Medical Device Protocol Design for Clinical and Payer Decisions

Clinical evidence demonstrating safety and efficacy is not only critical for meeting regulatory requirements (through risk-benefit assessment) to be able to market your device, it’s valuable to clinicians and patients in understanding the preferred use of your device, health systems, and physicians in making purchasing decisions, and payers in evaluating product value and making reimbursement decisions.
Your protocol can be designed to answer clinical questions while also collecting evidence relevant to payer, provider, and health-system decisions. Planning those needs early can make the study more useful across the product lifecycle.
Before conducting your study and generating evidence, your clinical protocol must be approved by regulators and institutional review boards. Your protocol should detail your study objective(s), the rationale for conducting the study, study design, methodology, key definitions of primary events, situations requiring data to be excluded, data management and analysis techniques, and more.

The cost to conduct a pivotal study is typically in the millions. Depending on your device’s risk stratification (i.e., class designation), it may not be necessary to conduct a clinical trial for market release in the US. Class I and many Class II devices are typically exempt from needing to conduct clinical studies. In the EU, however, Class I & II devices require clinical evidence of safety and efficacy.
Evidence requirements depend on the device and submission pathway. Some 510(k) submissions require clinical data to support substantial equivalence.
Study success does not always imply device approval, and study findings often influence device modifications.

TTi helps MedTech teams select study designs, endpoints, comparators, and data-collection strategies that align with the clinical question and the decisions the resulting evidence is intended to support.
Our experts can maximize your pre-approval clinical studies by carefully adding economic endpoints to your planned clinical protocol, collecting crucial payer- and provider-focused data alongside safety and efficacy data within the same evidence-generation plan. If your studies are already underway and don’t include economic data, we can implement several possible strategies to collect this data.
With a collective 20+ years’ worth of successful FDA and IRB submissions, we can help develop your clinical protocol and handle IRB submissions.

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