The Clinical Need for Diversity in Medical Device Product Development (The MedTech Download)

Kelly Springs-Kelley
June 09, 2021

Key Takeaways

  • The lack of diversity in clinical trials leads to a critical absence of data in the development of medical devices. This data gap can mean that devices may not work for underrepresented patients.
  • Fractyl Labs has developed a device that helps to reduce or eliminate insulin therapy for patients with type 2 diabetes.
  • A recent study showed that patients with heart conditions are more likely to get medical procedures if they monitor their health data via a wearable device.

New FDA-Backed Initiative Seeks to Boost Diversity in MedTech

One of the biggest challenges facing healthcare innovation is a lack of diversity. And while many assume that translates to a need for more people of color as providers or MedTech developers (which is also true), it is the lack of diversity in clinical trials that has led experts to declare a state of emergency. When medical device clinical trials do not include data from specific segments of the patient population, there are consequences. As STAT reports, “Unless clinical trial participants represent the people who will be using a new therapy, then we can’t know how it will work for those who need it the most.”

MedTech Color is a collaborative of leaders in the medical device community, including FDA liaisons from CDRH and the Office of Minority Health and Health Equity. An article in Mass Device explained that, “The stated goals of the MedTech Color Collaborative Community include increasing clinical trial enrollment participation to represent diverse populations — and creating awareness of different disease states, prevalence rates in people of color and symptom recognition among minority populations.”

How Fractyl Labs is ‘Reversing’ Type 2 Diabetes to Reduce or Eliminate Insulin Injections

Type 2 diabetes is a metabolic disease, one in which the body loses its ability to regulate blood sugar. Unlike type 1 diabetes, which is an autoimmune disease, type 2 is often attributed to diet and lifestyle. Often, adjusting a patient’s diet and increasing exercise to combat insulin resistance can in large part “reverse” the disease. However, for some patients, regular insulin therapy is necessary to maintain healthy blood sugar levels.

But insulin therapy does not come without risk. Too much insulin can lead to dangerously low blood sugars, which can result in loss of consciousness, coma, or even death. This is one of the reasons why Fractyl Labs “developed a therapy to change the trajectory of the disease rather than putting a Band-Aid on its symptoms,’ according to CEO Harith Rajagopalan. The company’s technology, Revita DMR, helps the body better regulate blood sugar levels on its own by resurfacing the upper intestine lining. The device received the FDA’s Breakthrough Device designation and has already been approved for use in Europe.

Apple Watch, Fitbit Users with Heart Conditions Get More Medical Procedures

The use of digital therapeutics is mainstream, both for those managing chronic health conditions as well as for the health conscious. No matter what an individual is using the tech for, the truth is that we have more data related to our health than ever before. But there is debate about the value and use of that data. In some cases, physicians are uncomfortable using data from certain platforms due to concerns over accuracy and oversight. But, when you ask users, the perception related to the value of these devices is strong.

Recently it was reported that those with irregular heartbeats who use wearable devices like Apple Watches and Fitbit to monitor their conditions were not more likely to call their doctors with concerns. They were, however, more likely to have more medical procedures, like ablation. But, as the article points out, the study “can’t answer the chicken-or-egg question: it’s not clear from this study if the people who wore wearables and had ablations actually had more severe symptoms than the control group and needed the treatment, or if the wearables nudged them to see a doctor prematurely.”

Cork’s Intelligent Implants Gains Key Designation from the FDA

Last year’s surge in the use of telemedicine opened doors for a multitude of medical devices and platforms that allow doctors to care for patients remotely. Far beyond video visits and HIPPA-compliant data management, telehealth is inclusive of cardiac-monitoring, virtual ICUs, and much more.

One addition to the telemedicine mix is Cork medtech company Intelligent Implants, who has received breakthrough device designation from the FDA. Their small, implantable device “electrically stimulates and monitors bone growth after a procedure like spinal fusion. The device allows for the remote monitoring of a patient’s recovery in real time.” The technology reduces the risk of complications and allows doctors to make better decisions related to treatment and recovery for their patients.

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