The Key to Meaningful Patient Engagement in Medical Device Trials? Engage Patients Early and Often

MassMEDIC recently hosted a panel of speakers to discuss Patient Engagement & Medical Devices, featuring Alicia Staley (Vice President, Patient Engagement, Medidata Solutions), Anna Legassie (Patient Advocate), and Stephanie Reffey (Patient Advocacy and Alliance Relations Director, Exact Sciences). They discussed their perspectives on how medical device companies can better engage and work with patients, since research shows that an increase in patient engagement typically leads to better outcomes for the trial, including better data captured, a better patient experience, and increased retention rates.

Below are highlights of the three panelists’ perspectives.

Patient Engagement Technology Solution Perspective

Alicia Staley discussed how patient engagement and patient centricity are critical components for building a framework to provide clinical trial solutions. 

Medidata has identified five pillars around the concept of patient experience and engagement to ensure meaningful conversations with patients: 

1. Education 
2. Trust and transparency 
3. Awareness
4. Connection 
5. Collaboration

“You will be surprised at what you learn by just staying engaged with patient communities.”

– Alicia Staley, Vice President, Patient Engagement, Medidata

Medidata has a Patient Insights board of 10 patient advocates who work closely with the design and development teams to integrate their feedback and suggestions into the software development life cycle. Medidata recently finished its first full product release for one of its solutions, myMedidata—a patient portal, designed by patients for patients. Patient advocates were part of the process from start to finish, where their input in solution design was incorporated in every step of development. The life sciences industry has a lot of opportunity to adopt a mindset that allows patient advisors to be involved throughout the entire development life cycle for any kind of solution like software or services. That, in turn, creates patient ambassadors who feel ownership over the products or solutions rolled out.

Finally, dashboards and how data is communicated to patients is a big component of how medical device sponsors can serve as good stewards of trial data. Without full transparency and a shared sense of ownership, it can be challenging to truly engage and motivate patients to continue in a clinical trial. This is a foundational element of shared decision making and a best-in-class perspective for the life sciences industry.

Patient Advocate Perspective

Anna Legassie emphasized the importance of patient engagement, especially when it comes to medical device companies. These companies tend to be further behind biotechnology and pharmaceutical companies in engaging with patient affairs and patient advocacy, early and often, during the development life cycle in order to build trust with the patient community. 

Patient engagement is a great opportunity to make sure that the interventions developed are in line with patients’ expectations, relevant to patients and their needs, and can manage expectations for quality of life and improvement compared to the current standard of care.

Keep in mind it’s also very easy to lose the trust of that patient community. This is especially true if they do not see a good alignment in developing better interventions, products, devices, and value and a more positive impact for them. Patient engagement has to be intentional and genuine for it to meaningfully influence the process. Patients will quickly disappear if they sense it is not a genuine conversation. 

Industry Perspective

When it comes to patient engagement, Stephanie Reffey underscored that medical device companies should engage early and engage often. It is never too early.

Patients are the end users of the products that are developed. If the medical device is not meeting their needs, then the product will not be successful. Sponsors must communicate with patients directly to understand what their needs are and how to meet them. Exact Sciences engages with patients frequently—both directly and through patient advocacy groups—to better develop that understanding and involve them throughout the process. Patient engagement occurs as early as when strategies and goals are being set, and an open and sustained conversation is key. 

To be successful, the industry needs to understand the full spectrum of the medical device patient journey and how it can impact trial design, outreach, and potential engagement. Without understanding the patient experience, it becomes difficult to design solutions or determine how a medical device may impact quality of life.

“When we involve patients, not only do we engender trust and have input into what we are doing, but patients also learn more about our industry and the challenges we face. It becomes a reciprocal relationship where they help us while we are helping them.”

– Stephanie Reffey, Patient Advocacy and Alliance Relations Director, Exact Sciences

Diversity and inclusion are also significant factors to consider. If different populations, genders, ethnicities, ages, and even socio-economic statuses are not intentionally included, then it cannot be assumed that a product or solution is serving those populations. These voices should be invited early to engender trust and gain an understanding of their individual journeys. 

Last, reimbursement and the cost of medical care is an area where patients and medical device companies are in good alignment, since both want coverage. This is extremely important and should always be at the forefront during development to avoid a situation where the only way patients and advocates can insure coverage is by lobbying elected officials. 

Click here to watch the MassMEDIC webinar.

Visit our Patient Insights & Engagement page to learn more about how Medidata is supporting patient centricity in clinical trials.