Don’t Sweat the Supply Chain: Proactive Strategies for Sourcing Success
We had an entrepreneur reach out last month whose team spent nearly two years developing a cardiac monitoring device. Strong clinical data, engaged investors, clear regulatory pathway... Everything looked good.
Then their component supplier called with news that stopped everything cold: their primary microprocessor was back-ordered for eight months because of automotive demand.
This is something we see over and over in medical device development. Supply chain disruptions don’t care about your development timeline or funding runway. While you’re solving the hard technical problems (which absolutely should be your focus), the availability of components shifts in ways that can kill your project.
This is because the medical device industry creates unique sourcing challenges that don’t exist in other sectors. Component changes trigger cascading effects through your design files, testing protocols, and regulatory submissions.
How can you get ahead of these challenges? Learn to understand supply chain dynamics before they become crisis situations.
The Supply Chain Risks Nobody Talks About
Most entrepreneurs we work with focus intensely on perfecting their technology and treat sourcing as something they’ll figure out later. That can work in many industries, but medical devices are different.
Because when Tesla ramps up production or Ford goes electric, they consume massive quantities of the same microprocessors and sensors used in medical devices. We’ve seen components go from available to “impossible to source”—overnight—because automotive contracts dwarf medical device volumes by orders of magnitude.
To make matters worse, process validation adds complexity that catches many teams off guard. If you’re developing something that needs to be sterilized, your manufacturer has to validate the entire process for your device. Here, we’re talking months of documentation, testing protocols, and regulatory paperwork.
Teams that wait until their design is “done” to start these conversations add 6-12 months to their timeline right when they thought they were finishing up.
Another problem we see frequently: entrepreneurs who let their manufacturer control design documentation. When a manufacturer offers design support, promises faster development, and makes everything sound easier, it can be easy to hand over the reins. And sometimes it works out fine! But we’ve also helped companies who found out they didn’t actually own the documentation for their own product when they needed to switch manufacturers. You definitely don’t want to make this mistake.
Why Startup Sourcing Strategy Must Be Different
We’ve seen startups damage supplier relationships by approaching negotiations like established players. But the truth is that walking into meetings with volume projections but no purchase history creates an awkward dynamic.
A supplier might engage politely, provide quotes, and attend meetings—then prioritize million-unit orders when production slots get tight.
Large manufacturers love to hear about your growth potential, but they’re managing real production schedules with real capacity constraints. When you’re ordering 1,000 units but demanding enterprise-level treatment, you’re asking them to bet their production efficiency on your future success. Most won’t take that bet, especially when established customers need the same capacity.
The entrepreneur who doesn’t recognize this dynamic often pushes harder, talks loudly about investor backing, makes bigger promises about future volumes, and so on. This usually backfires because it highlights the mismatch between current reality and future aspirations.
Mid-tier manufacturers understand startup realities better. They’ve built businesses around companies at your stage and know how to balance current volume constraints with growth potential. These partnerships typically provide the attention and flexibility that emerging medical device companies actually need.
Remember, success requires matching your approach to your actual situation—not your projected situation. Be straightforward about current volumes, realistic about timelines, and clear about the kind of partnership you need right now. This will build a productive relationship instead of creating disappointment.
Building Your Sourcing Strategy
Don’t wait until you’re ready to manufacture; check lead times and supply stability now. We often recommend clients purchase key components with extended lead times well ahead of their production needs. Yes, this ties up cash, but it’s cheaper than missing a market window.
After all, that microprocessor that’s easy to source today might become scarce if demand patterns shift in automotive or consumer electronics. Research the broader ecosystem around your key components to anticipate potential bottlenecks.
Second sourcing is a great strategy here, but it requires more planning than most teams realize. Alternative components need separate testing and validation work, which, for regulated devices, can extend timelines significantly and increase testing costs. It’s best to plan for this complexity upfront so you don’t treat backup suppliers as simple “swappable” alternatives.
When you’re evaluating manufacturers, look beyond their technical capabilities. What’s their experience with startups? Can they provide references from companies at your stage? Do they understand process validation requirements for medical devices? How do they handle volume fluctuations and growth planning? Ask these questions and more.
Geographic considerations also matter for international suppliers. Different regulatory requirements, documentation standards, and supply chain vulnerabilities can affect the availability of all kinds of components. Make sure to factor these elements into your sourcing timeline and backup planning.
Timing Your Sourcing Decisions
Don’t research components after your design is complete. Research alongside your design development so you can change designs if your preferred components become unavailable. Waiting until the design is complete often creates situations where availability constraints force expensive redesign work. (For products that require sterile processing, it’s best to engage manufacturers at least 6 months before production. )
Consider building relationships with suppliers before you need them urgently, because suppliers respond better to partnership discussions when you’re not looking for an emergency solution. In other words, you might get better terms and more favorable treatment.
The Bottom Line
Start with a component availability assessment for your current design. Research lead times, market dynamics, and alternative sources for critical parts. Update this quarterly to stay current with changing conditions.
Then, identify potential manufacturing partners across different capability levels. Try talking to mid-tier specialists first to set realistic expectations for timelines and capabilities.
Next, create a sourcing timeline that works backward from your target launch date and include buffer periods for unexpected delays. Factor in process validation requirements, testing schedules, and regulatory submission timelines; all of these can derail a project if you have to get creative with sourcing.
Finally, stay involved in sourcing decisions rather than delegating completely. Your understanding of sourcing constraints should influence your design choices, timeline planning, and funding requirements.
And if this all seems too much, don’t worry. At Concise Engineering, we help medical device entrepreneurs develop sourcing strategies that anticipate challenges, not react to them. Our vast experience with supply chain planning helps clients avoid the delays that can kill projects, and we’d love to help you, too. If you’re ready to explore a different approach to sourcing for your medical device, schedule a call with our team.
Looking to dive deeper into MedTech entrepreneurship? My book “Medical Device Fireside Chats: Essential Conversations for Startup Success” offers comprehensive insights, strategy suggestions, and detailed discussions about what it’s like to work for years in the space. Order it here.
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.
Stay tuned for future editions where we'll continue to share valuable information and industry updates.