The medical technology sector has been slow to see the value of patient engagement. Now a new suite of tools — co-created by patient advocates and industry insiders — offers practical ways to put patients at the heart of its work
The medical technology sector is nothing if not diverse: it features tiny high-tech start-ups and global corporate giants; products range from diagnostics and implantable devices to wearables and apps. But despite its natural tendency for innovation, industry leaders acknowledge that the sector is behind the curve when it comes to patient engagement.
Despite lagging behind their counterparts in the pharmaceutical sector, medtech companies are well-placed to catch up quickly. Several companies have begun to explore how collaborating with patients can bring value to their work while patient advocates are open to engaging early in the product life cycle.
Adapting patient engagement guidance
However, even companies keen to step up their patient engagement work can struggle due to the absence of common definitions, training courses and practical guidelines on how to make it happen. The topic was addressed in an interactive workshop held during the Patient Engagement Open Forum (PEOF) on 7 October 2021.
‘There has been a lot of activity in the patient engagement space but most of it has been in pharmaceutical development. The medical device sector has been a little slower to evolve,’ said Barry Liden, VP of Patient Engagement at Edwards Life Sciences. ‘We are really committed to helping patients but we know we cannot do this alone. It takes a community.’
A group of medical device companies and patient advocates has come together to adapt existing PFMD resources to ensure they meet the needs of the medtech sector. Virginie Delage, Patient Engagement Manager at Medtronic, said four PE tools have been reviewed and adapted. ‘These include the PE Quality Guidance document which provides a practical guide to help us plan, deliver and assess our work under seven quality criteria,’ she said.
Could online training drive culture change?
Delage also highlighted the potential of Synapse – which she described as a LinkedIn for patient engagement’ – to connect various actors, initiatives and resources for those working on PE. In addition, online training can help to raise awareness and competence within companies.
‘We now have a short 15-minute Introduction to PE e-learning programme; a 45-minute training course that goes deeper in the value of PE; and a 90-minute version on PE in action,’ she explained. ‘In addition, we have co-created reference contracts and guiding principles for contracting between patients and industry.’ Delage said the 15-minute version of the training programme should be mandatory across the industry to ensure it becomes part of industry culture.
Patient training will also play a key role in building capacity both in the medtech industry and among patients, carers and patient organisations, according to Paola Kruger, Patient Expert at EUPATI. She called for a ‘change of mentality’ within companies to ensure that patients are involved at the design stage rather than after prototyping, but added that patients will need to be ready to engage.
EUPATI’s well-established Patient Expert Training Programme is being expanded to include content on medical devices. ‘Medtech is the next challenge for patient engagement, and patient training is a key enabling factor in improving patient participation,’ she said. ‘It is important that stakeholders work on this together and grow as a community.’
Authorities can drive patient engagement
Regulators can help to ensure companies are at the heart of product development, study design and postmarket work, Michelle Tarver, Center for Devices and Radiological Health (CDRH) at the US FDA, told the PEOF.
The FDA itself has undergone a cultural evolution in recent years which has seen patients move centre stage. It has established the Patient & Caregiver Connection which provides a platform for sharing individual experiences of the disease, medical devices and current trends in medtech. ‘We currently have 19 partners and are open to other patient organisations,’ she said. ‘This helps us to ensure that we consider patients and their perspectives in our daily business.’
In addition, the CDRH Patient Engagement Advisory Committee provides a formal way to hear from patients, their families and advocates. The Committee provides formal recommendations to the FDA on matters related to medical devices.
‘Patient voices are useful across the total product lifecycle, from discovery and ideation all the way through to post-market monitoring,’ said Tarver. ‘This helps to develop products that are human-centred by design and it informs our communication on the benefit-risk of devices.’
In addition, the FDA liaises with the Medical Device Innovation Consortium (MDIC), a public-private partnership bringing together industry and government stakeholders, as well as working with the European Medicines Agency on patient involvement.
The PEOF session concluded with a Group map exercise that explored barriers to advancing PE in the medtech sector. It revealed a need for more medtech-specific data on the value of patient engagement and sharing of best practices, as well as calls for a social media campaign to champion PE in this sector.