Medical device commercialization is typically broken into Four Phases: Phase Zero Product Definition, Phase One Engineering Design and Development, Phase Two Transfer, and Phase Three Manufacturing. This blog covers Phase Two Medical Device Transfer to Manufacturing tips and examples from our employee experts.
Medical device projects generally have an S-Curve Model curve for costs. Low at the beginning, rising steeply in the middle and then flattening out towards completion. To manage costs, effort should always be put into the early stages of a project (or product development) to ensure that the project is as well defined as possible […]
I realized recently that I’ve been leading product development projects for more than a quarter century now, with a bunch more years of product design experience on top of that. Over this time, I’ve collected a list of project management tips that seem more and more valid to me as time goes by.
Have you made your medical device commercialization resolutions for 2023? We polled our quality, regulatory, project management, manufacturing, and engineering experts for their New Year resolutions. De-risking early, communicating often, testing, and managing pivots were top themes for 2023. Read their medical device commercialization resolutions below:
Working effectively as teams with distributed members will continue to be of utmost importance, even as many of us return to the office. This blog explores three concepts we use to improve teaming in our project managment group.
We share our newest and most interesting blog posts in a monthly newsletter. Inevitably some articles prove more popular than others, so we have consolidated a list of the most read 2022 Medical Device Articles determined by our readers.
The risk management approach ALARP (As Low As Reasonably Practicable) to AFAP (As Far As Possible) and medical device risk management has always been a tricky one. The nature of the products, their intended use, and the markets in which they are sold influences the approaches in controlling risk. When it comes to risk, the […]
I could spend a lot of time trying to make sure my medical device project plan is useful. But most effective proof for me is hearing this phrase: “Hey Doug, I was looking at the plan…”. Let’s count the wins in that phrase: 1) Someone thought about accessing the plan. AKA, they saw value in […]
My goal as a medical device development program manager is to save time while managing risk. I save time by reinforcing a concept you likely apply every day, but might not use in your medical device development project. In my experience, dealing with the fires of the day always take precedent over managing things that […]
Although engineering students graduate from their program well-equipped with the theoretical concepts taught in class, they often lack practical knowledge regarding their particular industry [1]. Such gaps between technical teachings and industry requirements could potentially be filled by integrating an industry perspective into programs and course delivery. Further benefit can be derived when such industry-integrated […]
Two new medical device commercialization blogs, one returning champion, and two new authors join our 2021 “most read” list. Electrical engineering amd regulatory articles tie for the most popular blog topics. Many thanks to our employee authors past and present for sharing their insights and experience with medical device colleagues.
Our top 2020 medical device development videos include 6 new videos. They join favorites from previous years and cover subjects including 2020 updates, COVID implications for research and POC devices, optimizing founder value, manufacturing for NPI, IVD insights, and working at StarFish.
