Apr 3
TPP: The secret to efficient diagnostic device design
2020 highlighted the importance of rapid diagnostics. Many companies approached us in 2020 looking to develop a better COVID-19 diagnostic test. No matter what the technology, state of development or size of the company, we have found that the key differentiator between a successful medical device product and an unsuccessful one, was having a good, well-defined Target Product Profile (TPP) going into the development cycle.
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You and your team have made the decision to outsource the development of your medical device. Now, how to pick the best development partner? Finding the right development partner can be a daunting task, even in the best of times.
Starting a new job can be risky. Interviews reflect everyone on their best behavior. What will it really be like a few months down the line? StarFish is full of company culture. While preparing our January issue on medtech careers and recruiting, our employees shared their biggest surprises about working at StarFish Medical.
The ability to quickly verify Environmental stress cracking (ESC) is important because it is one of the most common failure mechanisms in parts made of polymeric materials. Proper selection of polymers is crucial to the successful design, production and longevity of any product, but it is particularly vital to the purpose and usage of medical devices. In addition to standard mechanical and thermal properties, sensitivity to environmental stress cracking should be a major consideration, especially when dealing with polycarbonate.
One of the key values at StarFish is that we “look deeper and solve the right problems.” This blog is about a situation where dig deeper – IEC 60601 saved me from potential problems later down the road.
FDA launched their pilot ASCA (Accreditation Scheme for Conformity Assessment) Program on September 25, 2020. The intent for the ASCA program is to utilize accredited third-party testing laboratories to assess premarket applicants’ declarations of conformity to consensus standards for safety, performance and biocompatibility. The final guidance outlining the accreditation scheme for the ASCA pilot program can be found 
This blog provides an overview of optical technologies for point of care (POC) medical devices that have been developed or show promise. Point-of-care (POC) testing is diagnostic testing conducted at or near the location where a patient is receiving medical care (away from a clinical laboratory).
3 compelling reasons to pursue a Bio Services career in medical devices
