Neonatal aspirator, the winning design from the 3DHEALS and Voices of Africa hackathon by Kyle Gaiser

In a time of customization to match our personal needs, why do we continue to use the healthcare technologies designed for adults on newborns? The NeoDesign focus group, organized by the Division of Neonatology at the Stanford Children’s Hospital, meets monthly and aims to change this. The event on May 15th, 2017 was hosted by Dr. Vinod Bhutani and Dr. William D Rhine.

The goals of the group are to better understand and incorporate “design thinking” into clinical workflow and innovation efforts, as well as recognize the clinical, business, and ethical hurdles to testing and implementing devices and technology into neonatal care. The take home-points from this conference are valuable to everyone who wants to innovate in healthcare anywhere in the world. In fact, many of the issues addressed during the conference were encountered during our (3DHEALS) collaborative hackathon with Voice of Africa Foundation very recently in designing a neonatal aspirator. (We will report on this later.)

There are three main take-home points:

  1. Idea generation

Finding a use case before making the device!

Too often a device or software is created and it is only after this that the search is on for a use and how it can be integrated into the current standard of care. Connection forum(s) are necessary to bring nurses, clinicians, and engineers together to identify and solve problems. Even better is having engineers actually go and see what the doctors and nurses are doing in their practice. In this way, everyone can see what is being done and understand the real problems.

In addition to the NeoDesign group, the Biodesign program at Stanford (represented at this meeting by Dr. James Wall) is another trying to bridge this gap. They help create teams of engineers, clinicians, and industry partners in addition to teaching them to manage innovation teams. One example of how they do this is by bringing a psychologist to speak with the teams to help create a common language between the different disciplines.

      2. Funding the idea

The NIH has a budget in 4 month increments, which makes it hard to predict funding in the future. The Coulter centre and NSF were identified by panelists as other potential sources of grants and funding. These are all possible opportunities but a love of your work and an internal desire to create a better healthcare system are necessary to succeed.

I spoke with one clinician, Regine Marie Fortunov, MD at Baylor College of Medicine, whose goal was to create a new neonatal resuscitation documentation software. To accomplish this, she learned to code in-between putting her kids to bed and her own midnight bedtime. Then she would wake at 6 to get the kids to school and head back to the hospital. In the hospital, in addition to her own work, she gathered feedback on the app from nurses and other clinicians. She couldn’t outsource the coding aspect because funding wasn’t available. A positive spin to the fact that the coding was done by herself, meant that feedback could be instantly integrated for a new update. After six months of hard work, she is now partnering with other hospitals and hoping to develop the software for widespread adoption. This is just one example of how a project first needs the investment from the individual.

      3. The testing hurdles

Demonstrating safety is the minimum entry test into the healthcare system. There are regulatory trials to show safety, and clinical trials to prove that the device or software is actually useful. These trials are sometimes overlapping but is not always the case. The NIH panelist during the conference gave a heads up that the NIH will be revamping how they are doing and accepting clinical trials in the future, including the quality of clinical trials. For both safety and efficacy studies, it is suggested to have composite (and/or many) different endpoints so as to better define the difference that introducing the device or technology has on the current standard of care.

In an evidence-based system, data demonstrating the usefulness of new devices and software is paramount to approval for use. A lack of studies using, and benefiting from, the new technology is therefore just as large a hurdle as demonstrating safety. A proposed solution is greater communication and connections between academia, hospitals, and manufacturers to create evidence of efficacy. In other words, a meeting of the minds on validation and development.

Finally, throughout the innovation process, involvement of patients and parents should not to be forgotten. They are often the key drivers to push for change and innovations, at the same time, acting as great advocates and potential sources of funding.