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How to architect your medical device program: From Hardware to Testing

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Nothing impacts human life more than a medical device, whether diagnostic or interventional. This is why, developing a successful medical device demands a rigorous and disciplined approach through the hardware, industrial design, prototyping, and testing phases.

This article explores a structured framework to guide startups and SMEs in architecting a robust medical device program. A well-defined hardware development process, and user-centric industrial design coupled with rigorous prototyping and testing methodologies, can help medical device companies bring safe, reliable, and user-friendly products to market.

Key Considerations for Success

Designing medical devices isn't just about function; it's a complex juggling act of user needs, regulations, and hefty development costs.

SureTouch Breast Exam – SureTouch was developed to provide comfortable, accurate, safe, and painless clinical breast exams to millions of women in the US and the world.

Building a Robust Hardware Platform

In 2021 alone, 36% of medical device failures were caused by materials related and another 4% was due to electronic failures. Remember to choose materials consciously.

Monitra UpBeat – A Novel and Waterproof Electrocardiogram patch that is a natural evolution of cable-based heavy holters with a different design. This convenience for patients is driving the evolution of the market.

Creating User-Centric Industrial Design

Surgeons prioritize usability over fancy features, so design your medical device for comfort and ease of use first.

Ensuring Success through Verification and Validation

On average, it can take anywhere from 3 to 7 years to bring a new device from concept to market approval. About 6-12 months for just conceptual design and 1-3 years for clinical trials alone.

Comprehensive Documentation

Startups and SMEs need to maintain documentation in line with IS-13485 in order to apply for regulatory certification. Key features of this standard include:

Additional Considerations for Success

Choosing the wrong problem to solve has been a common issue amongst startups formed by entrepreneurs with little or no experience. Acquiring a mentor addresses this issue early on in the process and enhances the program’s financial viability. It is also beneficial to have investors on board with access to clinical facilities for multiple user testing and clinical trials.
This structured approach, emphasizing user-centric design, rigorous testing, and regulatory compliance, empowers medical device companies to bring innovative solutions to market, ultimately improving patient care.

Join hands with us!

Are you an SME/Startup looking to launch an innovative medical device: all while stretching the dollar to its utmost?

Working together, we transform innovative ideas into tangible solutions that open new markets. And do so with the flexibility of an in-house team and the benefits of an offshore one! Contact us today to discuss how we can collaborate and bring your vision to life.

With 25+ years of experience working with Fortune 500 majors and pioneering startups, we cross-pollinate ideas from multiple domains to arrive at unique solutions. Our efforts have resulted in life-saving devices such as the Embrace Infant Warmer or the Monitra Upbeat to name a few.

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