Prototyping and Feasibility Studies

Feasibility Strategy

The Regulatory Role of Feasibility in Design History

FDA's design controls regulation (21 CFR 820.30) does not explicitly address feasibility studies — it addresses design inputs, outputs, verification, and validation. But feasibility work occupies a critical position in the design history because it is often where design inputs are first tested against prototype implementations, where early failure modes are identified, and where the design direction is established. Feasibility data that is not captured in the DHF creates a gap in the design narrative that FDA investigators will notice: why did you go in this direction rather than that one?

The practical question for most development teams is how much of early feasibility work should be treated as design-controlled and documented in the DHF, and how much can remain in engineering notebooks and internal records. The answer depends on whether the feasibility data will be cited to support design decisions in the DHF, used in the submission, or represent safety-critical choices that FDA would expect to see documented. We help teams make this determination before data is generated so that feasibility experiments are structured and documented appropriately from the start.

Bench Testing Protocols: Writing Tests That Mean Something

A bench test protocol is a pre-defined document that specifies the test objective, samples required, equipment and instrumentation, procedure, acceptance criteria, and pass/fail determination rules. The acceptance criteria must be written before the test is run — criteria defined after observing results are not acceptable in a regulated context. For feasibility studies, acceptance criteria may be exploratory (characterizing performance without a pass/fail threshold), but that framing must be explicit in the protocol.

Test protocols written for feasibility should be designed with verification protocol requirements in mind. The transition from feasibility to formal verification often involves running similar tests on design-controlled prototypes with tighter acceptance criteria — but the fundamental test method should not change significantly, because method changes introduce comparability questions. We write feasibility test protocols with the verification analogue in view, so the transition doesn't require a complete methodological restart.

Failure Mode Analysis During Feasibility

Early-stage FMEA during prototyping serves two purposes: it identifies design vulnerabilities before design commitment, which is when they are cheapest to address, and it produces risk information that feeds directly into the ISO 14971 risk management file. Failure mode analysis at the prototype stage is not a quality system exercise — it is an engineering discipline that shapes design decisions. The FMEA produced during feasibility becomes the baseline from which the formal risk analysis is developed, with each design iteration reducing or redistributing risk across the identified failure modes.

What We Deliver

• Feasibility documentation strategy: what to capture and where in the DHF
• Bench test protocol development for feasibility studies
• Failure mode analysis (FMEA) at prototype and pre-design-freeze stages
• Feasibility study reports with DHF integration
• Feasibility-to-verification transition plan: method bridge documents
• Design input extraction from feasibility findings
• Pre-submission gap analysis: what feasibility data supports vs. what verification still requires

Align Your Development Program