Posts categorized as“Project Management”

Martine Janicki

Managing Medical Device Software Projects: Realities and Tips

Very few medical devices consist solely of electro-mechanical technologies these days. Most have firmware to drive the core therapeutic or imaging modalities. Medical device software (including an algorithm to compute results), and data transfer logic connect the devices to hospital networks and populate enterprise data warehouses. In my experience, writing, testing and debugging medical device […]

Astero StarFish

Insights and observations that spark medtech innovation

Improve your medical device innovation process Everyone has a mental toolkit of innovation – a series of patterns that innovative people find. They take something and they break it into pieces or they take pieces and put them together or they put things upside down or they hollow them out or they turn them inside […]

David Felix

3 ways to leverage talent in medtech development  

I would like to take us all back to high school Biology for a moment to remember the concept of emergent properties. These properties only come out when individual parts start interacting with each other in any given system. Take common salt for example. The fact that it tastes salty does not mean that the sodium and chlorine which make up salt also taste salty. Saltiness […]

Andrew Morton

Program Architecture: Engineering for the Vision and the Mission

Medical device commercialization projects often require the Project or Program Manager to also wear the hat  of “Program Architect.”  “When it is obvious that the goals cannot be reached, don’t adjust the goals, adjust the action steps.” Confucius What’s your product vision? And what is the mission that you will undertake to get there? These are […]

Promita Hazra

How to use Agile in medical device 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 […]

Henry Ho

First-to-Market strategy, trade-offs and tips for medical devices

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 […]