Medical Device Handbook Archives - Page 2 of 5

The promise and pain of startup customers: 3 ways to support early-stage innovators without becoming a high-risk investor

Kate Stephenson is the owner and founder of Dyad Engineering. [Photo courtesy of Dyad Engineering]

Startups represent a highly lucrative opportunity for suppliers to get in on the ground floor of a whole new product line, but their low success rate and high-touch needs can make them a dangerous distraction from your main customers.

Kate Stephenson, Dyad Engineering

Enthusiastic and highly committed to their cause, medical device startup founders speak with a deep passion about righting the wrongs of healthcare and the immense potential for profit in doing so.

However, they also tend to be overly confident, naïve about the sheer amount of work their idea represents and perennially underfunded.

The risks and rewards of working with startups are constantly shifting. To mitigate the risks without resorting to a blanket “no startup” policy, there are three strategies every medical device manufactur…

How to speed through the 60601 drop test with finite element analysis

Figure 1: From 3D CAD model (left) to FEA meshed model [Image courtesy of Flex]

Finite element analysis can help design a robust mechanical architecture to pass one of the toughest tests in medical device design.

Giorgio Sardo, Flex

Time to market is a key factor for new medical product success. Designers now use modeling and simulation to pass one of the most severe tests: 60601-1, an international standard applicable to all medical electrical equipment and systems. By skipping costly trial-and-error iterations, they can quickly define the parameters for a robust mechanical architecture. Drop simulation can predict the test result and also support a failure analysis investigation.

If you’ve ever dropped your phone, your immediate concern is if it still works. Medical device users don’t experience the same anxiety if they drop their device because medical electrical equipment must meet a set of…

Selecting cables and connectors for your medical device

Fischer Connectors’ solutions suited for medical devices include several types of connectors and associated cables (from left): Fischer Core Series Brass, Plastic, Disposable, Fischer MiniMax Series, and the Fischer Freedom Series. [Photo courtesy of Fischer Connectors]

Connectivity for safety and performance is a complex consideration when designing modern medical equipment.

David Ptacek, Fischer Connectors

In patient care settings from surgical to imaging and diagnostics, therapeutics and patient self-care, the use of medical electronic equipment is ubiquitous and continues to grow. Advanced technology featured in new equipment and devices is bringing about ever more innovation to benefit patient experience and outcomes.

Such new designs typically need to integrate connectivity solutions: cables, connectors and electronics. Even though it may seem straightforward, connectivity today is a complex en…

Plastics and medical devices: Changes for safety and cost

The move toward polypropylene and polyethylene in medical devices requires new manufacturing and assembly solutions such as ultrasonic and laser welding.

Didier Perret, Emerson

Emerson’s Branson GSX Ultrasonic Welding Platform [Photo courtesy of Emerson]

Plastics are ubiquitous in medical applications thanks to their light weight, durability and flexibility, among other attributes. However, concern has been increasing in recent years about the possible negative effects of some ingredients and components in certain plastics. This is leading medical-device companies to research and use other resins or combinations of plastics without the same risks. However, they do not have the same processing characteristic, and the changes often require companies to implement new production processes, especially around assembly and joining technologies.

For instance, polyvinyl chloride (PVC) is used in 40% of all …

The advantages of an AI/ML-enabled search engine for FDA records

(Image courtesy of the FDA)

The FDA’s exciting new list of artificial intelligence and machine learning-enabled devices highlights opportunity for improvement.

Craig Coombs and Qiang Kou, Nyquist Data

The FDA released a list of cleared or approved artificial intelligence and machine learning-enabled devices in September, documenting much of the agency’s work in the innovative area of AI/ML.

Extracting this information from the FDA’s decades-old database is labor-intensive at best — and often impossible. Despite the time spent by the FDA to make this new list, a lack of even text-based searching capability makes the list itself cumbersome and time-consuming to review.

Wouldn’t it be better if there was an AI resource that could quickly compile a list of FDA’s AI/ML clearances and approvals, allowing searches in seconds rather than hours?

Get the full story at our sister site, MassDevic…

3 pitfalls to avoid when choosing fasteners for wearables

[Photo courtesy of YKK]

Though they’re a small component, fasteners play a critical role in device performance.

Keith Glaser, YKK (U.S.A.)

Medical wearables technology — devices worn on the body or clothing that diagnose, treat or alleviate disease, or help mitigate injuries — has advanced significantly in recent years. While many people think of fitness trackers and health watches, this booming market also includes items like orthopedic braces, wearable injectors and compression garments.

Fasteners play a critical role in product performance, even though they are a small component of the overall device. They are probably the most frequently touched part of the product, used to attach it to the body or make it tighter or looser based on user need.

Let’s explore three key pitfalls to avoid when choosing fasteners that can result in underperforming wearables, wasted time and money and missed opp…

How vapor degreasing is helping to future-proof medical device reliability

The demand for digital wellness means an increasing need for small, complex electronic components. [Image courtesy of MicroCare]

Precision cleaning of electronic medical devices boosts reliability.

Jay Tourigny, MicroCare

COVID-19 has brought the importance of wearable and remote monitoring and diagnostic devices to the forefront. But these devices, with their intricate PCBAs (printed circuit board assemblies) must deliver reliable and consistent performance, particularly as they are often used in devices that are life-sustaining.

Cleaning is a key contributor to PCBA performance consistency and should be factored in when designing complex and multifaceted electronics. What cleaning processes should be adopted and how do you ensure cleanliness standards are met?

Why is reliability important?

The medical electronics market is estimated to be worth $6.3 billion in 2021 and projected to reach $8.…

Tungsten cable for surgical robotics: A complex material serving a complex application

These 0.001in. tungsten wire filaments are used to manufacture tungsten mechanical cable. [Photo courtesy Carl Stahl Sava Industries]

Tungsten mechanical cables are the most popular for surgical robot makers.

The mechanical cables that reside within the motion control systems of the most modern surgical robots can be so small that the individual filaments themselves are nearly impossible to see with the naked eye.

So tiny are the wires comprising tungsten cables for surgical robotics that they contain individual strand diameters as small as one-fourth the thickness of a single piece of paper.

When a surgical robotics designer comes to a cable manufacturer with a tungsten cable application, there is a specific set of criteria that the cable must satisfy. The cable must tolerate a precise load, for example, while maintaining a miniature diameter, as well as a critical factor of safety. After all, a tun…

September 2021 Issue: Our latest Medical Device Handbook is out!

Making medical devices: Everything you need to know

The innovation-fueled evolution of drug eluting stents

Dexcom CEO Kevin Sayer says G7 will be ‘wonderful’

Getting the inside scoop behind top medtech innovations

Autumn is upon us, and it is once again time to sip a pumpkin spice latte — or a pumpkin beer — and crack open our latest Medical Device Handbook.

Once again, we’ve reached out to experts across the industry to curate dozens of “what is” and “how to” types of articles that cover a breadth of categories: components, drug delivery, manufacturing and machining, materials, product design and development, regulatory, software, sterilization services and tubing.

As the years go by, I’m proud that we’re including more insights from the major medical device companies in each succeeding issue. This time around, we spoke to experts involved in some of the major industry innovations of the past decade:

Now VP of R&D …

Connected workers are key to meeting medical device manufacturing demands

Here’s how medical device manufacturers can navigate the “year of the connected worker.”

Louis Columbus, Delmiaworks

[Image from Pixabay]

Perhaps the only thing that medical device companies and contract manufacturers can predict for 2021 will be continued unpredictability across supply chains, market demand, sales forecasts, and skilled workers’ availability.

In the United States, elective surgeries are on the rise after being postponed due to the pandemic—leading to higher demand for medical equipment, artificial joints, and other devices used in routine procedures. However, the application of the Defense Production Act (DPA) continues to prioritize the availability of materials and manufacturing resources in the fight against COVID-19, resulting in shortages elsewhere.

The workforce also continues to be impacted by the pandemic. Many parents have quit working to care for…

3 questions medical device manufacturers should ask before ISO 10993-17 updates

The upcoming publication of ISO 10993-17 will support the latest ISO 10993 expectations already in place. Gain insights into what this standard will mean to the evaluation process and how to prepare in advance.

Sherry Parker, WuXi AppTec Medical Device Testing

[Image from Pixabay]

Following ISO 10993-1, the lens of medical device biological safety evaluation changed to a risk management process, impacting how manufacturers prepare their medical devices for submission.

The newest version of ISO 10993-17 is approaching publication. These revisions expand current guidance on establishing limits for leachable substances to assess the toxicological risk of medical device chemical constituents. The changes allow for a more consistent evaluation and will likely lead to a more device-specific approach to subsequent biological safety evaluations.

While the ISO 10993-17 guidance document is still in the dra…

Does your human factors drive design, or does your design drive human factors?

A solid commitment to human factors in the design process can be critical to a medical device’s success.

MaryBeth Privitera, HS Design, a SteriPack company

[Image from Pixabay]

In some early education circles, there is a philosophy that one can learn from testing. If you want a child to know vocabulary words, you can have them briefly study, then give them a quiz, show them what they missed and do the quiz again — all in hopes for a better score without a concerted effort towards improvement. In medical devices, some may approach human factors as simply a test to meet a regulatory imperative. It’s a test that must get done but not one that truly informs design. The testing becomes the focus, the driving force viewed as another task rather than a powerful tool.

Ultimately it is the device design that matters. Through innovative technology design, we have new opportunities to advance clinical c…