Gadgets, devices, doo-dads, oh my! The Duke Global Health Institute (DGHI) recently hosted three of its members to lead a panel on creating medical devices for low- and middle-income countries. The event was called “Global Medical Device Innovation: Three Models for Creation and Commercialization.”
Each sought to decrease costs and increase scalability for medical procedures. In short, they are expert inventors who are doing good in the world.
We’ll go step-by-step in a moment, but to start you on your journey to being just like our panelists, here’s a short glossary:
Standard-of-care: a public health term for the way things are usually done.
IRB: institutional review board, a group of people, usually based in universities, that protect human subjects in research studies.
Screening: when doctors look at signs your body might show to determine
whether you need to be tested for certain conditions.
Supply-chain: the movement of materials your product goes through before, during, and after manufacturing. It is a general term for a group of different suppliers, factories, vendors, advertisers, researchers, and others that work separately.
Regulatory pathways: supply-chain for government approvals and other paperwork you need to have before introducing your product to the public.
Step 1: Meet your Mentors
Walter Lee is Chief of Staff of the Department of Head and Neck Surgery & Communication Sciences, Co-Director of the Head and Neck Program, and an affiliate faculty member at the Duke Global Health Institute. He presented ENlyT (pronounced like en-light), a newfangled nasopharyngoscope – a camera that goes down your nose and down your throat to screen for cancer. He wants to expand with partners in Vietnam and Singapore.
Marlee Kreiger helped found the Center for Global Women’s Health Technologies at Duke in 2007. Since then, she has led the Center in many interdisciplinary and international ventures. In fact, the Center for Global Women’s Health Technologies spans both the Pratt School of Engineering and the Trinity College of Arts and Sciences. She presented on the Callascope, a pocket-sized colposcope – a camera device for cervical cancer screening.
Julias Mugaga will soon be a visiting scholar at Duke – until then, he heads Design Cube at Makerere University in Uganda. He presented his KeyScope, a plug-and-play surgical camera with 0.3% of the cost of standard-of-care cameras.
Step 2: Name your Audience
DGHI has “global” in the name, so it is no surprise that these presenters serve communities around the world. Perhaps something that inventors like Dr. Doofenshmirtz often get wrong is that new innovation should come at the benefit of underserved communities, not at the cost of them. For Lee, that focus would be in his collaborations in Vietnam; for Mugaga it was his community in Uganda; and for Kreiger, it was the many studies conducted in Zambia, Tanzania, Kenya, Costa Rica, Honduras, and India.
Each of the presenters could agree that the main strategy is simple: find partners. Community members on the ground. Organizations that can benefit from your presence.
Another notable aspect of your audience will be the certification you vie for. Depending on your location, you may need different permissions to distribute your product, or even begin on the journey to secure funding from certain sources.
In the United States, the most relevant regulatory pathway is FDA clearance, which is notably less restrictive than the CE mark distributed in the European Union. Both certifications are accepted in other countries, but many of the inventors on the panel opted to secure a CE mark to potentially appeal to a wider variety of governments around the world.
ISO is an international organization that is also necessary for certification, particularly if you are looking to test a medical product. No reason to be dragged down by the paperwork, though! When asked about securing Ugandan product certification, Mugaga declared, “This is one of the most exciting journeys I have taken.” His path to clearance was even more wrought with uncertainty – without steady sources of material in the Ugandan economy, it is harder to earn FDA or CE approval, two of the most widely-acknowledged certifications in the world.
Step 3: Test
Now that you have permission, you can start changing lives. Many participants in our panelists’ studies were patients in community health clinics across the globe. Their partners in these clinics also had the opportunity to save tens to hundreds of thousands of dollars in equipment. While it seems like a no-brainer, there are ethical concerns that need to be addressed first. For that, you need to fill out…. You guessed it: more paperwork. IRB approval is usually granted by educational institutions (as you should recall from my handy glossary), and is crucial to secure before any testing with humans is started. In fact, the government (and most private investors) won’t even give you a second glance if you ask them for money without IRB approval.
One big hurdle many of the panelists noted was a distrust of the technology and institution it came from – a foreign entity testing their products on you does not always invoke fear, but it certainly does not always promote trust. Kreiger noted that the work of their community health partners does the heavy lifting on that front; not only are they known community pillars, but they have authority to promote health technology through their existing relationships. If you run into trouble identifying partners in your inventorship journey–never fear. Lee has a message for you: “Ask around. At Duke, there’s always an expert around who’s willing to lend you their time.”
Step 4: Distribute
Now that you are an expert, your invention works, and you’re saving lives, you can attempt to cement your design as standard-of-care. This may look different depending on where in the world you want to distribute, but the next step is to contract a large-scale manufacturer. Your materials have been sourced by now (FDA says they better be) — so finding someone to put them together at an industrial scale should be easy! Your cost may fluctuate at this scale with the increased labor costs, but bulk production and distribution altogether should provide you, your institution, and your clients the best possible chance at changing the world.
Lee did not receive NIH funding until his fourth attempt at applying. Kreiger did not settle on the first manufacturer contracted. Mugaga is still in the process of securing a CE mark. And yet, all of them are success stories. You can see the ENlyT saving lives in hospitals in Vietnam; you can track the reallocation of $18,000 in savings from purchasing a Calloscope; and if you’re lucky, you’ll catch Mulgaga on campus next year as a visiting scholar at Duke!
Post by Olivia Ares, Class of 2025