What Are the Most Important Goals for a New Medical Device? (The MedTech Download)

Kelly Springs-Kelley
March 04, 2021

Key Takeaways

  • In an interview with Medsider, the CEO of Lungpacer Medical revealed 3 critical insights related to the goals that new medical device teams should set.
  • Despite COVID-related uncertainty in much of MedTech, diabetes wearables continue on an upward trajectory, reporting revenue increases in 2020.
  • According to an article, hospitals will lose an estimated $53 to $122 billion in revenue this year, in large part due to procedure cancellations.

3 Critical Goals Every New Medical Device Should Aim For: Interview with Doug Evans, CEO of Lungpacer Medical

New Medical Device

For medical device companies and startups, bringing a technology to life can be arduous. The technology itself requires tremendous focus and capital, both in resources and time. Proving efficacy and clearing FDA hurdles is top priority, but so is conducting stakeholder research to craft a meaningful value proposition. And at each stage of the process, there are seemingly infinite challenges, distractions, and considerations. These factors often leave  MedTech teams shifting and moving goal posts in the quest for a viable product. 

Doug Evans, CEO of Lungpacer Medical, knows this process well. According to Medsider, Doug has “decades of experience launching startups, developing products, working with payers & regulators, and commercializing novel technologies.” In an interview, Doug provides key goals and insights that every new medical device should consider. One element he emphasizes is focusing on critical product features rather than “nice to haves,” so companies can get their first-gen tech to market as quickly as possible. He explained that companies often get caught up in elements that actually complicate the product, leading them to miss the mark. “I’ve seen customers opt for the simpler product even with inferior data rather than spend some extra time on something that’s more difficult to use,” Doug explained. Listen to the whole interview here.

Diabetes Wearables Look Resilient Through 2021, Bucking Broad Medtech Trends

According to the American Diabetes Association, in 2018, 34.2 million Americans, or 10.5% of the population, had diabetes. Of that group, close to 1.6 million Americans have type 1 diabetes, including about 187,000 children and adolescents. The disease is far-reaching, and especially for those living with type 1, medical technology dramatically improves quality of life. Because type 1 is an autoimmune disease, it is not improved by diet or exercise, leaving patients dependent on advancements in technology to improve their quality of life. But, those same advancements can also improve outcomes for those with type 2, making them valuable to millions of people.

It is for this reason and the increase in point-of-care technology that diabetes-related wearables have continued to grow in popularity. The industry appears to be defying COVID-era uncertainty within MedTech, as many companies, including Dexcom, Abbott, and Insulet, announce significant increases in sales.

Hospitals Could Lose $53B This Year — and That’s in the Best-Case Scenario

To outsiders, it can seem unfathomable that hospitals are in financial trouble due to the current public health crisis. Headlines warning of crowded emergency rooms and limited beds lead many to believe that, much like home delivery services, hospitals are coming out of the pandemic better off. Afterall, with so many patients paying for beds, that has to translate to revenue, right?

The sad reality is that 2020 put a strain on hospital systems, and looking into 2021, a new report prepared by Kaufman Hall and released by the American Hospital Association predicts that, “even in the most hopeful scenario, U.S. hospitals are expected to face a massive financial loss in 2021.” The article goes on to say that, on the optimistic side that assumes “a consistent and complete recovery of patient volumes,” a smooth vaccine rollout and consistent decline in cases, hospitals could lose $53 billion in revenue. The pessimistic scenario assumes “a slow and partial recovery of volumes, delayed progress in the vaccine rollout and cyclical surges of Covid-19 cases.” In this case, hospitals could lose $122 billion in revenue, “with the biggest loss stemming from outpatient revenue.”

FDA OKs Device to Avert Traumatic Brain Injury During Sports

What have been described as “silent killers,” concussions and traumatic brain injury are an epidemic in sports, especially football. The game results in regular traumatic brain injury in players, with the NFL seeing its highest number of concussions in 2015 with 271 confirmed diagnoses. But, some of the largest concerns surrounding concussions are found in children’s sports. According to MedTech Dive, “A CDC analysis found 2 million children visited an emergency department due to a TBI sustained during sports and recreation activities from 2010 to 2016.”

To combat the problem, the FDA recently authorized a medical device designed to protect athletes’ brains from the effects of repetitive subconcussive head impacts. According to the article, the Q-Collar applies “compressive force to the internal jugular veins, thereby increasing the volume of blood in the vessels of the skull. The additional blood restricts the movement of the brain inside the skull. As the brain moves less, it may be protected from the negative effects of the “slosh” movement that occurs in unprotected athletes who suffer head impacts.”

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