Inside the Design Process of Medical Devices

Designing a new product, particularly in the medical device sector, is a complex and collaborative process. It requires input from multiple disciplines, a deep understanding of regulatory requirements, a focus on user needs, and the ability to resist the temptation of using trendy technology when it may not be the right fit.

Matthew De Remer brings this perspective to life. As a seasoned engineering leader, he supports the startup community through mentorship and speaking engagements. His background includes leadership roles at Bayard Design and Terrafugia, and he currently serves as VP of Engineering at Mission-Driven Tech, where he specializes in fractional engineering management for early-stage companies.

Here, Matthew shares five key lessons to help startups successfully design medical devices - from managing risk and regulatory requirements to staying focused on the real needs of your customers.

1. Weave Quality and Regulatory Requirements into Your Design Process, But at the Right Time

One of the biggest mistakes startups make is waiting too long to think about quality and regulatory requirements. If you delay, you risk missing something critical or realizing too late that the regulatory pathway is more complicated than expected. But swinging too far in the other direction, focusing on quality and regulations too early, can also slow your team down. You may end up bogged down in paperwork before you fully understand your product’s design or potential failure points.

So, what’s the right approach? Start by focusing on product development with a few regulatory assumptions in mind. Once your design starts to take shape, that’s the time to formally integrate quality processes and regulatory requirements. This ensures you stay on track for FDA approval without overcomplicating the early stages of development.

Key Takeaway: The timing matters, build quality and regulatory requirements into your process, but don’t let them stall early innovation.

2. Make Risk Management a Core Part of Your Design Process

When designing a medical device, understanding risk isn’t optional - it’s critical. The FDA requires companies to identify potential risks, understand worst-case scenarios, and show how the product’s design helps prevent them. This isn’t just about checking boxes, if a device malfunctions, real people can be harmed.

The most effective way to meet these requirements is to integrate risk management into every stage of the design process. That means thinking beyond just product safety. Risks can also include project costs, timelines, and technical challenges. Addressing these early reduces the chance of major setbacks down the road.

Key Takeaway: Risk management isn’t a one-time task, it’s something you should build into every step of the design process.

3. Teamwork Drives Innovation - Use Tools That Keep Everyone Aligned

In today’s fast-paced innovation economy, no one builds a successful product alone. For engineering teams, effective collaboration is essential—and that starts with having the right tools in place.

One of the most important tools is the Product Requirements Document (PRD). This document should be created early and updated regularly throughout the design process. It serves as a shared source of truth, keeping everyone, engineers, designers, and stakeholders, aligned on the product’s goals and requirements. As development progresses, many other documents will build off of the PRD, but it remains the foundation for ensuring the entire team stays on the same page.

Key Takeaway: A shared, living document like a PRD keeps your entire team aligned and accountable throughout the design process.

4. Never Lose Sight of the Customer

Between navigating regulations, managing risk, and keeping your team aligned, the design process can feel overwhelming. But through it all, one thing should guide your decisions: the customer.

Your product needs to solve a real problem, and solve it in a way customers will actually use. Many startups fail because they either misunderstand the market need or design a solution that doesn’t work in the real world. To avoid this, it’s critical to stay connected to your customers throughout the entire design process. Listen carefully, ask the right questions, and make sure you're solving the problem the right way.

Key Takeaway: The customer is your North Star, keep their needs at the center of every design decision.

5. Be Thoughtful About Using AI in Your Product

Artificial intelligence is everywhere right now, and for good reason. It can be a powerful tool. But just because AI is popular doesn’t mean it’s always the right fit for your product.

For startups, the priority should be solving the customer’s problem as efficiently as possible. If AI helps you do that, great. But don’t force it into your design just to keep up with trends. The wrong use of AI can add unnecessary complexity, cost, and risk.

If you do decide AI is the right solution, use it strategically. AI excels at automation and handling repetitive tasks that don’t require constant oversight. But it struggles with tasks that need nuance, human judgment, or high levels of accuracy right out of the gate. Misusing AI often leads to poor performance - and wasted time and money fixing mistakes.

Key Takeaway: Use AI only where it adds clear value. The most cutting-edge technology isn’t always the best tool for the job.

Conclusion

Designing a medical device is never simple, but the right approach can help you avoid unnecessary roadblocks. The goal is to minimize surprises and set your product up for success from the start.

For startups, that means finding the right balance between quality, regulatory requirements, and risk management. It also means building a strong, collaborative team, keeping the customer’s needs front and center, and being thoughtful about when (and if) you incorporate new technologies like AI.

By focusing on these priorities, your team will be better equipped to design a medical device that not only works but truly makes an impact.

About the author: Nicholas Ewing is a graduate of UMass Lowell in Business Administration: International Business. He is a practice coordinator at Tufts Medical Center in Framingham. His hobbies include writing stories and going for walks in nature. You can connect with him here.