November 2022 Issue: 2022 Medical Device Handbook


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Innovate together

Medical devices have never been more complex than they are today.

They’re getting smaller, smarter and safer. They’re more effective, intuitive and sustainable. Medical device companies manufacture some to last longer — and then redesign others for just a single sure-fire use.

Device developers have more options than ever: advanced materials, cutting-edge components and new technologies like 3D printing, artificial intelligence and robotics that lend a helping hand in the operating room and on the production line.

It’s also never been harder to go…

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Braiding technology options for innovative biomedical textile structures

Low-density braided textile [Photo courtesy of Cortland Biomedical]

Making informed choices between high-density, low-density and 3D braiding offers greater design flexibility for implantable textile components that are fit-for-purpose.

Maddy Moncla, Michelle Lishner and Zachary Robbins, Cortland Biomedical

Biomedical textiles have the potential to enable lower-profile medical devices, less invasive surgical procedures and greater overall flexibility and biocompatibility across a variety of medical applications. But unlocking the full potential that textiles can offer starts at the earliest stages of the product design and development process. The right decisions must be made on how to create an implantable textile component that’s optimally fit-for-purpose.

Braiding raw material (i.e., fiber) is one of the most prevalent methods of creating biomedical textiles structures, but within this category, t…

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How antimicrobial coatings of the future will better prevent infections

A BioInteractions laboratory employee holds a TridAnt coated surface and a non-coated surface. [Photo courtesy of BioInteractions]

State-of-the-art antimicrobial technology represents a paradigm shift in the prevention and treatment of surgical infections.

Arjun Luthra, BioInteractions

In the past century, modern medicine has broken countless barriers toward a safer, more effective healthcare protocol. One of the most important discoveries has been antibiotics. Unfortunately, the widespread use of antibiotics has led to growing antibiotic resistance.

According to the European Centre for Disease Prevention and Control, more than 4 million people acquire a healthcare-associated infection (HCAI) each year, resulting in 37,000 deaths. Combatting HCAIs is a significant problem for the healthcare sector globally. HCAIs are the sixth leading cause of death in Western countries. However, treating these infec…

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Is there a better way to weld medical wearable components?

Syringe filters contain thin membranes that, if damaged during assembly, would render them useless. [Photo courtesy of Emerson]

Emerson officials think their PulseStaking offering provides a new option for welding the small, delicate structures found in filtration parts.

David Devine, Branson Welding and Assembly, Medical at Emerson

Technology and market demand are pushing designers and manufacturers to create medical devices that are ever smaller and more compact. The miniaturization trend is especially true of wearable devices used for drug delivery and patient monitoring. Assembling these plastic components, especially those with tiny filters that are frequently used in wearable devices, presents special challenges.

There are plenty of options for joining plastics, including ultrasonic welding, laser welding and staking and swaging processes that use ultrasonics or thermal technology. However, inc…

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Pushing the boundaries of brain-computer interface software

[Image from Milad Fakurian on Unsplash]

Neuroscientist Sumner Norman and AE Studio develop open-source and free tools for the brain-computer interface (BCI) space.

BCI technology has become one of the hottest areas of medtech. Companies are developing a multitude of methods with their own systems that would allow patients to control a computer with their brain. Such technology could enable immobile people to control a mouse cursor, keyboard, mobile device/tablet, wheelchair or prosthetic device by only thinking.

“My goal is to give abilities back to those that have lost them, and eventually, to improve how all of us interact with technology and each other — the ultimate human-machine interface,” Norman told Medical Design & Outsourcing. “And what’s more human than our brain, the organ that contains our every memory, thought and intention?”

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How the Utah Array is advancing BCI science

Blackrock Neurotech’s Utah array is used in its brain-computer interface to sense brain signals. [Photo courtesy of Blackrock]

This gold-standard brain-computer interface technology is creating a platform for better patient outcomes.

Florian Solzbacher, Blackrock Neurotech

Brain-computer interface (BCI) science has seen exciting advances and heightened public attention in recent years, and for good reason. The promise of BCI for individuals with paralysis is monumental: To intuitively restore communication, control external devices, and provide the independence that many able-bodied people take for granted.

Sitting at the core of today’s BCI innovation is a tiny device that has quietly powered advances in the field for decades: the Utah Array.

Studied in humans since 2004, this bundle of microelectrodes, also known as the NeuroPort Array, remains the only FDA-cleared high-channel microel…

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Best practices when outsourcing medical injection molding

TransMed7’s SpeedBird biopsy devices are made with injection molding, among other manufacturing processes. [Photo courtesy of Fictiv]

Part design, material selection, tooling and quality assurance are the keys to success when outsourcing medical injection molding.

Robbie Long, Fictiv

Injection molding is known for producing high volumes of tight-tolerance parts. What medical designers may not realize, however, is that some contract manufacturers can also cost-effectively prototype functional samples for testing and evaluation. Whether it’s for single-use devices, repeated-use devices or durable medical equipment, plastic injection molding is a versatile process that can help you bring products to market faster.

Like any manufacturing process, there are best practices for injection molding. They fall into four major areas: part design, material selection, tooling and quality assurance.


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How to center patients when designing distance care medical devices

Philip Remedios is principal and design director at BlackHägen Design. [Photo courtesy of BlackHägen Design]

Patient-operated medical devices — such as those used in insulin delivery — require a focus on the usability requirements of the less-experienced end user.

Philip Remedios, BlackHägen Design

User-centered design is critical when developing new medical devices to support distance care. Medtech companies are now specifically designing devices for patient use outside of clinical settings. Digital technologies and ingenious benefits for providers and payers have enabled the shift.

However, it is imperative to focus on benefits to end-users in the design process. Device creators must consider environmental factors and design for elderly, infirm or inexperienced users. It may also include issues such as increased battery life, fall detection and other risk-mitigating sensors like innovative applicat…

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Can I get IP for my healthtech AI?

With healthtech AI investment booming, companies are seeking guidance on when and how to protect that work.

Andrew (A.J.) Tibbetts, Greenberg Traurig

(Image courtesy of the FDA)

Can you get intellectual property (IP) for artificial intelligence (AI)? Absolutely. Should you file a patent application? Maybe, but there are alternatives. Should you consider data options? Yes. Is there a standard strategy for AI? Not if you want to see value from your IP.

The healthtech industry is investing heavily in software engineering and data science as it increasingly develops decision support, medical telemetry, surgical navigation and countless other medical software applications. The software investments naturally raise questions on how best to protect against copycats. It is certainly wise to obtain IP for your AI and software, to protect market position or set partnership terms. But while protecting other tec…

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4 ways to usher in next-gen medical device design

[Photo courtesy of 3M]

The future of medical device design is in our hands. Here’s what it’ll take to get there.

Tony Kaufman, 3M

It’s an exciting and challenging time in medical device history. From tracking vital signs to enabling more informed conversations with health professionals, device users can take control of their health in new and powerful ways.

But the rapid acceleration and advancement of data is only just beginning. What lies ahead is a complex web of questions that one person, one team, one company alone can’t solve.

For example, how can we further prioritize user experience from the start of the device’s development? How can we keep pushing the bounds of wear time? What have we learned from COVID that we can bring forward?

To unlock continued innovation that improves lives, all of us from across the device development process must come toge…

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6 power management considerations for developing and scaling smaller, smarter micromedical devices

Efficient electrical power management systems drive continued innovation for medical grade devices from design engineering through end-of-life disposal or recycling. [Image courtesy of Intricon]

Supercharge every phase of micromedical device product development with these questions.

Mitch Johnson, Intricon

Some of the biggest considerations for designing, manufacturing and scaling today’s smaller, smarter medical innovations center on providing power to microelectronic systems.

From mechanical functionality to data operations and wireless communications, effective power management drives continued device innovation. Addressing five fundamental issues can help multidisciplinary teams bring new and next-generation medical devices to market on-time and on-budget.

1. Why: The use case

The obvious starting point is documenting the intended use. Why is a product being built and how will it be used? …

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How to pass the patent eligibility test for Software as a Medical Device

Kathleen Daley is a partner at Finnegan, Henderson, Farabow, Garrett & Dunner. [Photo courtesy of Finnegan]

There’s “significantly more” to it than a good idea for an SaMD algorithm.

Kathleen Daley, Angeline Premraj and Jason Zhang, Finnegan

Technology continues to change the practice of healthcare, and one area where this has become evident is the increasing prevalence of software aimed at healthcare applications. This can include software that is integral to a medical device, software used in the manufacture or maintenance of a medical device, or software that is itself the medical device, also known as Software as a Medical Device (SaMD).

SaMD is an area of tremendous growth in the medical healthcare field. However, there is still significant unpredictability in the patent eligibility of SaMDs. This article provides an overview of the challenges facing the patent eligibility of SaMDs and…

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