How to Make Investors More Confident with Clear Documentation
Investors want more than ideas. They demand evidence that you understand regulatory pathways. They need to see that you have a risk management strategy. And they need to see you have to have documentation to prove it.
You have a medical device that solves a market need, and you’ve put together a great team.
But when you pitch to investors, something isn’t clicking. In other words, even though your prototype is great, you leave without securing funding.
Unfortunately, this happens every day. Even brilliant ideas fail to get funded because of poor technical documentation and unclear development processes.
That’s because investors want more than ideas. They need evidence that you understand regulatory pathways. They want to see that you have a risk management strategy. And you have to have documentation to prove it.
This article will show you exactly what investors want to see… and tell you how to give it to them.
What’s Working in MedTech Funding Today
MedTech funding bounced back strongly in 2024. After dropping to $18 billion in 2023, the sector raised $34 billion by Q3 2024. That’s an 88% increase over the entire previous year.
But this funding wasn’t evenly distributed. Commercial-stage companies got more than two-thirds of the investment.
So what separated the successful companies from the also-rans?
Our experience at Concise Engineering shows that funded companies usually share one key trait: clear technical documentation, the kind that demonstrates readiness without overwhelming investors with details.
Winning companies strategically show their technical information, using detail to make investors more confident without drowning them in the weeds.
And in our experience, this kind of balance is what has become a differentiator.
What Investors Actually Want to See
When investors look at MedTech opportunities, they typically find it’s not innovation that’s missing... It’s clarity. Your documentation should show you can deal with complex regulations and get products to market quickly.
Here’s what investors look for:
Quality Management System Framework
You don’t need ISO 13485 at the seed stage but you should demonstrate that you’re aware of the standard, and show that you’re progressing toward compliance for your development phase.
Risk Management Documentation
Show you’re on top of potential risks, and that you’ve got mitigation strategies ready in case you need them. A comprehensive risk management file following ISO 14971 principles will make investors more confident.
Design Control Documentation
Include requirements specifications, verification protocols, and your plans for validating your design. The level of sophistication should match your development stage. Early-stage companies need a framework, while companies approaching clinical trials need more robust protocols.
Regulatory Strategy
Clarify your classification strategy and your go-to-market timeline. Identify any predicate devices (if you’re pursuing 510(k) clearance) or explain your novel technology pathway. Remember, a clear regulatory roadmap shows you know what the FDA and international bodies want.
Connected Documentation
Show how risk management influences design controls and how both support your regulatory strategy. This shows you’re technically competent.
Quality matters more than quantity. Five well-structured documents showing your regulatory pathway and risk management approach will make investors more confident than fifty disorganized files.
Building Your Documentation Strategy
Focus first on what matters most at your current stage:
Core SOPs
Develop standard operating procedures for ISO 13485 and ISO 14971 compliance, starting with design controls, software control (if applicable), and risk management.Design and Development
Create a simple SOP outlining how you’ll manage design inputs, outputs, verification, and validation. Expand this as you progress.Risk Management
Start with a risk management plan outlining your approach to identifying and mitigating risks. Create a living risk analysis document that grows more detailed as your product matures.Formalized Testing
Document test protocols, results, and conclusions in structured reports rather than informal notes. Consistent templates and organized storage are enough initially.Usability Engineering
Document your approach to understanding user needs and validating that your design meets those requirements.
Don’t worry about implementing a full quality management system too early. Instead, create a document that maps your quality system structure, and identifies the critical processes for your current stage. Include implementation timelines as you move toward commercialization.
Avoid Extremes
MedTech entrepreneurs often fall into one of two traps: either they provide too little documentation or offer too much information.
Too little will leave investors questioning whether you understand the regulatory process, and maybe even doubting whether you’ll be able to comply. They’ll assume you’ll need significant resources later, which will increase their perceived risk.
However, drowning investors in tons of unstructured documentation creates confusion rather than confidence, especially when it’s mostly literature reviews and market analysis without clear connections to your product development.
There’s another problem, too... Sub-par documentation. As one investor put it, “I’d rather see a company acknowledge gaps in their documentation than give me low-quality documents. One shows awareness. The other just demonstrates incompetence.”
Bottom line: if you’re worried about your docs, focus on quality. Prioritize things like design controls, risk management, and regulatory strategy. When gaps exist, acknowledge them and outline your plan to fix them.
What Next?
Showing technical clarity to investors demonstrates you can navigate from concept to market. The documentation you create is evidence of your strategic thinking and regulatory awareness, and has the potential to set investors’ minds at ease.
Take these concrete steps to impress investors:
Compare your current documentation to your investors’ expectations, as well as the regulatory requirements for your stage.
Create a timeline for key documentation, focusing on the elements that address investor concerns about regulatory compliance.
Create a high-level document outlining your quality approach and referencing procedures you have or will have.
Create a traceability matrix showing links between user needs, requirements, verification tests, and risk mitigations.
Ensure your documentation changes with your product and continues to align with your development progress as you move along.
Remember, clarity creates confidence. Focusing on quality and connecting technical matters to business strategy will help you build a narrative that will soothe cautious investors.
At Concise Engineering, we’ve helped many MedTech innovators turn technical documentation from a burden into a strategic asset. We understand the balance between regulatory compliance and practical execution that today’s investors demand.
If you’re struggling to communicate the technical bits to investors, book a call with Justin today. We’ll identify the next steps and develop a strategy that sets you apart in a competitive funding landscape — and that’s a documented fact.
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.
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