Policy Windows and Patient Impact: A MedTech Moment Worth Seizing

A quiet but consequential policy development unfolded last week: U.S. Representatives Blake Moore (R-UT), Suzan DelBene (D-WA), Rudy Yakym (R-IN), Terri Sewell (D-AL), Gus Bilirakis (R-FL), and Lori Trahan (D-MA) introduced the Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 5343), advancing a bipartisan push to close the longstanding gap between FDA approval and Medicare coverage for innovative medical devices. While it didn’t dominate headlines, the bill—along with its previously-introduced Senate companion (S. 1717)—has the potential to reshape the innovation-to-access timeline for seniors in profound ways. 

Today’s innovators operate in an increasingly complex ecosystem, where regulatory, policy, and communications pathways must be aligned to bring novel therapies to patients, particularly aging Americans who rely on Medicare. Despite FDA approval, medical devices often face a multi-year lag before CMS issues a coverage determination. The consequences of this are deeply personal for patients and create significant headwinds for companies charting a viable path to market. 

The Narrative team has closely tracked this landscape, and one trend is increasingly clear: the traditional device-versus-drug framing is becoming obsolete. Many of today’s breakthrough products—wearables, implantables, and bioelectronic devices—blur those lines. They deliver therapeutic benefit but do so through novel platforms that don’t neatly fit into existing reimbursement models. 

Case in point: a wearable oncology device that uses electric fields to target cancer cells. Approved by the FDA in 2011, the device wasn’t covered by Medicare until 2019, despite clear evidence of clinical benefit. That eight-year delay illustrates the very access gap Congress is now attempting to close. 

However, legislation alone isn’t enough. Manufacturers must help catalyze this policy window with smart, diversified engagement. 

We see a unique opportunity for MedTech leaders to rethink their external affairs approach. That means articulating the clinical and economic value of their products, elevating real patient stories, deploying new communications platforms, and building broader coalitions.  

• Engage emerging influencers in the MAHA-verse. Reach audiences that shape opinion within the Administration by connecting with conservative-aligned health organizations, podcasts, and outlets trusted by key decision-makers. 

• Expand traditional alliances. Equip physicians, advocacy groups, and policy champions with compelling, data-driven narratives about what delayed access costs in lives and dollars. 

• Create convening moments. Whether through summits, roundtables, or virtual town halls, elevate the conversation about how CMS and FDA can better align to reflect the pace of medical innovation. 

These are not just tactics—they are strategic investments in the policy environment that will determine whether the next generation of medical breakthroughs reaches patients in time. 

The path forward requires both policy action and sustained public affairs strategy. By combining smart coalition building with a sharp understanding of today’s policymaking dynamics, MedTech innovators can seize this moment, not just to shape legislation, but to redefine how life-saving devices are valued and accessed in the healthcare system. 

At Narrative, we help our partners translate innovation into impact. This legislation represents a critical inflection point. Now is the time to move.