AMDSLast week, over 200 regulators, engineers and company executives from across the US attended the 3rd Annual American Medical Device Summit. The event’s program explored the challenges and opportunities in product development, quality management, speed to commercialization and regulatory harmonization. Attendees witnessed first-hand case studies and walked away with strategic insights to streamline processes, reduce costs and remain compliant in an ever-evolving environment.

A majority of the sessions focused on specific FDA sanctions, rulings and best practices, but there were several distinct themes that stood out during the American Medical Device Summit.

Summit presenters:

  • Acknowledgedhow public policy impacts the medical device industry in terms of leadership and competitiveness in the world.
  • Identifiedthe opportunities and challenges in various regulatory markets.
  • Highlighted the importance ofperformance, safety, business economics, risk management and regulatory requirements as a basis for device design.
  • Emphasized the benefits of developingand sustaining the gains of a quality culture and adopting proven change management techniques.

While the agenda was tailored towards an upstream applicability, presenters touched on topics that undeniably make their way downstream as well.

A Top Takeaway

Develop a design (and a plan) with humans in mind.

Dr. Marco Costa, VP & Chief Innovation Officer of University Hospitals, discussed an essential component of developing a medical device: design it with humans in mind. It’s critical for device makers to consider the end user—but it is equally important to take into account how the product will impact the support staff, the hospital system, the patient and even the caretaker.

During the early phases of a new device idea, the engineering team should ask themselves:

  • Will physicians find it easy to use?
  • Will the learning curve for nurses and techs be reasonable?
  • Will it make sense economically for larger systems and smaller practices?
  • Will it improve or save the patient’s life?
  • Will the patient’s caretaker be able to make the transition from hospital to home?

For a medical device to bring holistic value, the answer to each of the above questions should be an unwavering “yes.”

The concept of human-centered design must be applied at the earliest stages of developing a new medical device—but it also serves a purpose when bringing that device to the marketplace. It is just as important to consider all stakeholders and their needs when it comes time for marketing and selling the device.

When developing a go-to-market plan for a medical device, it’s the marketing team’s job to bring value to each and every one of those “humans” that the engineering team had in mind from the very beginning.

Marketers can start by answering these questions:

  • How can we demonstrate the device’s easy-to-use functionality to physicians?
  • How can we educate nurses and techs on the device?
  • How can we effectively message our pricing strategy to reimbursement teams?
  • How can we assure the patient that their life is our number one priority?
  • How can we assist the caretaker as they transition from the hospital back home?

Companies can no longer depend solely on the physician to make the final purchasing decision—they must tailor the value they bring for each and every stakeholder that is part of the decision-making process.

To read more top takeaways from the American Medical Device Summit, check out the brief below.