
Knowing the Limits for Successful Medtech Design Transfer
Dana Trousil explores how understanding essential performance limits can drive successful design transfer in MedTech.
In the fast-paced world of medical device development, ensuring a smooth design transfer is critical for product success. However, a common pitfall arises when limits around essential performance are not well defined. In his recent article for Medical Product Outsourcing (MPO), Dana Trousil, StarFish Medical’s Mechanical Engineering Team Manager, dives into the challenges and solutions for addressing these issues.
Trousil highlights that understanding both what makes a product good—and more importantly, what makes it bad—is vital during design transfer. Without clear limits, variations in manufacturing processes can lead to unexpected issues and costly consequences.
Key takeaways include:
- The Role of Variations: Manufacturing variations—caused by factors like wear, machine vibrations, or environmental changes—can impact product performance even when inputs remain consistent.
- Defining Essential Performance: Essential performance parameters must be thoroughly explored during development to avoid narrow validation ranges that could lead to failures in full-scale production.
- Mitigation Strategies: Trousil discusses the importance of tools like Design of Experiments (DOE), proper tolerancing, and compensation circuits to manage variability and ensure consistent output.
Trousil emphasizes that failing to understand the limits of essential performance can result in:
- Increased production costs due to higher scrap rates or material rejections.
- Delays from additional manufacturing runs or sourcing unavailable materials.
- The need for costly post-launch revalidation efforts, including repeated clinical trials.
By characterizing the relationships between variables and testing edge cases, manufacturers can avoid these risks and ensure stable, scalable production.
To mitigate these risks, Trousil recommends:
- Resisting the rush through development phases to ensure a deeper understanding of core technology.
- Identifying key performance limits early in the process.
- Conducting thorough testing of input/output relationships.
- Designing systems to compensate for variations before validation activities.
About StarFish Medical
StarFish Medical provides award-winning design, development, commercialization, and flexible manufacturing outsourcing services —100% dedicated to the medical device and life science marketplace. StarFish Medical partners with innovative companies to create and manufacture breakthrough products for a full range of medical specialty areas including: Digital Health, Cardiovascular, Neurology, Urology, Gastroenterology, Otology, Ophthalmology, and In-Vitro Diagnostics.
StarFish Medical’s technical expertise includes electronics, mechanical, software/firmware systems engineering, in addition to industrial design and human factors. Regulatory Affairs (RA) and Quality Assurance (QA) consultants at StarFish Medical provide regulatory assistance for FDA, CE Mark and Health Canada submissions. Services include QA support for setting up QMS for start-up companies with implementation at the client’s site, and assisting with ISO 13485 certification audits..
Empowering Medtech Innovation®. www.starfishmedical.com
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