The MedTech industry thrives on innovation, focusing on creating medical devices that are safe, effective, and usable, while meeting strict regulatory standards. In MedTech product development, User-Centric Design (UCD) extends beyond simply meeting user needs and preferences. It integrates safety and functionality into the design framework to reduce risks and enhance usability.
A design-driven device can delight users but risks failure in audits if safety and regulatory requirements are not fully addressed, while a compliance-driven device ensures functionality and regulatory approval but may frustrate users if their needs are overlooked. The balance between user-centric design (UCD) and regulatory compliance forms the foundation of successful MedTech development, ensuring both innovation and safety. In this blog post, I will take you through the design process that drives the innovation phase, highlighting key steps and insights along the way.
The Intersection: User-Centric Approach + Compliance in Innovation
The overlap between user-centricity and compliance is where MedTech innovation thrives giving assurance in different and transformative ways. A truly innovative device isn’t just groundbreaking, but it is also safe, effective, and aligned with regulatory standards like MDR (EU Medical Device Regulation) and FDA guidelines.
• User-Centric Design ensures that the device meets the functional and emotional needs of its users.
• Compliance in Innovation ensures the device aligns with global safety and performance requirements.
This intersection provides a clear path for companies to:
Enhance product acceptance by demonstrating usability and safety.
Reduce time to market by avoiding redesigns due to non-compliance.
Key Compliance References in MedTech Design (Case study in the Research phase)
Designing medical devices requires a foundation of clear references and standards to navigate the complexities of regulations and user needs. I would propose combining Design Thinking techniques (e.g., user interviews, observations, journey mapping) to identify pain points and then adding the compliance-focused task like understanding intended use as per ISO 14971 and evaluating potential use errors as required by IEC 62366.
Example Scenario: Operating the heart-lung machine during a complex cardiac surgery
The goal of the research in the Design Thinking approach is to observe how surgeons interact with the interface in simulated environments to optimize ease of use. While in Compliance, we want to analyze the risks of incorrect parameter settings and ensure mitigation measures are in place. To combine these two approaches, start by adopting a user-centric design and then ensure it adheres to the regulations.
User Needs Statement (User-Centric Design) | +Compliance |
“As a surgeon, I need the machine to have safety alarms that warn me of potential issues (e.g., low oxygen levels, high pressure) so I can take immediate corrective action.” | Alarms must differentiate between critical and non-critical issues with clear visual icons and varying alarm tones. Compliance Standard: ISO 60601-1-8 (alarm systems) and ISO 14971 (risk management). |
Design Inputs: The device must trigger alarms within 2 seconds of detecting deviations in oxygen levels or flow rates. |
Risk Analysis and Usability Validation
User-Centric Design | +Compliance | |
Risk Analysis | Task analysis: breaks down user tasks to understand workflows and identify potential points of failure or user error. | Risk Analysis (based on ISO 14971): Identify potential hazards (e.g., pump failure, incorrect blood flow rate). Mitigate these risks through design features (e.g., redundant systems, automated alerts). |
Usability | Usability testing focuses on improving the user experience during the design and development phase. Includes iterative testing of prototypes to identify pain points and refine the design. | Usability Validation (IEC 62366) is consisted of simulated tests with perfusionists to ensure:
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Documentation in MedTech Innovation
The journey from concept to market-ready medical device involves rigorous documentation. Without it, innovation becomes chaotic, and compliance becomes unattainable. Here is an overview of how documentation is named in the world of Compliance:
Example of a documentation:
User Needs Document (UND) A User Needs Document (UND) serves as a structured record of what the end user (e.g., patients, clinicians, caregivers) requires from a medical device to ensure it is safe, effective, and usable. The machine must include audible and visual alarms triggered within 2 seconds for events such as:
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Beyond serving as regulatory evidence, these documents provide clarity and traceability, ensuring every stakeholder understands the “why” and “how” behind the design decisions.
The Blueprint: Design History File (DHF)
The Design History File (DHF) is a central repository of all design activities and decisions. It is the primary document of MedTech development, especially in the innovation phase.
This file:
• Captures how user needs evolve into design requirements.
• Demonstrates compliance with usability engineering and risk management.
• Serves as a critical tool for audits and regulatory submissions.
In other words, the DHF transforms creativity into a structured, compliant innovation process.
Making Innovation Easy: Integrating Compliance from Day One
Innovation in MedTech doesn’t need to be overwhelming. By adopting user-centric design alongside compliance frameworks, companies can streamline their development process. Here’s how:
1. Start by understanding user needs through research, observation, and testing.
2. Align these needs with regulatory requirements to create design inputs that prioritize usability and safety.
3. Document every step in the DHF, ensuring traceability and accountability.
4. Use risk management (ISO 14971) and usability engineering (IEC 62366) as guiding frameworks to mitigate risks early.
5. Validate the final design through real-world usability testing and align with clinical evaluation requirements.
The result of integrating user-centered design into compliance is a product that not only fulfills user expectations but also complies with regulatory standards from the beginning.
Final Thoughts: The Future of MedTech Design
In a fast-evolving industry like MedTech, the integration of user-centric design and compliance is not optional—it is the path to success. By combining the empathy of UCD with the rigor of regulatory frameworks, companies can develop devices that are safe, effective, and loved by users. Like and share our blog if you like this topic.
Source:
International Organization for Standardization. (2019). ISO 14971:2019: Medical devices – Application of risk management to medical devices. International Organization for Standardization. https://www.iso.org/standard/72704.html
Nielsen, J., & Norman, D. (n.d.). User need statements. Nielsen Norman Group. Retrieved November 25, 2024, from https://www.nngroup.com/articles/user-need-statements/
Thrive Thinking. (2024, March 29). Task analysis: Critical for delivering excellent user experiences. Thrive Thinking. https://thrivethinking.com/2024/03/29/task-analysis-critical-for-delivering-excellent-user-experiences/?utm_source=chatgpt.com
At AX1 Medical, we believe in simplifying innovation. Whether you’re navigating MDR or FDA regulations, our team helps you turn user needs into market-ready solutions, faster and smarter.
About the author:
Vivian has been working in design innovation for more than 5 years, and she has proven some success stories of Design Thinking in innovation processes.
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