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Establishing a Global Standard for Wearable Devices in Sport and Exercise Medicine: Perspectives from Academic and Industry Stakeholders

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Abstract

Millions of consumer sport and fitness wearables (CSFWs) are used worldwide, and millions of datapoints are generated by each device. Moreover, these numbers are rapidly growing, and they contain a heterogeneity of devices, data types, and contexts for data collection. Companies and consumers would benefit from guiding standards on device quality and data formats. To address this growing need, we convened a virtual panel of industry and academic stakeholders, and this manuscript summarizes the outcomes of the discussion. Our objectives were to identify (1) key facilitators of and barriers to participation by CSFW manufacturers in guiding standards and (2) stakeholder priorities. The venues were the Yale Center for Biomedical Data Science Digital Health Monthly Seminar Series (62 participants) and the New England Chapter of the American College of Sports Medicine Annual Meeting (59 participants). In the discussion, stakeholders outlined both facilitators of (e.g., commercial return on investment in device quality, lucrative research partnerships, and transparent and multilevel evaluation of device quality) and barriers (e.g., competitive advantage conflict, lack of flexibility in previously developed devices) to participation in guiding standards. There was general agreement to adopt Keadle et al.’s standard pathway for testing devices (i.e., benchtop, laboratory, field-based, implementation) without consensus on the prioritization of these steps. Overall, there was enthusiasm not to add prescriptive or regulatory steps, but instead create a networking hub that connects companies to consumers and researchers for flexible guidance navigating the heterogeneity, multi-tiered development, dynamicity, and nebulousness of the CSFW field.

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Acknowledgements

The authors thank Dr. David Korfhagen for transcribing the session recordings, Ms. Chanelle Simmons for providing edits and comments on the manuscript, and the organizers of the virtual events, especially Ms. Leslie Dawkins from the Yale Center for Biomedical Data Science.

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Correspondence to Yannis P. Pitsiladis.

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Conflict of interest

Dr. Robert Huggins is currently employed by the Korey Stringer Institute, which is a 501(c)3 not-for-profit organization with corporate partners that support the mission of the institute. These partners include the National Football League, Gatorade, the National Athletic Trainers’ Association, Mission Athletecare, Kestrel by Neilsen Kellerman, Eagle Pharmaceuticals, and DeFibtech. These entities provided no financial support, other support, or other influence toward the manuscript. Dr. Stuart Weinzimer has received honoraria for serving as Speaker and/or Consultant for Medtronic, Insulet, and Tandem, manufacturers of diabetes technologies that are relevant to the subject of the manuscript; these commercial entities were not in any manner involved with the research, preparation, or review of the manuscript. Mr. Robert Jarrin has been compensated as a strategic advisor by the CTA, MiCare Path (consulting fees or honorarium), and Strive Orthopedics, Inc. (stock/stock options). In addition, he serves as Member/Advisor to the American Medical Association (AMA) Digital Medicine Payment Advisory Group (DMPAG). Drs. Garrett Ash, Matthew Stults-Kolehmainen, Michael Busa, Allison Gaffey, Mr. Konstantinos Angeloudis, Drs. Borja Muniz-Pardos, Robert Gregory, Nancy Redeker, Lauren Grieco, Kate Lyden, Ms. Esmeralda Megally, Dr. Ioannis Vogiatzis, Ms. LaurieAnn Scher, Drs. Xinxin Zhu, Julien Baker, Cynthia Brandt, Michael Businelle, Lisa Fucito, Stephanie Griggs, Bobak Mortazavi, Temiloluwa Prioleau, Walter Roberts, Elias Spanakis, Laura Nally, Andre Debruyne, Norbert Bachl, Fabio Pigozzi, Farzin Halabchi, Dimakatso Ramagole, Dina Janse van Rensburg, Bernd Wolfarth, Chiara Fossati, Sandra Rozenstoka, Kumpei Tanisawa, Mats Börjesson, José Casajus, Alex Gonzalez-Aguero, Irina Zelenkova, Jeroen Swart, Gamze Gursoy, William Meyerson, Mr. Jason Liu, Drs Dov Greenbaum, Yannis Pitsiladis, and Mark Gerstein declare that they have no conflicts of interest relevant to the content of this article.

Funding

Dr. Garrett Ash was supported by a fellowship from the Office of Academic Affiliations at the United States Veterans Health Administration and a Robert E. Leet and Clara Guthrie Patterson Trust Mentored Research Award, Bank of America, N.A., Trustee. Dr. Elias Spanakis was partially supported by the VA MERIT award (#1I01CX001825) from the United States Department of Veterans Affairs Clinical Sciences Research and Development Service. Dr. Allison Gaffey was supported by a research grant from the National Institutes of Health (R01HL126770). Dr. Stephanie Griggs was supported by mentored research scientist awards from the National Institutes of Health (K99NR018886) and the American Academy of Sleep Medicine (220-BS-19). Dr. Walter Roberts (K23AA026890), Dr. Laura Nally (K12DK094714-10), and Dr. Gamse Gursoy (K99HG010909) were supported by mentored research scientist awards from the National Institutes of Health. Dr. Mark Gerstein was supported by the National Institutes of Health (R01DA051906). No other sources of funding were used to assist in the preparation of this manuscript.

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The first draft of the manuscript was written by Garrett Ash and Yannis Pitsiladis. All authors commented on subsequent versions of the manuscript until all authors were able to approve the final manuscript.

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The data are the transcription of the session recordings, available from author Garrett Ash (https://orcid.org/0000-0002-8655-7525, garrett.ash@yale.edu) and permitted for reuse with his permission.

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Ash, G.I., Stults-Kolehmainen, M., Busa, M.A. et al. Establishing a Global Standard for Wearable Devices in Sport and Exercise Medicine: Perspectives from Academic and Industry Stakeholders. Sports Med 51, 2237–2250 (2021). https://doi.org/10.1007/s40279-021-01543-5

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