To Speed Up MedTech Development, Engage Manufacturing Early
Most medtech entrepreneurs we meet say the same thing: “We need to move fast. We’ll figure out manufacturing later.”
We get it. Funding timelines are tight, investors want progress, and every month of delay feels like another lost opportunity.
But here’s what we’ve learned after 40 years in medical device manufacturing: the entrepreneurs who rush past early manufacturing conversations don’t move faster. They move backward.
The assumption seems logical. Why slow down to talk about manufacturing when you’re still perfecting the design? But “perfecting” a design without understanding manufacturing realities means you’re perfecting something that can’t be built at a reasonable cost. Sometimes it can’t be built at all. We’ve watched this scenario play out dozens of times: entrepreneurs discover the problem six months into their timeline, and changing course means starting over.
Here’s the counterintuitive truth: early manufacturing engagement protects your timeline and your budget. It ensures you’re building something that works the first time.
Why “Moving Fast” Often Means Moving Backward
We had a client approach us last year with what looked like a brilliant design. Beautiful CAD models, innovative functionality, and a clear market need. They’d spent eight months perfecting it.
The problem? Their design required a manufacturing process that only three suppliers in North America could handle, and all three had 18-month lead times. They hadn’t asked about manufacturing until they were ready to build.
This happens more often than you’d think. Entrepreneurs skip early manufacturing consultation because they’re trying to “save time.” What they’re actually doing is gambling that their design happens to align with manufacturing reality.
Sometimes they win that bet. Usually, they don’t.
Discovering fundamental manufacturing issues after you’ve locked your design is the hidden timeline killer. At that point, your options are expensive: find specialized suppliers with long lead times, redesign major components, or compromise features you’ve already promised to investors. Each option pushes your market entry back by months.
We see this pattern repeatedly. Engineers come to us with designs that look perfect on screen but require processes that will limit their supplier options, drive up costs, or create quality control nightmares. The earlier we see these designs, the simpler the fixes. When someone contacts us after they’ve already committed to a manufacturing approach, our options for helping them become much more limited.
What’s Possible vs. What’s Achievable
Advanced CAD software and 3D printing create a dangerous illusion: if you can design it and print a prototype, you can manufacture it. Sounds reasonable. Then you try to scale production.
A 3D-printed prototype proves your concept works. It doesn’t prove you can build 1,000 units at a cost your market will accept. We’ve reviewed designs that would require custom tooling costing more than the client’s entire Series A funding. The entrepreneur had no idea because their prototype looked great and worked perfectly.
Manufacturing continues to improve, but the communication aspect of the design process remains the same. You need to talk to people who understand process limitations before you finalize anything. CAD and 3D printing technology blur the line between what’s possible and what’s achievable. (And cost-effective.)
Here’s a question we ask clients early... What scale are you actually building for?
If you’re planning to serve 1,000 customers in your first two years, you can’t design like you’re Apple serving millions. Apple-level design complexity requires Apple-level manufacturing infrastructure and Apple-level budgets. A startup building a thousand units needs a completely different design philosophy focused on manufacturability and cost control.
The entrepreneurs who succeed understand this distinction. They design for the reality of their market, not for the aspirations of their pitch deck.
Why Off-the-Shelf Shortcuts Lead to Expensive Redesigns
There’s a pattern we see constantly, where entrepreneurs find an existing product, assume those parts can be sourced through Alibaba or off-the-shelf suppliers, and start building.
In the medical device space, this approach fails almost every time.
The regulatory environment doesn’t care that you found a cheap component online. You need documentation, quality systems, traceability, and supplier relationships that can withstand FDA scrutiny. That Alibaba supplier won’t provide the documentation you need for your 510(k) submission. Most off-the-shelf component manufacturers won’t either, unless they specifically serve the medical device industry.
Does this sound familiar? You build a low-budget prototype using components you can source easily. You test market acceptance. Customers love it. Then you start the regulatory process and discover none of your components meet documentation requirements. Now you’re redesigning from scratch.
We call this “building it twice.” Unless you’re testing market acceptance with a truly disposable prototype, early-stage low-budget designs waste effort. When you design with cheap OTS products, you end up redesigning later to meet regulatory requirements.
However, the cost of building twice goes beyond engineering hours. You’re also delaying market entry, burning funding on redundant work, and potentially losing the competitive window that made your device attractive to investors in the first place.
The Counterintuitive Path to Faster Market Entry
Early manufacturing engagement actually accelerates your timeline.
When you bring manufacturing partners into your design process early, they identify issues while they’re still simple to fix. A design feature that looks elegant might require custom tooling, adding three months to your schedule. A material choice that works perfectly in your prototype might not survive sterilization. A “reasonable” tolerance specification might double your per-unit cost.
Simple changes at the design stage become expensive problems after you’ve committed to an approach. We’ve seen modifications suggested by manufacturing partners that cut production costs by 30% without compromising functionality. These are small adjustments, but only someone familiar with the actual manufacturing processes would think to suggest them.
The manufacturers who’ll support your efforts long-term want to see that you understand these realities. If you define specific processes that very few suppliers have access to, you limit the number of suppliers willing to support your efforts. Design refinements for look and feel often complicate manufacturing if you don’t include the manufacturing side in the design.
Three Questions Before Finalizing Your Design
Before you lock your design, ask yourself:
Have you consulted manufacturing partners about your process requirements? Not just whether your product can be built, but whether your choices make sense for your scale and timeline.
Are you designing for the scale you actually need? Match your design complexity to your realistic production volume.
What will a redesign cost you? Calculate the real cost in time, money, and regulatory delays if you discover manufacturing issues late.
The Bottom Line
Early engagement with a team like Concise Engineering protects your timeline and your budget by ensuring you get things right the first time. That’s important because avoiding the expensive mistakes that slow everyone else down can be a real competitive advantage in medtech.
If you’re planning your manufacturing strategy and want to spot potential issues before they impact your schedule, reach out to schedule a call with Justin. We help entrepreneurs work through these manufacturing decisions before they become problems that derail timelines and burn through funding… And we can help you make sure your design efficiently translates to reality.
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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