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 […]
Posts categorized as“Project Management”
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 […]
As a seasoned project manager, and years of trial and error, I have come up with a few proven ways to manage technical teams with the goal for everyone to win. The results are usually a happy and collaborative team and a satisfied client. Here are five practical tips for managing technical teams.
Testing underpins the entire medical device development process. It provides the tangible evidence of device efficacy and safety. Testing generally begins with a reasonably ad hoc approach in Phase Zero for proof of concept and then shifts to a more formalized testing strategy to address safety and efficacy. At this point in time, product definition […]
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 […]
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 […]
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 […]
Looking for a good resolution to improve your medical device commercialization in 2019? Here are 9 great resolutions recommended by our team of engineers, designers, QA/RA, and manufacturing professionals.
StarFish Medical videos are created to help viewers learn about medical device design, development and manufacture. They are also a great way to get a better sense of the people you will be partnering with at StarFish. The top 10 viewed Starfish Medical videos for 2018 include 2 new videos and many favorites from previous […]
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 […]
A Decision Matrix is a decision making technique used when a number of candidate solutions exist and one or more must be chosen for further development. It was proposed by Kepner and Tregoe in 1965 as part of the Kepner-Tregoe methodology.
There is more to project management than looking after the budget, timeline and resources. Much more is needed to maximize opportunities for success. Here are five things project managers can do to achieve great results and empower team members to perform at their best.