Involving patients can help deliver innovations that address unmet needs, but it’s still early days for the medtech industry’s patient engagement drive
Working with patients to set research priorities and develop medicines is swiftly becoming the norm in the pharmaceutical sector. Evidence is piling up that patient engagement saves time and money, increasing the chances of getting new medicines from bench to bedside.
Compared with the medicines sector, medical technology companies are relative newcomers to co-developing products with patients. While the lifecycle of medtech innovations – from devices and diagnostics to apps and wearables – differs from that of drugs, the value of patient input may still be considerable.
Take Parkinson’s disease, for example. Tremor is typically the most visible sign of the condition, but patients often highlight the burden of non-motor symptoms including fatigue, constipation, swallowing and communication problems.
Medication can help control some of these symptoms, but new medical devices are also helping some patients. The most high-profile innovation in recent years is deep-brain stimulation which involves implanting electrodes in the brain. These electrodes produce pulses that help to regulate movement.
New wearable devices also promise to help track movement, measuring the impact of medicines or other devices, or detecting any decline in clinical symptoms. With so many new technologies on the horizon, the question is how to figure out what to prioritise – and what patients really want from the next wave of innovation.
Engage early, engage often
The solution is clear, says Karlin Schroeder, Associate Vice President, Community Engagement at Parkinson’s Foundation: work with patients early to find out what matters to them and keep them involved throughout design, development and product improvement processes.
The Parkinson’s Foundation has recently embarked on two patient engagement projects with medtech firms. The Foundation has previously worked with University of Minnesota researchers to train Parkinson’s patient advocates to understand medtech R&D and consider what they would like to see researchers focus on.
‘During that session, we spoke about how devices are developed and the differences with a typical drug clinical trial, and we talked about which endpoints matter to patients,’ Karlin said. ‘Patients spoke about non-motor symptoms such as cognition, gastrointestinal problems, visual problems, and if devices can address these.’
The group of patients and caregivers voted for their top three symptoms, helping to narrow a list of six down to three. Of these, cognition topped the poll.
Discussing deep-brain stimulation, patients discussed how the technology might be used to positively affect cognition and, if so, what outcomes would be most important to people with Parkinson’s disease. The group considered what meaningful change would look like and how to balance risks and benefits.
‘The goal is to build out a risk-benefit framework,’ Karlin explains. ‘But the time to do this is from the start of the development process rather than when a product has already been created.’
Companies and patients have a lot to gain from collaborating as early as possible. ‘Feasibility and usability testing of devices are the easy parts, but there’s so much more we can do if patients are at the table from the outset,’ Karlin said. ‘It cannot be a box-ticking exercise before a product is launched. We need to think about what symptoms a proposed technology could address and what endpoints are meaningful for the community.’
Similar challenges arise with wearables where the temptation is to track what can be easily measured rather than aiming for meaningful change in people’s lives. ‘Patients might not care whether their watch can track clinical changes or improve their score on a clinical test; they want to know if that will translate into helping them button their clothes in the morning.’
The Parkinson’s Foundation also works with a bioethicist who helps to tease out the unique risks and benefits of developing devices. Studies on new surgical interventions, for example, might involve ‘sham’ procedures which may carry some risk without the promise of benefits. ‘Balancing risks and benefits can be challenges for our patients, but many will take part in a study even if they have reservations about the risks.’
What next?
As medtech innovation is iterative (involving regular improvements based on experience in the real world), building long-term relationships between patients and experts would be mutually beneficial.
‘I’d like to see standing patient advisory boards that companies could check in with regularly,’ Karlin said. ‘Rather than speaking with patients at the end, it would be about bringing a group of participants along for the ride and consulting them regularly. This would also offer insights to companies on how patients see the future while giving the Parkinson’s community a sense of the big picture in terms of the medtech pipeline.’
While there is already a suite of patient engagement tools available to help companies and patients work together, adapting these to suit medical technologies is becoming increasingly urgent. Karlin joined a PFMD Working Group to brainstorm on how this can be achieved.
‘I was really excited by that,’ she says. ‘I’ve never seen so many medtech companies and patient groups in the same room talking about patient engagement. We looked at the roadblocks, how to adapt training courses and the benefits of collaboration. There is a lot to do but it’s an exciting moment for medtech and patients.’
