Strategic Project Planning for Medical Device Development
In medical device development, engineering brilliance alone isn’t enough. True success depends on disciplined, strategic project management, the kind that anticipates challenges, controls risk, and creates a path that’s both aggressive and realistic.
At Concise Engineering, we believe that effective project management is the backbone of every successful MedTech innovation. In this edition of MedTechMan, Justin Bushko, President at Concise Engineering, breaks down the core principles that drive project success in medical device development—principles shaped by decades of hands-on engineering, regulatory navigation, and real-world product launches.
Start With Detailed, Grounded Planning
A successful project begins long before CAD models or prototypes, it starts with clarity. When setting up a development program, it’s essential to define timelines, budgets, and responsibilities at a granular level. High-level milestones may look good in a presentation, but they rarely provide enough structure to guide a team through a demanding regulatory and engineering process.
When setting up a development program, it’s essential to define timelines, budgets, deliverables, and responsibilities at a granular level. Many teams create high-level milestones that sound impressive on paper but lack the depth needed to actually guide execution. These broad strokes may look good in a presentation, but they rarely support a team through the realities of verification, validation, regulatory interaction, and iterative engineering.
“You’ve got to go through a lot of low-level detail to make sure you’re going to get to the end where you need to be,” Justin explains. This means understanding each step of your development cycle, knowing what resources you need, and identifying where risks are likely to appear. Teams that invest in this early-level detail inevitably navigate challenges with greater confidence.
More importantly, it means identifying where risks are most likely to appear and incorporating strategies to address them before they become schedule killers. Risk mitigation is not a late-stage activity. It begins the moment the project is conceived. By evaluating technical uncertainties, regulatory dependencies, and potential failure points early, teams can shape a plan that absorbs disruption rather than collapses under it.
Teams that invest in this early-level detail inevitably navigate challenges with greater confidence. They know what to expect, they understand the interconnectedness of tasks, and when setbacks arise (as they always do), they have the foresight and buffer to course-correct without derailing the entire project. Grounded planning doesn’t just support a project, it strengthens it, giving teams both clarity and momentum as development moves forward.
Plan for Iterations Because They Will Happen
One of the most common pitfalls in medical device development is planning as if everything will work perfectly the first time. It rarely does. Many teams create a schedule with statements like, “We’ll finish on Friday and ship Monday,” but real-world engineering simply doesn’t behave that neatly.
Unexpected issues, component failures, design oversights, and supplier delays will surface. A prototype might need rework. A part may require redesign. A verification test might reveal a variable you didn’t anticipate.
A resilient project plan gives you space to fail early, fix intentionally, and keep moving without blowing the entire timeline. Teams who build iteration cycles into their schedule stay on track. Teams who don’t often find themselves scrambling.
Build in Time for FDA Communication
Regulatory engagement is another area where unrealistic planning frequently causes delays. The FDA review process is iterative by nature. Even with strong documentation, the agency may request clarifications, additional data, or adjustments to your approach.
This means FDA interaction must be treated as a living part of your plan, not an afterthought. Include time for Q-sub meetings, feedback cycles, and documentation updates. Recognize that regulatory timelines shift, and your plan should shift with them. When communication is anticipated and structured, delays become manageable rather than catastrophic.
A proactive regulatory strategy not only keeps you compliant, it keeps your team aligned and reduces the stress of unexpected requests. When communication is anticipated and structured, delays become manageable rather than catastrophic, allowing the project to maintain momentum even in the face of evolving regulatory expectations. Ultimately, your relationship with the FDA should feel like an ongoing dialogue, not a series of last-minute scrambles.
Expect Certification to Take Longer Than You Think
Electrical, mechanical, and safety certifications, especially through organizations like UL are major milestones in device development.
Certification failures don’t mean the project is doomed. They mean the project needs time. Teams who plan for certification failures can recover efficiently; those who don’t often face major budget overruns.
Success demands:
Early stage testing
Iterative risk mitigation
Design-for-compliance reviews
Certification retest cycles built into the schedule
When certification is treated as a formality, projects stall. When treated as a pathway, they succeed.
Create a Realistic Timeline You Can Actually Deliver
The strongest project managers aren’t the ones who build the shortest timelines. They’re the ones who build realistic ones. A realistic timeline acknowledges that testing may reveal new design challenges, that FDA interaction requires patience, and that certification can extend longer than expected.
This is the heart of medical device project management: anticipating failure without being derailed by it. When teams build in time for iteration, regulatory communication, and certification complexity, they create pathways that lead to consistent, predictable progress, even when obstacles appear.
Justin Bushko
President, Concise Engineering
Next Steps
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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