Posts categorized as“Product Development”

50 years of research in stem cell biology, immunology, molecular biology, genomics, engineering and advanced materials, are transforming the therapeutic landscape much like antibiotics once did for infectious diseases.  Regenerative Medicine (RM) and advanced therapeutic products encompass a very diverse and broad range of approaches that enable the body to repair, replace, restore and regenerate […]

In a previous medical device company, I worked on a project where First-to-Market (FTM) was a deemed a priority for the company’s survival.  To meet that highly compressed timeline, we decided to skip the phase-gate process and replace it with a FTM production release strategy. FTM product commercialization carries a much higher overall project risk […]

Observations are an integral part of summative evaluations, the final validation that a device’s user interfaces are safe to use. During a summative evaluation, the manufacturer sets up a set of scenarios that capture all of the tasks that the device is expected to perform. The manufacturer creates environments that mimic the real use, capturing […]

When I arrived at StarFish with my idea for a patient handling device, I had just completed my engineering degree and was searching for further education in medical device development. Fortunately for me, StarFish provided master-level classes (albeit unaccredited) in project management, including Dealing with Vendors 101: Expect Delays and QMS 201: How to Maintain […]