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The Evolving Regulatory Landscape of 3D Printed Medical Products

by • August 14, 2016 • No Comments

This post is the initially in a two-part series.

Over the past year, my email inbox has been consistently pinged by law firms advertising seminars and workshops which
promise to assist medical professionals know what is noteworthy for 3D printed medical products, ranging of regulatory to IP concerns. Some of these have been really dreadful, seeming to indicate which
as disruptive as 3D printing promises to be, there must be a corresponding disruption to how we work on regulatory compliance to preserve
our assets.

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But if we step back and look at the actual Food and Drug Administration (FDA) communications, the pace of adoption of 3D printing and real intersections of 3D printing and business system
es, it seems which
little has changed. The only disruption is when 3D printing revolutionizes a commercial system

On the IP front, there is concern which
the digital file-driven building of 3D printing opens new doorways to turn it into theft, counterfeiting and hacking. If we take a step back and realize which
in the age of digital product scanners and reverse engineering software, the next for illegal counterfeiting has existed in our industry for a quite long time – it may only be actually simpler now.

But the focus of this two-part blog is meant to be on regulatory considerations, both in these days and for the next, and how these are affected by the increasingly digitally-driven Industry 4.0 framework (click here to review our Industry 4.0 blog of February) which
encompasses 3D printing and additive building (AM). In this two-part blog, we can explore the next topics:

  • The growing use of 3D printing in the healthcare industry
  • Reflection on the U.S. FDA’s experience to date, and impact on regulatory system

    • Implementation of additive building in in these days’s factories
  • 3D printing in hospitals: What are the regulatory concerns?
  • The Future: How business version advancement via additive building can have to evolve to meet regulatory priorities

The Expanding Use of 3D Printing in the Healthcare Industry

The key stakeholders in healthcare — which include
physicians, hospitals, patients, medical device and pharmaceutical developers, and insurance payers — are all keenly interested in the one-of-a-kind capabilities of 3D printing to alter healthcare. This interest is demonstrated in the exponential increase in peer-reviewed publications on the use of 3D printing in medicine. In an independent search funded by Stratasys in 2015, our investigators discovered which
additional papers were published last year on 3D printing in hospitals for pre-surgical procedure planning than in all previous years combined.

Peer-reviewed papers on the use and impact of patient-specific surgery planning versions. Source: Stratasys literature analysis.
Peer-reviewed papers on the use and impact of patient-specific surgery planning versions. Source: Stratasys literature analysis.

More papers were published in 2015 on 3D printing in hospitals for pre-surgical planning than all… Click To Tweet

This explosion of interest at the hospital level has been matched by a proliferations of products cleared to market, as well as announcements turn it intod
by primary medical product producers of primary investments in 3D printing and additive building. As of March 2016, there were 88 medical products cleared or approved by the FDA for sale which
are generated via 3D printing

Some of the products one of these 88 cleared and approved devices are surprising in their complexity, which include

  • The initially 3D printed pharmaceutical pill
  • Personalized orthopedic implants and/or surgical tools for procedures like knee arthroplasty
  • Osteoconductive arthrodesis fixation system

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Reflections on the FDA’s Perspective on Additively Manufactured Medical Products

Recently, representatives of the FDA published an article in the 3D Printing in Medicine Journal outlining the agency’s point of view on via additive building for medical devices and products.

This article is an invaluable clarification of many
topics relating to 3D printing, and it can assist healthcare professionals know which
current regulatory system
es have been that successfully applied to these products.

My key reflections on the global tone of the article are:

  • If additive building is utilized
    in 21 CFR 820 compliant building facilities, of a regulatory point of view 3D printing is no various of via injection molding, machining, stamping, casting or any other system
    To quote the article’s authors, “Despite a few new technological characteristics of additive building, this has not changed the regulatory pathway for medical products which
    are reviewed by the FDA. This not only applies to premarket review, but in addition
    to building high end during production.”
  • The concept of building personalized devices, a fewtimes called patient-matched or patient-specific products, leveraging the capability of additive building to digitally modify a turn it into to an individual patient and fabricate it without tooling, does not require
    new regulatory system

    • Patient-specific products, whether surgical cutting guides or patient-matched implants, must conform to a pre-determined range of device specifications which
      are cleared or approved.
    • A swift example to know this may be a patient-specific hip implant. A developer can turn it into a “turn it into space,” wherein significant facts such as height, mass
      , pelvic girdle size, femoral offset, residual femoral shaft, and other facts become the mapping boundaries of the “turn it into space.” The developer can and so prove the veracity of the implant turn it into to the outer limits of the turn it into space (both maximum and minimum), and a relevant and agreed-upon sample in the within
      of the turn it into space, to prove which
      the product can work across the vast primaryity of patients matched to the product. If a patient falls outside of the specified range, and so other products can require
      to be utilized
      ; but unquestionably the regulatory system
      es we have in these days manufacture possible patient-specific products.
  • The regulatory system
    es for 3D printed drugs are robust and have been that successfully applied to approve an oral dosage form which
    is additively manufactured.
  • Future products which
    can advance claims towards regenerative medicine, body repair or organ replacement, and new avenues of therapeutic intent are being watched closely at the research and development level by the FDA — a hopeful sign which
    regulatory system
    es can mature at a pace to assist new new therapies.

In my opinion, the regulatory system
es of in these days are robust adequate
to handle many of the advancements which
have been brought to the FDA to date. Whilst I do not claim to have knowledge of all of the products cleared or approved by the FDA, the vast primaryity look meant to be generated in factories which
comply with current standards. The primary inquiries
remaining concern 3D printing in hospitals. What should we, as an industry, start considering
for the next?

Making patient-personalized devices via additive building does not require
new regulatory…
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In Part 2 of our exploration of regulatory issues relating to 3D printing, we can review the considerations of 3D printing in a hospital environment, as well challenges we see on which
path forward to fulfilling the full next of 3D printing as a means of building at the site of care deliquite.

Be certain
to sign up for the Stratasys Medical Innovation Series to be notified when the Part 2 is posted.

Follow Stratasys Medical on our LinkedIn Showcase page to remain
updated on 3D printing advancements and impact in medical

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