Before a medical device reaches a patient’s bedside, it must go through a rigorous multi-step process that includes design, development, testing, regulatory review, and manufacturing.
Andrew Morton, Engineering Project Manager at StarFish Medical
StarFish Medical, a product development consultancy based in Victoria, British Columbia, helps companies large and small navigate this process and create breakthrough products for a number of medical specialty areas.
They couldn’t do this without some serious project management muscle.
We talked with Andrew Morton, PE, PMP, who manages the project management group, to learn more about the medical device design process, how StarFish Medical project managers collaborate with clients, and what it takes to be a project manager in the medical device space.
We have a project management office. At a very high level, the PMO is looking for consistency on projects. Do we have the minimum set of processes on our projects? Is that satisfactory to be successful for both internal tracking purposes, as well as to satisfy the needs of our clients? Are the PMs following those processes?
Being a consultancy, we have a lot of different clients and customers. The needs are very diverse. It’s often a tradeoff between what might work for 50, 80, 100 percent of the projects. We try to balance the needs of the majority with the needs of everything.
My background is in engineering. I have a bachelor’s degree in engineering/physics, and a master’s degree in mechanical engineering. Most of my professional experience has been in project engineering or project management. I’m a certified PMP.
I started in engineering and was always very interested in the coordination piece. Bringing together the efforts of many different functions within the organization and doing that in a structured way to get something really meaningful at the end of the day has always been appealing to me.
There are three things:
Whatever I’m doing, I want it to be meaningful. It helps substantially. The day-to-day challenges are diminished when you think about the impact our work has on people’s lives.
Cutting-edge technology is a huge interest of mine. New medical device design is very much in that area. We are pushing the boundaries of technology and finding ways to apply that in a meaningful way for people and patient outcomes. For me, it’s also interesting to be in a cross-disciplinary design environment, where we’re working on hardware and software.
What attracted me to StarFish is the company’s great reputation for excellence. Being a consultancy, we work on many different products at any given time. Everything we work on is quite diverse.
Within StarFish, we have design, regulatory, and manufacturing capabilities.
We have a phase-gate design approach. Phase 0 is our proof of concept, development process. Phase 1 is detailed design. Phase 2 is transfer to manufacturing.
In Phase 3, which is less common, we focus on sustaining engineering. This a product that is already being manufactured. There may be enhancements or feedback from the market about needed adjustments.
We touch all of those in our different phases. Sometimes we only help a client with a piece of Phase 1. Sometimes we get involved in the whole lifecycle, moving from Phase 0 to getting the product to manufacturing.
A lot of our work is around first of a kind development. I would put us in the category of new product development project management.
We are innovating a lot, and the path forward is uncertain. A lot of our projects lend themselves to Agile methods. We also do Phase 2 and 3 projects, in the manufacturing realm. Those are going to look like more traditional Waterfall approach to project management, where there’s very little design activities to be done.
Our project managers tend to focus more on the front-end design work, which I would put under the umbrella of new product development.
In regards to new product development, I think the major difference is that our products eventually need to be sold in a regulated environment, complying with FDA or Health Canada regulations.
While the regulatory piece is not uncommon in project management, I think it’s uncommon to be looking be looking at regulatory at the same time in new product development. We’re doing that from day one.
It really depends on the project. The one universal is that every project has a project manager. From there, one project can look very different from another.
Sometimes the client is one person, and he or she has a big idea. They have funding, but they don’t have any engineering capabilities themselves. They come to StarFish to do it all. In that case, there’s a project manager supporting them, and, basically, StarFish i...
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