A human-centered approach can help by ensuring every aspect of the system is tested with users by default, throughout. (Credit: Tone Product Design)

Implantable medical devices may be nothing new — doctors have been inserting things like pacemakers and cochlear implants into their patients’ bodies for decades — but as the relationship between people and technology becomes ever more co-dependent, it’s only a matter of time before implantable devices become an obvious way to do everything from health monitoring to long-term drug delivery.

Active implantable medical devices (AIMDs) are getting smaller, smarter, more connected. They’re more efficient, with better performance and greater patient data capabilities. All of which requires a fresh perspective on the design of such devices.

As a design consultancy, we perform daily balancing acts between factors like technical priorities and user complexity, reducing development risk while building user trust, or increasing manufacturing efficiency while retaining an aesthetic design that people want to live with. The goal is to find win-win solutions that make contrasting priorities suddenly align.

These are exactly the sorts of challenges that designers will need to overcome as implantables become the norm — from psychological barriers, including ensuring patients trust the device and can effectively and consistently justify its value, through to designing clever ways to keep them fully charged.

Oscar Daws

The design roles involved in taking a product from idea to manufacture to use have traditionally been diverse and distinct. You have engineers and industrial designers building the physical product; packaging designers and graphics experts focusing on instructions for use and safety messaging; and website and app creators specializing in patient-facing user experience and digital onboarding.

But from a patient’s perspective, the product for an implantable is, in many ways, its interface. If you think about it, a patient might never see, touch, feel, or perceive the implantable itself. The reason you’re reminded it is there is because you have to charge it, or refill it, or, increasingly, because of a connected app. The benefits are real, but the product doing the work is invisible.

A New Kind of Design Coordination

With an estimated global market worth around $85.31 billion in 2021 and a projected growth to $143.1 billion by 2028, the world is rapidly seeing the potential in AIMDs. New advancements are developing all the time. 1 For example, continuous glucose monitoring implants for adults with diabetes that pair with a mobile app; inserts that deliver microelectrical impulses to patients with sleep apnea to keep their airways open, and devices that help control the side effects of Parkinson’s, including deep brain stimulation for symptoms such as tremor. 2, 3

The immense potential in the health opportunities afforded to us with the use of AIMDs means these ever more digitally enabled products also have the potential to grow in application from niche and highly specialized medical interventions to wider quality-of-life improvements. These could include continuous health monitoring, or managing long-term back pain, or even human-machine interfaces for those with severe disabilities. Due to the highly integrated and co-dependent nature of this design challenge, the job of design manager becomes increasingly important.

Their vital role is to ensure that every touchpoint is designed with a seamless and consistent user experience — from the physical product design, to packaging, digital UX and UI, instructions for use and physician-side software. It’s not like you can just stop using an implantable if, for whatever reason, you change your mind. The procedure to insert and remove it can be very invasive, and for this reason it is incumbent on the device manufacturers to adopt a human-centered approach to every single design decision.

The battery capacity might sound like an engineering problem, but it could have a vast impact on the patient’s quality of life if it means recharging it more often, especially if the charging system has not also been thoroughly designed to be easy and seamless to use. Therefore, although there is also a vast untapped potential in AIMDs for lower-risk health and wellness interventions, they will require a much greater level of rigor in the design process than is often needed with current health-tech products and apps that live outside the body.

While the benefits of implantables are currently more obvious for people with heart problems or other serious conditions, we’ll also see an uptick in implant-able-as-lifestyle-choice. As humans and technology become fundamentally more interconnected (see Apple Vision Pro), more of us will use implantables to look after ourselves — an extension of wearable technology. It’s in these contexts that the considerations above become even more important. If it’s anything less than a life-saving medical intervention, people need to want it, and technical features alone are not enough to make that happen.

Pulling Together Different Elements

Tone design a packaging solution for Proteus that would help patients set themselves up at home and be distributed through a mail-order pharmacy. (Credit: Lottie Crumbleholme)

While working with Proteus Digital Health, a pioneer in digital medicines and the first company to successfully gain FDA approval for a fully ingestible digital sensor designed to monitor drug compliance, we gained first-hand experience with the importance of fully coordinated design and manufacture approaches. Proteus asked Tone to design a packaging solution that would help patients set themselves up at home and be distributed through a mail-order pharmacy.

Rather than working in isolation, as is so often the case, we sat round the table with people from app design, engineering, and graphics, as well as clinical teams, to devise the most efficacious approach. All our roles combined to develop a user-friendly and safe product designed to make it easier for patients to set up at home while taking the fear out of making a mistake.

As the relationship between healthcare, patients, technology, and design continues to evolve, we’re now dealing with a jigsaw puzzle rather than a linear system. To embrace new innovations fully, we need to acknowledge these shifts and commit to putting human-centered design at the heart of the process, bringing together every element involved.

This editorial was written by Oscar Daws, Co-Founder and Managing Director, Tone Product Design, London, UK. For more information, contact This email address is being protected from spambots. You need JavaScript enabled to view it. or visit here .

References

  1. Active Implantable Medical Devices Market Size, Share, Growth Report 2030,” Zion Market Research, May 10, 2022.
  2. All About Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea,” Healthline, January 3, 2022.
  3. Deep Brain Stimulation,” Parkinson’s UK.


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Medical Design Briefs Magazine

This article first appeared in the November, 2023 issue of Medical Design Briefs Magazine.

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