Posts categorized as“Product Development”

While every inventor wants his/her product to reach the market first, it is not often an easy task. The technical capabilities required are many in number and the unknowns are greater. This is even truer for medical device first-time entrepreneurs who have a prototype and are maneuvering through processes, FDA requirements, certifications and mass manufacturing […]

The demand for medical devices that must do more with less power is continually increasing.  So, what kind of tricks can we designers resort to in order to keep up with increasingly stringent power requirements? As usual, creativity and good judgement play a key role in successful designs. Here are 10 tips to help improve […]

Electromagnetic Compatibility (EMC) testing is a key part of device development for medical or other devices. It consists of two different sets of tests: Emissions testing, and immunity testing. As you might guess from the name, emissions testing looks at the electromagnetic emissions from the device under test (DUT), while immunity testing looks at what […]

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 […]