Why Your MedTech Project Keeps Missing Milestones (And How to Fix It)
You have a brilliant medical device idea. You’ve secured initial funding. Your engineering team is talented. Yet somehow, you keep missing the milestones you promised investors.
Sound familiar?
We see this pattern constantly in the MedTech space. Smart engineers with solid technical skills find themselves drowning in project coordination, scrambling to meet deadlines, and discovering requirement gaps after work has already started. The problem? Engineers are being asked to orchestrate entire product development processes while simultaneously designing the device.
Here’s what we’ve learned from working with dozens of MedTech startups: not making milestones usually comes down to project structure, not technical capability. And if you’re struggling to hit your deadlines, understanding why this keeps happening is the first step toward fixing it.
The Hidden Cost of “Figuring It Out As You Go”
Most entrepreneurs we work with discover project requirements as they go rather than understanding the full scope upfront. This isn’t because they’re unprepared—it’s because the MedTech landscape has become incredibly challenging to navigate.
The regulatory world keeps changing. FDA requirements evolve. Design control expectations shift. More entrepreneurs are entering the space without formal product development backgrounds. They’re learning these requirements in real-time rather than planning for them from day one.
What happens? Backward steps. We’ve watched companies lose six months because they missed a key verification requirement and had to circle back. One client discovered halfway through prototyping that their biocompatibility testing approach wouldn’t meet FDA expectations. Another realized their design history file documentation was incomplete only after building three iterations.
These backward steps don’t just delay timelines—they erode investor confidence. When you promise specific milestones and keep pushing them back, funders start questioning whether you have the right team structure in place.
What’s actually missing is clarity about scope from the beginning. When you understand the full regulatory path, documentation requirements, and testing protocols before diving into design work, you avoid those expensive do-overs.
The “Idea Chasing” Problem that Engineers Face
Engineers need a sounding board, not an endless stream of new ideas.
We’ve seen this challenging dynamic repeatedly: A founder gets excited about a potential feature enhancement or pivot based on a conversation with a potential customer. The engineer starts exploring it. Then another idea comes. And another. Before long, your talented engineer is chasing multiple directions instead of executing on the core design. We have seen this occur with other firms losing nearly a year and a cold, hard million before being corrected.
One of our recent clients had a brilliant biomedical engineer who spent half his time creating investor presentation decks rather than solving technical challenges. Engineers aren’t trained communicators - they’re trained problem-solvers. But without dedicated project management, they become the default person handling everything from CAD work to PowerPoint slides to investor updates.
The burnout we see from this pattern is real. Engineers lose focus. Quality suffers. Deadlines slip because attention is fragmented across too many responsibilities.
A dedicated project manager serves as that strategic filter. When a new idea emerges, the PM evaluates it against project goals, regulatory requirements, and the project's timeline. Some ideas get incorporated. Others get parked for version two. The engineer stays focused on the technical work that actually moves the product forward.
Strategic filtering protects your engineering resources so they can deliver on the core innovation you’ve already committed to investors.
Why Project Managers Shouldn’t be Optional
Bringing a medical device to market now demands specialized knowledge that makes dedicated project management essential for staying competitive.
Regulatory requirements alone require deep expertise. You need someone who understands design controls, risk management protocols, verification versus validation testing, and how to structure documentation for FDA submissions. More entrepreneurs are entering MedTech from other industries, which is fantastic for innovation but means they’re navigating this regulatory maze without a guide.
We’ve found that strong project management in MedTech does four essential things.
First, it helps everyone understand the full scope before work begins. Instead of discovering gaps mid-project, a good PM maps the entire regulatory pathway, identifies testing requirements, and plans for documentation from day one.
It also provides that strategic sounding board we mentioned. PMs evaluate ideas and changes against project objectives, keeping the team focused on execution rather than constant pivoting.
Third, it handles communication so engineers can engineer. Your PM creates those investor updates, coordinates with testing facilities, manages vendor relationships, and keeps all stakeholders informed. Your engineer focuses on solving technical challenges.
Finally, it enables you to proactively course correct. We had a client project where our PM identified that the testing approach wasn’t yielding useful data. Instead of continuing down that path, we adjusted the methodology and brought in a different specialist. The project stayed on track because we caught the issue early and had the authority to make changes.
This kind of management directly impacts investor confidence. When you consistently meet milestones and provide professional project updates, funders see that you have the right team structure in place. They’re investing in execution capability, not just technical brilliance.
What Good Project Management Looks Like in MedTech
Not all project management approaches serve your interests equally.
Some firms operate on a scope creep business model—changes and extensions create additional billable hours, so there’s a financial incentive to let projects expand. We take a different approach. We want your product to be well-designed and efficient. Our goal is successful market entry, not maximized billing.
The difference shows up in how projects run. We focus on the division of labor that actually accelerates progress: Engineers handle technical challenges. PMs coordinate team efforts and manage communication. Founders focus on investors and future customers.
Our project managers understand how engineering teams work together. They identify waste, capture what’s been accomplished, and adjust course when something proves inefficient. Sometimes that means changing the testing approach. Sometimes it means adjusting staffing to better match project needs.
Here’s what a typical week looks like with this structure: Your engineer spends 40 hours on actual design and problem-solving work. Our PM spends 10 hours coordinating testing, updating documentation, communicating with stakeholders, and planning the next phase. You spend your time talking to investors and potential customers. Everyone stays in their zone of expertise.
Get the Right Team Structure Now
Product development demands only increase from here. A smart team gives you investor confidence and accelerates progress.
At Concise Engineering, we help companies understand the full scope upfront, so you’re not discovering gaps after work has started. Our PMs keep projects on track while your engineers focus on innovation. We’ve built our approach around efficiency—getting well-designed products to market, not maximizing changes and revisions.
If you’re missing milestones or wondering whether dedicated project management would help, let’s talk. Schedule a call to discuss your project, identify next steps, and determine who else should be involved at this stage. We’ll help you build the team structure that turns technical brilliance into market success.
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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