% good parts or zero scrap.

Or, it can mean the ability to complete good welds on plastic parts that could not be reliably ultrasonically welded before.

The role of weld force control For a given set of weld parameters, the precision and responsiveness of the actuator can make a major difference.

Variations in force control that apply too little force reduce compression of the mating surfaces, reduce the heat generation needed for plastic melt, and result in “cold,” relatively weak welds.

Similarly, force variations that apply too much force can cause part joints or energy directors to deform, deflect or break, or can suppress the delivery of enough vibratory energy for proper part friction, melt flow and polymer entanglement to occur. This also results in weak welds.

Applying just the right amount of force at just the right time results in

higher-quality welds with highly consistent characteristics and strength. But achieving ideal force levels throughout the welding process is difficult. Ideal force control requires rapid, dynamic changes in the clamp force/downspeed applied by the actuator following the melt of the plastic.

This automated adjustment, called “dynamic followthrough,” enables each weld cycle to adapt to partto-part variances and other factors such as the type of plastic, joint style and part geometry.

As the speed and precision of force control and dynamic follow-through increase, the strength, quality and consistency of plastic welds follow. For example, the strongest “pull force” for a part weld results from a controlled force profile that allows for complete and random

polymer chain entanglement that makes the weld as strong as the parent material.

More consistent and complete polymer chain entanglement and stronger welds are a direct result of technical improvements in actuation and force control. By evening out even small

Applying just the right amount of force at just the right time results in higher-quality welds with highly consistent characteristics and strength. force variations very quickly, advanced process controls and actuation systems maintain more consistent horn-to-part contact and enable weld parameters to be executed far more accurately and gently.

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So, for even hard-to-weld shapes and small or delicate parts, advanced process control and actuation systems like this can provide superior weld quality and improved yields, characterized by uniform and consistent weld collapse depths and minimal flash or part marking.

Benefits of improved force control In a series of laboratory tests and customer trials, the advanced process controls and electromechanical actuator developed for the Branson GSX-E1 welder: • Produced parts with a higher average pull strength and more consistent and repeatable levels of break force (e.g. lower standard deviation in results) than an industry-leading pneumatically actuated ultrasonic welder.

• Demonstrated the ability to maintain very tight torque test values across multiple GSX-E1 welders performing the same task. In this trial, multiple welders held torque values to within a nominal range of approximately 0.2 Nm over a run of 50 production-quality welds. Such control proved impossible with the customer’s pneumatically actuated ultrasonic welders.

• Consistently produced welds with higher-than-expected break-push strength on parts with a very thin (~0.5 mm) plastic shear joint. One customer’s production trial delivered 3000 parts with an average break force of 152 lb — nearly double the customer requirement — and did so with zero scrap parts.

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The improved force control capabilities in an ultrasonic welding platform can enable it to produce these and similar results while reducing weld cycle time, peak power input and total weld energy consumption compared to welders equipped with less-responsive and precise actuation systems.

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PRODUCT DEVELOPMENT

7 ways to make the most of clinical trials

Two experts explain how design engineers can get the most valuable information out of clinical trials.

Kris Godbey | 3M | Robin Huneke Rosenberg 3M |

Y

ou ďŹ nally have reached the time when you get to evaluate your product in a clinical trial.

There are many important steps to keep in mind when advancing your project to this next level. Here are seven that you should not skip: 1. Call a lawyer The clinical trial is just one of the many steps in an iterative product process.

Before sharing information on your product with external parties, work with an attorney to help with guidance on documentation needed for clinical trials.

This step is often overlooked but is a critical component that can help protect your proprietary information.

2. Do your homework Clinical trials are carried out to determine whether your product will perform as intended. Planning for a clinical trial is a process that may require your team to assist with the planning and design of the clinical protocol.

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5 • 2020

As the product engineer, you may be providing input to the clinical trial design, submitting product materials and supporting reports to verify that the product is safe for human use.

As you begin to design and plan a clinical trial, consider how other companies with similar products approached their clinical trials. Consult public information sites such as Clinicaltrials.gov to review information about clinical studies with similar products.

For medical clinical trials, consult the FDA Code of Federal Regulations for guidance on additional submission requirements before your trial begins.

3. Engage the team early in the process Clinical trial designs depend on early decisions and strategies. Identify crossfunctional team members, including engineering, regulatory, clinical and marketing, to allow experts to contribute in their particular areas. Each member will have a different role within the clinical trial process.

www.medicaldesignandoutsourcing.com

Clinical trial designs depend on early decisions and strategies.

To ensure you get the needed design feedback for the product, let the cross-functional team know which steps are most important.

It’s your job as the expert in design and product functionality to communicate how to effectively use your product.

4. Study planning As part of the investigational trial plan, study subjects will be identified using inclusion/exclusion enrollment criterial.

Terms may differ depending on the content provided, trial photography use and storage, and whether product team members can participate in the trial or enrollment process. Another consideration is whether participants will wear monitors or keep diaries to track activity levels.

Before any data is collected or observations recorded, study-related documents are reviewed and approved by an institutional review board (IRB).

The trial investigator or delegate reviews the informed consent document with the participant before enrollment. Subject

participant consent must be obtained before the start of any study.

5. Demographics matter Part of designing a trial is to address the needs of the end-user. For instance, for trials testing a wearable product, consider the participants’ skin and its unique characteristics. Are you allowing people with tattoos to participate?

What age groups are involved? What ethnicities are included?

In addition, you need to consider external factors such as skin preparation, whether the weather is humid or dry and how active participants will be.

Work with your clinical team to get a demographic reflective of your customer and from regions where the product will be sold.

6. Keep records and documents secure Recording documentation, including photography, will make several aspects

easier at trial’s end. For instance, if there is an unexpected complication such as an adverse skin reaction, photography may support the adverse-event documentation and subsequent timed observations.

7. Stay involved with the team to the end We often think we’ll understand how people will engage with our product design, but we have no idea what happens when it is in their hands. Being able to see the subjects’ responses to using your product is critical to the final product design.

Observe how the instructions are given to the subject, as well as how the product is applied, especially if the product is to be applied by the user. You may learn things about your product you may not have considered previously such as: Does it catch on a subject’s shirt every time they change?

Is the product too small to maneuver for someone who has arthritis?

If you are unable to observe performance in person, have detailed discussions with the clinical study manager on product use.

Clinical trials provide helpful information, so it helps to avoid common mishaps that may occur along the way.

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SENSORS

Sensor innovation for sensitive medical devices is just getting started Medical sensors have helped improve healthcare for years. New sensor solutions are helping patients manage their own care will help the industry and providers advance precision medicine.

Scott Larson | TE Connectivity |

Pete Smith | TE Connectivity |

Justin Gaynor | TE Connectivity |

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Medical Design & Outsourcing

F

rom their humble origins measuring patients’ blood pressure and temperature, sensors have increased in sophistication, enabling their use across a wide array of applications.

Sensors measure pressure, air bubbles, airflow, respiration, glucose levels, force, heart rate, humidity and position — among other variables — and can be combined in multisensor modules. They’re being miniaturized, are increasingly digital, and are available in low- or even no-power options, with the ability to self-generate power.

They’re also available in a variety of forms that adapt to specific applications, such as respiratory equipment, interventional tools, wearables and implanted devices.

All of these innovations, with the increased flexibility and capabilities they provide, have enabled their use in a growing number of consumer and commercial-grade applications. It’s no wonder that the medical sensors market is slated to reach $1.7 billion by 2025, according to a recent report by Markets and Markets.

At home On the consumer side, sensors are transforming home health care. Wearables and sensor-tagged medications enable providers to remotely monitor patient health conditions and adherence, receive automated alerts and provide targeted support via telemedicine. Patients are more empowered and motivated to increase their fitness, make better health choices and manage chronic conditions

5 • 2020

Microcatheters less than 1 mm in diameter are being used to navigate the neurovascular system and treat brain diseases.

Image from TE Connectivity

using real-time information that reinforces their adherence to drug regimens and other healthcare protocols.

As an example, someone with diabetes can now wear their insulin pump on their belt like a cell phone, receiving continuous micro-injections to stabilize their medical condition. With sensor-driven home health care, providers can drive better outcomes, reduce costs and avoid expensive hospital readmissions due to lack of patient adherence.

In care settings On the commercial side, sensors are used in imaging, diagnostics, interventional radiology and surgeries. Image sensors help provide ultra-high-resolution X-rays, CT scans and more for diagnostics.

Diagnostic temperature and pressure sensors can provide real-time updates on vital conditions, helping to focus care

www.medicaldesignandoutsourcing.com

F

B m d p a

delivery and avoid hospital-associated infections. When combined with other data sources — equipment status, population demographics, disease prevalence and others to power big data analytics — sensor data can help inform treatment plans for patients with similar disease conditions or the population at large.

On the interventional front, sensors are transforming medical devices into smart devices. Companies are developing long-term technology roadmaps to increase sensor capabilities and build a broader portfolio of products. Sensor expertise gained in other industries and applications — including engineering know-how, best practices and new materials — are accelerating innovation in healthcare industries and putting powerful new tools in the hands of surgeons to make surgery more precise and accurate. To borrow an example from the automotive market, it’s like moving from conventional vehicles to fully autonomous cars guided by highly intelligent systems that can ingest

These enable healthcare providers to obtain high-quality, real-time images of patient organs during minimally invasive surgeries, such as placing rhythm management devices or performing structural heart valve therapies.

and process torrents of data and make adjustments in micro-seconds.

A look ahead That future is already within reach. With the ability to put sensors into catheters less than a millimeter in diameter, doctors can reach new areas of the anatomy and collect real-time data during a procedure.

Consider these recent innovations: • Catheter connection platforms that are compatible with different medical devices for minimally invasive surgeries. These low-profile, sensordriven catheters capture real-time, vital patient data as they navigate throughout the human body.

• Lightweight, twisted-pair cables that reduce wrist strain for sonographers performing multiple ultrasounds each day.

• Twisted-pair fine wires that pack more connectivity into small, light devices without compromising functionality.

Sensors are helping drive results in a new era of outcome-based medicine, thanks to their powerful microprocessors and eversmaller form factors. With complex medical conditions and surgeries, earlier interventions typically drive the most successful results.

Manufacturers need to work closely with healthcare providers to understand market needs and the regulatory landscape so that they can address critical health and safety requirements before products can be taken to market. However, in an era when healthcare talent, time, and financial resources are increasingly stretched, sensors have a powerful role to play in helping patients manage their own health and empowering providers to deliver better, more scalable care.

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TESTING

How to navigate testing for devices that use wireless technology The Federal Communications Commission (FCC) has different testing requirements for wireless medical devices than the FDA. Here are some tips for choosing a testing method for FCC compliance.

S Colin Halladay | Laird Connectivity |

(ABOVE) Controlled syringe pump in a modern clinic

Image from Laird Connectivity

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Medical Design & Outsourcing

ome hikes are simple, others aren’t as easy, and some are downright complicated. Testing medical products that use wireless technology can be very similar: You can take a simple, moderate or complicated path, contingent on the design of your product.

The path you choose for integrating wireless technology into your medical product will help determine your complexity. The key to succeeding is to first define which path you need to take, instead of walking up the wrong one and needing to walk back down to start over.

In this article, we will explore different paths, assuming the design has wireless technology in it. We will also focus on the Federal Communications Commission’s (FCC) certification standpoint, in lieu of the FDA’s because the FDA’s review and approval is another process. (While overlaps exist, my purview is within the FCC certification process.)

5 • 2020

Also, keep in mind that there are variations from country to country, and although FCC test results are widely accepted in other countries, always communicate to your test lab the countries in which your product will be distributed. Your test lab will help you ensure your product goes through all the correct testing and document review for those respective geographies.

Selecting the right testing partner It’s important to understand what to look for in a wireless medical device testing partner. Some of the fundamentals of this stage involve considerations such as your potential partner lab’s abilities to test for the geographies where you want to import your product. A potentially lifesaving device cannot proceed from a concept to a product unless it can pass regulatory tests to get to market.

Another consideration is whether the potential lab partner has the right capabilities and proficiencies to test your product.

www.medicaldesignandoutsourcing.com

© 20

M

The three paths The “easiest” path is using a modular certification. One example of this could be a Bluetooth Low-Energy (BLE) module integrated into a pulse oximeter.

In this example, wireless certification is handled at the module level, and the end product (the oximeter) will only need simple emissions testing as well as some basic host-specific module integration transmitter testing. Under this path, no filing with the FCC is required, and a test report can be kept on hand for reference, if requested.

The “moderately difficult” path involves implementing a certified module, but with an antenna different than what accompanies the module’s grant of authorization. Let’s assume the pulse oximeter has an off-board PCB trace antenna that wasn’t certified with the module originally. First, the medical device manufacturer will require a “Change of ID” from the module manufacturer. This will transfer the

test data and information about the module’s certification from the module manufacturer to the manufacturer of the medical device. Second, the medical device manufacturer needs to perform some additional testing using the new antenna. Third, the new grant owner will take the new antenna test data and file it using the “Class II Permissive Change” process, adding the new antenna to the medical device manufacturer’s new grant.

The “hardest” path is certifying a chip-down design. This could be a pulse oximeter with a complete onboard Bluetooth low-energy design.

Chip-down design testing is the most complex because all testing has to be completed on the product design, and then certified from scratch. Whereas the easy and moderate paths involve using pre-certified modules, only requiring simple updates and integration testing of the host, a chip-down design requires full radio testing and filing with the FCC. The customer will be required to have all

of the specific test modes, perform all of the certification testing, and manage their own certification filing documentation.

Medical devices are heavily scrutinized by several regulatory agencies, and for good reason: They must perform their intended task without interfering with other devices, as well as prevent doing any harm to human lives. Ensuring you’re following the right product certification path can be a challenge. But understanding how the standards apply — and how your design is affected by them — can make compliance a much smoother journey.

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TUBING TALKS

Steve Anderson glassblowing at the bench with the Carlisle CC bench burner and hand torch.

Lathe in the background.

Image from Steve Anderson/ Mayo Clinic

How glass tubing supports Mayo Clinic innovation At the Mayo Clinic Glass Shop, scientific glassblowing creates glass tubing and apparatuses for cardiac, transplantation and tissue perfusion research — and more recently, to help fight the COVID-19 pandemic.

Danielle Kirsh | Senior Editor |

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Medical Design & Outsourcing

S

teve Anderson is one of only two scientific glassblowers in Minnesota.

As a senior scientific glassblower at Mayo Clinic, he has developed glass aneurysm models, aortic stent placement training aids and liver perfusion systems.

Recently, he received a request to make nebulizers to test the fit of N95 face masks in the fight against coronavirus. It was an apparatus he’s never made before.

“They can purchase the nebulizers made of plastic, but the people doing the testing prefer the glass models,” Anderson told Medical Design and Outsourcing. “They only have a few of the glass models, which are probably quite old, so they asked me to make up 20 more for them.”

Scientific glassblowing is a form of glasswork that is used in organic chemistry, medical devices, pharmaceutical applications and research. Some of the earliest examples of scientific glassblowing include Galileo’s thermometer and Thomas Edison’s light 5 • 2020

bulb, according to the American Scientific Glassblowers Society. Today, scientific glassblowing offers highly specialized glass apparatuses for a number of applications, from training to nebulizers.

The Mayo Clinic Glass Shop goes back to the early 1900s and specializes in scientific glassblowing. It works in collaboration with clinical and research groups within the Division of Engineering at the Rochester, Minn.–based health provider. The shop has manufactured a number of glassblown apparatuses and models for research and training aids for physicians to practice endovascular skills and more.

The unique properties of glass offer benefits that medical researchers sometimes prefer over other materials like plastics.

“Glass is a real inert material, and it’s resistant to most acids,” Anderson said. “It has a low coefficient of expansion, so you can autoclave it. You can adjust the temperature of an experiment rather quickly, and it won’t

www.medicaldesignandoutsourcing.com

TUBING TALKS

break. When you’re all done, you can wash it up and reuse it again, sterilize it with the autoclave and put it back into service.”

For his new nebulizer project, Anderson is reverse-engineering one of the plastic nebulizers Mayo Clinic has. He starts with a 4- to 5-ft length of glass tubing and a 4 mm diameter tube to make the spray nozzle. The main body of the nebulizer is made from a 10 in. piece of 18 mm tubing with a 32 mm bulb that has a 5 ml reservoir on one end. Then, 4 mm OD tubing is used to fabricate a small injector that has a venturi-type effect to create a scented mist.

“I seal the venturi tube into the bottom of the 5 ml reservoir. So, when they give it a burst of air, it siphons up a small amount of water with some kind of scent in it. This creates a little mist that blows into a small hood area where the person is wearing a mask. If they can smell the scent, the mask’s seal is no good,” Anderson said.

For medical devices, glassblowing offers high mechanical strength against

They make glass with many different properties, so you can actually seal glass to different metals and alloys for glass-tometal sealing, which is good for working in vacuum systems. pressure and impact. Most of the scientific glassblowing Anderson does consists of borosilicate glass, which is more commonly known by the trade name Pyrex.

Glass for scientific glassblowing has working characteristics that are much stiffer than artistic glassblowing, according to Anderson. The soft glass in artistic glassblowing has a higher coefficient of expansion than the borosilicate used, so it stays soft and pliable longer.

“They make glass with many different properties, so you can actually seal glass to different metals and alloys for glass-tometal sealing, which is good for working

We are proud to be an essential supplier for the medical industry during these unprecedented times.

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5 • 2020

www.medicaldesignandoutsourcing.com

in vacuum systems,” he said.

Glass tubing is made using tools such as bench burners, hand torches and lathes. To make the tubing, Anderson puts a piece of glass on a lathe with a stopper connected to a swivel with a latex blowhose that allows the glassblower to blow through.

Anderson heats up the glass as he turns it in the lathe. He can then bring in the tail stack of the tube as the glass melts or softens — thickening it or pulling it out thin. He can also shape tubes into different fixtures or fittings with joints on one side and a piece on the other.

“For high precision or larger pieces, I use a lathe. Smaller pieces I’ll make by hand, sitting at a bench with my torch,” Anderson said.

Anderson has also developed perfusion tissue baths with ECG capabilities at the Mayo Clinic Glass Shop. The perfusion tissue bath was created for cardiac researchers who requested a new design because the perfusion tissue baths they were using could not simultaneously record multiple cardiac parameters without damaging the myocardium. The glass version allows for simultaneous automatic recording of the electrocardiographic, biochemical, hemodynamic and electrophysiological changes from a perfused heart in temperature- and oxygenation-controlled environments.

Anderson and engineers within Mayo Clinic’s Division of Engineering have also made a liver perfusion system for transplantation research. The glass design increased the average viability of the liver

Residents and fellows can learn and practice advanced endovascular skills with a stent deployed in a glass aortic training aid. Image from Steve Anderson/Mayo Clinic

cells and the average yield of cells per gram of liver tissue. Human cells that have been isolated in the perfusion system have been used to study liver cell engraftment, virus traits and the disease mechanism of the liver.

They have also been use in vaccine testing and for work in creating an artificial liver.

Mayo Clinic fellows and residents can practice intricate procedures on glassblown models without being exposed to radiation

or injuring a patient. In a recent project, Anderson and his colleagues made a training aid for aortic stent placement. The model is a glass replica of the aorta with major arterial branches that can replicate aneurysmal disease of the aorta.

Scientific glassblowing has been a labor of love for Anderson. “Most people that do it, they love it, and they’re hooked on it.”

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Medical Design & Outsourcing

31

TOM SALEMI DEVICETALKS EDITORIAL DIRECTOR

COVID-19 IS HERE : Medtech may never be the same The COVID-19 pandemic could accelerate hospital transformation, endanger medical device startups — and much more. Here’s what industry insiders think.

T

he COVID-19 pandemic promises to change nearly every aspect of our lives — remote working, social distancing and Zoom-bombing likely will be part of our professional lexicon for years to come.

But the pandemic also will bring big changes to the medtech industry, which got caught in the center of some political, geopolitical and yes — medical — controversies.

While we still haven’t emerged from the other side, it’s not too early to begin assessing what those changes might look like. Medical Design & Outsourcing surveyed medtech professionals about how their industry performed during the 32

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5 • 2020

recent emergency and gauged how it might change to meet future challenges.

Sixty percent of the 57 respondents — many of them medtech executives, engineers and salespeople — described their sector’s performance as “excellent” or “good,” but nearly 75% said medtech companies will need to operate differently at this time next year.

“We’re going to learn a lot from the coronavirus experience,” said Chris Hartlage, director of global business development and customer service for assembly technologies at Emerson in Danbury, Conn. “And we’re going to carry those lessons into traditional medical device and PPE manufacturing as we www.medicaldesignandoutsourcing.com

move beyond the coronavirus world.”

What will those lessons look like?

Medtech executives suggested the spots where the industry might have to change.

1. Hospitals need to transform faster Hospitals were already evolving before COVID-19. In fact, many of the practices they’ve recently employed helped them manage a deluge of critically ill patients.

But some challenges were unexpected. During the surge, the Mayo Clinic in Rochester, Minn., and Beth Israel Lahey Health in Boston overcame supply shortages by using inhouse 3D-printers to produce personal protective equipment (PPE) as well as

swabs to collect samples for COVID-19 diagnostic tests.

With the surge clearing in some areas of the country, hospitals are working toward normalcy.

“Now, instead of preparing for the surge, we’re trying to figure out how to bring elective procedures back” by making the facility as safe as possible for patients and staff, said Mark Wehde, chair of the Mayo Clinic’s division of engineering. They’ll need to find new ways to cycle air supply in hospital rooms more quickly for patient turnover, source necessary PPE, and spread out patient appointments to keep people out of waiting rooms and avoid overcrowding.

In addition, hospitals may decide to commit more of their capital expenditures to equipment that make them more resilient in the future rather than build larger facilities.

2. Medical device startups are an endangered species Entrepreneurs and investors face a great deal of change in a post-COVID world.

Ironically, the healthcare sector needs new tools and technology now more than ever, but the economic impact of the pandemic will affect customers, close clinical trial sites and disrupt already unsteady paths. This may make investors less likely to commit to new ventures. www.medicaldesignandoutsourcing.com

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Medical Design & Outsourcing

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COVID-19

"We can see a recovery into Q3 and into Q4, especially for these more elective procedures.

There are some that, yeah, you can push out, but they are important. They are lifesaving.

They are solving some significant problems, whether it's a stent, a pacemaker, repairing a mitral valve. ... I don't believe that they're going to come back at the same speed that they came down, but like I said, these are important procedures and I do see them coming back. ... Clearly, it's quite possible that other industries might take longer to recover, but I think for healthcare, the data — our modeling here suggest the kind of recovery that I've just described."

(Murrieta, Calif.). He watched startups wither after the attacks of Sept. 11, 2001, and the Great Recession of 2008.

“I’m curious to see if this might be the final nail on the coffin of the traditional startup,” Murray said. “I don’t think the model really serves us anymore.”

Murray said incubators and accelerators help, but he sees the virtual model adding more value.

— Robert B. Ford, CEO of Abbott Terry Murray has been involved with startups for over two decades, either as part of the company or working with them as he does today as VP of strategic development at Rev1 Engineering

3. Is it time to reshore some medical device production?

Over the past two decades, medical device makers have sought the same efficiencies and lower costs as those in other industries by moving manufacturing to China and Mexico and to countries with emerging economies. But the nationalism evoked by COVID-19 in the U.S. and other countries revealed vulnerabilities in the supply lines that delivered devices and protective equipment to U.S. hospitals.

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5 • 2020

EXPERIENCE. PRECISION.

COVID-19

"After SARS in the early 2000s, we made the decision to prepare for future crises by investing in significant surge capacity at each of our respirator plants around the world. ... As you know, compared to prior emergencies, COVID-19 has caused an unprecedented explosion in demand. When the virus broke out, we were able to immediately activate our surge capacity and maximize production to support the public health response. ... In the U.S., we will be producing N95 respirators at a rate of roughly 50 million per month in June, a 40% increase from current levels."

– Mike Roman, CEO of 3M

Even as car manufacturers and smaller device makers stepped up to fill the ventilator gap, the task of securing parts through traditional channels was more difficult as the pandemic hit suppliers in other parts of the world. Some suppliers were pressured by their own governments to stem the supply of parts headed out of the country.

This exposed a vulnerability that medtech companies must correct, according to industry professionals.

Medtech companies will likely be looking to bring at least some of their operations back to the U.S. “I don’t believe it’s going to be that drastic,” said Michael Heyl, a partner at the international law firm Hogan Lovells.

“But I do believe companies will be diversifying their supply chains so there aren’t sole-source suppliers or regions for things that they need.”

4. Cooperation between government and industry is improving The COVID-19 crisis created an environment for greater cooperation between industry and government.

The FDA, for example, had issued 84 emergency use authorizations as of April 23, giving temporary greenlights to diagnostic and serological tests, ventilators and other potential weapons against the deadly virus.

Meanwhile, state governments and the Centers for Medicare and Medicaid Services tore down barriers that once blocked widespread use of telehealth and other remote monitoring. This has opened the door for physicians to see patients virtually.

The relationship has had some rough patches. President Trump, after invoking the Defense Powers Act, sharply criticized 3M after the company sold some supplies to customers outside the U.S. 3M CEO

Mike Roman fired back, but they quickly came to an amicable arrangement.

Mark Leahey, CEO of the Medical Device Manufacturers Association, said the medtech industry benefited from the relationships it built to repeal the medical device excise tax connected to the Affordable Care Act of 2010. Leahy hopes regulators and payers will agree to keep the door open to more telehealth and remote monitoring, and also strengthen rural healthcare.

5. The diagnostics space needs attention Investors and innovators clearly need to pour more resources into diagnostic technology, as these tests will be the key to reopening the economy and society in many countries. Medtech leaders like Abbott have moved in quickly to develop a first line of diagnostics, but more attention is needed from entrepreneurs and venture investors, executives said.

Keith Figioli, general partner at LRV Health, said his firm — which invests more heavily in startups streamlining patient care and administration — will commit more of its capital to startups developing diagnostics.

“We’ve been doing it all along,” Figlioli said. “But we think there are going to be a lot more people looking at this.”

6. Digital manufacturing’s time is now The quicker path to a safe supply line could come through digital manufacturing companies that 3D-print devices in plants closer to customers.

“In some ways we were built to do this,” said Brian Peters, chief marketing officer of Protolabs, a publicly traded digital manufacturing company. “It’s all about speed and rapid production.”

"I can summarize it this way: Q2 is going to be a really tough quarter. It's come down hard, and we're living that right now. Even the numbers that we're providing for Q2 are probably moderately better than it is right now. I might add that our structural heart businesses feel it even more acutely than our critical care business. ... We also know that the diseases we treat are very serious and that we expect those diseases are not easy to postpone, and we know that many of the patients that might have been treated in Q1, Q2 and so forth might indeed be treated in Q4. And so the combination of those factors encourage us to say that we're likely — and again, there is a broad range of possibilities — but we're likely to be in a more typical volume situation in Q4."

– Michael A. Mussallem, CEO of Edwards Lifesciences 36

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www.medicaldesignandoutsourcing.com

COVID-19

7. There’s a need to adopt virtual prototyping The COVID-19 pandemic brought a new focus on medtech innovation, particularly in areas like respiratory therapy, where innovation had been limited.

The shutdown also demonstrated that medtech innovation that relies heavily on an in-person “build-test-fail” approach leaves companies vulnerable if employees can’t make it to work.

Mark Burchnall of Stress Engineering Services in Cincinnati said the remote work required by many companies only strengthened the case for computational modeling that uses virtual prototypes rather than actual ones.

“You’re not going to eliminate the need for prototyping,” Burchnall said.

“But you can learn a lot in a virtual model, and you can do a lot of iterations virtually as long as the model is credible.

This is a really huge area in the medical device industry that has been exposed.”

"While the expected short-term impact to our financial results is significant, it is consistent with the impact discussion broadly across the medical device industry. Importantly, we are starting to enter the early stages of a global recovery. As hospitals begin to resume broader treatment of non-COVID-19 patients around the world, we expect our business to begin to recover as well. In addition, given the financial strength of the company, we are executing strategies to come out of this pandemic even stronger, attracting and retaining top talent and increasing and innovating the products and services that we offer physicians, patients and healthcare systems to win in the evolving marketplace."

– Geoff Martha, CEO of Medtronic

www.medbioinc.com www.medicaldesignandoutsourcing.com

5 • 2020

Medical Design & Outsourcing

37

COVID-19

8. Get ready to ride the information wave Collecting patient information will be even more paramount in a post-pandemic world. Medical device makers need to be ready to ride the information wave as they develop new tech.

“I tell people, if you’re building a new medical device, you have to think about how you’re going to connect it even if you don’t know what you’re going to do with the data yet,” said Bill Betten, president of Betten Systems Solutions.

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9. Remote possibilities will grow Technology to keep more healthcare in the home will be in demand as providers work harder to keep long hospital stays to a minimum. But remote technology also has made life easier for medtech companies that have been holding status meetings with the FDA via teleconference. Tracy Eberly, CEO of Fang Consulting (Roseville, Minn.), said change doesn’t come quickly at the FDA, but adoption of virtual meetings would be welcomed by industry.

“There are a lot of people who are saying, `Finally, and can we not go back to making us fly to Washington to present for an hour?’” he said on the DeviceTalks Weekly podcast.

10. Reps on iPads?

The pressure to reduce the risk of exposure to infection could leave medtech sales teams making remote calls to ORs rather than scrubbing up for surgeries.

Skender Daerti, CEO of The Clinician Exchange, a Parsippany, N.J.-based company that connects medical device companies to physicians, said kinks in the supply chain have opened up opportunities for smaller companies to sell their surgical systems. In some cases, the company wasn’t able to send a member of the sales support team to walk surgeons through their implants, so they had the conversation over a tablet.

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MEDICAL DEVICES are ready to launch in 2020 Despite the COVID-19 pandemic, medical device companies are still working to gain regulatory approvals and launch new devices this year.

T

he pandemic has largely fixed the FDA’s focus on emergency use authorizations (EUAs), leaving more typical device approvals waiting. At press time, the regulatory agency had granted 84 EUAs since Feb. 4 and had approved only 10 non-coronavirus-related devices this year — the last one on March 18. In comparison, the FDA approved 16 devices by May 2019 and 46 during all of last year.

The slowdown in premarket approvals could even stretch into next year, according to Debbie Wang, a senior analyst at Morningstar.

"Considering how busy the FDA will be with COVID-19 diagnostic testing oversight (not to mention trials for COVID-19 treatments and vaccines), we wouldn’t be surprised to see the pace of new device approvals slow through 2020 and into 2021," Wang told Medical Design & Outsourcing.

Some medtech companies have devices in the research and development pipeline for this 40

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fiscal year, but a few companies have publicly announced temporary holds on trials and studies of devices: Edwards Lifesciences paused enrollments in its active pivotal clinical trials of transcatheter mitral and tricuspid therapies on March 28; three weeks later, Medtronic put a temporary hold on clinical trial enrollment.

"Timelines are likely going to get stretched due to most trials being put on hold for a period of time, as well as delays in review," Raj Denhoy, a Jefferies analyst, told MDO. COVID-19 has also caused companies to reevaluate their financial guidance for the fiscal year: •

Medtronic reported in April that its weekly revenue in the U.S. was down 60% because of the pandemic. The Fridley, Minn.-based company said products from its cardiac and vascular group, minimally invasive therapies group and diabetes group are in high demand, but that it expects COVID-19 to negatively affect its fourth-quarter performance.

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Boston Scientific said that business trends through the first two months of the year were in line with financial expectations, and found first-quarter revenue growth on a GAAP basis to be up just 2% compared to 2019. “We are continually assessing shifting market dynamics related to the pandemic and will disclose any updates to our timelines in accordance with SEC regulations,” Boston Scientific spokeswoman Kate Haranis said.

•

Edwards Lifesciences lowered its outlook, saying it couldn’t accurately predict the progression of COVID-19 or the disruption to hospital procedures that would use Edwards devices. The company said second-quarter sales will be severely affected, followed by a gradual recovery in the third quarter and a Q4 that better matches its original sales expectations. Edwards now expects 2020 sales in the range of $4 billion to $4.5 billion, down from the previous range of $4.6 billion to $5 billion.

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"As for COVID-19, we suspect the device makers will be loath to reduce their R&D resources," Wang said. "Even if they reduce R&D spending in the near term, we would expect they'll try to hang onto as many engineers as possible. During the Great Recession, the device makers managed to preserve their R&D capabilities."

Despite the challenges gaining timely approval, the medical device pipeline is full of devices ranging in applications from renal denervation to single-use scopes. Here are seven devices whose manufacturers expect to gain approval during this fiscal year.

1. Medtronic: Symplicity Spyral renal denervation system Medtronic re-introduced its Symplicity Spyral renal denervation system in March 2020, six years after a clinical trial produced disappointing results.

First announced in 2010, the Symplicity device is designed to treat high blood pressure through ablation of the renal arteries. After its HTN3 trial failed to meet its efficacy endpoint, Fridley, Minn.-based Medtronic suspended enrollment in other Symplicity trials and took a $200 million write-down on its renal denervation assets.

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DEVICES READY TO LAUNCH

Medtronic’s Symplicity Spyral renal denervation system Image from Medtronic

Renal denervation, however, is making a comeback. Medtronic said in February this year that it started enrollment in a pilot study of the Symplicity system in a targeted procedural approach with fewer radiofrequency ablations.

Results from a pivotal trial of the Symplicity Spyral were presented as a late-breaking clinical trial at American College of Cardiology Scientific Session on March 29. Renal denervation using the system was shown to be safe, effective and superior to sham in reducing blood pressure at three months in patients without anti-hypertensive medications.

"It's hard to speculate on when we might see a U.S. approval because that's dependent on discussions and determinations by the FDA," Medtronic spokeswoman Riley Schweiger told MDO. "Our conversations have gone well, and they have reacted positively to our approach to collecting a comprehensive set of evidence."

2. Medtronic: Percept deep brain stimulation system Medtronic is planning to launch its Percept deep brain stimulation (DBS) system this year. The device secured CE Mark approval in January.

Percept’s BrainSense technology senses and records brain signals while delivering DBS therapy to people with neurological disorders, according to Medtronic. The neurostimulator is designed to treat symptoms associated with Parkinson’s disease, essential tremor, primary dystonia, epilepsy and obsessivecompulsive disorder.

Medtronic launched the Percept PC neurostimulator in Western Europe on Jan. 15. The company anticipates U.S. approval during the summer.

Medtronic’s Percept deep brain stimulation system Image from Medtronic

ability to accommodate tapered vessels It has fully launched in Europe, and the company expects it to receive FDA approval this year.

4. Boston Scientific: Watchman FLX LAAC Boston Scientific designed its Watchman FLX left atrial appendage closure device to occlude the left atrial appendage of the heart, reducing the risk of bloodclotting and stroke in high-risk patients.

Health providers can easily implant the Watchman FLX and recapture and re-position it during the implantation procedure, according to the company. It comes in 20 mm, 24 mm, 27 mm, 31 mm, 35 mm sizes and can treat ostia from 14 mm to 31.5 mm. The closure device is preloaded into the delivery catheter to reduce preparation time.

The Watchman FLX has a nitinol frame with polyethylene terephthalate (PET) and a distal fluoroscopic marker.

It has fully launched in Europe.

Boston Sci said it expects to receive FDA approval in 2020.

5. Boston Scientific: Exalt Model D single-use scope Boston Scientific is expecting to fully launch its disposable duodenoscope in the first half of this year.

The company designed the Exalt Model D single-use duodenoscope for use in endoscopic retrograde cholangiopancreatography procedures. It received FDA clearance in late 2019 and CE Mark approval in January.

Duodenoscopes have traditionally been intended for use on multiple patients with cleaning and disinfection between each use. But the devices are complex. The small moving parts can trap contaminated tissue or fluids. Studies have shown they can transmit infectioncausing bacteria between patients, and the devices have been associated with deadly superbug outbreaks.

3. Boston Scientific: Synergy Megatron Boston Scientific is expected to launch its Synergy Megatron bioabsorbable polymer coronary stent system in fiscal year 2020.

Synergy Megatron is designed for large proximal vessels, including left main, bifurcations and ostial lesions. It is available in 3.5 mm to 5.0 mm diameters.

It boasts increased strength and the www.medicaldesignandoutsourcing.com

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DEVICES READY TO LAUNCH

6. J&J: Robotic surgery systems Johnson & Johnson plans a regulatory submission for a robotic knee surgery system by the second half of the year.

The orthopedic robotic system is part of Johnson & Johnson's Velys digital surgery platform — and is meant to be J&J's answer to Stryker's popular Mako robotassisted surgery systems.

The platform consists of connected technologies that will use data insights for patients, surgeons and health systems to enhance the orthopedic experience at all points of surgical procedures, according to J&J. The medtech giant, in general, has been making big moves in the robot-assisted surgery space. J&J ended 2019 by announcing its purchase of the remaining stake in Verb Surgical, following what J&J described as a successful strategic collaboration with the Alphabet life sciences unit Verily.

J&J’s Ethicon subsidiary in early 2019 inked a $3.4 billion deal to pick up surgical robotics pioneer Dr. Fred

Johnson & Johnson’s existing Monarch surgery platform Image from Johnson & Johnson

"As for COVID-19, we suspect the device makers will be loath to reduce their R&D resources. Even if they reduce R&D spending in the near term, we would expect they'll try to hang onto as many engineers as possible."

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www.medicaldesignandoutsourcing.com

Moll’s newest robotic surgical play, Auris Health, and its FDA-cleared Monarch platform.

The Monarch system now provides bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures in the lung. J&J plans to seek clearance in endourology for kidney stone treatment and expand with a GI endoscopy indication in the future.

The company previously planned a robotic surgery reveal on May 13, but it postponed the event due to the coronavirus pandemic.

7. Edwards Lifesciences: Konect Resilia To dovetail with its TAVR technologies, Edwards Lifesciences is planning to gain regulatory approval of its Konect Resilia conduit in 2020.

Konect Resilia is a pre-assembled aortic-valved conduit for use during the Bentall procedure. The device consists of a Carpentier-Edwards Perimount Magna Ease aortic valve stent, Resilia tissue leaflets and a new DualFit sewing ring that is pre-assembled to a Terumo GelWeave Valsalva graft.

In a study published in the Journal of Cardiovascular Surgery in 2019, the aortic-valved conduit’s handling and implantability were shown to be uniformly satisfactory in human cadaver hearts. The valve was easily extracted surgically and left the conduit and coronary ostia intact, the authors said.

Edwards Lifesciences’s Konect Resilia, expected to gain regulatory approval in 2020 Image from Edwards

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How are

alternative ventilators

helping during the COVID-19 pandemic?

Amid the shortages of vital equipment during the pandemic, ventilators stand out — their presence a matter of life or death for people needing respiratory assistance.

S EA N W H O O LEY A S S ISTA NT ED ITO R

C

ommon invasive ventilators are in short supply. While numerous companies have stepped forward to scale up production of the expensive products (usually between $25,000 and $50,000), the need for equipment continues to grow.

“If a patient goes to a hospital, and all of the ventilators are taken up, the only other option the patient has is to have a nurse or, God forbid, a loved one, actually ventilate that patient by hand,” University of Minnesota Earl Bakken Medical Center lab supervisor Aaron Tucker recently told the DeviceTalks Weekly Podcast.

Tucker, in collaboration with the University of Minnesota’s Dr. Stephen

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Richardson and an interdisciplinary university team, developed the Coventor as an alternative to the common intensive care unit ventilator. The device, touted as a design costing just $150, became the first of its kind to garner FDA emergency use authorization (EUA).

Boston Scientific is acting as the sole manufacturer of the device, which the company expects to sell at-cost at approximately $1,000 per unit.

A one-armed robot The Minnesota researchers created what they call a “one-armed robot” to replace the person who would have to ventilate by hand, freeing up nurses and preventing loved ones from having to perform the task themselves.

www.medicaldesignandoutsourcing.com

This Ambu-bagbased ventilator from Georgia Tech, Cranfield University (U.K.) and Emory University is designed to help with the ventilator shortage during the COVID-19 pandemic.

Image courtesy of Stephen Norris, Georgia Tech

www.medicaldesignandoutsourcing.com

5 • 2020

Medical Design & Outsourcing  47

ALTERNATIVE VENTILATORS

A University of Minnesota team developed the Coventor ventilator, the first device of its kind to win FDA emergency use authorization.

The device features a bag valve mask (commonly known as an Ambu-bag) and does not require pressurized oxygen or air supply, unlike commercially available ventilators.

The Coventor’s mechanical actuator was designed to stabilize and compress a commercially available ambulatory ventilation bag filled with oxygen or ambient air if oxygen is unavailable.

That bag is connected to the patient’s endotracheal tube. It is possible to produce the device’s frame using metal stamping, 3D printing or by modifying consumer goods, according to the Coventor website.

“We are not trying to replace the highend ventilators,” Tucker said. “We’re in such a unique time right now that we didn’t think they could build those high-end ventilators fast enough… We wanted to give another option in the case of dire need.”

More ingenuity Tucker and the Minnesota team aren’t the only researchers putting together these kinds of machines. Georgia Tech Woodruff School of Mechanical Engineering associate professor Shannon Yee and a global group contributed to designing a device at Cranfield University in the United Kingdom before building and testing it at Georgia Tech, in collaboration with Emory University.

The collaboration’s mechanical-assist product includes two Ambu-bags to offer the capability to ventilate two patients at once with individual controls for each patient’s volume. The device doesn’t rely on a microprocessor or sensors and instead uses a mechanical design with an eye on scaling more rapidly.

Yee told Medical Design & Outsourcing that he estimates that the bill of materials for just the parts comes in at less than $100, with the most expensive component being the motor and gearbox system at $63 when bought off the shelf.

Including labor, Yee said they’re looking at a couple hundred dollars as the cost to make each machine. In the pilot assembly line, the team assembled seven devices in two hours, giving Yee confidence in the ability to scale production.

“I wouldn’t classify it as home-built,” Yee said. “What we specifically targeted in our design was recognizing that we’re going to be facing a logistics- and supplychain problem. We wanted our design to 48

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Image courtesy of University of Minnesota

be simple enough so that conventional manufacturing techniques … could be employed in order to mass-produce these makeshift ventilators.”

Like the Minnesota researchers’ device, this design is targeting the option to ventilate patients without replacing the common ICU machines. Clinicians offered positive feedback on the device and the next steps include pursuing FDA EUA after licensing the product to a manufacturer.

How will we know if they’re helping or hurting?

Device Events founder & CEO Madris Tomes, who previously worked in the FDA’s post-market surveillance division, raised concerns over the agency’s relaxed guidance on reporting problems with devices so manufacturers can focus on getting supplies out.

Tomes pointed out that that problems could arise with certain data www.medicaldesignandoutsourcing.com

not being reported to the FDA, and that word-of-mouth may not be enough to prevent the use of potentially problematic devices.

“With the relaxed rules, we’re not going to get that data,” Tomes told MDO. “It’s not a place where the FDA should be relaxing.”

However, if products like the Coventor prove safe and effective enough for FDA authorization, and more efforts like the product Yee’s team developed reach the market as well, the potential to plug a massive hole in the shortage of ventilators excites the former FDA employee.

“It’s amazing that they’re coming up with different ways to help these patients,” Tomes said. “To have a second option, even if it’s not as sophisticated … It’s fantastic that people all around the world are trying to help solve this problem.”

Old ventilators will get new life from a nationwide network of engineers and technicians.

David Lindsay, a senior biomedical equipment technician and field service manager, works on an old ventilator in Jackson, Tenn.

COULD REFURBISHED VENTILATORS n BE A o p a e w t e r c e s AGAINST COVID-19?

Image courtesy of Co-Vents

N A N C Y C R OTTI M A N A G I N G ED ITO R

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A

pair of medtech industry veterans formed a not-for-profit corporation in April to obtain and repair used ventilators for patients fighting COVID-19.

Co-Vents has six FDA-approved and ISO-certified ventilator service centers lined up to do the work in New Jersey, Tennessee, California, Illinois and Georgia, according to co-founder Michael Raymer. The organization is seeking decommissioned Puritan Bennett, Philips/Respironics and CareFusion critical care ventilators to refurbish, Raymer told Medical Design & Outsourcing in an interview.

5 • 2020

Co-Vents will buy or accept donations of old ventilators from hospitals, rental firms and brokers, Raymer said. If a ventilator is beyond repair, the shops will salvage the most expensive working parts and use them to repair other machines.

With the help of the White House Coronavirus Task Force, Co-Vents has obtained a $300,000 grant from a private foundation to start purchasing the machines so it can offer them at a fixed price to the national or state stockpiles once they’re repaired, according to Raymer. Proceeds from ventilator sales will go back into repairing and shipping others.

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REFURBISHED VENTILATORS

Co-Vent will also pay for ventilator parts, labor and shipping, and aims for a turnaround time of just over a week. In the next two months, the organization aims to deliver 500 to 1,500 repaired or refurbished ventilators.

“Our goal is not to distribute directly to hospitals because we don’t want to encourage hoarding,” Raymer said.

The Co-Vents team knows its way around ventilators. Now a business consultant and chief strategy officer for investment and networking platform AngelMD, Raymer was general manager of clinical information systems for ventilator manufacturer Puritan Bennett from 1988 to 1998. He formed Co-Vents with his former boss at Puritan Bennett, Paul L. Woodring. Woodring spent 19 years at that company, serving as chief engineer, VP of engineering, VP and general manager.

Woodring also worked for six years as

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president of Respironics’ hospital division.

William “Chip” Furniss has signed on as engineering manager for Co-Vents.

A principal partner for product incubator and design consultancy Spectrum Biomedics, Furniss helped develop the first microprocessor ventilator at Puritan Bennett and went on to become a business unit manager there. Furniss later served as senior director of clinical research at Respironics and VP of surgical equipment R&D at Bausch + Lomb.

(Co-Vents is not alone in its mission to repair and redeploy old ventilators.

According to a report by The Associated Press, fuel cell manufacturer Bloom Energy is doing the same, at the request of California Gov. Gavin Newsom.)

Raymer said he and Woodring came up with the idea for Co-Vents in late March when news started coming out about ventilator shortages

www.medicaldesignandoutsourcing.com

and automakers like General Motors and Ford gearing up to manufacture the lifesaving machines. They called the U.S. Department of Health and Human Services for help and found an Indianapolis firm that helped them incorporate the organization in 24 hours and file an expedited form for 501(c)3 tax-exempt status with the Internal Revenue Service. Co-Vents gained that status and accepted its first tranche of “retired” ventilators in mid-April.

“We really did it because Paul and I had seen what was going on in New York and we called each other and said, ‘There are ways to get ventilators to patients instead of sharing ventilators or trying to convert a C-PAP device to a ventilator,’” Raymer said.

“We think it’s a pretty remarkable story.”

Raymer wrote in an AngelMD blog post that starting with existing ventilators, whose designs that have already been approved by the FDA, is a lot more likely to ease a shortage than setting up new ventilator assembly lines in converted auto factories. One problem: Some ventilator designs have assembly steps that require clean rooms, perhaps timeconsuming to set up in settings such as converted auto assembly lines.

“The Puritan Bennett 7200, for example, had two proportional valves that were fast-acting,” explained Co-Vents executive Dave Crawford. “One supplied oxygen from a high-pressure source, another supplied air. Those valves were assembled in a clean room because they had to be clean.”

A point also favoring refurbishment rather than making new machines is that the testing protocols for refurbished ventilators are relatively straightforward, Crawford added. “After the refurbished machine has passed its initial tests, you run it at temperature for a few days and test it again. If it passes, it is good to go,” he said. “The FDA approves the process, but they don’t monitor every machine.”

Co-Vents CEO Woodring said he and his former colleagues could not stand by and watch patients suffer without access to ICU ventilators.

“Over the past three decades, we have designed, built, manufactured and sold the leading ventilators in the world,” he said.

“We have assembled an all-star roster from those businesses to help fill this 90-day ventilator gap for our country while new ventilator production ramps up.”

TUESDAYS Working remotely is going to get a little less remote.

• •

Each week, the organizers of DeviceTalks conferences will bring a lively, informative and enjoyable opportunity to catch up with medtech colleagues, gain insights on our evolving sector, and make new essential connections to help you move forward.

• •

Working with medtech leaders, our DeviceTalks team will bring together medtech professionals for a 90-minutes to discuss pressing issues of the day in these five critical areas in our industry.

•

INNOVATION & FINANCE PROTOTYPE & PRODUCT DEVELOPMENT MANUFACTURING & SOURCING REGULATORY, REIMBURSEMENT & MARKET DEVELOPMENT NEW TOOLS AND TECHNOLOGY Each DeviceTalks Tuesday will kick off with a quick briefing from the Editors of MassDevice and Medical Design and Outsourcing. These presentations will give attendees insights on what trends will be moving medtech in the days to come.

Next, Tom Salemi, host of DeviceTalks Weekly, will interview medtech leaders and facilitate discussions or presentations tackling critical areas within medtech.

Attendees will leave with new contacts, fresh perspectives and a critical connection to our dynamic DeviceTalks community.

Join your medtech colleagues every Tuesday afternoon.

REGISTER NOW

ENGINEERING BETTER DEVICES. BUILDING BETTER COMPANIES. presented by:

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For more information, contact Mary Ann Cooke. 781.710.4659 | maryann@massdevice.com

Medtech make it work during a pandemic Employees working the ďŹ rst shift at Nelson Labs Europe in Leuven, Belgium, practice social distancing while having a quick break.

Image from Nelson Labs

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www.medicaldesignandoutsourcing.com

From coping with wild fluctuations in demand to keeping workers safe and customers satisfied, these medical device industry suppliers have found ways to adapt amid COVID-19 and an uncharted business environment.

M

edical device contract manufacturers are finding ways to keep business going during the coronavirus pandemic.

Medical Design & Outsourcing conducted an informal survey of manufacturers and other companies that serve the medtech industry.

Here’s some of what we learned.

NAN CY CROT T I M AN AGI N G EDI TOR

Changing priorities Companies that serve multiple industries have made medtech their priority. Quick-turn manufacturer Protolabs (Maple Plain, Minn.) said it’s seen an influx of COVID-19-related medical components needing urgent production, ranging from test kits to parts for ventilators.

Protolabs has been waiving expedite fees for COVID-19-related orders with more than 4 million components produced at no additional charge, according to company spokeswoman Sarah Ekenberg. “Most/all are using our injection molding services because that’s the only manufacturing service capable of producing tens of thousands of parts in days,” Ekenberg said.

Web Industries (Marlborough, Mass.) has a 6,500-square-foot facility in Holliston, Mass., built specifically for manufacturing lateral flow immunoassay (LFI) tests. During the pandemic, the company has dedicated production at that plant to LFI tests for COVID-19, as the tests are among the solutions researchers are considering to efficiently test large numbers of people.

Web Industries’ medical team has devised processes to help LFI device manufacturers expedite the transition from the research lab to large-volume, reel-to-reel production of millions of tests, according to the company.

“Our LFI manufacturing plant is ready to work on a priority basis to be part of the solution,” said VP of corporate development Kevin Young. “We can help LFI device developers to efficiently scale up production after they discover a viable LFI solution.”

Northfield, Ill.-based Medline Industries, a major manufacturer and distributor of medical supplies, reported that it switched manufacturing in its Hartland, Wis., plant to producing hand sanitizer for healthcare providers, shipping its first lot of alcoholbased hand sanitizer on April 13.

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CONTRACT MANUFACTURING

“Production was up and running just three weeks after the company made the decision to begin making the new product — at the point when the nationwide supply of hand sanitizer was beginning to rapidly diminish,” said Medline spokeswoman Stacy Rubenstein.

“Already, the facility is outpacing early production estimates. We’re currently producing 200,000 bottles per week and expect to quickly ramp that up to 400,000 bottles in the next few weeks.”

West Pharmaceuticals is supporting customers around the world who are developing diagnostics, treatments and vaccines for COVID-19. Its contract manufacturing sites in Scottsdale and Tempe, Ariz., are producing injectionmolded parts to support diagnostic testing, including a rapid test recently authorized by the FDA, according to spokeswoman Michele Pelkowski.

Its Jersey Shore, Pa., elastomer site is producing more than 13 million

Steele said. “For the time being, we are able to balance our workload effectively with our current staffing. Although a few customers have put their POs on hold, other customers who have medical devices used in this ongoing battle against COVID are experiencing spikes and have increased their orders.”

Protecting employees’ health Respondents told us they’re also working to keep employees healthy, including on-site social distancing, implementing work-from-home policies for all who can do so, taking employees’ temperatures when necessary, requiring sick employees to stay home, and cleaning — lots of cleaning.

Several said they had implemented the Centers for Disease Controlrecommended safe best practices and implemented new cleaning regimens.

“We are daily disinfecting multiple touchpoints throughout the offices,

temperature-monitoring and face coverings to ensure service continuity.”

Trelleborg spokeswoman Karin Larsson said the Swedish tubing and extrusion company has implemented contingency plans at its global operations to more efficiently and safely handle deliveries of materials and products.

“We are monitoring the situation very carefully with regard to our employees’ well-being and commitments to our customers, country by country, facility by facility,” Larsson said. “Health and safety measures have been implemented at our sites, and we are following the requests and recommendations made by local authorities, such as extraordinary measures to implement civil protection.”

MicroSpec’s Elizabeth Steele reported spending thousands of dollars on employee health and safety, rearranging workstations and adding acrylic barriers where it couldn’t; separating break areas; creating separate entrance doors; adding a time clock in a new area of the building; and enforcing employee compliance with CDC guidelines.

"Production was up and running just three weeks after the company made the decision to begin making the new product — at the point when the nationwide supply of hand sanitizer was beginning to rapidly diminish." components that are going directly to test, treat or prevent COVID-19.

MicroCare (New Britain, Conn.), which manufactures fluids and tools for industrial cleaning, coating and lubrication, reported its supply chain is in good shape as it has multiple sources — with most located in North America.

MicroCare said on its website that it’s been able to maintain production and delivery schedules and expects demand to rise. “Indeed, there is going to be an increased need for effective critical cleaning fluids in all the industries we serve,” the company said.

MicroSpec (Peterborough, N.H.) temporarily shut down its third shift when the pandemic hit the U.S. but has since resumed operating all three shifts to nearly full capacity, according to VP Elizabeth Steele.

“We have alerted our customers who have submitted prototype [purchase orders] to understand that their POs may be delayed during this emerging crisis,” 56

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restroom facilities, as well as common gathering areas, etc.,” said Jake Wakley, VP of quality and regulatory affairs at interventional device contract manufacturer Biomerics in Salt Lake City. “Where and when possible, facilities are handling all inbound materials and giving each item a thorough review. Each item will be cleaned and wiped down, if needed, to avoid any further spread of illness.”

Also in Salt Lake City, Nelson Labs president Jeffrey Nelson said that testing operations continue using a rotating shift schedule with divided teams to ensure service continuity and minimize the risk of infection. All non-laboratory staff are working at home, and the company cafeteria is closed.

“We are proud to be playing an important role in supporting our customers in this fight against the virus with ongoing validation of PPE and other critical hospital supplies,” Nelson added. “We are also instituting employee www.medicaldesignandoutsourcing.com

Staying in touch, looking ahead Several companies also reported on how they were keeping in contact with customers while keeping themselves and those customers safe.

“We have asked any customers who need components to support COVID-19 diagnosis and treatment to reach out to us for priority handling,” added Debbie Morrison, spokesperson for Ronkonkoma, N.Y.–based Qosina, which supplies thousands of OEM single-use components to the medical and pharmaceutical industries. “While our supply chain continues to remain strong, we recognize that products and services of this nature are of extreme importance and timing is a priority. Our goal is to ensure we understand our customers’ critical component priorities and that we are aligned to their needs.”

None of the respondents would speculate on how the pandemic would affect sales.

Most said it’s too early to tell, but Spectrum Plastics Group CTO

CONTRACT MANUFACTURING

Gaurav Kapoor said that the Alpharetta, Ga.-based company is keeping customers up to date on orders and supplies and asking how it can help.

“Given the nature of this global pandemic, SPG is also reaching out to our industry partners to determine how we can bring our technical and operational capabilities to assist in managing this crisis,” Kapoor added. “These are challenging times and our key message is that we are all in this together and that SPG is committed to the success of our partners and communities.”

Other companies offered words of support to customers and employees.

Integer Holdings, the world’s largest medical device contract manufacturer (Plano, Texas), noted that patients and healthcare providers are relying on the medtech industry now more than ever.

“We work in a critical infrastructure industry – vital work that helps sustain and save human lives,” the company said through spokeswoman Kelsie Aziz. “We are proud of how our team has stepped up to continue to take care of our customers during very uncertain times.”

Medical Device Manufacturing From Concept To Market We are vertically integrated to provide you with all the services and capabilities essential for complete medical device contract manufacturing.

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Medical Design & Outsourcing

57 MSC-3149 MICRO 2020 Medical Ad Final 5.125x8.375.indd 1

4/20/20 11:08 AM

DEVICETALKS

How can we keep our medtech community connected?

Everyone has had to rethink some priorities since the COVID-19 pandemic began circling the world. We’re working hard to make and renew connections in this critical industry with an eye toward personal safety and good health.

O

rganizing conferences during the COVID-19 pandemic certainly creates new challenges. Most of us can’t travel to our offices, never mind board a plane to a distant destination.

Attending a conference with hundreds of our colleagues and peers isn’t an option. We all have much higher and more important priorities — our families, our health and our communities.

To meet those first two priorities, our company has closed its office in Cleveland and called off our June DeviceTalks meetings in Minneapolis and San Jose. We’ll see you in those cities in 2021. (DeviceTalks Minneapolis will be May 4-5; DeviceTalks West, TBD.) Now, how do we honor that last priority, community?

First, we’re excited to be moving forward with our DeviceTalks Boston event, still scheduled for Sept. 2425, 2020. Weeks of abiding by social distancing followed by a careful reopening of our everyday lives should

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

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allow everyone to be part of our flagship meeting at the Hynes Convention Center in the beautiful Back Bay neighborhood of Boston, my hometown.

We’ll roll out the agenda in a month or two. If you have something you’d like to contribute, we’re still accepting input. If you have an idea for a discussion, please email me at tsalemi@wtwhmedia.com.

Second, we’re building out a new platform to connect with our community members right away. As I wrote in this issue, the COVID-19 pandemic is changing how the medtech industry designs, constructs, sells and uses devices. As part of medtech, DeviceTalks is evolving as well.

I’d like to introduce you to DeviceTalks@Work, a series of podcasts and webinars to bring the news and insights of DeviceTalks, MassDevice and MDO directly to you.

We’ve already published eight episodes of DeviceTalks Weekly, the news-oriented podcast that I host with

www.medicaldesignandoutsourcing.com

the familiar face — and friendly voice — of Chris Newmarker, our Executive Editor of Life Sciences. Every Friday, DeviceTalks Weekly delivers a wrapup of the week’s top news as well as insights from device makers, Wall Street analysts and specialists in engineering, intellectual property, clinical trials, regulatory and other critical areas.

Soon, we’ll be launching DeviceTalks Keynotes —another podcast series that will bring known and new voices to you. Please look for DeviceTalks podcasts on the podcast player on your phone or computer.

Subscribe to the podcasts and every show will come directly to you.

Next, we’ll launch our DeviceTalks Tuesdays Connected Conference, beginning May 19. We’re glad so many of our partners are finding new ways to get their message out via webinars and other virtual events, and we’d like to help them amplify their voices by creating a central gathering place for these virtual meetings.

DeviceTalks Tuesdays will be an online conference where attendees will hear from newsmakers, editors at MassDevice and MDO, and, most importantly, from medtech leaders who are shaping our industry. We’re bringing in speakers from the FDA; Mayo Clinic; Northwestern University; the law firm of Finnegan, Henderson, Farabow, Garrett & Dunner, and other industry leaders.

This medtech industry is my community. I’ve been interviewing and writing about medtech entrepreneurs, investors and executives for 22 years.

I’ve covered booms, busts and booms again. I’ve watched startups get funded, go public and get acquired all on the way toward developing devices that help treat thousands. I’m proud of how the medtech industry has responded to this global pandemic, and I’m eager to find new ways to help you tell your stories.

Please email me if you’d like to be part of any of our DeviceTalks programs.

You’ll be glad you did.

"I'm proud of how the medtech industry has responded to this global pandemic, and I'm eager to find new ways to help you tell your stories."

Podcast Series

www.devicetalks.com/podcast/ www.medicaldesignandoutsourcing.com

5 • 2020

Medical Design & Outsourcing

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KNF Neuberger debuts two new pumps KNF Neuberger (Trenton, N.J.) recently developed two quiet, compact and high-performance compressor/vacuum diaphragm pumps. Micro gas pump NMP850 HP is based on the same footprint as the existing NMP850 series. Its high flow rate, compact size and quiet operation may make the NMP850 HP well-suited for use in wound and medical compression therapy, respiratory care devices and environmental monitors.

The pump is available with 2- and 4-wire brushless motors.

The new compact N 96 diaphragm pump produces flow of up to 8.5 L/min and starts up against the full pressure/vacuum range of up to 36 psig (2.5 bar g) / 100 mbar absolute (26.9 inHg). Its brushless DC motor and rotational speed control enable the pump to meet the requirements of complex operating profiles.

It is low heatemitting, can be used for the transfer of gaseous and vaporous samples and is designed for use with a broad spectrum of media at temperatures up to 70 °C (158 °F). — NC

MicroCare touts rubbing alcohol alternative The shortage of isopropyl alcohol — recommended for disinfection during the COVID-19 pandemic —has left some electronics and medical device manufacturers short on cleaning products they normally use during and after production. Those who can find it are also finding much higher prices, according to an April article in the Wall Street Journal. MicroCare (New Britain, Conn.) said that it offers alternatives to isopropyl alcohol (IPA) that it claims clean just as well if not better. They include cleaning fluids such as the SuprClean heavy duty flux remover, ESD cleaning wipes and the No-Clean flux remover cleaning pen. Unlike IPA, their ingredients are non-flammable. “Because we have a strong supply chain and multiple manufacturing locations, we have the flexibility to produce our products and deliver as scheduled so customers can still achieve optimal cleaning results,” said MicroCare national sales manager Dan Sinclair in a news release. — NC

Freudenberg Medical completes extractables testing for its PharmaFocus Premium tubing Freudenberg Medical (Carpinteria, Calif.) is touting extractables testing performed on its PharmaFocus Premium silicone tubing used in biopharma fluid processing and single-use applications. Eurofins Lancaster Laboratories conducted the independent extractables testing for Freudenberg Medical, drawing on BPOG and USP 665 protocols. “We understand that identifying extractable and leachable substances is extremely important for our biopharma customers, “ said Jeff Mohror, VP and GM of Freudenberg Medical Carpinteria.

“When specifying tubing into a process, this data will save customers valuable time and cost when bringing a new process into production. “ Tubing undergoing extractables testing included PharmaFocus Premium Silicone Tubing (ASTC), PharmaFocus Premium Reinforced Tubing (ASTR), and PharmaFocus Premium Peristaltic Pump Tubing (ASTP). Freudenberg Medical also put the PharmaFocus Premium tubing through additional physical, chemical and biological tests. There was also select testing on finished products in addition to the silicone material. Outside laboratories conducted all of the studies. — CN www.medicaldesignandoutsourcing.com

5 • 2020

Medical Design & Outsourcing 61

PRODUCT WORLD

Panasonic unveils new lithium ion pin batteries for wearables

Qosina touts EnFit connectors for tubing ports Qosina (Ronkokoma, N.Y.) recently touted its line of EnFit connectors, caps and plugs for tubing ports. The line of connectors, caps and plugs, stopcocks, spikes and syringes is ISO 80369-3 standard and designed to improve patient safety and reduce small-bore misconnections used in liquid healthcare applications.

EnFit connectors were designed using non-traditional orientation and larger dimensions that don’t typically allow for connectivity with common conical luer. They have been tested in strict validation processes that include human factors research, usability analysis, performance testing, misconnections assessment and computer-aided design techniques. — DK

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Panasonic Industrial Devices Sales Co. of America recently announced a new addition to its line of lithium-ion pin cells for the wearables market.

The Panasonic CG420A lithium-ion pin batteries have a spiral-wound construction that enables higher reliability and rapid charging (80% charged in 20 minutes), according to Panasonic. The company says the batteries, which are 4.7 mm in diameter, are ideal for a range of wearable applications including hearing aids, smart inhalers, smart glasses, styluses and more.

Panasonic officials also opted for a stainless-steel exterior container rather than polymer material to provide dimensional stability and prevent swelling over the CG420’s lifetime. — CN

Zeiss expands its portfolio of microscope cameras Zeiss (Oberkochen, Germany) recently announced that it has added four new CMOS cameras for digital imaging in light microscopy to its Axiocam series.

The Axiocam 705 color and 712 color are designed to high-quality images for histology, pathology or material research and analysis. The Axiocam 705 mono and 712 mono models feature fast frame rates and high dynamic range for fluorescence live-cell imaging. They also have extended near-IR sensitivity, designed to allow for deeper insights into sample structures. New CMOS in these cameras offer small 3.45 µm pixels and low noise levels in combination with a USB 3.0 platform for fast imaging experiments and the new cameras’ global shutter architecture allows for capturing dynamic samples without creating motion artifacts. The Zeiss Axiocam 705 mono and Axiocam 705 color are 5-megapixel cameras optimized for fast speed and high dynamic range. The company’s Axiocam 712 mono and Axiocam 712 color are designed for the acquisition of large samples with 12 megapixels and may greatly reduce the need for stitching. — NC www.medicaldesignandoutsourcing.com

IDS touts AI-based cameras and image processing system IDS Imaging Development Systems (Obersulm, Germany) is touting its IDS NXT, which it describes as an all-in-one solution for AI-based image processing. IDS NXT includes camera hardware with a self-developed AI core and training software for creating individual artificial neural networks and support. Users only need their application expertise and sample images to create a neural network, according to IDS. The IDS NXT cameras could support medical equipment where there is no space for a powerful GPU, the company added. The AI-executed, on-board of the cameras might also support doctors making medical diagnoses — checking for skin cancer, for example. IDS officials also think there are microscopy uses. — CN

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Accumold ........................................................... 19 AllMotion .............................................................. 4 Altech Corporation .......................................... 2, 3 B. Braun ............................................................. BC Bird Precision ..................................................... 42 Cadence ............................................................ 23 CGI Inc. ............................................................... 41 Chieftek Precision ................................................ 7 Eagle Stainless Tube.......................................... 21 Fabco-Air Inc. ..................................................... 20 Hobson & Motzer .............................................. 45 IKO International, Inc. ....................................... 34 International Polymer Engineering .................. 14 Interpower .......................................................... 51 Keystone Electronics Corp.................................. 5 Master Bond....................................................... 52 maxon ................................................................. 49 Medbio ............................................................... 37

MICRO ................................................................ 57 MicroCare Corp. ................................................ 27 Microlumen .................................................. 30, 31 MW Industries - Marox ...................................... 35 MW Medical Solutions ...................................... 39 New England Wire Technologies & New England Tubing Technologies ............ 29 Orchid Orthopedic Solutions, LLC ................... 13 Quadrant Magnetics ......................................... 42 Reading Alloys ................................................... 17 Resonetics ........................................................ IFC Rรถhm..................................................................... 9 Smart Products USA .....................cover/corner, 1 Solar Atmospheres Inc. ..................................... 38 Solenoid Solutions, Inc...................................... 15 Sorbothane, Inc.................................................. 16 Spectrum Plastics Group................................... 25 STEUTE Meditech, Inc....................................... 11 Tegra Medical .................................................. IBC

SALES Mike Caruso mcaruso@wtwhmedia.com 469.855.7344

Neel Gleason ngleason@wtwhmedia.com 312.882.9867 @wtwh_ngleason

Jami Brownlee 224.760.1055 jbrownlee@wtwhmedia.com

Michael Ference mference@wtwhmedia.com 408.769.1188 @mrference

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Bill Crowley 610.420.2433 bcrowley@wtwhmedia.com

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Mike Francesconi mfrancesconi@wtwhmedia.com 630.488.9029

Courtney Seel cseel@wtwhmedia.com 440.523.1685 @wtwh_CSeel

Ashley N. Burk 737.615.8452 aburk@wtwhmedia.com

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

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

5 โ ข 2020

EVP Marshall Matheson mmatheson@wtwhmedia.com 805.895.3609 @mmatheson

www.medicaldesignandoutsourcing.com

CONNECTWITH US! Follow the whole team on twitter @MedTechDaily

MD&O_FP_braid_02.2020_pdfx1a.pdf 1 2/17/2020 11:22:46 AM

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