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 […]
Posts categorized as“Project Management”
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.
After years of trial and error, I have come up with a few proven ways to manage technical teams with the goal of everyone wins. The result is a happy, collaborative team and satisfied client. Here they are in no specific order:
One universal attribute of project management is that each company’s deployment will look a little different. Obviously technology commercialization projects are going to be managed differently than infrastructure or IT, but even within the domain of technology projects, there can be considerable difference.
Very few first product realization versions meet the expectations of end users. That is normal and should be anticipated and addressed with “enterprise business agility.” Managing evolving requirements is now a core competency given our changing business requirements (and technical specifications) based upon a better understanding of the likes, wants and dislikes of health care […]
There are lots of stories about FDA recalls where the FDA notes that if the vendor had followed the FDA’s approach, the recall could have been avoided. With that as our inspiration, our blogging team of medical device designers, developers, QA/RA, and manufacturing professionals recently brainstormed 11 medical device development mistakes that have surfaced multiple […]
The New Year brings reflection and desire to improve. We asked our designers, engineers, manufacturing, supply chain and regulatory experts to consider projects finished in 2017 and think about things they could have done better or wish they had considered. Here is their list of 2018 resolutions and smart things to do that would speed […]
The top 10 StarFish Medical blogs of 2017 feature a heady mix of regulatory, engineering, and practical information and advice. Seven of the blogs are perennial favorites with high ranking on Google and other search engines. The remaining three are from new writers and hint of new evergreen standards in the works. New or tried […]