Comprehensive Risk Management Strategies
Launching a medical device startup comes with opportunity and risk. Effective risk management isn’t about slowing down, it’s about making smarter decisions at the right time.
In this MedTechMan insight, Justin Bushko outlines practical risk management strategies that help early-stage MedTech companies avoid common pitfalls and build a more resilient path to success.
Plan Funding Earlier Than You Think You Need It
One of the biggest risks for MedTech startups is underestimating funding needs. If you’re looking for capital at the moment you need it, you’re already behind. Funding should be planned at least six months in advance, with clear visibility into second and third funding tranches.
It’s also critical to ask for more than your initial estimate. Development costs are often underestimated, and shortfalls can stall progress at critical moments. Securing adequate funding upfront provides flexibility when timelines shift or unexpected challenges arise.
Validate With Real Users, Not Just Positive Feedback
Early engagement with key opinion leaders and target users is essential. Getting your product into users’ hands early helps validate not just interest, but true buying intent. A product that users say is “great” but wouldn’t actually purchase presents a serious commercial risk.
Honest feedback at this stage allows teams to refine features, adjust positioning, or even rethink direction before investing too heavily. Real validation reduces the risk of building a product that struggles to find a market later.
Use Simulation and Prototyping to Avoid Costly Mistakes
Moving too quickly into tooling is another common risk. Injection molding and tooling decisions should be informed by thorough simulation, 3D printing, and prototyping. Rushing this step can lead to discovering missed features or design flaws after expensive tooling is complete, often requiring a second round of investment.
Taking the time to validate designs through simulation and early prototypes helps identify issues before they become costly. Finding the right development path early protects both your budget and your timeline.
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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