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Introduction to Patient Engagement in MedTech in the U.S.

Executive Summary of a Playbook for Patient Engagement in MedTech in the U.S.

Stakeholder groups in the healthcare ecosystem recognize the value patient engagement can bring in developing patient-centered initiatives throughout lifecycle management. However, the MedTech industry has not yet taken full advantage of the opportunity patient engagement presents. Properly executed patient engagement strategies can lead to improved service of patient needs, improved outcomes, and maximized market access.

The Patient Engagement Think Tank in MedTech was established in 2021 by Alira Health in partnership with MassMEDIC, The Center for Patient Advocacy Leaders (CPALs), and MedTech industry participants – 3M, Abiomed, Boston Scientific, Exact Sciences Insulet and Smith & Nephew. The goal of the Think Tank was to deliver actionable insights on how the MedTech industry can successfully incorporate patient engagement activities in medical device and diagnostic development — at every stage of the product lifecycle.

Published on:
May 17, 2023

In 2023, Think Tank has released “A Playbook for Patient Engagement in MedTech in the U.S.” which amalgamates ideas, research, findings, and forecasts containing the following insights:

  • How MedTech stakeholders can leverage bidirectional patient engagement strategies to ensure that patients’ experiences, perspectives, and priorities are captured and meaningfully incorporated into product lifecycle management;
  • Key pain points, opportunities, value propositions, and activities across stakeholder groups that span: Clinical Development, Regulatory and Market Access and Pre- and Post-Commercialization;
  • A Patient-Centered Co-Design methodology for MedTech that ensures products and solutions serve patient needs, improve outcomes, and maximize market access.

Keep reading to get key playbook takeaways and download the full playbook for more.

The Importance of Patient Engagement

The U.S. healthcare system is complex, with countless stakeholders, settings, and providers. Patients often represent the only consistent factor within the patient journey, inherently making patients essential partners to delivering high quality care effectively and efficiently. Evidence increasingly shows that patient engagement can improve patient knowledge, patient–provider relationships, healthcare utilization and satisfaction, treatment adherence, health outcomes, and healthcare costs.​ [1]​ ​[2]​

We know from the success of patient engagement in the pharmaceutical industry that these activities also add significant financial value for sponsors at each stage of the product lifecycle — from avoiding protocol amendments to enhancing clinical trial enrollment and clinical trial retention. ​[3]​ And while the MedTech industry recognizes the importance of patient engagement, it currently lacks the expertise, infrastructure, and standardization protocols to implement sustainable patient-centric strategies. In a 2021 survey of the MedTech industry, 60% of respondents said that patient perspective is important, but only 15% had fully implemented patient engagement initiatives as part of their product development. ​[4]

The slow adoption of patient engagement and lack of MedTech industry expertise in this area drove the establishment of the Patient Engagement Think Tank. Over the course of one year, the Think Tank brought together patient advocates and industry players to explore how patient engagement can be successful in key aspects of the product lifecycle: clinical development, regulatory, market access, and pre- and post-commercialization.

Results and Insights

Creating a clear, industry-standard definition of “patient engagement” was the first step in helping MedTech companies think about how to create effective and successful strategies. The Think Tank defines patient engagement as:

“The systematic approach to ensure that patients’ experiences, perspectives, and priorities are captured and meaningfully incorporated into the whole lifecycle management by establishing a bidirectional partnership between manufacturers and patients with the goal of generating products and solutions that serve patients’ needs, increase access, and improve outcomes.”

With this common definition, the Think Tank was able to define the challenges, opportunities, and value propositions of patient engagement activities throughout the product lifecycle.

Properly executed patient engagement strategies can lead to improved service of patient needs, improved outcomes, and maximized market access.

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Clinical Development

While an overall cultural shift is occurring around the patient’s role in healthcare, this shift is not happening at the same pace in clinical research. The current sentiment in clinical research is more that it is “performed on patients, not with patients,” positioning patients as a “source of data” rather than an active participant in the process.”​ [5]

However, including patient, caregiver, and advocate insights can help researchers plan and execute clinical trials with more feasible protocols, improved inclusion/exclusion criteria, and meaningful endpoints — saving time and financial resources while also yielding more impactful results and addressing unmet medical needs.

Regulatory and Market Access

Patient engagement in the regulatory process has historically been dictated by the U.S. Food and Drug Administration (FDA), whose current published guidance encourages incorporation of patient-reported outcomes, experiences, and patient preferences into regulatory filings.​ [6]​ ​[7]​ ​[8]​ The Centers for Medicare and Medicaid Services (CMS) and private payers, in contrast, have issued disparate policies and unclear expectations for patient engagement in market access considerations and health technology assessments (HTAs).

Even with this disconnect, there are many logical and pragmatic benefits that, though not easily quantifiable, are understood based on the increasing desire of regulators and payers to receive patient insights and data. Utilizing patient-generated insights and data can improve regulatory approval, time to market, return on investment (ROI), market access, coverage, and payment determinants. ​[9]

Pre- and Post-Commercialization

MedTech’s commercialization shortcomings are largely due to its reliance on only one or two patient communication channels and inadequate access to patient data. The result is limited presentation rates and lack of patient awareness around diagnosis, treatment, and quality of life improvement. ​[10]​ The COVID-19 pandemic exacerbated these pre-existing challenges, with patients postponing visits and delaying treatment.

Engaging patients through mobilization efforts, education initiatives, support systems, and partnerships with patient advocacy organizations can have widespread impact on improving patient presentation rates and awareness — benefiting patients with unmet needs as well as the commercial success of the medical device or diagnostic.

What’s Next for MedTech?

Patients, as well as caregivers, providers, and patient advocacy partners, are uniquely positioned to contribute to medical device and diagnostic development. Properly executed patient engagement strategies can serve patient needs, improve outcomes, and maximize market access. It is time for leaders in MedTech to establish industry-wide expertise and infrastructure and standardize sustainable patient-centric strategies. Leveraging the strategies outlined in this playbook will help establish industry awareness of patient engagement activities throughout the product development lifecycle, accelerate patient engagement efforts, and drive commercial success while meeting significant unmet needs.

patient engagement playbook for US MedTech
Get the Playbook

Download “A Playbook for Patient Engagement in MedTech in the U.S.


1. Patient Engagement. Health Policy Brief. 2013.

2. Gagliardi AR, et al. “Factors constraining patient engagement in implantable medical device discussions and decisions: interviews with physicians” International Journal for Quality in Health Care, 2017, 29(2), 276–282. Accessed July 11, 2022.

3. Levitan B, et al. “Assessing the Financial Value of Patient Engagement: A Quantitative Approach from CTTI’s Patient Groups and Clinical Trials Project”. Therapeutic Innovation and Regulatory Science. 2018;52(2):220-229. doi:10.1177/2168479017716715.

4. de Maria, Annabel, Ouensanga, Aude. A Survey to Assess US MedTech Patient Engagement (Unpublished). Boston: Alira Health, 2021.

5. Sacristan J, Aguarón A, Avendaño-Solá, et al. Patient involvement in clinical research: why, when and how. Patient Prefer Adherence. 2016;10:631-640.

6. Weldring, Theresa, and Sheree M.S. Smith. “Patient-Reported Outcomes (PROs) and Patient-Reported Outcome Measures (PROMs).” Health Services Insights 6 (August 4, 2013): 61–68.

7. CMS, “Patient Reported Outcome Measures”, (2021).

8. “Evolution of Patient Engagement at the FDA.” FDA, July 8, 2021.

9. This value proposition was workshopped over the course of the 3rd Think Tank meeting to come to a conclusion that was satisfactory for all participants.

10. Bhatnagar, Sudhanshu, Shepley, Tanya. How to bridge patient engagement capability gaps for MedTech commercial success. ZS. January 11, 2021. Accessed July 20, 2022.

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