When you have a GI tract issue, do you go to a gastroenterologist or a general practitioner? If you want to handle a property dispute, would you go to a real estate attorney or a general practice attorney? Now, think about your medical device project. If you want a project manager for it, would you prefer a typical project manager or a project manager with experience in the medical device industry?
The math is simple.
If you want the best service, you need to go to people who specialize in it.
Just because someone understands the problem doesn’t mean they have the knowledge and skills to resolve it effectively. There are numerous reasons why a project manager with experience in medical device development is always better than one without. Below, you’ll find some of them.
Why it is better to have a project manager with experience in medical device development.
Reason #1: A project manager experienced in medical device development knows about industry requirements and quality systems regulations specific to the industry.
The medical device industry is highly regulated to ensure patient safety and product efficacy. These quality systems regulations are an integral part of the development process and guide every aspect of it, from ideation to manufacturing.
So having your project manager learn on the job–for the first time–how to do a Class II or Class III FDA submission is really good education for them but a disservice to your project.
A project manager well-versed in medical device development knows how to:
- Obtain regulatory approvals and compliance with ISO 13485 or FDA.
- Implement robust risk management processes to identify, assess, and mitigate potential risks throughout the project lifecycle.
- Integrate quality practices at each stage of the lifecycle, from design and development to manufacturing and post-market surveillance.
- Ensure that proper documentation is maintained throughout the project
- Select and manage suppliers who also adhere to quality standards.
- Ensure any device modifications are implemented in a controlled and compliant manner.
- Be prepared for audits and inspections.
Plus, your medical device development project will be the most cost-effective when you focus on the speed and quality of development. And the less your project manager knows, the longer it takes for them to learn. And the longer it takes for them to learn and implement, the longer it takes them to plan, manage, and execute a successful project.
Reason #2: Project managers experienced in the medical device industry have a highly developed BS meter.
A project manager experienced in medical devices can estimate task completion times and predict potential bottlenecks. They also have a highly developed BS meter when it comes to medical device development projects.
This is particularly helpful because engineers often have a distorted view of their(or their team’s) capabilities. They may over or underestimate their ability to get something done on time. Experienced project managers are good at knowing when an engineer is trying to pull a fast one on them and when they’re for real.
This allows them to set realistic expectations for getting specific tasks done quickly and identify and address issues before they become major problems.
Reason #3: They can handle the volume of documentation recorded
Medical device engineering is 90% documentation and 10% “real” engineering.
The sheer amount of documentation can slow down the pace of a project significantly. If the project manager doesn’t get that upfront, they’re going to be very frustrated at the pace of the project’s progress. Or, they may be wildly optimistic about the project. Neither of which is conducive to a successful project.
A project manager’s first priority is to accomplish the project on time, efficiently, and with the right level of quality. This means having the foresight to predict task completion times, team members’ availability, capabilities, and potential obstacles. And this requires experience with similar projects. I.e. other medical device projects.
This helps the medical device project manager ensure that everyone is on the same page and that the project is on track to meet its goals.
Reason #4: Your project manager is the face of your project team.
A project manager serves as the face of a medical device project in several key ways. They:
- build trust and transparency by effectively communicating project updates, progress, and challenges to various stakeholders, including team members, executive management, regulatory bodies, and clients.
- collaborate with the team, make decisions to mitigate risks, and find solutions to ensure the project stays on track.
- often serve as the primary point of contact with the client, building and maintaining a positive client relationship.
- also represent the project in front of investors and potential business partners if needed.
They may not know everything about the project, but they know where to get that information. At times like these, not having a medical device background becomes very obvious very quickly, and it’s not a good look for representing the project team or the company. Conversely, if you have someone who does know medical devices and can speak to it more widely, that looks very good for both the project and the company.
While a project manager without experience in medical device development can still be effective, choosing one with experience in medical device development can make a significant difference in the success of your project. Project managers experienced in the medical device industry can understand the industry’s requirements and regulations, manage the volume of documentation, predict potential bottlenecks, and serve as the face of your project team, ensuring that your project is completed efficiently, effectively, and with the right level of quality.
Are you developing a medical device? Or perhaps looking for a medical device project to manage?
With over 600 projects under our belt, Waddell Group is a team of project management consultants ready to lead medical device projects to success.
If you are:
- a project manager wanting to or already specializing in the medical device industry,
- a company looking for project managers experienced in the medical device industry
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