MD+DI: Hidden Costs of Medical Device Sterilization
In a recent article for MD+DI, StarFish Medical Project Engineer Nigel Syrotuck examines the hidden medical device sterilization costs that many development teams overlook when estimating the true cost of producing a terminally sterilized device.
Syrotuck opens with a striking observation: for many sterile devices, hidden costs can account for roughly a third of total production cost. Limiting a cost model to raw parts, assembly, and sterilization fees alone can result in underestimating total cost of goods sold by as much as 30%. He argues that understanding these costs matters for two reasons: setting accurate sale pricing targets and knowing where cost reduction efforts will have the greatest impact.
The article walks through the main cost categories most teams plan for, including raw parts, assembly, and sterilization fees, before turning to the costs that tend to surprise teams. These include shipping to and from the sterilizer, inspection and inventory management, distribution to customers, ongoing sterility testing, and cleanroom and contamination management. Syrotuck notes that shipping costs, in particular, make up a larger share of margin for lower-cost products and that planning for efficient pallet shipping during the design phase pays dividends later.
One of the more actionable points in the article is the connection between design decisions and downstream costs. Syrotuck highlights assembly cost as an area where design choices have an outsized effect, noting that parts designed to snap together quickly or processes supported by well-designed jigs can meaningfully reduce costs compared to approaches requiring fasteners or adhesives.
The article closes by noting that a complete cost picture also requires accounting for non-recurring costs such as sterilization validation, tooling, and production losses. For teams building profitability models around sterile disposable devices, understanding medical device sterilization costs in full is essential before setting a sales price.
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.
Related Resources
Many teams still underuse CM&S, often bringing it late in device validation, when key decisions have already been made. That approach leaves much of the value of CM&S untapped.
This article traces the Pennes bioheat equation from its 1948 origins to modern multiscale approaches, explaining how engineers select the right level of modelling complexity across device categories.
Five methods for building accurate project estimates, from gut feel to bottom-up, plus three add-ons that sharpen any estimate.
Designers and engineers today have no shortage of tools to improve designs, accelerate timelines, and meet cost targets. The challenge is knowing what to use and when.