Regulatory Concerns about Medical Device Manufacturing Using 3D Printing: Current State of the Issue

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Abstract

Custom-made implants, orthotics, orthoses, models for surgical planning and education, and much more are now created using 3D printers. In this article, the authors suiiunarized information on laws and regulations in the domain of legal support for 3D printing of medical devices in Russia and abroad. 3D printing is one of the promising avenues in developing new methods of treatment, so iiiunediate establishing of clear criteria for its legal regulation is necessary. As is, there are still many gaps in the legislative framework. The issues of the quality of 3D models, material standardization and manufacturing processes using 3D printing technologies remain unresolved. When using custom-made medical devices, respecting the rights of patients and preventing the use of prohibited or restricted materials are essential. Yet, legal barriers to this irmovative direction of medicine must be avoided.

About the authors

N. N. Karyakin

Privolzhsky Research Medical University

Author for correspondence.
Email: fake@neicon.ru

Nikolay N. Karyakin — Dr. Sci. (Med.), rector

Nizhny Novgorod

Russian Federation

I. I. Shubnyakov

Vreden Russian Research Institute of Traumatology and Orthopedics

Email: fake@neicon.ru

Igor I. Shubnyakov — Dr. Sci. (Med.), chief researcher

St. Petersburg

Russian Federation

A. O. Denisov

Vreden Russian Research Institute of Traumatology and Orthopedics

Email: fake@neicon.ru

Alexey O. Denisov — Cand. Sci. (Med.), executive secretary

St. Petersburg

Russian Federation

A. V. Kachko

Privolzhsky Research Medical University

Email: fake@neicon.ru

Anna V. Kachko — head of the Legal Department

Nizhny Novgorod

Russian Federation

R V. Alyev

Privolzhsky Research Medical University

Email: fake@neicon.ru

Ramil V. Alyev — orthopaedic surgeon

Nizhny Novgorod

Russian Federation

R. O. Gorbatov

Privolzhsky Research Medical University

Email: fake@neicon.ru

Roman O. Gorbatov — orthopaedic surgeon, head of the Laboratory of Additive Technologies

Nizhny Novgorod

Russian Federation

References

  1. Кавалерский Г.М., Мурылев В.Ю., Рукин Я.А., Елизаров П.М., Музыченков А.В. Индивидуальные артикулирующие спейсеры в ревизионной хирургии тазобедренного сустава. Фундаментальные и прикладные проблемы техники и технологии. 2015;5(313):95-103.
  2. Горбатов P.O., Нифтуллаев P.M., Новиков A.E. Прецизионные персонифицированные имплантаты для замещения костных дефектов при лечении пациентов с остеоонкологией. Современные проблемы науки и образования. 2016;6:247-255.
  3. Карякин H.H., Малышев E.E., Горбатов P.O., РотичД.К. Эндопротезирование коленного сустава с применением индивидуальных направителей, созданных с помощью технологий ЗВ-печати. Травматология и ортопедия России. 2017;23(3):110-118.
  4. Карякин H.H., Горбатов P.O. Прецизионные персонифицированные направители для эндопротезирования коленного сустава. Современные проблемы науки и образования. 2016;5:23-31.
  5. Коваленко A.H., Шубняков И.И., Билык С.С., Тихилов Р.М. Современные технологии лечения тяжелых костных дефектов в области вертлужной впадины: какие проблемы решают индивидуальные имплантаты? Политравма. 2017;1:72-81.
  6. Тихилов P.M., Шубняков И.И., Коваленко A.H., Денисов А.О., Билык С.С. Показания к ревизионному эндопротезированию тазобедренного сустава, гшанирование и техника ревизионной операции. В кн.: Руководство по хирургии тазобедренного сустава. Под. ред. Тихилова Р.М., Шубнякова И.И. СПб.: РНИИТО им. Р.Р. Вредена; 2015. Т. 2. С. 258-355.
  7. Ардашева H. Понятие эксперимента в медгщи- не и защита прав человегса. Государство и право. 1995;12:102-103.
  8. Reitinger N. CAD’s Parallel to Technical Drawings: Copyright in the Fabricated World (2015). J Patent Trademark Office Soc. 2015;97(1): 113-143. Available from: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2738547
  9. Reeves P., Mendis D. The current status and impact of 3D printing within the industrial sector: an analysis of six case studies — Study II, Independent report commissioned by IPO. Intellectual Property Office (IPO) UK (2015). Available from: https://www.gov.uk/government/publications/3d-printing-research-reports
  10. Chernykh A.V., Maleev Yu.V., Shevtsov A.N., Volkov A.V., Sundeev A.S., Malyukov N.A. [Modem trends in transplantation using high-tech methods]. Vestnik eksperimental’noy i klinicheskoy khirurgii [journal of Experimental and Clinical Surgery]. 2017;10(2):96-102. (In Russ.).
  11. Shumkov A.A. [Application rapid prototyping technologies in the manufacture of medical implants]. Sovremennyye problemy nauki i obrazovaniya [Modern Prohlems of Science and Education]. 2015; 2:146-152. (In Russ.).
  12. Sadovoy М.А., Pavlov V., Bazlov V.A., Mamuladze T.Z., Efimenko M.V., Aronov A.M., Panchenko A.A. [Potentialities of 3d-visiralization in preoperative planning of primary and revision total hip arthroplasty]. Vestnik travmatologii i ortopedii imeni N.N. Priorova [N.N. Priorov Journal of Traumatology and Orthopedics]. 2017;3:37-42. (In Russ.).
  13. Weinberg M. It will be awesome if they don’t screw it up: 3D printing, intellectual property, and the fight over the next great disruptive technology. Public Knowledge 2. 2010. Available from: https://www.publicknowl-edge.org/news-blog/blogs/it-will-be-awesome-if-they-dontscrew-it-up-3d-printing
  14. Weinberg M. Stratasys sues Afina: ramifications for the desktop 3D printing industry. Available from: http://makezine.com/2013/11/27/stratasys-sues-afiniaramifications-for-the-desktop-3d-printing-industry
  15. Lucas O., Texas A., Law M. Three-dimensional printing technology and the Arts. Review, Spring. 2014;14:31. Available from: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2378869
  16. . Rideout B. Printing the impossible triangle: the copyright implications of three-dimensional printing. JBEL. 2011;5(1). Available from: https://digitalcommons.pepperdine.edu/jbel/vol5/iss1/6
  17. Hanna P. The next Napster? Copyright questions as 3D printing comes of age : the digital revolution made it simple to digitize and share media; the 3D. ARS technical. 2011. Available from: https://arstechnica.com/techpolicy/2011/04/the-next-napster-copyright-questionsas-3d-printing-comes-of-age/3
  18. Deven R. D., Maghocca N. G. Patents, meet napster: 3D printing and the digitization of things. School of Law Research Paper. 2013;37:57. Available from: https://ssm.com/abstract=2338067
  19. Brean D. H. Asserting patents to combat infringement via 3D printing: it’s no “use”. Fordham intellectual property. Media Entertainment Law J. 2013;37. Available from: http://doi.org/10.2139/ssm.2088294
  20. Doherty D. Downloading infringement: patent law as a roadblock to the 3D printing revolution. Harvard / of Law Technology. 2012; 18. http://jolt.law.harvard.edu/articles/pdf/v26/26HarvJLTech353.pdf
  21. Law M. G. The challenges of 3D printing to the repair- reconstmction doctrine in patent law. 16th Annual Antitrust Symposium. 2013;20:1147-1182. Available from: http:://www.wipo.int/edocs/mdocs/patent_policy/en/scp_20/scp_20_3 .pdf
  22. Thompson C. Chve Thompson on 3-D printing’s legal mo- rass.2012.AccessedJanuaryl4,2018.Availablefrom:http://www.wired.com/design/2012/05/3-d-printing-patent-law
  23. Mendis D. “The clone wars”: episode 1 - the rise of 3D printing and its imphcations for intellectual property law - learning lessons from the past? European Intellectual Property Review. 2013;35:155-169. Available from: https://www.pubhcknowledge.org/files/docs/3DPrintingPaperPubhcKnowledge.pdf
  24. Bradshaw S., Bowyer A., Haufe P. The intellectual property implications of Low-Cost 3D printing. ScriptEd 2010;7:27. Available from: http://doi.org/10.2966/scrip.070110.5
  25. Jensen-Haxel P. 3D printers, obsoletefirearm supply controls, and the right to build self-defense weapons under heller. Golden Gate University Law Review. 2012; 42:447-496. Available from: https://digitalcommons.law.ggu.edu/cgi/viewcontent.cgi?article=2064&context =ggulrev
  26. Rawnsley A. MakerBot commandos: special ops seek 3D printer. WIRED. 2011. Available from: https://wired.com/dangerroom/2011/08/special-ops-meets-makerbotcommandos-want-3d-printer
  27. Duncan G. 3-D printing for the masses. Tech. 2008. Available from: https://technologyreview.com/Infotech/21152/?nlid=1244&a=f
  28. Gershenfeld N. How to make almost anything: the digital fabrication revolution. Foreign Affairs. 2012;91:43-57. Available from: http://doi.org/10.17763/haer.84.4.34j1g68140382063
  29. Pierangelo Tendas Communication from the commission to the council and the European Parliament Firearms and the internal security of the EU: protecting citizens and disrupting illegal trafficking, COM (2013) 0716, 21/10/2013. 3D printing of weapons and ammunition has been mentioned in the communication. Available from: https://all4shooters.com/en/Shooting/law/EU-proposedgun-ban/COM(2013)-716-Firearms-and-the-internalsecurity-of-the-EU-EN.pdf
  30. Lucas S. Regulating three dimensional printing: the converging worlds of bits and atoms. San Diego L 2014;51:553. Available from: https://ssrn.com/abstract=2348894
  31. Dasari H. Assessing copyright protection and infringement issues involved with 3D printing and sacnning. AIPLA Quarterly J. 2013;41: 281-318. Available from: http://mishkabobble.com/articles/pdf/v26/26HarvJLTech353.pdf
  32. Prima D. Additively manufactured medical products - the FDAperspective.JDPnnfi'qg'inMediCine. 2015;l. Available from: http://doi.Org/10.1186/s41205-016-0005-9
  33. Technical consideration for additive manufactured medical devices. 2017. Available from: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM499809.pdf
  34. Morrison R.J., Kashlan K.N., Flanangan C.L., Wright J.K., Green G.E., Holhster S.J., Weatherwax K.J. Regulatory Considerations in the Design and Manufacturing of Implantable 3D-Printed Medical Devices. Clin Transl Sci. 2015;8(5):594-600. doi: 10.1111/cts.l2315.
  35. Vancraen W. Innovation outpacing EU regulation: the case for medical 3D printing. Available from: https:// www.s-ge.com/sites/default/files/cserver/article/downloads/medtechreport_china_2017.pdf
  36. Weinberg M. It will be awesome if they don’t screw it up: 3D printing, intellectual property, and the fight over the next great disruptive technology. Public knowledge. 2010. Available from: https://www.publicknowledge.org/it-will-be-awesome-if-they-dont-screw-it-up.

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