Strengthen Medical Device Development with a Well-Defined Design Feasibility Gate

Additional Contributor: Tina Berthiaume 

Executive Summary 

In early stages of medical device design, many innovators or teams rely on a proof of concept, which focuses on concept function, not the holistic viability of the concept’s development pathway. Too many jump from concepts to detailed design without clearly defining an official, early milestone to vet design direction and confirm it can achieve both development and commercialization goals. 

A well-defined design feasibility gate clarifies what must be proven now, what can be deferred, and how to prove it efficiently. Officially integrating this into the design control process ensures cross functional input within the early design phases and reduces avoidable development risks that arise in later phases. Resulting in documented design iterations with key considerations that inform design inputs and a robust design history file for future reference and improved regulatory compliance.   

The Missing Milestone in Medical Device Design Controls 

Design controls require planning, defined design inputs, managing risks, and holding design reviews. These elements are necessary, but they do not explicitly require an early milestone that confirms a design direction is ready for detailed design. That gap leads to later phase development churn, schedule delays, and budget surprises. Design feasibility fills the early-design gap by defining the burden of proof, executing the leanest plan to meet it, and confirming results before detailed design. A well-defined design feasibility gate will answer a clear question: do we have objective evidence that this direction can satisfy requirements within real-world constraints? 

Medical Device Development Proof of Concept 

A proof of concept shows that a single idea can work. Teams build a prototype, run bench tests or evaluate user tasks, and gather data.  
 
“Proof of concept” in early medical device design phases is inconclusive because:  

• It focuses on one concept and overlooks strong alternatives. 

• It rarely checks system constraints like sterilization, environmental extremes, shelf life, shipping, serviceability, or cost of goods. 

• It may not tie results to written and testable requirements. 

• It can bias decisions before usability and safety risks are explored. 

Treat each POC as a proof point feeding feasibility, not the milestone itself. 

Design Feasibility: A Holistic Medical Device Development Milestone 

Design feasibility is the early gate that concludes, with evidence, that a design direction is ready to enter detailed design development. It is broader than a single proof of concept and different from pharma or clinical “feasibility,” which often refers to trial logistics. In devices, this early design work compares the following aspects to lead to informed down selection with the most viable direction to achieve feasibility. The output is a documented decision, including down-selection rationale and plans to close remaining gaps. 
 

The Design Feasibility Evidence Package, Organized and Right-sized 

Use the minimally viable evidence approach, for each element. Define the smallest proof that credibly closes risk with a blend of applied research, utilization of prior data, SME rationales, and / or targeted testing. 

User 

• Critical task list with risk ratings and acceptance criteria. 

• Formative or simulated-use findings on critical tasks, representative users and environments, observed use errors, & mitigations planned. 

• Early UI flow, labeling, and training concepts where relevant. 

• Possible Deliverable for Design Feasibility: Capture 2–3 short sessions on the highest-risk tasks with task-level success thresholds in design review, a full formative study isn’t required.  

Technology 

• Bench or breadboard data for hardest performance claims, including tolerance and repeatability, sample sizes justified. 

• Software behavior evidence for safety-related functions, data integrity checks, cybersecurity threat thinking at a high level. 

• Constraint checks: sterilization modality and materials compatibility scan, packaging concept plus basic transit exposure, shelf-life rationale or plan, environmental exposures, serviceability paths. 

• Possible Deliverable for Design Feasibility: An initial testing rig to measure key metrics under worst-case conditions; materials screen against the likely sterilization modality; ISTA-lite exposure on a packaging mockup. With testing set up, initial data, and noted risks or further development areas noted to discuss in design review.  

Business 

• Preliminary COGS model with the top cost drivers and sensitivity band. 

• Pricing and reimbursement scan, including target codes or coverage path where applicable. 

• Development timeline realism and supplier implications at a high level. 

• Possible Deliverable for Design Feasibility: a 1-page cost model with three costed assemblies, a payer snapshot, and a list of supplier gating items with a summary to discuss in the design review. 

Requirements and risk traceability 

• Summary of design parameters with considerations and initial acceptance criteria. 

• Summarized risks noted with design parameters or summarized into an initial risk tracker that will be referenced for official risk management files. 

• Possible Deliverable for Design Feasibility: Note the high-consequence design parameters and / or risks and show initial analysis via rationales, previous product or competitor data, and / or initial applied research testing. 

Decision record 

• Controlled documents summarizing areas of feasibility along with a meeting record that includes an independent reviewer for the down-selection meeting(s) and design review(s). 

• This can include multiple documents and an electronic record that will become part of the Design History File.  
  
  

Design Feasibility, Done Right.  

• Map the burden of proof: Identify the few questions that could break the program. Turn each into a proof point tied to a requirement, a hazard, or a constraint, with clear acceptance criteria. 

• Prototype with purpose: Use fast-to-function rigs for critical mechanics and feels-like models for tasks and ergonomics. Measure what matters. Skip polish. 

• Keep options alive, then down-select: Explore viable concepts or variants in parallel. Compare with quantified tradeoffs. Maintain multiple options, as appropriate based on risk, until feasibility is achieved. 

• Right-size with an MVP of evidence: For every element, define the smallest credible proof early in the process. Rely on applied research, prior art, and SME rationale where risk is low. Reserve testing for the remaining unknowns.
• Hold an independent review and record the decision: Include qualified reviewers who were not the builders. Capture issues, resolutions, the go or hold, and owners for open gaps. File the record so it carries into development.

Add Design Feasibility as An Official Medical Device Development Milestone 

If your medical device roadmap jumps from concepts to detailed design, add the missing gate. A formal, focused design feasibility milestone gives leaders credible forecasts, reduces late rework, and sets up the project for success. We can help you plan the feasibility effort, build the right proof points, and facilitate an independent review so development progresses smoothly with confidence. Get in touch. It’s never too early.  

FAQ 

What is a proof of concept in medical device development? 

A proof of concept shows that one idea can work under defined conditions. Treat it as an input to feasibility, not the go-forward milestone. With Veranex’s Innovation CRO approach, proof points are executed by one cross-disciplinary team, so usability, engineering, and regulatory learnings feed each other in real time, not in vendor silos. That reduces churn and accelerates decisions.   

What is design feasibility and how is it different? 

Design feasibility is the early gate that proves a design direction can satisfy testable requirements within real-world constraints. It evaluates multiple concepts or variants and ends with a documented decision. Veranex integrates the evidence across discovery, rapid prototyping, human factors, regulatory strategy, market access strategy, and even considering manufacturing scale-up, so feasibility is a single evidence stream rather than a stack of disconnected studies.  

How does design feasibility fit within design controls? 

Feasibility operationalizes planning, inputs, risk management, and design reviews into one decision point early in development, then carries the record into the Design History File. Utilizing the same team to execute early discovery, usability, and engineering also aligns regulatory, quality, and commercialization strategies, will de-risk regulatory submissions and strengthen your evidence plans for market adoption and success.  

What evidence is required to pass the design feasibility gate? 

A right-sized, risk-based minimum viable evidence package of testable requirements, targeted results, simulated-use findings based on critical tasks, and early constraint checks like sterilization, packaging, shelf life, and cost. Best constructed with cross-functional teams, because, with Veranex, design, software, human factors, manufacturing, regulatory, quality and market access live under one roof, so you get decision-grade evidence without relaying between vendors.  

About the Author: As Vice President, Innovation and Technology, Joe Gordon drives innovation by identifying strategies, opportunities, and technologies impacting clients across medical devices, healthcare delivery, diagnostics, and consumer healthcare. Over 30+ years and 400+ projects, he leads cross-functional teams developing creative solutions for complex challenges, including a digital surgical robotic system developed in just over three years. Joe excels at guiding innovation through chaos, bringing clarity to complex concepts, and navigating crowded patent landscapes while building robust IP protection strategies. His expertise spans complex capital systems, next-gen wearables, and integrated drug delivery platforms.