"Innovating in the field of medical devices can get extremely complicated and overwhelm even the most experienced engineers", says Jurgen Oskamp from Leuven MindGate member Achilles Design. "For startups all the necessary areas of expertise can prove to be too much, but even for well-established medical companies it is not an easy task to keep up with the ever-changing field, increased complexity and regulations of medical devices."
Areas of expertise
The first thing you need is a multidisciplinary team that covers all the different areas of expertise. For startups, this is often impossible, and they need to look for external services to complement their skills. If you take this external route, look for teams that are flexible and can work well together with your team. Look for a team that has an extensive history in medical products and other fields. They can provide a wealth of expertise and experience in various areas that even some medical device manufacturers may lack internally. This will ensure you look at your project from different angles and transfer solutions from other fields.
Experienced design firms have tried and tested development methodologies that will guide you through the whole process. They know where the pitfalls are, and can work according to the required ISO standards
Start from the user
Human factors, user-centric design, and usability engineering play an increasingly important role in the medical device industry. Designing for healthcare must start from the user (patient, doctor, caregiver), not the technology. Particularly crucial is designing for human factors from patient acceptance, to increasing patient and user safety, to minimizing the risks of potential human errors. Acquiring insights into user needs, fears, and use from patients and workers is essential for designing a successful medical device. Therefore, extensive user research and testing are an absolute must in the development process.
Medical products are not stand alone anymore. Many products are connected to platforms and exchange data with patients, doctors, and caregivers. This requires new insights and disciplines to design frustration-free user interfaces, secure data protection, and interconnected products.
Additionally, some healthcare is shifting away from hospitals and other medical environments to patients’ homes. Connected smart products collect medical data and make it available for patients, and doctors, in real time, to make the right decisions. This not only makes the development of products more complex, with smart censors and high connectivity, but also demands a complete rethinking of how healthcare services are delivered. These products become product-service systems that require a service design expertise to make them successful on the market.
Finally, when you have your minimal viable product, proof of concept, and final prototype, you must be able to produce it in a consistent error-free way. Thinking about this is not something you start with after the design is finished. Design for manufacturing should already be part of the design process from the very beginning. Production and product cost need to be taken into account at the very start of development. Finding the right partner to produce your product is also essential, and if you start early enough, a good partner will help you in the last stage to go to production.
Go to market
Established healthcare companies have the necessary expertise to market their products in-house. For startups this can be a challenge. Even the best designed product can fail if it is not brought to market the right way. At the start of the development, product marketing and branding must already be part of the thinking process. This is the only way to make sure they will reinforce each other and avoid unpleasant surprises at launch.
How does Achilles face medical design?
We advance healthcare through people-centered design. We prototype early and often, to ensure we keep the people we design for at the heart of the process. By putting ideas in hands of users with low-fidelity paper interfaces to 3D-printed prototypes and high-level immersion VR, we can systematically identify improvements and preventively exclude risks while keeping our intuitions in check.
We believe better health is achieved by engaging people at every stage of their health journey. Our cross functional team consisting of biomedical engineers, designers, usability experts, and a doctor, work across disciplines to integrate the needs of people with responsible technology and sustainable business models. We thrive to establish innovative healthcare service solutions that drive business value by advancing the standard of healthcare.
Jurgen Oskamp, Founding Partner at Achilles Design