Commercial Success of Medical Devices By Design

New medical technology that works in a lab has a long road to travel to commercial success. To bridge this gap, designers work alongside researchers to ensure that new devices are not only technically sound but also practical, user-friendly, and commercially successful by design.

Safe and Effective Does Not Mean Commercially Successful

Medical device founders tend to focus on FDA or other market’s submission requirements for it to be proven safe and effective, while losing sight of market forces and stakeholder requirements that limit them from being widely adopted. Factors like capital amortization, reimbursement strategies, intuitive use even without the IFU, and the challenge of pilot run manufacturing volumes can prevent even the most advanced technologies from becoming commercially viable. A design-led approach helps navigate these hurdles, ensuring that medtech innovations don’t just remain theoretical but become products that improve healthcare, are manufacturable at stage-gate volumes, and generate real market demand.

A study published in BMJ Innovations highlights how early-stage medtech innovations often fail due to a lack of design considerations, reinforcing the need for a structured design-informed approach.

Understanding the Patient and Stakeholder Experience

When creating new medical devices, thinking beyond just how they function is essential. Patients, practitioners, and purchasing stakeholders have real needs and challenges that must be considered. Even the most advanced technology can fail to make an impact without thoughtful design. A human-centred design approach helps ensure that medical innovations improve stakeholder experiences, making healthcare more effective and accessible.

A study in Springer explores how design-thinking principles directly impact patient engagement and treatment adherence.

How Design and Research Work Together

Many people wrongly assume design is just about form and aesthetics. It isn’t. At Cortex we practice what we call “Big D Design”, which considers all stakeholder requirements at a very early stage of the product commercialization sprint. The design process involves bridging the gap between the founders who are attempting to launch a new medical device and the stakeholders who must believe and adopt the technology. Identifying and responding to their pain points ensures devices are technically advanced, comfortable, safe, and easy to use – but also consider the purchasers, marketing teams, and clinician Key Opinion Leaders.

Learn more about Cortex Design Process

A great resource on how design influences healthcare medical devices can be found in this overview from Design for Health.

Bringing Medical Devices to Market

Even after a breakthrough technology is developed, there are many challenges before it can reach hospitals and clinics. Factors like cost, manufacturing, safety, and sustainability all play a role. A design-led approach helps balance these concerns, ensuring that new medical devices are innovative, practical, and ready for commercial success.

Learn more at: Precision Tools for Medtech Manufacturing

Key Takeaways

For engineers and designers working in medtech, focusing on design-informed research isn’t just a best practice—it’s the difference between a safe and effective device that is never sold, and the medical device products that experience commercial success. Combining research, usability testing, regulatory compliance, and all stakeholder requirements can turn promising medical technology into real, impactful healthcare medical devices that reach the market and benefit patients.

Want to Learn More?

Speak with a specialist at Cortex Design about strategic partnerships. Our research-led design services can help transform your medtech innovations into commercially successful, patient-centric medical devices.

🔗 Related Reading & Resources:

• Explore the role of design-led research in bridging breakthrough medtech hardware to commercially successful applications.
• Learn how cost, safety, and sustainability affect the journey from lab to market
• Discover how design-led research transforms concepts into market-ready medical devices.