The Quadruple Aim describes population health goals including decreasing costs, improving the patient experience, improving patient clinical outcomes, and improving the experience of providing care. Implementing new technologies into the current healthcare delivery system remains challenging and the Quadruple Aim goals play a role in the successful clinical adoption of a medical device.
Shifting from “fee-for-service” toward value-based payment has prompted medical device innovators to compare the perceived value of their device for patients, providers, and payers. To bridge the gap between device development and adoption, it is critical to understand the facilitators and barriers to implementation.
The Consolidated Framework for Implementation Research (CFIR) gathers together the main constructs that are associated with effective implementation and provides a bank of questions that can be used to assess them. The framework includes potential barriers and facilitators in preparation for implementing an innovation. Since 2013, NEPDC has granted funding and in-kind services to support commercialization of pediatric medical devices. By utilizing CFIR interview questions and conducting interviews with NEPDC grantees, we have identified factors that facilitate and factors that limit pediatric medical device implementation.
Among preliminary findings from these NEPDC grantee interviews, a few stood out as important considerations for pediatric medical device innovators:
- Valued elements of the Quadruple Aim varied depending on where within the healthcare delivery system (e.g. outpatient clinic, ICU, emergency department) the device would be implemented.
- Higher quality of evidence available to support the efficacy and safety of the device resulted in more willing users (i.e. patients and/or clinicians) and increased levels of clinical evidence corresponded to more advanced stages of implementation (e.g. one clinic, multiple clinics, or delivery system wide).
- Organizational structure of the targeted site impacts the ability of device to be pitched, piloted, and purchased. Smaller, independent organizations appear to have a lower barrier to entry. This enables innovators to get devices to users and collect data before approaching larger, more complex organizations.
- Cost remains a priority in supply chain and value analysis committees, although it is not always the priority of the device innovator.
With this information in mind, NEPDC offers recommendations to pediatric device innovators:
1 ) Obtain clinician engagement in research and development (R&D): Offering early device adopters the opportunity to participate in research enhances device credibility, gets the device to clinicians and patients earlier, and improves your access to clinical champions and key opinion leaders for sales and adoption.
2 ) Connect with patients and their caregivers: Meeting their needs and encouraging them to inquire about the device at their provider’s practice facilitates implementation, specifically when quality of life and treatment compliance are highly valued outcomes.
3 ) Create implementation plans: Plans for implementation are seldom created due to a lack of knowledge about their development and importance. This includes setting measurable objectives, creating a communication plan for your customers to stay informed, confirming that a support structure is in place for customer service and technical support.
Even the best laid plans hit snags and this is particularly true for the unique circumstances of the pediatric medical device market. The following are recommendations to the various stakeholders in the pediatric device environments to support clinical adoption and implementation of new technologies:
For healthcare delivery institutions
As previously mentioned, cost remains a priority in supply chain and value analysis committees. Particularly for pediatric patients, consider modifying policies to more heavily weigh patient outcomes over cost such as quality of life improvement for patient and caregiver.
For Technology Transfer Offices (TTO)
These offices see a high volume of products at academic institutions and this can delay getting a device to market, particularly if there is low return on investment (ROI). Prioritizing clinical impact of pediatric medical devices and other values of the Quadruple Aim, in addition to ROI, will ensure that the products needed by children will reach them sooner. If your TTO is unable to prioritize pediatric medical device commercialization, consider collaborating with organizations that do.
For funding agencies
Federal government and funding agencies provide competitive funding for device development, but limited support to improve access to new technologies. Consider how these new technologies will reach their intended users in the market and how, as a funder, you can support pediatric device innovators at later stages commercialization.
 The Consolidated Framework for Implementation Research was developed by implementation researchers affiliated with the VA Diabetes Quality Enhancement Research Initiative.
NEPDC awardee interviews were conducted by Tiffany Brazile, NEPDC Resident Fellow and results were presented at the Academic Pediatric Association’s Regional Meeting in Waltham, MA. This article is written by Cassie Brugger, NEPDC Senior Program Administrator and Tiffany Brazile with contributions from George Price, Dr. Christine McDonough, Dr. Ann-Christine Duhaime, and Dr. Ryan Ratts.