BoneZone Journal: Risk Management Under ISO and MDR
March 10, 2020
How to Approach Risk Management Under ISO and MDR Updates by Virginia Anastassova, StarFish Medical Regulatory Affairs Manager/Senior QA Specialist, is the ASK THE...
June 4, 2020
The June 4, 2020 online edition of MPO features Six Key Design Features to Ensure Medical Device Packaging Meets ASTM D4169 written by Nigel Syrotuck, Mechanical Engineering Team Lead, at StarFish Medical. Subheaded “Well-thought-out packaging is an oft-delayed but essential part of ensuring a medical device operates safely and effectively in the field,” the article draws on Syrotuck’s personal experience and research.
“Shipping conditions can vary wildly over a range of temperature, impact forces and vibrations, pressure, time, and other factors. U.S. and EU medical device regulations do not call out a “required” set of specifications, so it’s up to the designer to choose a standard or pick their own. ASTM D4169 is a common choice respected by regulatory bodies. Using this standard, rather than defining your own parameters, helps put quantitative values to the possible stresses related to common forms of shipping (rail, truck, air, etc.) as well as other considerations,” notes Syrotuck before providing his six key design features.
Design features include: Design for Shipping, Carts Are a Little Special, and bonus tips not directly related to the ASTM Standard.
Syrotuck concludes the article noting: “The goal is always to maintain the safety and efficacy of the medical device throughout its lifetime. At the end of the day, it’s up to the medical device designer to ensure the risks are understood and mitigated as much as possible through effective packaging design.” READ THE FULL ARTICLE.
Nigel Syrotuck is a mechanical engineer team lead at StarFish Medical. His background includes a diverse project development portfolio including sustainable power solutions, assisted living devices, and nano-satellite design. Read Nigel’s StarFish Medical blogs here.