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Page 612 – Stanford Medicine X

Patients Taking Charge: #WeAreNotWaiting, medical hacking, and other non-approved FDA activities

Michelle Litchman michelle.litchman@nurs.utah.edu
Perry Gee perry1gee@gmail.com
Dana Lewis danamichellelewis@gmail.com
Mila Ferrer mila_ferrer@me.com


Patients have long been self-experimenters. Technology, including social media, has sped up the pace of self-experimentation and sharing of solutions. In some cases, technology created by the patient community has outpaced commercially available technology. While this is not unique to one community, the diabetes community is well known to be active in the DIY innovation space. This panel will highlight examples and stories of successful DIY innovation while also touching on significant topics such as non-traditional collaborations for research and innovation, new paths for FDA review and regulation, and suggestions for sparking ongoing innovation and approval in medical technology.

Perry Gee, a nurse, clinical informaticist, and research scientist from Dignity Health, studies chronic disease, eHealth, aging, and technology. He will moderate the panel, framing the discussion around the need for patient collaboration to spark innovation in research and design and the need to streamline the approval of technology to improve patient-centered care.

Dana Lewis first built her own do-it-yourself “artificial pancreas” - and then founded the open source artificial pancreas movement (known as "OpenAPS") - to lead the community to make safe and effective artificial pancreas technology available (sooner) for people with diabetes around the world. She will speak about being a vocal part of the #WeAreNotWaiting movement and collaborating with people across various patient communities around the world to encourage solving healthcare problems in new and innovative ways. She will also discuss collaborating with numerous stakeholders (academia, traditional industry device makers, and FDA) to develop and implement new review processes to meet the growth of makers and other rapidly-innovating patient-driven research projects, and thereby demonstrate the safety and efficacy of new ideas and approaches far faster than what can be done using traditional development and approval processes.

Mila Ferrer is a passionate diabetes advocate, communications director for an English and Spanish speaking online community, and mother of a teen with type 1 diabetes. She will speak about her family’s experience with the do-it-yourself technology, Nightscout, which has improved their quality of life. She will also discuss the conversation occurring within diabetes online communites with regards to non-FDA approved activity.

Michelle Litchman, nurse practitioner and Assistant Professor at the University of Utah, examines the use of technology to support diabetes management. She will discuss non-FDA approved activity as it relates to real-time continuous glucose monitoring use and the black market purchasing of medical devices, supplies, and medications. She will also review the safety and education implications and provide insight about the future of strategies for examining safety and approval of non-FDA approved activity.  
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