Test and powerful technologies are helping independent makers get much-needed safe and affordable medical devices into the hands of professionals and patients.
With a quick search, you can find answers to help you create almost anything. But can that “do-it-yourself” attitude apply to a highly regulated, safety-first industry like the medical field? With new tools and technologies available, can just anyone design a medical device? Short answer: probably not—but test makes developing medical devices more accessible. With innovation from more individuals, accessibility also extends globally to professionals and patients who will benefit from more affordable, reliable devices in the market.
In a recent Testing 1, 2, 3 podcast, Kipp Bradford, a faculty member at the Harvard School of Engineering, remarked that he understands how the idea of a “hobbyist” developing medical devices could make some patients squeamish. But in reality, the medical industry’s regulatory infrastructure never accepts failure when safety is on the line.
While Bradford has a formal background in biomedical engineering, his 30 years of real-world experience making things and launching startups has shown him that other individuals from various backgrounds can also develop the skills to work with the complicated tools and technologies used to design medical devices. As long as rigorous evaluation testing and review procedures such as FDA approval are still at work, the field of medical device innovation can open up.
In his opinion, the tools available to people are so powerful now that the distance between an idea and bringing it to implementation is much shorter. The modern maker movement that is underway has democratized tools and their accessibility. Bradford emphasized, “All of a sudden, you didn’t need a background in embedded computing and an understanding of several programming languages, plus Assembly, plus the whole toolchain to get an LED to blink. You could get an Arduino and download some code, and the process will become very accessible.”
We now have the technology available to build interesting, impactful medical devices—and we must embrace that someone without an engineering degree or an engineering background can successfully create them.
One way to reach and treat more patients faster and improve equity in healthcare is by decreasing the size, cost, and invasiveness of the devices. Creating a more seamless device experience helps medical professionals and veterinarians diagnose patients—humans and animals alike—more quickly and accurately. Companies like the Butterfly Network are playing a pivotal role in bringing these types of devices to market.
The Butterfly Network has created a portable ultrasound machine that can be used to provide point-of-care ultrasounds in a war zone, within an ambulance, at an accident site, or even in a cow pasture. Medical professionals serving in developing nations or working to provide healthcare to underserved communities may find the $2,000 portable ultrasound more mobile than the large, traditional $25,000 ultrasound cart, especially in locations that do not have adequate voltage and amperage to run a cart.
These handheld devices undergo a multitude of tests that analyze features ranging from comfort in the hand to start-up speed, making them ideal for providing quality care in the field. Instead of lugging bulky equipment, ordering an ultrasound test, and involving a technician, a primary care doctor can connect a mobile device to a portable ultrasound and image organs on the spot to make a quick diagnosis—which is quite a breakthrough.
Aaron Feldstein, Manager of Test at Butterfly Network, told us in this podcast episode that test is essential to the creation of these medical devices because there is no room for error. Test engineers must think of every scenario that could possibly go wrong to achieve certainty under every circumstance. Feldstein affirmed, “You can’t have a probe not boot up the first time quickly. It can’t boot up 95% of the time. It has to boot up every single time. It has to charge every single time.”
With a less invasive diagnosis process, professionals can help ease some of the emotional and physical hardships patients experience when confronted with disease. As devices advance and give results faster, physicians have a better chance at slowing down or even curing diseases.
Innovators at Kitasato University and System House Co. in Tokyo created a system that enables doctors to detect cancer during a medical checkup without the patient undergoing a biopsy.
The real-time 3D optical coherence tomography (OCT) imaging system measures light, which is less invasive than a traditional biopsy that uses sound.
Researchers at ADVITOS GmbH, formerly Hepa Wash GmbH, in Garching, Germany, created a cost-effective liver dialysis therapy prototype for clinical trials specifically with the idea in mind to expand healthcare affordability and access. The prototype automatically generated traceability documents between requirements, design, and tests to help researchers quickly obtain authorization for clinical studies, which in turn helped patients gain access to new treatments faster.
Ventec Life Systems in Washington state developed the mobile and lightweight critical care VOCSN Ventilator, which combines a ventilator, oxygen concentrator, cough assist, suction, and nebulizer into one respiratory system. This system gives patients with spinal cord injuries, asthma, muscular dystrophy, COVID-19, and other conditions more mobility and provides their caregivers with an easier way to monitor them.
With advancements in embedded intelligence, user interface design, and data collection and analysis, the device experience will continue to improve and give patients more control over the devices that help them in their everyday lives, such as hearing aids and insulin pumps.
Bradford explains that we already have the technology to make devices smarter at our fingertips. “We have the embedded computation ability to be able to do the logic and computation needed to convert the knowledge that we’ve accumulated into the function behavior of a device,” he said. As devices function at higher levels, users and patients can also interact with them at a more advanced and intuitive level, where the device is responsive to the body in real-time and customized to the body’s needs.
For society to reap of the benefits of new, high-performance medical devices, makers need to consider the importance that test plays in the development process. Testing too slowly may mean a medical device doesn’t get to patients who need it in time to save them. Testing too superficially or too quickly may result in harm or worse to a patient.
While there are some regulatory mechanisms to fast-track lifesaving devices when the reward outweighs the risk, the right combination of innovation and regulation produces the safest, most effective medical devices. Bradford warned, “Making bad decisions when it comes to safety freezes innovation. Let’s go a little slower, so we can go faster.”
Hear more from Kipp Bradford and Aaron Fieldman about how test is safeguarding the tools that save lives in their full podcast episode on Testing 1, 2, 3.
For more insights, listen to other episodes from season 2 of our Testing, 1, 2, 3 podcast. This engineering podcast connects you to tech leaders discussing how test plays a pivotal role in solving society’s biggest challenges—now and in the future.
In the U.S., only 21 percent of engineering majors and 19 percent of computer science majors are women, and only 22 percent of all science and engineering bachelor’s degrees go to Black, Latinx, or Native American students.
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