When I began my medical device career, I started as a product development engineer. Part of the role included—right, wrong, or indifferent—project management. And I’ve found throughout my career and from discussions with hundreds of others in the industry that this is very commonplace.
What I learned, however, a few years into my career is this: Just because you are a product development engineer does not mean you have any project management skills. I would even go so far as to state that most product development engineers are, in fact, terrible project managers.
Which poses the question: Why do so many medical device companies have product development engineers also serve as project managers?
I believe that project management should be its own discipline/function within a business and probably have different org chart reporting structures. In my early years of project management, I was taught or at least learned that this meant prolifically using Gantt charts and MS Project.
Yes, I’m guilty of drafting Gantt charts with well over 300 tasks. Yes, I’m guilty of the overuse and misuse of predecessor tasks and definitely was a bit of a “theory of constraints” disciple (thanks to The Goal). I remember being very proud of my Gantt charts, imagining and sometimes outwardly prophesying that this was our roadmap to project success. Did I really believe this or did I just want it to be true? Probably the latter.
I could continue on with several more examples of my project management faux pas. Let me summarize it this way: It took me longer than it should have to realize the misconceptions regarding project management.
Let me share with you seven project management tips that will hopefully help you to be a bit more successful with medical device product development.
Tip #1: Define project scope
What is a project? I think sometimes there is a great deal of confusion between a project and a product within medical device product development. A project defines the beginning, middle, and end of designing, developing, and launching a product. A project should have a defined beginning and a defined end.
All projects should have defined criteria and requirements. A key project requirement includes scope of work. What are you developing? What is the goal of the project? What resources will be required?
It is also important to know what is NOT in the scope of work, too.
You and your project team should be in alignment with the product you are developing. There should be alignment on the major milestones and deliverables. Yes, schedule and timeline are important but not so much that it should drive the project.
When defining project requirements with respect to timeline, think more high-level (e.g. Q2 2022) versus being too date specific. (I share some thoughts about schedule and timeline management below.)
Tip #2: Manage product requirements
The most important aspect of any medical device product development is 100% dependent on the product requirements. Think user needs and design inputs. It is imperative to define the requirements early. Otherwise, how will you really know if you are able to achieve project success? How will you know if your project timeline is realistic?
When defining requirements, it is very important to collaborate and to review with the team. Poor requirements definitions and lack of stakeholder buy-in will directly relate to project management failure.
A common mistake that I’ve seen is the desire to fully and completely define all product requirements in early stages of development. My advice to you is to be okay with iterating often throughout development. It is also okay to not know all the answers right away. Identify any ambiguous requirements so engineering doesn’t.
There is a point in time when making changes to requirements can be problematic. As you get later and later in the project and in development, too many big changes can become an issue that will wreck your project.
Don’t allow the requirements to frequently change drastically during development. Some change is expected, but if you’re giving the design team a new grand direction or new requirements every other week they’re not going to make forward progress on the big picture project.
Tip #3: Define regulatory strategy
One of the biggest impacts on a project relates to understanding the regulatory pathway(s) to bring the product to market. Identify the regulatory paths and options with a regulatory advisor and the project team very early on in a project.
I suggest that you also revisit this every few months or so because aspects of the regulatory landscape can change during the course of a project (e.g. new predicates, etc.).
A key component of project management success is about managing and mitigating uncertainty and ambiguity. And regulatory strategy and paths can be a source of uncertainty. I am a huge fan of the FDA pre-submission.
A pre-submission is a great way to get an audience with FDA regarding your product and the potential regulatory pathways. This option is especially useful for products that have some uniqueness or when you are trying to get some clarity about how FDA will view your product. Be aware, however, that the pre-submission process, while helpful in mitigating uncertainty, is technically non-binding from FDA.
Outside the U.S., the regulatory pathways are determined more by a rule-based/decision tree type of methodology. It is important for you to understand the potential markets for your product and how the product will be classified, knowing product classification will have a significant influence on project management.
One example, while an oversimplification, is that a class III device generally will be more complex, have more criteria to address, and take longer to bring to market.
Tip #4: Focus on tasks at hand
Project management success does require focus. Yes, being flexible, iterative, and nimble to pivot are important attributes of project teams. In order to focus, work hard to remove unneeded distractions.
For example: don’t allow every idea that an investor whispers in team members’ ears to become the new direction; it can derail the timeline and budget for the project. Take the suggestions and put them in your backlog of ideas for future evaluation and/or consider initiating a research project to explore viability of these ideas.
Tip #5: Manage budget & schedule
Remember that good project management is largely about managing and mitigating uncertainty and ambiguity. It might be very tempting to craft a very detailed Gantt chart that lists every single possible task you can think of as a means to manage and mitigate the project. I assure you that taking this path is not a path to project success. In fact, taking this path will definitely stifle project progress.
A highly detailed Gantt chart might be decently accurate within the next couple of months. However, beyond that, it will be too vague and inaccurate. And you will be constantly spending your time updating the Gantt chart.
Don’t mishear me, though. There might be points in time and aspects of project management where a Gantt chart can be useful. But realize that product development has a great deal of uncertainty and ambiguity in and of itself. Here are some suggestions to consider:
Long range: Roadmap at an executive level. Perhaps a very high-level Gantt chart that shows the major phases/stages and milestones.
Medium range: No detailed planning that looks further out than 2 months. No unit of measure finer than 1 week.
Short range: Blinded to project leadership. Let the teams self organize and manage themselves how it best suits them. Trust the team to do the work.
Focus on information needs for interdependencies, not tangible deliverables.
Plan out a high level schedule with extra time built in for design iterations, testing failures, and supply chain delays. I assure you that just about every product development project will have all of these “issues” surface at some point in time during the project.
The testing phases of a project can often present some of the more challenging parts of a project. Getting a good handle and understanding of the testing that’s required, as soon as you can, will be very helpful. Plan out the testing path early.
Verification, validation, reliability, fault injection, electrical and mechanical safety, other regulatory testing – any/all of this can inform requirements and cause design iterations, additional time, and increases in costs if not identified early.
You have to de-risk the testing path. Build confidence in your testing by running non-GLP or “benchtop” studies first. In fact, my strong advice is to leverage benchtop testing as part of your product requirements definition (previously described in this article).
Consider exploring multiple paths and options for the high risk and most uncertain items. If a potential solution to a technology issue is risky, figure out two or three ways to solve it, and pursue all of them in parallel.
Tip #6: Manage “go to market” process
One of the ultimate goals of a medical device product development project is to “go to market” (GTM). A major element of doing so will involve the transfer of knowledge and information from development to manufacturing. You’ve probably heard the term “design transfer” or “transfer to manufacturing.”
A mistake that some make is that they view design transfer as a milestone or finite moment in the project timeline. It is not. Design transfer should involve a series of tasks and activities and should begin fairly early in product development. Manufacturing should be a core member of the project team.
Be sure you firmly understand the manufacturing resource needs and allocation. This is especially true when you work with a contract manufacturer. Are there manufacturing engineers available to write work instructions? What about technicians for product testing? Who/how will the supply chain be managed?
As you get further into the project and closer to GTM, development and manufacturing should spend quite a bit of time working closely on verification and validation builds, pilot production, etc.
Tip #7: Assess & evaluate
The objective of any medical device product development should be about launching a product that will be successful and have a positive impact on the quality of life. How will you know that your product is going to be successful? When will you find out?
I suggest that you incorporate activities throughout the product development process, starting very early on, that engage key opinion leaders and eventual users of your device. Use these engagements as opportunities for inflection, introspection, and validation (not to be confused with formal design validation per se). At various stages of development, you will be making decisions based on assumptions and data. Having actual users involved improves the credibility.
While not every medical device warrants or requires actual clinical evidence prior to GTM, I do think there is a ton of value in building time, budget, and resources into your project management to address before the full product launch.
Yes, design validation and human factors/usability testing are definitely means to address this. Just give yourself the opportunities to learn, adjust, and react to what you learn from these activities before the full launch.
Do you want to learn more about project management? Here are a couple of resources suggested by one of the article co-authors.
Design Structure Matrix (DSM) - Design Structure Matrix Methods and Applications by Steven Eppinger and Tyson Browning
Distributed Leadership - X-Teams: How to Build Teams that Lead, Innovate, and Succeed by Deborah Ancona and Hendrik Bresman
Global Medical Device Podcast Episode - Project Management for Product Development of Medical Devices
Greenlight Guru Academy Course - Introduction to Project Management for Product Development of Medical Devices
Co-authors of this article:
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