Healthcare was front-page news in 2022, as the world successfully battled the most significant global pandemic in centuries. We gained a whole new vocabulary as terms like mRNA, quarantine, contact tracing, and “flattening the curve” came into everyday usage.
The pandemic touched virtually every aspect of civic and business life, and MedTech is no exception. As we transition to the post-pandemic era, here are the top four MedTech trends we see impacting life science companies and patients.
The pandemic forced a massive, sudden, and ad-hoc shift to remote and hybrid care delivery models. Now that these models have proven successful and cost-effective, there is no going back. According to McKinsey, telehealth usage has stabilized at levels 38X higher than their pre-pandemic baseline. Fueled by the increasing patient acceptance and chronic shortages of skilled providers, remote and hybrid care models are the new norm. Product developers are rapidly designing and retrofitting products for safe remote and virtual access.
Consumer healthcare apps are on the rise, sitting at the nexus of self-driven, remote, and personalized healthcare. Today more than 350,000 apps for the detection, monitoring, or treatment of health conditions sit on top app stores, a number growing by over 250 apps per day. Apps for the detection, monitoring, or treatment of medical conditions are projected to grow by over 30% a year to over $17 billion in 2027.
The digital health marketplace is growing through both demand-pull and supply-push. On the demand-pull side, it’s instructive to look at continuous glucose monitoring. In 1999, Medtronic introduced the world’s first continuous glucose monitor (CGM) device, improving the standard of care for Type 1 and Type 2 diabetics. Over the ensuing decades, the technology was embraced and refined by additional medical device manufacturers targeting the treatment of diabetes.
In the past year, multiple startups – Signos, Levels Health, Nutrisense – have crossed the chasm from disease treatment to prevention, releasing CGM solutions targeted to consumers. Signos is undertaking a 20,000 person study to prove its device can help people lose weight. Levels Health is analyzing 51 million data points collected from users to rank the best and worst foods for managing blood sugar. All are navigating the happy problem of massive demand.
On the supply-push side, it’s instructive to look at Germany’s Digital Health Initiative, which establishes a legal framework for doctors to prescribe (and insurers to pay for) Digital Health applications. Based on its positive reception, the German approach has encouraged other countries to consider reimbursable apps. French president Emmanuel Macron recently announced plans to replicate the reimbursement model.
Rapidly maturing AR technology is making its way into the surgical theater. Augmented reality in healthcare has traditionally been the domain of medical training, through applications that allow medical students to interact with realistic 3-D simulations.
Increasingly, we are seeing the rise of AR in applications that reduce complexity and/or surface hidden information during live medical procedures. Accuvein superimposes AR visualizations of veins and arteries on patients, allowing clinicians to target needle placement more accurately. Medtronic’s partnership with Surgical Theater is helping surgeons navigate critical brain structures hidden deep within the cranium. The solution overlays AR renderings created from patient brain scans onto the surgical site, allowing surgeons to perform the most delicate and high-risk of surgeries with greater precision and confidence.
Although still in its early days, the partnership represents an exciting maturation of AR technology, with enormous potential for surgeons and patients alike.
Regulatory agencies have never been known for speed or agility. Add a global pandemic to the mix, and it’s easy to see why the pathway to EU-MDR (European Union – Medical Device Regulation) compliance is a longer and more winding one. According to an Obelis Group survey, more than 500,000 medical devices remain in queue to receive their new MDR certificates, and it’s taking organizations a daunting 13-18 months to obtain initial certification.
On January 6, 2023, the inevitable happened: the EU proposed an extension of its deadline, and while it was at it, narrowed the scope of the MDR in select device categories. (See this excellent blog and triage flowchart). However, the grace period comes with a caveat: device makers must have already been actively working towards conformance in order to qualify. Fair enough.
Across the pond, the FDA is doing its best to catch up with the extraordinary growth of digital health software. On September 28, 2022, the agency issued final guidance documents on clinical decision support (CDS) software, mobile medical applications , and medical device data systems. In early 2023, the agency updated its Digital Health Policy Navigator accordingly. An excellent summary of the changes is available on this blog.
The world of MedTech is ever-changing and always fascinating. What surprises are in store for the year ahead? Which trends will accelerate, and which will plateau? Along with our customers, I look forward to watching the future unfold.
Hanna Taller is a content creator for PTC’s ALM Marketing team. She is responsible for increasing brand awareness and driving thought leadership for Codebeamer. Hanna is passionate about creating insightful content centered around ALM, life sciences, automotive technology, and avionics.