MEDdesign

Setting the Stage for the Next Generation of Medical Devices

By Brian Stallard
February 16, 2022


• Categories: 01-Digital Health, 03-Manufacturing Execution, 04-Product Design & Development, 05-Quality/Regulatory, Clinical Decision Support, Connected Care, Interoperability, Manufacturing, MEDdesign, Medical Devices, Product Design, Tech-enabled Services, Topic - Health Information Technology

Interventions for Innovation

In a bid to accelerate innovation in the health technology industry, a pair of organizational behavior experts recently explored seven techniques for inspiring creative solutions to common health technology problems. They stress, however, that for true innovation to occur in any technology-related field, the process cannot simply stop at inspiration.

Innovative ideas must be swiftly acted upon through structured development and implementation, Meena Andiappan, Ph.D., assistant professor at the University of Toronto, explained in an article recently published in BI&T, the peer-reviewed journal of health technology and sterilization from AAMI.¹ Unfortunately, the expert warned, embracing innovation efficiently may require changes in company culture.

“Creating a culture in which failure is embraced, creativity is nurtured, and risk-taking is encouraged is not without its dangers,” wrote Andiappan and McMaster University research assistant Joshua Anih. “Organizations and managers must be cognizant of issues such as moral hazard and resource wasting, such that positive processes of innovation are installed without undue waste.”

Referencing nearly 40 scholarly articles and case studies, the duo provided seven evidence-based methods (four team-level and three organization-level interventions) managers can use to establish and foster a culture of employee innovation within their organizations.

On the team level, they proposed strategies for empowering employees such as delegating ownership of projects and encouraging self-led decision-making. They also showcased the efficacy of some lesser-known workplace culture shifts such as the servant leadership model. In this model, team leaders are treated as stewards responsible for the well-being and growth of team members.

“Studies have indicated that the servant leadership model fosters a positive team environment, including a service climate and knowledge sharing, both of which encourage the cross-pollination of ideas,” the authors said. “When individuals feel like they are able to enter an open dialogue with the free exchange of ideas, the first seeds of innovation are often sown.”

On an organization level, Andiappan and Anih strongly advised against letting fear of failure become prevalent in the workplace culture, lest employees miss out on valuable opportunities for serendipitous discovery and learning.

“This is particularly important in an industry such as the medical device sector,” they warned, “where the strong presence of regulatory bodies and numerous regulations that guide product development may create cultures that are highly risk averse and less open to experiences of failure.”

Preparing for the Interoperability Revolution

With innovation in the medical device space driving forward, some experts have posited on a future where medical system components can be seamlessly combined using common communication networks. Instead of functioning as standalone elements, as is often seen with networked devices today, the next generation of devices may be outfitted to serve as modular components of customizable systems.

“Clinicians will be able to create new medical systems simply by assembling interoperable devices,” explained Paolo Masci, PhD, a senior research scientist at the National Institute of Aerospace, in a BI&T article.

For instance, an infusion pump could be administering pain relief medication intravenously to a patient while a separate device, a pulse oximeter, monitors vital signs. As long as these devices are interoperable, an app could integrate and control these two devices, monitoring patient parameters produced by both. If the parameters reported by the oximeter move outside safe ranges, the program would stop the infusion pump and notify clinical staff.

In this way, “combinations of medical devices may provide checks and balances that can be used to enhance the effectiveness and safety of the individual devices,” said Masci.

In anticipation of the commercialization of this next generation of medical devices, experts from regulatory authorities, industry, and academia worked together to create recommendations for safe and effective device interoperability. These recommendations were published as a first-of-its-kind standards document in 2019, ANSI/AAMI/UL 2800-1:2019, Standard for Safety for Medical Device Interoperability. That same year, the FDA formally recognized the standard “as a baseline set of requirements for assuring safe and secure interoperability for interoperable medical systems” within a healthcare environment,” paving the way for medical device manufacturers to explore the potential for seamless device interoperability.

Of course, questions remain. How, for instance, can manufacturers anticipate and prevent confusion that may arise when one interoperable device is coupled with another? With countless combinations of component medical devices being developed for future systems, how can innovators appropriately assess the usability of their device, to prevent human error in the hospital room?

According or Masci and Sandy Weininger, PhD, senior engineer with the Division of Biomedical Physics of the Office of Science and Engineering Laboratories in the FDA’s Center for Devices and Radiological Health, there’s really no need to reinvent the wheel. Instead, they build upon it.

In an analysis article recently published in BI&T, Masci and Weininger successfully demonstrate “how an existing model-based analysis method can be adapted to support usability engineering of next-gen integrated interoperable medical devices.”²

The team started with a common model-based method called system theoretic process analysis (STPA).

“STPA covers the analysis of use errors but offers limited tools for reasoning about latent design anomalies in system design that could trigger use errors,” they wrote. “The method presented in this work extends STPA by using established human factors engineering principles, which provide a more direct explanation of how design aspects of an interactive system can trigger use errors.”

The modified method accounts not only for a system’s devices, but also the humans who will be interacting with them. It has innovators follow four key steps:

• Develop a control diagram
• Identify foreseeable use errors
• Identify design anomalies
• Generate design recommendations

The original method was conceived for stand-alone devices, they added, but by taking cues from the human factors field, the improved method is applied to interoperability functions with success.

Still, medical devices that can interoperate with devices from another manufacturer or vendor are not yet available in any market. As a consequence, the technology remains relatively untested. “This may create blind spots in the analysis performed early in the development process,” Weininger and Masci warned, urging innovators to employ the analysis multiple times throughout a new device design’s development.

References

1. Andiappan, M. and Anih, J. (2022) “Seven Ways to Inspire Innovation in the Health Technology Industry.” BI&T. https://doi.org/10.2345/0899-8205-56.1.1
2. Masci, P. and Weininger, J. (2021) “Usability Engineering Recommendations for Next-Gen Integrated Interoperable Medical Devices.” BI&T. https://doi.org/10.2345/0890-8205-55.4.132