MD+DI: Medical Device V&V Cost and Timeline Explained
In a recent article for MD+DI, StarFish Medical Project Engineer Nigel Syrotuck breaks down the realistic medical device V&V cost and schedule for terminally sterilized devices, picking up after design freeze and walking through each major phase of the process.
Syrotuck frames V&V as one of the most consequential milestones in medical device development. Passing moves a team toward regulatory clearance and market launch. Failing means time spent solving problems just to return to the same point. For terminally sterilized devices specifically, he notes that schedule and sample costs tend to run higher than most teams anticipate relative to testing fees alone.
The article identifies four cost categories teams need to budget for: testing fees, sample builds, engineering effort, and schedule. Testing fees for sterilization, aging, biocompatibility, package testing, and related work typically run between $150,000 and $250,000 USD. Sample builds require roughly 300 to 500 production-equivalent units. Engineering effort should be budgeted at an average of at least one full-time equivalent engineer across the program. On schedule, Syrotuck notes that a device targeting a one-year equivalent shelf life should allow at least six months to reach regulatory submission, with additional time to follow up on real-time aging results.
The article also emphasizes that upfront planning shapes everything that follows. Locking down sample sizes, vendor relationships, cleanliness requirements, and sterilization processes before building anything reduces surprises later and keeps the program on track.
For teams also evaluating the broader cost of producing sterile devices, Syrotuck’s related MD+DI article on the hidden costs of medical device sterilization offers a complementary perspective on what drives total COGS beyond V&V.
Explore the full discussion by visiting the complete MD+DI article.
About StarFish Medical
StarFish Medical is a full-service medical device design, development, and specialty manufacturing company headquartered in Victoria, British Columbia, with additional offices in Toronto and Irvine, California.
StarFish Medical works with founder-led start-ups and global enterprises across North America that need to navigate the complexity of building and launching regulated medical technologies. The company combines product design and development with quality and regulatory expertise and manufacturing readiness to help teams move from early concept through commercialization and scaled production. Its experience includes diagnostics, drug delivery, surgical, therapy, and remote devices.
Founded in 1999, StarFish Medical has grown into Canada’s largest full-service medical device design, development, and commercialization partner. It operates as part of StarFish Holdings, which also includes ViVitro Labs, a global cardiovascular device testing company with facilities in Victoria and Marseille, France. In 2020, StarFish Medical led a multi-company Canadian team that updated the Winnipeg Ventilator to address COVID-19 supply chain and operational challenges.
Empowering Medtech Innovation®. www.starfishmedical.com
Contact Patrick Dean, Director of Marketing, for media inquiries.
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