When a company believes they’re ready to take their medical device to market, they often discover that what they thought was the finish line is actually just the beginning of a much longer journey.
“People often come to us and say they’re basically ready to go to market,” explains Andy Schimmoeller, Senior Project Manager at CMD MedTech. “They’ve built something that works, they’re ready to go, but they haven’t started all the documentation and the process required to get through the various phases.”
This disconnect represents one of the most common medical device project management challenges facing companies today—particularly startups and teams new to the medical device space. Understanding these challenges early can mean the difference between a successful FDA submission and expensive delays.
Here’s what every medical device company needs to know about managing projects from concept through FDA submission.
Issue #1: Timeline Expectations
One of the biggest misconceptions about medical device development timeline expectations is how long it takes. While a typical commercial product might take a year to develop, medical devices often require 2-3 years—and that’s after the technology is proven to work.
This extended timeline is the result of fundamental differences between commercial and medical device development:
Depth of Risk Assessment
Medical devices require comprehensive risk analysis across multiple dimensions—patient safety, operator implications, cybersecurity, and usability. Commercial products face lower stakes and typically require less extensive risk documentation.
Regulatory Documentation
The FDA, notified bodies, or other regulatory agencies don’t want to see a finished product–they want to see the complete design history showing how you discovered issues, addressed them, analyzed risks, and evolved your approach across safety, cybersecurity, and usability dimensions.
Phased Validation Process
Certain activities have minimum timelines regardless of technology readiness. Verification and validation processes that confirm the device does what it’s supposed to do and that users can operate it appropriately follow established timeframes that cannot be compressed.
Issue #2: Underestimating Medical Device Project Risks
When managing medical device project risks, it’s best to start at project initiation, not after problems emerge.
The most successful approach involves implementing comprehensive risk tracking from day one using a risk signal chart or key performance indicator (KPI) tracker that monitors several risk categories.
Monthly risk reviews allow teams to discuss potential mitigations, identify new risk management strategies, and maintain open, honest communication about project health, which includes:
Performance Risk
Can the technology actually deliver the therapeutic effect or diagnostic accuracy required? Has the team demonstrated that their system can take proper measurements or deliver appropriate treatment?
Regulatory Risk
Does the development approach align with FDA expectations? Are there gaps in the regulatory strategy that could cause submission delays?
Business Risk
For startups especially, this includes investment milestones that directly impact project funding. Many startups face the challenge of needing to demonstrate specific achievements before receiving additional capital, creating a parallel set of milestones that may not align perfectly with the natural progression of medical device development.
Technology Readiness
This concept goes beyond whether something works in a lab. It encompasses understanding what problems remain to be solved and having a realistic plan to address them before investing heavily in regulatory documentation.
Issue #3: Getting the Timing Right for FDA Submission Project Planning
Strategic FDA submission project planning requires understanding not just what the FDA, notified bodies, or other regulatory agencies want to see but also when they want to be involved in the process. This timing can significantly impact project success.
The FDA and other regulatory agencies expect to have input on certain aspects of device development and provide feedback at key stages. Success depends on building these FDA interactions into the project schedule at appropriate points.
For clinical studies and usability testing, the FDA expects to review protocols before implementation. Scheduling these FDA meetings requires careful consideration:
- Information Readiness: You need the right information available to facilitate productive discussions. Too early, and you won’t have enough detail. Too late, and you may have already committed to approaches that the FDA questions.
- Strategic Question Framing: How you ask questions matters enormously. Approaching the FDA requires strategic regulatory thinking about what to ask and how to frame it. Questions that are too specific or too open-ended can lock you into unfavorable approaches that cost significant time and money to reverse.
Issue #4: Lack of Comprehensive Project Scheduling
You can build the perfect project schedule for developing a medical device, but it won’t be 100% accurate. “Things change, and you know that going in,” Andy says. Dates are never exact, durations shift—yet understanding your medical device development timeline through detailed scheduling remains essential.
So why invest time in detailed scheduling? Because the schedule’s real value lies in showing relationships and dependencies.
A comprehensive project schedule’s true value lies in showing how activities connect and depend on each other. As things change, evolve, or new requirements surface, teams can update the schedule to see the cascading impact and communicate it effectively.
This becomes a critical communication tool that helps teams:
- Visualize complexity: The schedule links together activities from multiple disciplines—systems engineering, regulatory, quality, software, hardware, and mechanical engineering.
- Assess impact: When delays occur or new requirements emerge, the schedule immediately shows how those changes ripple through the project.
- Manage expectations: Rather than surprising stakeholders with delays, the schedule provides early warning and supports data-driven discussions about timeline and resource needs.
- Track performance: Using earned value management techniques, teams can project completion dates and budgets based on actual progress and efficiency.
Issue #5: Not Realizing the Cost of Underestimation
Perhaps the most common of all medical device project management challenges is underestimation—of timeline, budget, and complexity. Companies coming from commercial product backgrounds often struggle to grasp the additional requirements medical devices demand.
The challenge isn’t just the absolute time and cost, but the implications for business planning and fundraising. Startups especially need realistic projections to secure adequate funding rounds, set achievable investor milestones, make informed decisions about MVP features versus future generations, and plan for the actual runway needed to reach revenue.
When to Engage Project Management Expertise
The pattern we commonly see at CMD MedTech? Companies that engage experienced project management early fare significantly better than those that wait.
For startups and companies taking their first product to market, timing is everything. “The sooner proper plans can be put in place, risks identified, and the pathway laid out with all the steps, the better they’re able to plan, budget, and raise funds,” Andy emphasizes.
This early engagement allows teams to:
- Identify minimum timelines: Certain activities have irreducible timeframes. Knowing these upfront prevents unrealistic promises to investors or partners.
- Spot technology gaps: Engineering expertise combined with regulatory knowledge helps identify issues before they become expensive problems.
- Make strategic trade-offs: Not every feature can make the first generation. Experienced project managers help teams determine what’s MVP and what’s generation two based on value, feasibility, and timing.
- Plan FDA interactions: Understanding when and how to engage the FDA can accelerate rather than delay the process.
Don’t Let Hidden Challenges Derail Your Medical Device Project
The difference between medical device projects that succeed and those that struggle often comes down to one factor: engaging experienced project management early enough to establish realistic plans, identify risks before they become crises, and navigate FDA requirements strategically.
Ready to discuss how integrated project management can help your medical device development avoid delays? Contact CMD MedTech to learn how our approach keeps projects on track from concept through FDA submission.