SVP, Chief Revenue Officer
Walk the floor at The MedTech Conference and the innovation is impossible to miss: AI-enabled imaging, nanoparticle therapies, implanted neurostimulators, and molecular tests designed to run outside the lab. But in my conversations with sponsors this year, from first-in-human device developers to established diagnostics companies, the questions that kept coming up weren’t about the technology. They were about evidence: what regulators will expect, how to fund the studies that generate it, and how to make sure the data that wins authorization also wins adoption. Three themes stood out.
1. Clinical evidence is a strategy, not a milestone
Too many development programs still build evidence one milestone at a time: a feasibility study to answer a safety question, a pivotal study to satisfy FDA, and then, often too late, a scramble for the data clinicians and payers need. Each step is designed in isolation, and each new question means a new study.
The sponsors best positioned for success are planning evidence once. They define endpoints, populations, and comparators that serve regulatory, indication-expansion, and commercial goals at the same time. That matters most for early-stage companies, where limited runway means there is rarely budget for a second pivotal study.
Real-world evidence is part of this conversation, but as a complement to prospective studies rather than a replacement. Data quality, relevance, and regulatory acceptance remain real constraints, and sponsors who treat RWE as a shortcut risk learning that lesson late.
2. For diagnostics, authorization is not the finish line
Diagnostic developers face a gap that is easy to underestimate: the distance between regulatory authorization and commercial adoption. A test can demonstrate strong analytical and clinical performance, earn clearance, and still struggle to gain coverage, because clinical utility and reimbursement evidence were never part of the plan.
This is especially true for molecular, companion diagnostic, and early-detection tests, where payers want to know not just whether a test is accurate but whether it changes decisions and outcomes. Point-of-care and decentralized tests add another layer: performance must hold up across settings and intended users, not just in a reference lab.
The answer is not more studies; it is better-designed ones. Building clinical utility endpoints and payer-relevant questions into validation studies from the start can shorten the path from clearance to adoption considerably.
3. Regulatory readiness starts earlier than most sponsors think
For novel technologies, including De Novo devices, AI-enabled software, combination products, and first-of-a-kind therapies, the hardest regulatory question is often not which pathway to choose. It is whether the evidence will be ready when the sponsor gets there.
The most effective tool for reducing that uncertainty remains early engagement with FDA, particularly through the Pre-Submission program. Sponsors who bring a well-reasoned evidence plan to FDA early, covering intended use, endpoints, reference standards, and study risk, get feedback while it is still inexpensive to act on. Those who wait often discover gaps after studies are underway.
AI-enabled devices raise a related question: how to generate evidence not only for initial authorization but for algorithm updates across the product’s lifecycle. Combination products add jurisdiction and dosing questions that need answers before the first protocol is written.
What this means for sponsors
The common thread across these conversations is that clinical and regulatory strategy can no longer be treated as downstream activities that begin once the technology is ready. The sponsors moving fastest are building evidence planning into development itself: asking early what regulators, clinicians, and payers will need, and designing studies that answer all three.
At Beaufort CRO, that is where we see the greatest opportunity to help: working alongside sponsors from early feasibility through pivotal and postmarket studies to build evidence strategies that hold up at every stage. Innovation gets a product noticed. Evidence gets it to patients.