By Richard Pearce, Theragen
“Product innovation” isn’t just a term; it’s a system used to create products that deliver significant value. How? It balances three crucial business concerns: user desirability, business viability, and technical feasibility.
When applied to developing medical devices, product innovation leads to products that doctors believe in and prescribe, that patients use as directed, and that businesses are able to maintain and evolve within their existing operational and budgetary realities. But what if the first business concern, user desirability, is the most difficult to discern?
Identifying The Innovation Opportunity
When it’s an at-home therapy, as is the case for our ActaStim-S, a wearable device that delivers energy to stimulate bone growth and promote healing after spinal fusion surgery, day-to-day adherence decisions rest solely with the patient. If your technology is like ours, it has been clinically proven and is prescribed to be used throughout the day on a consistent basis for several months as dictated by the patient’s doctor. However, patients only realize the benefit of the therapy if they consistently use the device. So, one way to improve the odds of a successful recovery would be finding a way to get more people to use the device as prescribed — ie, to boost adherence.
In our case, we thought a companion app could play a role — maybe it would provide reminders to use the device. Or encourage people to use it. Or actually provide data showing patients how they are progressing. There were so many directions we could go, and patients recovering from spine surgery have unique and specific challenges and needs. How would we know where to focus our app development and how best to use the resources to do so?
Determining Your Product Innovation Framework
One reason product innovation appealed to us so much was that it emphasizes de-risking products as you develop them. It wasn’t just a matter of making sure we developed an app that post-surgery patients felt comfortable using — their surgeons had to value the app enough for it to be a deciding factor in their prescribing our device over similar competitive products.
And not only that, but if we determined that we could build such an app, we had to make sure we could build it in such a way that we’d be able to maintain it and adapt it over time, meaning that we had the internal resources to commit to app maintenance.
At a high level, this framework was incredibly useful in guiding our thinking about developing a companion app for the ActaStim-S. Design thinking clarified how we might go about deciding what to build, and, from there, the overall framework of product innovation helped us decide whether we could build it in a way that was sustainable for our business.
Leveraging User Research To Inform Your Product Design
The process of creating the app itself started with user research. We partnered with a firm called TXI that specializes in product innovation and customer research. We worked closely with them to understand what we could provide our patient and doctor customers and how we could test our companion app concepts.
We used the process of design thinking, researching how people interact with their environments and looking at the challenges spine fusion patients experience post-operatively in maintaining a consistent therapy schedule. This was a big task, and we knew it could lead us in many directions. We didn’t know where to start.
Turns out, that’s okay. Product innovation and design thinking start with getting to know end users to understand what problems they have and, from there, how we might solve them. We spoke to people who had recently had lumbar spine fusion (including some who were also prescribed bone growth stimulators), as well as spine surgeons who prescribe bone growth stimulators and review patient outcomes.
The surgeons we spoke to laid out a few concerns:
- Patient outcomes post-surgery improved when patients wore the bone growth stimulator as much as possible and engaged in regular activity; but…
- Activity like walking can be painful following surgery, leading some patients to avoid it, which can prevent healing.
- Check-ins in the months after surgery are sporadic. It’s difficult to track recovery because surgeons rely primarily on patients’ memory of their pain to gauge how they’re improving — and memory of pain is notoriously unreliable.
We also spoke to patients, who admitted to not always using their bone growth stimulators as recommended, in part because they were unclear on its benefits.
These conversations helped validate the potential for a companion app and shape what that app might do for both patient and doctor. The version we launched does four key things:
- It tracks wearer activity, which it gets from an accelerometer built into the device.
- It prompts patients to track their pain levels daily (in a “pain diary”).
- It displays usage each day (including times of usage) over days, weeks, and months.
- It combines and presents visualizations of pain levels overlaid on activity and device usage levels so patients can track their progress over time and see the correlation between adherence and improvement while allowing for patient journaling to record time relevant events along the way.
Check out my previous article for a deeper dive into my three lessons learned in designing the app itself.
Where We Go Next
One of the most compelling things to me about the app we launched is that it tells a story — a visual and factual story helpful to both patients and doctors. That’s a good thing. Product innovation helped lead us to an app that solves real problems. The design thinking approach helped make sure the real users of our device, the patients, have useful information and motivation to see their prescriptive therapy help them towards a successful outcome.
Because we embraced the framework of product innovation and design thinking in building our app, we have seen positive app adoption, even among our users who are in their 60s, 70s, and beyond. Their doctors know whether their patients are using the recommended therapy and whether they’re using it as prescribed, which can be helpful in guiding post-surgical recommendations.
Just as compelling, in my opinion, is that product innovation does not aim to create “one and done” products. In fact, we’re still in collaboration with our product innovation partners, who encouraged us to view the app we have now as a starting point.
Patients and doctors using our app have helped us identify new opportunities that will allow us to evolve the app over time to meet their needs, always with the goal of improving post-surgery protocol adherence and, ultimately, helping to improve health outcomes.
Developing medical devices is a complex undertaking. And the stakes are much higher than in other areas of product development. Product innovation provides medical device creators with a framework that keeps the end goal(s) in mind at all times.
Richard Pearce is the chief operating officer and VP of research and development at Theragena wearable medical device company that developed a non-invasive stimulator to increase spine fusion surgery success rates.