Mastering Biomedical Engineering Project Management
Getting a medical device to market is no easy feat. The journey is full of tough challenges, from making sense of complex regulatory requirements to managing multiple specialists. That means that for biomedical engineers, project management isn’t a “nice to have”—it’s a must-have that can make or break your innovation.
Think about this: According to the Project Management Institute, organizations that undervalue project management have 50% more project failures. When one mistake can cost years of delay, can you afford to take that risk?
Here’s an example: A startup was halfway through their prototyping phase for a new wearable medical device when they discovered their design wouldn’t meet FDA requirements for data security. The oversight cost months of delay and a big budget blowout. With proper project management, this could have been identified and fixed in the planning stage—which would have saved a lot of time and money.
Biomedical Engineering is Changing
Biomedical engineering is moving fast, which means new challenges for project managers and entrepreneurs.
First and foremost, regulatory requirements are getting more complex. The FDA is increasing its scrutiny of medical devices, especially in areas like software as a medical device (SaMD) and artificial intelligence/machine learning (AI/ML) technologies. This means project teams need to be more on top of compliance at every stage of development than ever before.
Another big change? More entrepreneurs are entering the space without traditional product design backgrounds. While this brings fresh ideas, it also means many teams lack the experience to navigate the complexities of biomedical product development. This gap means strong project management is more critical than ever to get these exciting innovations from concept to market.
All of this means a robust project management approach is a necessity. Without one, even the best ideas risk getting stuck in regulatory hurdles, technical challenges, or resource mismanagement.
The Project Manager as a Sounding Board
One of the key roles of the project manager is to filter and prioritize new ideas. When an engineer comes up with a game-changing idea mid-project, it’s the project manager’s job to evaluate the impact on timelines, resources, and overall project goals. They ask the tough questions: Does this new idea align with our primary objectives? Can we fit it in without blowing the deadlines or budget? What are the risks and benefits?
For example, during the development of a new surgical robot, an engineer might propose a cutting-edge AI feature mid-project. While the feature might surely be innovative, implementing it would delay the launch by months and require additional regulatory approvals. A good project manager would evaluate the proposal, consult with stakeholders, and decide on whether to implement it now, save it for a future iteration, or dump it.
Communication and Reporting
Another of the key benefits a project manager brings is the ability to communicate progress. They translate technical jargon into clear, actionable information that non-technical stakeholders can understand and act on. This is super valuable when dealing with investors, regulatory bodies, or partnering organizations who need to be informed but may not have the technical background to interpret raw engineering data.
For example, instead of bombarding stakeholders with the intricacies of a device’s circuitry, a project manager might report: “We’ve miniaturized the power supply, making it 30% smaller with the same performance. We’re on track to deliver a more user-friendly product.”
Dealing With Regulatory Changes
Project managers also need to stay ahead of regulatory changes, especially as technology outpaces the regulatory frameworks. A good project manager keeps current with these changes and anticipates how they will impact the project. For example, when the FDA released new guidance on cybersecurity for medical devices in 2018, proactive project managers were already incorporating this into their development process so they wouldn’t have to do costly retrofits later.
By preparing for regulatory hurdles, project managers can smooth the path to market. For example, when developing a new AI-powered diagnostic tool, a project manager might schedule early meetings with the FDA to discuss the new technology and get feedback on the development and testing plan. This proactive approach will avoid surprises later in the development cycle and speed up the approval process.
Managing Scope Creep and Design Changes
New research findings, new technologies, new changes in market demand—all of these can impact your project. However, unchecked changes can lead to scope creep, budget blowouts, and missed deadlines. This is where the Concise Engineering approach comes in:
A formal change control process ensures all proposed changes are evaluated for impact on timelines, resources, and project goals before being approved.
A priority matrix to assess the urgency and importance of proposed changes helps the team decide which changes to implement now and which to delay.
Regular design reviews allow for controlled points to discuss and incorporate changes rather than constant disruptions to the workflow.
When Do You Need a Project Manager?
Knowing when to bring in professional project management can be a big win for biomedical engineering projects. Here are the key signs it’s time to consider professional PM support:
Project complexity: As your project grows in size or technical complexity, a dedicated PM team can help manage the details.
Multiple stakeholders: If you have multiple stakeholders (investors, regulatory bodies, partnering organizations), a PM team can help coordinate communication and align goals.
Regulatory hurdles: When dealing with complex regulatory requirements, especially for new technologies, professional PMs with industry experience can be a big help.
Resource constraints: If your technical team is already stretched, PM support can free them up to focus on the engineering work.
Missed deadlines or budget overruns: These are often signs that current management approaches aren’t robust enough for the project.
The Takeaway
The importance of getting a PM involved in biomedical projects can’t be overstated. By bringing in project management expertise from the start, you can define clear goals and realistic timelines, develop comprehensive risk management plans, and get regulatory considerations in from day one.
Realizing the value of project management can be the difference between a great idea that never gets out of the lab and a product that changes patient care. As you start your project journey, consider the challenges you’ll face and the expertise you’ll need to overcome them.
However, remember that you don’t have to do it alone. Contact Concise Engineering today to discuss your project management needs—our team can provide the expertise and support you need to navigate the complexities of biomedical product development and get your life-changing innovations to those who need them most.
Next Steps
Justin Bushko
President, Concise Engineering
We hope you find this newsletter valuable and insightful.
If you have any questions, if you have feedback or would like to explore any specific topics further, please feel free to reach out to us.
Please email me at jbushko@concise-engineering.com or to book a call with me, click this link.
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