Photo by Tool., Inc on Unsplash Over the past few years, I’ve been a mentor for startups launching from Washington State University (Go, Cougs!). Most of the co-founders I work with struggle to understand their product-market fit. They aren’t alone –...
Medical Products
Resolving the Biomanufacturing Talent Shortage
I’ve been working on talent development projects since 2018. Still, this effort kicked into a higher gear in 2020 when we received a grant to develop a Bioscience Career Launch program in our regional high schools. I’ve learned much from my colleagues and our...
FDA Guidance for Real World Data and Evidence
The collection and use of Real World Data (RWD) and Real World Evidence (RWE) is a hot topic of conversation. The number of commercially available mobile devices incorporating biosensors has increased dramatically since the first smartphone in 2007. The...
The eSTAR Program for 510(k) and De Novo Submissions
The FDA's electronic Submission Template and Resource (eSTAR) program currently supports medical device submissions for 510(k) clearance or De Novo evaluation. The program is voluntary, but these templates will be mandatory once the FDA publishes an adoption timeline....
What Does CLIA Mean For Laboratory Testing?
Testing for SARS-CoV-2, the virus that causes COVID-19), continues to be in the news, and you may hear the term CLIA in some of these conversations. CLIA refers to the Clinical Laboratory Improvement Amendments, which are amendments to the Public Health Act...
Hot New Medical Technologies
Part 1 - Additive Manufacturing of Medical ProductsLately, it seems like science fiction has exploded into the media. From the rapid delivery of effective vaccines against SARS-COV-2 to the first civilians in space, the pace of change is dizzying. This month’s series...
Setting Drug Expiration Dates
Have you ever wondered how the expiration date is determined for a pharmaceutical product you’ve used? Whether prescription or over the counter, all medications have their expiration dates determined through a stability program in which batches of the product are held...
Standards Organizations Play a Role in Medical Product Regulation
Regulatory bodies worldwide make use of consensus standards developed by independent organizations to establish best practices and conceptual harmony on specialized areas of expertise. Standards organizations for drugs include the regional Pharmacopeia USP, EP, and JP...