At every stage of medical device development, engaging relevant clinical stakeholders is essential for product success.
If you want clinicians, hospitals, or patients to buy your medical device, they must trust you. To earn that trust, they need to believe you understand their pain points and why those issues matter to them. This begins by asking clinical stakeholders the right questions.
Successful innovators recognize that stakeholder engagement is an ongoing, iterative process-not a one-time task. Building relationships with a diverse group of clinical stakeholders throughout product design and strategy development helps innovators create a compelling value proposition while reducing clinical trial and adoption risks. Early engagement enables innovators to identify key pain points, allowing them to develop products and strategies that deliver optimal value and facilitate seamless adoption.
Let’s define stakeholders: they are the various entities involved in delivering patient care, each with distinct values, needs, and perspectives. Examples include:
- Patients and Patient Advocates
- Providers (Physicians, Advanced Practice Providers, Allied Health members)
- Health Care Facilities
- Investors
- Payers
- Government
- Employers
- Medical Organizations, Quality Organizations, Clinical Researchers
Today, we’ll focus on clinical stakeholders-providers, facilities, medical and quality organizations, clinical researchers, and, of course, patients and their advocates.
Engagement should begin in the earliest stages of the design process, when defining an unmet clinical need-a fundamental issue that limits the quality or cost of care.
To do this effectively, innovators must intentionally educate themselves about healthcare delivery in their target market. This includes understanding clinical workflows, patient experiences, current guidelines from major medical associations, care locations and durations, costs, and information about existing products addressing the clinical need.
While basic data such as disease prevalence and market size are readily available online, the most valuable insights come from observing and interviewing stakeholders directly involved in patient care. Innovators must listen to those most affected by the technology, rather than assuming they know what will help. Speaking with a broad range of stakeholders is beneficial, as needs and practices can vary across regions. Both quantitative and qualitative data gathered from these interactions are crucial for future development.
This cycle of feedback and refinement continues beyond the initial idea and is vital to a robust R&D strategy.
As innovators refine their product, modifications should be guided by stakeholder input. Ultimately, for a product to succeed in the real world, it must address user needs. Products with strong feasibility have always incorporated deep feedback from future users and buyers. Once development progresses, feature and design input typically comes from a smaller group of key opinion leaders and target users. At this stage, building a talented advisory board can be transformative for innovation teams.
Successful innovators use stakeholder insights to develop clinical strategies aimed at demonstrating quality, value, and significance, while also driving adoption. It’s crucial to consider what evidence your target users and buyers will require to justify adopting your product.
At RLS, we help clients cultivate strong relationships with key clinical stakeholders throughout the entire innovation cycle. Gathering feedback from key opinion leaders should not be a mere checkbox for emerging technologies, but an ongoing process that provides our clients with a competitive edge in design, clinical trial success, and product launch.
Explore how we support emerging technologies as they launch their clinical phase.
Written by Natalie Freels, Clinical Consultant
