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September 25-27,2024 | SWEECC H1&H2

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Dos and Don’ts for Developing Medical Devices

10 Dos and Don’ts for Developing Medical Devices

Whether it involves focusing on ways to reduceheathcarewaste or trying to make your product “invisible,”Qmedhas come across plenty of helpful tips formedtechindustry experts.

Don’t Conflate Your Customer with Your Target User

In the consumer sector, finding the target user demographic is fairly straightforward; they are potential customers who will ultimately buy and use the products in question. 

In the medical device sector, however, the person buying the end product is often different from the one using it, explains AndySchaudt, director of usability services atMedStar’sNational Center for Human Factors in Healthcare. Complicating matters further is that much of the design feedback given to medical device engineers comes from the company’s own sales and marketing, which, of course, is also not the user demographic you ultimately want to target.

Once you think you have identified your target users—let’s say it’s a nurse, it is important to find out if there are other people who might use the device. Other staff at the hospital, for instance, might help maintain the device or, charge its batteries, and so forth. In many cases, you could be designing for a team of people, not just a single user.

Don’t Assume That You (or Your Client) Are the Expert

Always involve key stakeholders in your development, whether it be manufacturers, distributors, nurses, clinicians, and especially the patient, says AdamBilney, manager, medical division atOuterspaceDesign. “Understanding their needs and involving them in the design process will lead to a much more successful product.”

Do Understand the Way the Equipment Is Intended to Be Used

Understanding the way in which users or clinicians interact can be made simple and efficient while also encouraging correct data entry.


Do Try to Use Technology in Ways to Trim Healthcare Waste

It’s easy to get into a cost-cutting mindset when developing a medical device, given the unprecedented cost pressures facing the industry. But some technologies can help trim cost from the healthcare system at large. After all, about one third of all healthcare spending in the United States is waste. Technologies like Big Data have the potential to help device developers play a role in making healthcare more evidence based and less based on tradition and gut instincts.

Do Learn from Consumer Technologies

Even technologies that, on the surface, have nothing to do with medical devices can hold valuable lessons for medical device developers. Flight simulator technology, for instance, is being used to reboot surgery.

Or consider how Google Maps, for instance, could point to where medical devices are headed in the future. “Healthcare is essentially a navigation problem,” says Alan Greene, MD, chief medical officer ofScanadu(MoffettField, CA). “What we want to know is: where we are, where we want to get, and the best route with turn-by-turn support.”

Years ago, we navigated in our cars using huge fold-up maps. When we got really lost, we’d pull over and ask a stranger for directions. That is essentially how we have approached our own healthcare for the past several decades, where doctors and analogous to the strangers we would ask to help get us back on the right track.

Now, however, technology has thoroughly changed the experience of navigation. Google Maps, for instance, is already in its ninth iteration, giving users turn-by-turn navigation instructions with a bevy of contextualized information. For instance, it can show live traffic information, calculate how much anUberride will cost, or inform users of transit schedule changes. Meanwhile, much of medical practice is stuck at the MapQuest stage, Greene said, where patients are given, for instance, context-less paper printouts of lab results. “My wife recently wife had a concussion and received a printout that said: ‘head injury, adult,’” he explained.

Don’t Let Your Company’s Culture Shackle You

Ask not what your company’s culture can do for you, ask what you can do for your company’s culture.

OK, it’s understandable to want a supportive and fostering workplace culture. But you can play a big role in optimizing that culture. It is better to strive to be an agent for changing the culture—for the better—rather than letting it hold you back.

Here’s just one example of why that’s important: It’s hard to succeed in an operation whose culture doesn’t embrace quality principles in general and Six Sigma and Lean. One of the main challenges for Six Sigma and Lean principles to take hold is culture, says B. Braun’s DaveSchlederin a Q&A titled “Why Lean and Six Sigma Should Matter to You.” The culture should look to continuously optimize the production floor, which asSchlederputs it, is a “field of dreams.”

Even companies that have a history of embracing quality principles can lose ground. After establishing itself as a manufacturing leader, which helped formulate lean principles, Toyota let its high standards slide in recent years and to this day is dealing with the the ramifications of quality issues from nearly a decade ago. So don’t let “because that’s the way it is” hold you back. If you’re in a company that gives youblowbackfor that type of attitude, then maybe it’s time to find a better employer—or even try to start a company on your own.

Do Your Research When it Comes to Materials

The amount of materials traditionally used in the medical device sector is fairly limited. MichaelDrues, PhD, the president of Vascular Sciences, recommends branching out, and looking for materials that offer more than compatibility.“Biocompatibleisn’t good enough any more,”Druessays.“Biocompatibilityjust means you put something in the body and the patient doesn’t drop dead.”

At the same time, using custom material grades can pose their own challenges. “Price is one reason for this. More custom blends can drive the material’s price up, and the availability could be a question depending on how much of that grade the raw material supplier sells,” says PhilKaten, the president of injection molding firmPlastikos(Erie, PA).

Do Not Think Hackers Are Other Companies’ Problem

Whether it is Sony’s recent hacking troubles or Target’s, the medical device industry would be well served by learning from prominent hacking episodes and doubling down oncybersecuritymeasures.

Hackers have apparently not been on many medical device companies’ radar. Reuters in 2014 cited a private notice from the FBI alleging that “[th]e healthcare industry is not as resilient to cyber intrusions compared to the financial and retail sectors, therefore the possibility of increased cyber intrusions is likely.”

The industry has already seen some major security breaches. Medtronic, for example, already disclosed in its most recent annual report that it was victimized by hackers infiltrating the company’s computers—and that two other medical device companies faced similar hacking incidents.

Do Take Advantage of the Technology Out There, No Matter How Mundane

Scotch Tape is a great example of this. A young St. Paul, MN–based company called AtivaMedical found that sheets of 3M Co. adhesive polymer (pretty much tape) provided a savvy solution for producingAtiva’sbusiness card-sized test cards for blood samples. Researchers at the company figured out how to laser-etch micro channels on tape, allowing for a single drop of blood to flow through the channels on a test card as the company’s clock radio-sizedMicroLABdevice performs a variety of tests that include not only electrochemistry but also flowcytometry, imaging, andcolorimetricanalysis. The result is a complete blood count and a host of other tests that could be conducted within 5 minutes at a doctor’s office, or any other place a blood test is being done, versus being shipped off to a central laboratory.

Or how about thecapnograph—a common piece of medical equipment that measures carbon dioxide levels to ensure a breathing tube is inserted into the trachea and not the esophagus. MIT researchers have discovered an algorithm that could help medical professionals use acapnographto quickly determine whether or not a patient is suffering from acute emphysema versus heart failure.

Do Not Think Humans Always Have a Better Solution Than Mother Nature

From geckos to silk, scientists continue to draw inspiration from Mother Nature. In the medical device field, recent examples of this trend include a squid-inspired injection systemand a bioadhesiveinspired by barnacles. Simply put: you can’t go wrong in studying the intricacies of biology—especially when it relates to the human organism.

“The way your body responds to materials is similar to how your body responds to bacteria or any other antigen,” says MichaelDrues, PhD, the president of Vascular Sciences. “If you understand the biology, you can better understand what you need to achieve from a materials perspective.”

Do Strive to Make Your Products ‘Invisible’

Many of the best products fade into the background when not in use. The ubiquitous smartphone is an example of this. While you are not likely to leave home without it, you forget about it when it’s not in your hand—which it, admittedly, might be in a lot of the time.

Like smartphones, the most useful technologies become seamless technology that can be integrated into the fabric of our everyday living.

The consultant MarkDiPerrisays the BAM Labs sensor mat is a good example of this tend. The sensor goes under a mattress and monitors whether someone is in the bed, sleep pattern, heart rate, and breathing rate—all with minimal human intervention.

Do Not Ignore the Expertise of Your Contract Manufacturers

It sounds like common advice, but few OEMs take full advantage of the expertise offered by contract manufacturers. Involve them early and often—starting with the design process up through final production.

Contract manufacturers, in fact, are rising up to the challenge—and expanding their capabilities to better meet the needs of OEMs. So take advantage of it.

Do Seek Out Inspired Patients and Innovators to Collaborate With

Inspired patients and their loved ones can come up with some pretty innovative ideas for medical technology for two reasons: they have considerable insights and they are uniquely driven to relieve suffering. It is getting more common for such people to innovative medical devices themselves despite the considerable challenges involved in doing so.

Examples? Some of them are engineers from other disciplines like JohnCostik, an engineer forWegmansFood Markets, who has worked to develop a cloud-based continuous glucose monitoring system to help monitor his young son’s type I diabetes. Then there is a British boiler engineer who has created an implantable device to fix a pumping problem with his heart, and an Argentine car mechanic who developed a device for obstructed labor (shown above).

10 Clever DIY Medical Devices

From arobohandto a centrifuge for use in the developing world, examples abound when it comes to what do-it-yourself medical device designers are able to accomplish.