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

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

• Functionality: Clearly define the device's purpose and functionalities. e.g. What medical condition does it address? How will it interact with the patient?
• Target Audience: Identify the primary users (healthcare providers, patients, caregivers) and their needs. This understanding will inform design choices for optimal usability and ergonomics.
• Regulatory Adherence from the Start: Stringent regulations (e.g., IEC 60601-1) govern medical devices. Ensure all design decisions comply with these regulations from the outset.
• Financial Planning: Medical devices have longer turnaround times compared with consumer devices. They also have to undergo certification from regulatory authorities (US FDA for example), activities that consume a lot of time and money.

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

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Building a Robust Hardware Platform

• Conceptual Design Phase: Ideate initial hardware concepts, considering factors like technical feasibility, availability, and affordability. Using readily available platforms such as RaspberryPi or Arduino enables teams to reach a PoC (proof of concept) with minimum investment in time, effort, and resources.
• Detailed Design Phase: Development teams can focus on refining the PoC to a market-ready product once the PoC finds approval from various stakeholders. Custom hardware takes longer turnaround times and should be deployed only if the dimensions or costs of RaspberryPI or Arduino hinder their adoption for mass production.
• Biocompatibility is Paramount: All materials in contact with the patient/biological matter must be biocompatible to avoid adverse reactions. Clear communication with doctors who form a part of the stakeholder group is essential as certain materials that are not biocompatible cannot be prototyped and tooling up for testing may not be financially viable. Prior information to doctors and patients coupled around with limited exposure helps conduct early-stage clinical trials with prudent fiscal management.
• Power Management Strategies: Design for efficient power consumption, considering battery life or alternative power sources. This is true especially for continuous monitoring wearables which depend entirely on their internal battery to power all functions.
• Prioritizing Safety Engineering: Identify potential risks associated with the device (e.g., electrical hazards, mechanical failures) and implement robust mitigation strategies. Prioritize fail-safe mechanisms through DFMEA, FMEA, and Risk Management programs.
• Design for Manufacturability (DFM): Consider how the device will be efficiently mass-produced. Choose manufacturable components and simplify assembly processes.

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.

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Creating User-Centric Industrial Design

• User Research Drives Design: Conduct user research to understand user needs and pain points. A key insight here: Surgeons follow the old artists' axiom, “Only a poor artist blames his tools”. This informs the design process for usability, comfort, and aesthetics aligned with all users.
• Human Factors Engineering Integration: Apply ergonomic principles to ensure the device is comfortable, safe, and intuitive to use for the target users. A familiar process is essential for the early adoption of a new technology. For example, a continuous monitoring patch whose application is akin to that of BandAid is likely to gain traction amongst users.
• User Interface (UI) Design (if applicable): Design physical controls, displays, and indicators that are clear, easy to understand, and minimize errors. Prioritize intuitive interaction for both patients and healthcare providers as this helps get through clinical trials faster and encourages early adoption.
• The Power of Aesthetics: Consider the overall design language to create a device that is visually appealing, instills trust, and complements the medical environment. Ensuring that all exposed surfaces can be wiped clean by paramedics themselves contributes to the product's aesthetic longevity.

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

Ensuring Success through Verification and Validation

• Rapid Prototyping for Early Feedback: Hardware rapid prototypes can be developed using custom I/O boards in conjunction with off-the-shelf platforms. These can be coupled with 3d printed enclosures to develop PoCs to commence user testing gaining valuable feedback.
• Functional Prototypes for Core Feature Testing: Develop more advanced prototypes with working functionalities to test core features and ensure they meet design specifications. Subtractive prototyping allows for near-mass production quality housings enabling their use for stakeholder approval.
• Usability Testing with Target Users: Conduct usability testing with target user groups to assess ease of use, comfort, and satisfaction. Inform the target users about how the tests will be conducted and whether they will receive any compensation for participating. Addressing privacy concerns is a key to successful usability testing.
• Verification and Validation (V&V): Perform rigorous testing to ensure the device meets all functional and safety requirements as defined during the design phase. This may involve environmental testing, stress testing, and biocompatibility testing.

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:

• Design History File (DHF): Maintain a detailed Design History File (DHF) that captures the entire design and development process. This includes design rationale, risk assessments, material selection justifications, and test reports.
• Robust Version Control: Implement a system to track hardware revisions and manage design changes.
• Traceability Matrix: Implement a traceability matrix to link design requirements to design specifications, verification and validation activities, and risk mitigation strategies. This ensures a clear audit trail for regulatory purposes.
• Standard Operating Procedures (SOPs): Develop clear and concise Standard Operating Procedures that provide users with proper instructions for operating and maintaining the device.

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.

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.

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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.