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The Innovation of Medical Devices

  • S. Abbas Shobeiri
Chapter

Abstract

The innovation of medical devices is a useful and fulfilling activity. Medicine in general is fulfilling as it provides instant gratification to the physician and instant relief to the patient. Medical device ideas arise from the needs identified during the patient-healthcare team interactions. The journey from ideation to a commercially successful medical device product is the focus of this chapter with emphasis on pitfalls of medical device development with the use of vaginal mesh kits as a specific example.

Keywords

Innovation Medical devices US Food and Drug Administration Vaginal mesh kits Good manufacturing practice Adverse events Medical device recall Marketing 

References

  1. 1.
    Bayon Y, Bohner M, Eglin D, Procter P, Richards RG, Weber J, Zeugolis DI. Innovating in the medical device industry – challenges & opportunities ESB 2015 translational research symposium. J Mater Sci Mater Med. 2016;27(9):144.CrossRefGoogle Scholar
  2. 2.
    Abenstein JP. Technology assessment for the anesthesiologist. Anesthesiol Clin. 2006;24(4):677–96.CrossRefGoogle Scholar
  3. 3.
    Wieringa FP, Poley MJ, Dumay AC, van der Steen AF. Avoiding pitfalls in the road from the idea to certified product (and the harsh clinical environment thereafter) when innovating medical devices. Proceedings of the IEEE Benelux EMBS Symposium/ Belgian Day on Biomedical Engineering: Brussel: TNO Industrie en Techniek 30; 2007.Google Scholar
  4. 4.
    Geertsma RE, de Bruijn AC, Hilbers-Modderman ES, Hollestelle ML, Bakker G, Roszek B. New and emerging medical technologies: a horizon scan of opportunities and risks. Report 360020002. 2 Feb 2007. Bilthoven: Centre for Biological Medicines and Medical Technology. National Institute for Public Health and the Environment (RIVM). p. 116.Google Scholar
  5. 5.
    NHS England. Design for patient safety. A system-wide design-led approach to tackling patient safety in the NHS. London: Department of Health; 8 Oct 2003. http://www.nrls.npsa.nhs.uk/resources/collections/design-for-patient-safety/?entryid45=59881. 84 p.
  6. 6.
    Dumay AC. Innovating eHealth in the Netherlands. Stud Health Technol Inform. 2007;127:157–65.PubMedGoogle Scholar
  7. 7.
    Kim WC, Mauborgne RA. Blue ocean strategy, expanded edition: how to create uncontested market space and make the competition irrelevant: Harvard Business Review Press; 2015.Google Scholar
  8. 8.
    Innovation versus science? (Editorial). [Internet]. Nature 2007;448(7156):839.Google Scholar
  9. 9.
    Christensen CM, Bohmer RM, Kenagy J. Will disruptive innovations cure health care? Harv Bus Rev. 2000;78(5):102–12. 99.PubMedGoogle Scholar
  10. 10.
    U.S. Food & Drug Administration. Medical devices. Premarket approval (PMA). Last updated 27 Mar 2018. https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketapprovalpma/. Accessed 24 Apr 2018.
  11. 11.
    World Intellectual Property Organization (WIPO), Geneva. Statistical Country Profiles. United States of America. http://www.wipo.int/ipstats/en/statistics/country_profile/profile.jsp?code=US. Last updated March 2018. Acceessed 23 Apr 2018.
  12. 12.
    MedTech Europe. The European medical industry in figures. [Internet]. Brussels: MedTech Europe; 2018. http://www.medtecheurope.org/medtech-industry-in-figures. Accessed 25 Apr 2018.
  13. 13.
    World Intellectual Property Organization (WIPO), Geneva. Record year for international patent applications in 2016; strong demand also for trademark and industrial design protection. PR/2017/804. Geneva; 15 Mar 2017. http://www.wipo.int/pressroom/en/articles/2017/article_0002.html#designs. Accessed 3 Feb 2018.
  14. 14.
    Murphy LM, Edwards PL. Bridging the valley of death: transitioning from public to private sector financing. NREL/MP-720-34036. Golden: National Renewable Energy Laboratory; May 2003. http://www.cleanenergystates.org/CaseStudies/NREL-Bridging_the_Valley_of_Death.pdf
  15. 15.
    Steinmetz KL, Spack EG. The basics of preclinical drug development for neurodegenerative disease indications. BMC Neurol. 2009;9(Suppl 1):S2.CrossRefGoogle Scholar
  16. 16.
    Bingaman J, Simon RM, Rosenberg AL. Needed: a revitalized national S&T Policy. [Internet]. Issues Sci Technol. 2004;20(3)Google Scholar
  17. 17.
    Morrison RJ, Kashlan KN, Flanangan CL, Wright JK, Green GE, Hollister SJ, Weatherwax KJ. Regulatory considerations in the design and manufacturing of implantable 3d-printed medical devices. Clin Transl Sci. 2015;8(5):594–600.CrossRefGoogle Scholar
  18. 18.
    Li TW, Tu PW, Liu LL, Wu SI. Assurance of medical device quality with quality management system: an analysis of good manufacturing practice implementation in Taiwan. Biomed Res Int. 2015:670420.Google Scholar
  19. 19.
    Worldwide Medtech Sales by EvaluateMedTech® Device Area: Top 15 Categories & Total Market (2016 & 2022). http://info.evaluategroup.com/MTWP2017-EMF.html.
  20. 20.
    Roberts EB. Technological innovation and medical devices. In: Ekelman KB, editor. New medical devices: invention, development, and use. Washington, DC: National Academy Press; 1988. p. 35–47.Google Scholar
  21. 21.
    Makower J, Meer A, Denend L. FDA impact on U.S. medical technology innovation: a survey of over 200 medical technology companies. November 2010. [Internet]. http://www.medtecheurope.org/node/246. Accessed 3 Feb 2018.
  22. 22.
    Sharma A, Blank A, Patel P, Stein K. Health care policy and regulatory implications on medical device innovations: a cardiac rhythm medical device industry perspective. J Interv Card Electrophysiol. 2013;36(2):107–17.CrossRefGoogle Scholar
  23. 23.
    Long G, Mortimer R, Sanzenbacher G. Recent average price trends for implantable medical devices, 2007–2011. Sept 2013.Google Scholar
  24. 24.
    Goldman DP, McGlynn EA. U.S. health care: facts about cost, access, and quality. Santa Monica: RAND Corporation; 2005. https://www.rand.org/pubs/corporate_pubs/CP484z1.htmlCrossRefGoogle Scholar
  25. 25.
    Moss AJ, Hall WJ, Cannom DS, Daubert JP, Higgins SL, Klein H, et al. Improved survival with an implantable defibrillator in patients with coronary disease at high risk for ventricular arrhythmia: the Multicenter Automated Defibrillator Implantation Trial (MADIT) Investigators. N Engl J Med. 1996;335(26):1933–40.CrossRefGoogle Scholar
  26. 26.
    Buxton AE, Lee KL, Fisher JD, Josephson ME, Prystowsky EN, Hafley G. A randomized study of the prevention of sudden death in patients with coronary artery disease: the Multicenter Unsustained Tachycardia Trial (MUSTT) Investigators. N Engl J Med. 1999;341(25):1882–90.CrossRefGoogle Scholar
  27. 27.
    Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, et al.; Multicenter Automatic Defibrillator Implantation Trial II Investigators (MADITII). Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002;346(12):877–83.CrossRefGoogle Scholar
  28. 28.
    Kadish A, Dyer A, Daubert JP, Quigg R, Estes NA, et al.; Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) Investigators. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med. 2004;350(21):2151–8.CrossRefGoogle Scholar
  29. 29.
    Bristow MR, Saxon LA, Boehmer J, Krueger S, Kass DA, De Marco T, et al.; Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med. 2004;350(21):2140–50.CrossRefGoogle Scholar
  30. 30.
    Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, et al.; Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005;352(3):225–37. Erratum in: N Engl J Med 2005;352(20):2146.CrossRefGoogle Scholar
  31. 31.
    Drummond M, Weatherly H. Implementing the findings of health technology assessments. If the CAT got out of the bag, can the TAIL wag the dog? Int J Technol Assess Health Care. 2000;16(1):1–12.CrossRefGoogle Scholar
  32. 32.
    Brouwer WB, van Exel NJ, Baltussen RM, Rutten FF. A dollar is a dollar is a dollar – or is it? Value Health. 2006;9(5):341–7.CrossRefGoogle Scholar
  33. 33.
    Reijnen MM, Zeebregts CJ, Meijerink WJ. Future of operating rooms. Surg Technol Int. 2005;14:21–7. (Review).PubMedGoogle Scholar
  34. 34.
    Lee K. Designing the OR of the future [Internet]. Healthcare design. Construction and engineering. 24 Sep 2015. http://www.healthcaredesignmagazine.com/trends/construction-engineering/designing-or-future/. Accessed 2 Feb 2018.
  35. 35.
    Kopelman Y, Lanzafame RJ, Kopelman D. Trends in evolving technologies in the operating room of the future. JSLS. 2013;17(2):171–3.CrossRefGoogle Scholar
  36. 36.
    Gallagher AG, Smith CD. From the operating room of the present to the operating room of the future. Human- factors lessons learned from the minimally invasive surgery revolution. Semin Laparosc Surg. 2003;10(3):127–39.PubMedGoogle Scholar
  37. 37.
    Wieringa F.P. Pulse oxigraphy: and other new in-depth perspectives through the near infrared window [Internet]. Erasmus University Rotterdam; 2007. Available from: http://hdl.handle.net/1765/10031. Accessed 24 Apr 2018.
  38. 38.
    Vosburgh KG, Newbower RS. Moore’s law, disruptive technologies, and the clinician. Stud Health Technol Inform. 2002;85(85):88–113.Google Scholar
  39. 39.
    Baim DS, Donovan A, Smith JJ, Briefs N, Geoffrion R, Feigal D, Kaplan AV. Medical device development: managing conflicts of interest encountered by physicians. Catheter Cardiovasc Interv. 2007;69(5):655–64.CrossRefGoogle Scholar
  40. 40.
    Amoore JN. A structured approach for investigating the causes of medical device adverse events. J Med Eng. 2014;2014:314138.CrossRefGoogle Scholar
  41. 41.
    AACE Health Technology Foundation, Clinical Alarm Task Force. Impact of clinical alarms on patient safety: a report from the American College of Clinical Engineering Healthcare Technology Foundation. J Clin Eng. 2007;32(1):22–33.Google Scholar
  42. 42.
    Sensmeier J. Survey says: care, communication enhanced by IT. Nurses report ups and downs of current systems. Nurs Manag. 2006;37(Suppl):2, 4, 6 passim.Google Scholar
  43. 43.
    Bohn RE. Measuring and managing technical knowledge. MIT Sloan Manag Rev. 1994;36(1):61–73.Google Scholar
  44. 44.
    Want to please patients? Maybe you should start a specialty hospital. 1 Apr 2015. [Internet]. Advisory Board (advisory.com). https://www.advisory.com/research/health-care-advisory-board/blogs/at-the-helm/2015/04/patient-experience-and-specialty-hospitals. Accessed 2 Feb 2018.
  45. 45.
    Ibrahim AM, Dimick JB. Monitoring medical devices: missed warning signs within existing data. JAMA. 2017;318(4):327–8.CrossRefGoogle Scholar
  46. 46.
    Obeid NR, Pryor AD. Is the adjustable gastric band dead? Ann Surg. 2017;265(3):446–7.CrossRefGoogle Scholar
  47. 47.
    Moore BJ, Steiner CA, Davis PH, Stocks C, Barrett ML. Trends in hysterectomies and oophorectomies in hospital inpatient and ambulatory settings, 2005–2013. HCUP Statistical Brief #214. Nov 2016. Rockville: Agency for Healthcare Research and Quality. http://www.hcup-us.ahrq.gov/reports/statbriefs/sb214-Hysterectomy-Oophorectomy-Trends.pdf.
  48. 48.
    Levitz J, Kamp J. How morcellators simplified the hysterectomy but posed a hidden cancer risk. The Wall Street Journal. 11 Apr 2014.Google Scholar
  49. 49.
    Redberg RF, Jacoby AF, Sharfstein JM. Power morcellators, postmarketing surveillance, and the us food and drug administration. JAMA. 2017;318(4):325–6.CrossRefGoogle Scholar
  50. 50.
    Javadian P, Shobeiri SA. The disability impact and associated cost per disability in women who underwent surgical revision of transvaginal mesh kits for prolapse repair. Female Pelvic Med Reconstr Surg. 2017;  https://doi.org/10.1097/SPV.0000000000000489. Epub ahead of print
  51. 51.
    U.S. Food and Drug Administration. Center for Devices and Radiological Health. Urogynecologic surgical mesh: update on the safety and effectiveness of transvaginal placement for pelvic organ prolapse. July 2011. https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/ucm262301.htm. Accessed 6 Feb 2018.
  52. 52.
    U.S. Food and Drug Administration. Center for Devices and Radiological Health. Medical device recall report FY2003 to FY2012. www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhtransparency/ucm388442.pdf. Accessed 2 Feb 2018.
  53. 53.
    Stein KM. The long and winding road after FDA approval: a medical device industry perspective. Circulation. 2017;135(20):1877–8.CrossRefGoogle Scholar
  54. 54.
    Ackerly DC, Glickman SW, Schulman KA. Economic content in medical journal advertisements for medical devices and prescription drugs. PharmacoEconomics. 2010;28(5):429–38.CrossRefGoogle Scholar
  55. 55.
    Ray PP, Amaral JF, Hinoul P. Innovation best practices in the medical device industry. Tech Vasc Interv Radiol. 2017;20(2):90–3.CrossRefGoogle Scholar
  56. 56.
    Waardigheid en trots. Implementatie toolkit technolgie in de zorg. www.waardigheidentrots.nl. Utrecht. Accessed 24 Apr 2018.
  57. 57.
    FDA Warns Against Use of Energy-Based Devices to Perform Vaginal ‘Rejuvenation’ or Vaginal Cosmetic Procedures: FDA Safety Communication. 2018 August, 1 2018.Google Scholar
  58. 58.
    Reed TL, Levy D, Steen LT, Roach J, Taylor T, Call K, et al. Adverse event triggered event reporting for devices: report of a Food and Drug Administration-supported feasibility pilot of automated adverse event reporting. J Clin Eng. 2016;41(2):83–9.CrossRefGoogle Scholar
  59. 59.
    Moscovitch B, Rising J, Daniel G, Drozda J. Time to fix the black hole in Medicare data. [Internet] 29 June 2016. Health Affairs (Blog). https://www.healthaffairs.org/do/10.1377/hblog20160629.055612/full/. Accessed 6 July 2017.
  60. 60.
    Moscovitch B, Rising JP. Medical device identification in claims data. JAMA. 2017;318(19):1936–7.CrossRefGoogle Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.INOVA Health SystemFalls ChurchUSA

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