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Patient-reported outcomes in the regulatory approval of medical devices

Nature Medicine volume 27, pages 2067–2068 (2021)Cite this article

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To the editor — A medical device is an instrument, appliance or material manufactured for the purpose of diagnosing, monitoring or treating patients’ conditions1. Integrating the patient’s voice throughout the lifecycle of medical device development may provide valuable information to inform the evaluation and surveillance of medical devices2.

One way to systematically collect information on the impact of a medical device from a patient perspective is through the use of patient-reported outcomes (PROs). PROs are any report of a patient’s health, including symptoms, physical functioning, psychological impact and wellbeing, without interpretation of the patient’s response by a clinician or others2. Measuring the potential risks and benefits of a medical device at an early stage by such means is essential to avoid negative patient outcomes, as highlighted in the Independent Medicines and Medical Devices Safety Review report, entitled “First Do No Harm”3.

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References

  1. Council of the European Communities (CED). Council Directive 93/42/EEC of 14 June 1993 Concerning Medical Devices. http://data.europa.eu/eli/dir/1993/42/oj (CEC, 1993).

  2. US Food and Drug Administration (FDA). Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf (FDA, 2009).

  3. Independent Medicines and Medical Devices Safety Review (IMMDSReview). First Do Not Harm—The Report of the Independent Medicines and Medical Devices Safety Review (IMMDSReview, 2020).

  4. FDA. Draft Guidance: Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation (FDA, 2020).

  5. Center for Devices and Radiological Health (CDRH). CDRH Strategic Priorities 2016-2017: Value and Use of Patient Reported Outcomes (PROs) in Assessing Effects of Medical Devices (CDRH, 2017).

  6. FDA. 2020 Device Approvals (FDA, 2020).

  7. Calvert, M. et al. JAMA 319, 483–494 (2018).

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  8. Chalmers, I. & Glasziou, P. The Lancet 374, 86–89 (2009).

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  9. International Society for Quality of Life Research (ISOQOL). User’s Guide to Implementing Patient-Reported Outcomes Assessment in Clinical Practice (ISOQUOL, 2011).

  10. Calvert, M. et al. Health Qual. Life Outcomes 11, 184 (2013).

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Author information

Authors and Affiliations

  1. Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK

    Samantha Cruz Rivera, Andrew P. Dickens, Olalekan Lee Aiyegbusi, Philip Collis & Melanie J. Calvert

  2. Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK

    Samantha Cruz Rivera, Andrew P. Dickens, Olalekan Lee Aiyegbusi, Philip Collis & Melanie J. Calvert

  3. National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre, University of Birmingham, Birmingham, UK

    Olalekan Lee Aiyegbusi & Melanie J. Calvert

  4. National Institute for Health Research (NIHR) Applied Research Collaboration (ARC) West Midlands, University of Birmingham, Birmingham, UK

    Olalekan Lee Aiyegbusi & Melanie J. Calvert

  5. Medicines and Healthcare products Regulatory Agency (MHRA), London, UK

    Rebecca Flint, Camilla Fleetcroft & Duncan McPherson

  6. Patient partner, Toronto, Canada

    Philip Collis

  7. Health Data Research UK, London, UK

    Melanie J. Calvert

  8. NIHR Surgical Reconstruction and Microbiology Research Centre, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK

    Melanie J. Calvert

Authors
  1. Samantha Cruz Rivera
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  2. Andrew P. Dickens
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  3. Olalekan Lee Aiyegbusi
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  4. Rebecca Flint
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  5. Camilla Fleetcroft
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  6. Duncan McPherson
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  7. Philip Collis
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  8. Melanie J. Calvert
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Contributions

S.C.R., A.P.D. and M.J.C. conceived the idea for this article; S.C.R. developed the first draft; and all authors made substantial revisions and approved the final manuscript.

Corresponding author

Correspondence to Samantha Cruz Rivera.

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Competing interests

O.L.A. receives funding from the NIHR Birmingham Biomedical Research Centre, NIHR Applied Research Centre, West Midlands, at the University of Birmingham and University Hospitals Birmingham NHS Foundation, Innovate UK (part of UK Research and Innovation), Gilead Sciences Ltd. and Janssen Pharmaceuticals, Inc. O.L.A. declares personal fees from Gilead Sciences Ltd., GlaxoSmithKline (GSK) and Merck outside the submitted work. M.J.C. is director of the Birmingham Health Partners Centre for Regulatory Science and Innovation, director of the Centre for Patient Reported Outcomes Research and a National Institute for Health Research (NIHR) Senior Investigator. M.J.C. receives funding from the NIHR Birmingham Biomedical Research Centre, the NIHR Surgical Reconstruction and Microbiology Research Centre and NIHR ARC West Midlands at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Health Data Research UK, Innovate UK (part of UK Research and Innovation), Macmillan Cancer Support, UCB and GSK Pharma. M.J.C. has received personal fees from Astellas, Takeda, Merck, Daiichi Sankyo, Aparito Ltd., CIS Oncology, Glaukos, GSK and the Patient-Centered Outcomes Research Institute (PCORI) outside the submitted work. The other authors declare no competing interests. The views expressed in this article are those of the author(s) and not necessarily those of the NIHR, the Department of Health and Social Care or the MHRA.

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Cruz Rivera, S., Dickens, A.P., Aiyegbusi, O.L. et al. Patient-reported outcomes in the regulatory approval of medical devices. Nat Med 27, 2067–2068 (2021). https://doi.org/10.1038/s41591-021-01546-9

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