Medical device companies are under intense pressure to develop programs that get their products on the market fast. For the leaders in charge of the small or mid-sized firms that don’t have in-depth manufacturing engineering or manufacturing expertise in-house, that pressure manifests in the questions they repeat as they lay awake at night. Does my […]
Outsourced guidance on medical device packaging and sterilization comes at a cost many wish to avoid. Read about why that’s a bad idea.
See how manufacturing outsourcing partners help medical device companies navigate FDA 510(k), ISO 13485 & ISO 11607.
“Cost” is an awfully big word for being only four letters. And as developers of point-of-care diagnostic reagent blisters know well, the costs to bring reagent blister products to market have many different sources. Some are easier to spot than others. Some stay hidden until it’s too late, putting years of work (and lots of […]
The mechanical forces specified to access reagents packaged in on-board microfluidic blisters used in point-of-care diagnostic products is essential to their clinical use. But designers of these products must consider how these activation forces relate to risks inherent to the blister manufacturing process that could manifest in later clinical use. Identifying the ideal blister pack […]
The most obvious marker of a reagent blister product’s success is whether the test it helps perform provides fast, accurate results that guide patient care. But clinical factors are only a small share of what ultimately determines the viability of reagent blister products. Developers might be less familiar with the design and manufacturing considerations that […]
J-Pac Medical has commenced EtO sterilization services. New Ethylene Oxide services include “worst case,” EO exposure cycles to support packaging validation and material compatibility studies important to new medical device development. J-Pac also offers sterilization cycle development as well as contract sterilization for small footprint devices as well as bioabsorbable implants that need low-temperature EtO […]
J-Pac is monitoring and following the guidance from the US Centers of Disease Control’s “Interim Guidance for Business and Employers,” for plans, preparation and response to Coronavirus Disease 2019…
-Adds Additional Customer Support to Support Growth- Somersworth, NH– December 11, 2019 – J-Pac Medical announced today the addition of Kienan Hibbard in the position of Director of Program Management. Kienan will assume responsibility for all new customer project coordination including all customer facing project activities. This new role addition manages the new product realization […]
The FDA recently held a panel meeting regarding Eto Sterilization. Topics included replacement sterilization methods, reduction in EtO usage, impact of shortages, and reduced SAL requirements. J-Pac is currently adding in-house EtO capacity to help our customers, especially early stage customers, cope with the capacity reduction experienced in the industry. Learn more at https://lnkd.in/fVri6ja