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The drive towards greater patient centricity in the med tech industry has been reinforced by new EMA legislation. Can med tech follow pharma's example in engaging with patient advocates?
The traditionally separate worlds of pharma and medtech continue to converge, with pharma expertise helping medical device companies conduct clinical trials, an increasing use of combination products, and the ongoing move towards a patient-centric approach by both industries. This drive towards greater patient centricity is reinforced by new EMA legislation for medical devices. From May 2020, medical device companies must provide robust clinical evidence, including patient risk/benefit, before gaining marketing authorization.1,2 This legislation further creates an opportunity for medical device companies to embrace more formal working with advocates and patient groups across the life cycle, similar to the approach being followed today by pharma.
The scope and number of medical devices (approximately 500K) is vast compared to medical products (approx. 20K),3 with those classified as combination products, wearables, and diagnostics likely offering the greatest opportunity for formalized patient engagement. Combination products bring together drug or biologic products and medical devices to more effectively deliver treatments to patients. They are expected to contribute new levels of value to HCPs and patient care in the coming years and will continue to provide greater incentive for new treatment options offering even better patient outcomes.3 The market potential is strong, with approximately one in four medicines including a medical device component, and the majority of these involving an integral device. This includes, for example, pre-filled syringes and pens, patches for transdermal drug delivery and pre-filled inhalers.4 The global medical device combination market is forecasted to reach $140,000 million by 2025.4
Market growth of combination products is driven by the increasing incidence of chronic diseases, such as prostate cancer, cardiovascular diseases, colorectal cancer, diabetic neuropathy, obesity, diabetes, and the growing geriatric population.3 Pharma has seen that these areas already have robust patient representation at national and European levels, with patient engagement initiatives such as EUPATI, PARADIGM, and Patient Focused Medicine Development, whose ultimate shared aim is to capture patient insight to make treatments that patients want and need.
But the measurement of patient engagement remains unclear within pharma until more robust case histories are published. This evidence gap will be a consideration for medtech companies planning a patient engagement and advocacy strategy.
Successful pharma companies share some common characteristics with medical device companies, such as using simple measurement criteria, creating flexible compliance procedures, and a long-term view in building sustainable partnerships in areas of common unmet need. Medical device companies have some unique access challenges, however. For example, the role of the Notified Body in assessing product conformity before authorization is a step not seen in pharma. The present, limited number of Notified Bodies potentially slows down access to patients. The role of patient insight in what are often technical evaluations is far from clear, though national regulatory bodies are reaching out to patient groups. 6
Some medical device companies, such as those in the area of prefilled syringes, have pharma as their both their direct and immediate customer, limiting experience and opportunity to work direct with advocacy groups and advocates. The opportunity may be there for these and some of smaller companies to work with a formalized patient engagement strategy; it will just take time for the right value path to become clear.
Medical device companies have traditionally followed a different patient engagement pathway from pharma, focusing on post-marketing surveillance and user studies where patients or carers give input into the device use and application. But this lack of a more formal process of working with patient groups and advocates limits the creation of sustainable institutional partnerships that form the foundation of successful patient advocacy and engagement.
A common theme in medical devices is managing risks and meeting regulatory requirements. This involves building evidence that conveys why choices are made throughout the development process. At present, EMA legislation does not have a formal framework for assessing patient risk-benefit. Such risk-benefit studies would not be appropriate for certain medical devices, such as sterilisers or plasters. EMA refers to the use of surveys and focus groups for eliciting such insights.7 Well formalized, compliant, and robust methods for gaining such insight using credible patient advocacy groups and advocates represent a golden engagement opportunity for medical device companies. Such an approach can avoid the ever-present risk of presuming that the patient needs are clear.
While both the pharma and medtech industries serve patients, work compliantly, and have strong, innovative R&D cultures, their language does not share a common history. Within a patient/pharma context, compliance is focused more on responsible working with patient groups and ensuring no hidden or off-label promotion. In medical devices, compliance is more associated with QC considerations, such as the recent breast and spinal implant scandals. Both views are just as valid and have responsible working practices at their core. But on a practical level, it is likely to mean that the necessary SOPs (written in a patient-friendly format) and internal expertise, culture, and understanding of working with advocacy groups and advocates will be missing from med tech's internal compliance and other company functions. Similarly, the necessary degrees of separation between the patient engagement/advocacy and commercial functions, so common within pharma, may not be a feature of medical devices.
Pharma's traditional R&D function is changing. It now depends on leaders who can handle the ambiguity and challenges of early-stage research while being emotional intelligent enough to keep the patient need in focus throughout the development stage.8 Medical devices will likely need an approach similar to that of biopharma to bring in the patient insight earlier into the R&D cycle, which currently has a heavier emphasis on engineering.
Ongoing societal and health economic pressures, together with the possibility of personalized treatment plans, will continue to fuel the medtech market. Patient advocacy and engagement will make sense for some companies, but may not make economic sense for all. For some, there will be uncertainties around how such approaches can bring value.
Nick Hicks supports life science companies develop their patient-centric strategies.
A medtech webinar “Are you searching for the right patient engagement path in medical devices” takes place on December 3. To register, visit https://zoom.us/meeting/register/ce2f88f05f979537cde7dc3c8da9331e
2. TOPRA Symposium 2019: Janine Jamieson, "Medical devices used to deliver medicinal products - new regulatory processes from May 2020."
3. MDR Clinical data requirements: Competent Authority perspective TOPRA Symposium 2019.
7. TOPRA Symposium 2019:Robert van Boxtels, "Clinical Evaluation medical devices - introducing concept of benefit level."