Should You Develop an Implantable Medical Device or a Wearable?

Advances in both medtech wearables and implantables are supporting healthcare outside the clinical setting. “One of the great things about the wearables and implantables on the market today is that, for the most part, they are meant to be used outside of the clinical setting,†Ben Zwillinger, senior human factors engineer at Product Creation Studio, told MD+DI. “These products have allowed patients to not only have better outcomes but improve their quality of life by taking the treatment and integrating it into their daily life.â€

So, for some innovators developing a medtech product, the choice may no longer be between clinical or hospital use, but between wearable or implantable. “As technology continues to advance, there are opportunities for medical devices to be developed as either a wearable or implantable solution,†said Zwillinger.

At MD&M West 2020, Zwillinger and Scott Thielman, chief technology officer at Product Creation Studio, will explore the options in the session, “Wearables vs. Implantables: The Battle for User Adoption.â€

“We will present a framework to help companies and engineers determine what type of solution to develop,†Zwillinger said. “We will also provide some insight into where we think the implantable/wearable market is going in the future.”

Added Thielman: “We’ll provide a framework to encourage different perspectives as organizations sort through the balance of risk and opportunity. It’s easy to get excited about a single dimension, patient experience, and not equally balance other dimensions such as technical feasibility or business strategy.â€

Zwillinger pointed to two “fundamental technological advances†that have enabled development of both wearable and implantable products.

“Miniaturization is one of the largest factors. The same trend that has been at work in the consumer industry has been seen in medtech with more advanced capabilities using less power and fitting into a smaller form factor,†he said. In addition, “battery technology has significantly increased. This allows us to power devices with very small batteries that can be charged wirelessly, which is necessary for many implantables. Batteries have also influenced the wearable products, since the size to power ratio has allowed for devices that are comfortable and unobtrusive to wear.â€

As suggested by their MD&M session title, there is a battle for user adoption. “There can be a major struggle to gain user adoption, even when it benefits our health,†explained Thielman. “I wore an EKG patch for 2 weeks, and it was a horrible experience. It itched, it slid out of place when I exercised, [and] there was no indication if it was really collecting anything useful. It’s easy for users to decide ‘Hey, I don’t need this hassle.’ [That’s] a common phenomenon with many activity tracker products.â€

Added Zwillinger: “The challenge for medical device manufacturers with wearables and implantables is the same as all other products. Users have needs and desires, and just because you make a technologically advanced product, [it] doesn’t mean it will do well on the market. You have to work on understanding the use cases and user needs to determine how to best embody the technology you create.

“Users often have the power in the relationship, and you need to make sure your product is safe, user friendly, fits in their lifestyle, has a simple workflow, plays nicely with other products in the treatment workflow, and has desirable features or else users will go elsewhere,†he continued. “To that end, all manufacturers need to battle for user adoption unless there is no other treatment available—but even then price, safety, and access can be restrictive elements to user adoption.â€

When asked whether currently implantable medical devices could be made into wearable medical devices or vice versa, Zwillinger said that “this is a seemingly simple question that is dependent on many factors such as technology, use cases, user needs, and the business case. There are some devices that have both a wearable and implantable version on the market now. There are both implantable and wearable cardiac defibrillators, continuous glucose monitors, and ECG and EKG monitors.

“That being said, there are still many devices that exist as only a wearable or implantable,†he continued. “This could be due to technological challenges, business case, or user needs. For example, one implantable product that is very challenging to make a wearable are neurostimulation devices—the challenges with wearables is to effectively deliver the correct dose in the correct location for a sustained time from the outside of the skin is challenging to overcome. However, companies are working on this problem, and there are some examples of products on the market today. Conversely, there are wearable products like external portion of a cochlear implant that have significant challenges in being made into an implantable.â€

But Zwillinger cautioned that “the question isn’t always can we make an implantable and wearable version of the same product. Rather, does a solution exist that addresses the user needs, the business case, and is technologically feasible at this point in time? Once a solution exists, regardless of wearable or implantable, then we can discuss if the alternative solution addresses a different set of user needs, use cases, or business needs that warrant the development.â€

Thielman anticipates “a greater trend of wearables becoming implantable because of the user benefits of a more ‘permanent’ solution coupled with miniaturization of electronics that will allow for less traumatic implantations.†He pointed to the Carina implant from Cochlear as an example in which the wearable portion of the therapy is now fully implanted under the skin.

To switch from an implantable medical device to a wearable one or vice versa, “companies need to determine if there is a need and desire for the product and to de-risk the main technical challenges,†said Zwillinger. “This is what we call ‘Phase 0’ at Product Creation Studio. We conduct generative research to understand use cases and met and unmet user needs and we de-risk the key technical and business aspects to the product. We do this all before entering actual product development to ensure we can create a product that is desirable and feasible. Once those key questions are answered, classic user-centered product development can start including technical development, prototyping, user testing, round of iterative updates, industrial design, documentation, risk analyses, safety and regulatory testing, etc.â€

And it is “important to keep in mind the quantum difference in risk to patient safety when moving from wearable to implantable,†Thielman emphasized. “Material selection that might have been a footnote in a wearable device development effort becomes hugely important and expensive to validate. So there must be a reason to make the jump to implantable.â€

For next-generation devices, there are a couple technological challenges that still need addressing. Zwillinger said that for both wearables and implantables, further miniaturization and energy-efficiencies are needed. For implants specifically, he believes the next generation will be working towards the model of a point-of care procedure, which will require advances in the electrode-tissue interface, the electrode placement, and anchoring the electrode. In addition, he said “a greater understanding of neural pathways†is also needed for the next-generation implants.

Thielman explained why a few of these challenges can be limiting: “People don’t always like to sit next to the outlet while we charge their implants. There are reasons that implants can be low-powered (we got past the clothing and skin next to the tissues that matter), but electronics still need a power source. Keeping that battery topped-off might become the focus of energy harvesting strategies.â€

Zwillinger offered a product example in need of further advancement: the cochlear implant. “The current solution is vastly better than what was previously available but there is still work to be done to improve the solution to better integrate into a patient’s life, such as increased comfort, reduced social stigma of a visible product, and waterproofing,†he said. “While there are fully implantable middle ear implants, fully implantable cochlear implants that reproduce the same technology found in the wearable and making it an implant could have significant benefits for the user experience.â€

The good news is that innovators have a lot of achievements on which to build. “While not a technological advancement, I think one of the things that led to the current state of medical wearables/implants is the history of success,” said Zwillinger. “Patients have continued to see success in improved outcomes and quality of life from both wearables and implantables, which continue to drive the market and technology forward.â€

Don’t miss Wearables vs. Implantables: The Battle for User Adoption at MD&M West 2020 on Tuesday, February 11 at 1:15 PM – 2:00 PM, in Room 210B, as part of the paid conference. Zwillinger and Thielman will share:

  • Case studies of implantable and wearable solutions
  • Pros and cons of deploying each type of device
  • How to approach these forward-looking design applications

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