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Device Development for the Innovative Clinician: Intellectual Property and Regulatory Basics

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The SAGES Manual Ethics of Surgical Innovation

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Abstract

This chapter is meant as a primer on device development for the innovative clinician. This is a brief overview with an emphasis on the basics of intellectual property (IP) and regulatory definitions. Other aspects such as selecting and refining needs, reimbursement/business model considerations, and technical development only will be touched upon. An excellent resource for further investigation is Biodesign: The Process of Innovating Medical Technologies by Zenios, Makower, and Yock.

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Further Reading

  1. Fargen KM, Donald F, David F, McDougall CG, Myers PM, Hirsch JA, Mocco J. The FDA approval process for medical devices: an inherently flawed system or a valuable pathway for innovation? J NeuroIntervent Surg. 2013;5(4):269–75.

    Article  Google Scholar 

  2. Institute of Medicine. Medical devices and the public’s health: the FDA 510(k) clearance process at 35 years. Washington, DC: National Academies Press; 2011.

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  3. Curfman GD, Redberg RF. Medical devices–balancing regulation and innovation. N Engl J Med. 2011;365:975–7.

    Article  CAS  PubMed  Google Scholar 

  4. 7 Tips for Painless FDA 510(k) Regulatory Submissions. Vincent Crabtree, Ph.D., Regulatory Advisor and Project Manager, StarFish Medical. Blog: mdtmag.com. 11/13/13. Accessed 2 Apr 2015.

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  5. Zenios SA, Makower J, Yock PG. Biodesign: the process of innovating medical technologies. Cambridge: Cambridge University Press; 2010.

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  6. Pressman D. Patent it yourself. Berkeley: NOLO Press; 2008.

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  7. Patent Search Tutorial. Stanford Biodesign Program. http://www.stanford.edu/group/biodesign/patentsearch/inventor.html

  8. United States Patent and Trademark Office website. Uspto.gov. (Especially, Patents->Getting Started->Patent Basics and Process Overview. Also, Learning Resources->Resources by Audience->Inventors and Entrepreneurs

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  9. United States Food and Drug Administration website. Fda.gov. (Especially, Medical Devices->Device Advice: Comprehensive Regulatory Assistance->Overview of Medical Device Regulation

    Google Scholar 

  10. Roberts JJ. “First to file” patent law starts today: what it means in plain English. March 18, 2013. https://gigaom.com/2013/03/18/first-to-file-patent-law-starts-today-what-it-means-in-plain-english/. Accessed 4 Apr 2015.

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Author information

Authors and Affiliations

  1. Department of Biomedical Engineering, Case Western Reserve University, Cleveland, OH, USA

    Jeffrey Ustin

  2. Department of Surgery, Akron General Medical Center, Akron, OH, USA

    Jeffrey Ustin

  3. Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, OH, USA

    Jeffrey L. Ponsky

Authors
  1. Jeffrey Ustin
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  2. Jeffrey L. Ponsky
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Corresponding author

Correspondence to Jeffrey L. Ponsky .

Editor information

Editors and Affiliations

  1. Department of Surgery, Albany Medical College, Albany, New York, USA

    Steven C. Stain

  2. Division of General Surgery, Stony Brook School of Medicine, Stony Brook, New York, USA

    Aurora D. Pryor

  3. Department of Surgery, Triangle Orthopaedic Associates, Durham, North Carolina, USA

    Phillip P. Shadduck

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© 2016 Springer International Publishing Switzerland

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Ustin, J., Ponsky, J.L. (2016). Device Development for the Innovative Clinician: Intellectual Property and Regulatory Basics. In: Stain, S., Pryor, A., Shadduck, P. (eds) The SAGES Manual Ethics of Surgical Innovation. Springer, Cham. https://doi.org/10.1007/978-3-319-27663-2_13

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  • DOI: https://doi.org/10.1007/978-3-319-27663-2_13

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-27661-8

  • Online ISBN: 978-3-319-27663-2

  • eBook Packages: MedicineMedicine (R0)

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