Bridging the Gap: Navigating the Total Product Lifecycle for Medical Devices
By: Dr. Steven Farmer - Senior Partner, ABIG Health
The U.S. Food and Drug Administration (FDA) regulates the more than 175,000 medical devices that are on the U.S. market today. To enhance the transparency, efficiency, and agility of the agency’s oversight, FDA’s Total Product Life Cycle (TPLC) examines medical devices throughout their lifecycle — from development and design to post-market monitoring. The framework shortens review times, makes it easier for innovators to share information with the FDA, and helps FDA employees “develop a longitudinal, integrated, broader, and deeper view of device safety, effectiveness, and quality.”
Keep those three terms in mind. While absolutely essential, safety, effectiveness, and quality alone do not ensure market success.
While manufacturers need robust strategies to ensure successful engagement with the FDA, they cannot stop there. Challenges in the pre- and post-market phases in particular mean they must think about payer expectations at the same time they are working with the FDA.
Pre-Market Challenges: From Concept to First-in-Human
Inventor Wilson Greatbatch came up with the concept for the implantable cardiac pacemaker by chance. While engineering a machine to record the sound of an irregular heartbeat, he used a resistor that was the wrong size. Instead of recording the resulting device just emitted what sounded like an irregular pulse.
That sound was enough for Greatbatch to develop a concept. He abandoned his initial idea for a recorder and went on to develop a device that could stimulate a failing human heart. It took years before his invention ever came to market.
Today, the pre-market development phase includes a First-in-Human (FIH) study and approval of an Investigational Device Exemption (IDE), which is a regulatory pathway the FDA provides to permit use of a device in clinical studies. The IDE allows researchers to gather data on the safety and effectiveness of a new device, which is crucial for FDA approval.
While working to design trials that demonstrate safety and efficacy to the FDA, device manufacturers often underweight endpoints that are necessary to demonstrate the sort of health outcomes clinicians, patients, and payers want to see. Manufacturers limit early integration of reimbursement strategy into clinical development planning and miss opportunities to align evidence generation with broader stakeholder needs.
Market Entry: FDA Approval Is Just the Beginning
FDA market authorization does not mean a device is commercially viable. Indeed, as a result of the oversight discussed in the previous section, many devices enter the market without a clear path to coverage, coding, and, therefore, payment and reimbursement.
Typically, device manufacturers lack:
Robust data sets that demonstrate the impact the device could have on specific patient groups (this deficit is particularly gross when it comes to elderly populations);
Sufficient real-world evidence (RWE), or clinical evidence of a medical device’s safety and efficacy that is generated using real-world data (RWD) resulting from actual routine healthcare delivery;
Any notion of how to meet payer expectations.
The results of these oversights are devastating. They lead to delayed adoption and the manufacturer’s inability to recoup revenue — not to mention a failure to get a life-sustaining or lengthening device into the hands of practitioners and therefore patients.
Post-Market Hurdles: The Path to Coverage and Adoption
Device manufacturers can avoid this devastation by focusing on how to secure CPT/HCPCS codes for billing, establishing favorable payment rates, and creating strategies to obtain national and commercial payer coverage as soon as they enter the FHE and IDE stages.
Engagement with the Centers for Medicare and Medicaid Services (CMS) is essential to this work. That is because commercial payers often defer to CMS coverage decisions, particularly for novel technologies. Particularly in the current political environment where skepticism of drug and device manufacturers is high, if the federal government is willing to ask taxpayers to foot the bill, private insurers will follow.
And, again, the FDA’s bar for approval of a device is safety and efficacy. That demonstration is essential, but payers want more — especially payers backed by the U.S. Treasury. Because CMS places greater weight on improved health outcomes and cost effectiveness, device manufacturers who fail to develop studies that account for these questions will be at a disadvantage. Quite simply, CMS and private payers want proof of utility and long-term impact for patients in a real world setting.
Evidence that provides anything less will slow coverage decisions.
Recommendations: Planning for the Total Product Lifecycle
The good news is, much like the TPLC, there is a path device manufacturers can follow that can increase the likelihood of success before CMS and commercial payers.
First, innovators must strategize for regulatory and reimbursement approval as early as possible. This step means:
Aligning clinical trial design with both FDA and payer expectations; and
Including health economics, RWD, and patient-centered outcomes in studies.
It also means designing trials with dual-purpose endpoints. This step ensures a manufacturer will meet FDA’s requirements while also supporting compelling value propositions for clinicians and payers.
Third, it is important to engage stakeholders early and often. This step means:
Consulting with payers, clinicians, and patient groups during study design;
Leveraging advisory panels and CMS coverage pathways (e.g., CED: Coverage with Evidence Development); and
Iterating and adapting strategies so that they allow for post-market studies that close evidence gaps and proactively seek coding and payment decisions while building a compelling adoption story.
When Wilson Greatbatch presented his idea for an implantable cardiac pacemaker to his colleagues in the medical community, they balked. An idea, and even approval of an idea by the FDA, is just one milestone on a long journey toward market success. Patients, clinicians, and especially payers must be convinced.
Device manufacturers must have a lifecycle mindset to ensure patient access and commercial sustainability. Manufacturers, especially early-stage companies, must consider both regulatory and payer needs from the start to maximize the impact and adoption of their innovations. ABIG Health’s Go-to-Market Readiness services are designed to support both founders and product teams as they prepare for funding, launch, or scale. Whether your company is refining an early-stage concept, adding a new product or service, or gearing up to raise capital, we help you align your business vision with a practical, investor-ready strategy.
