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On the evening of January 22nd, 2018, 3DHEALS hosted the first pilot executive working conference at the Washington DC office of ReedSmith, a law firm with special interests in liability issues related to 3D printed medical device. The goal of this conference aims to bring executives from different healthcare organizations, additive manufacturing industry, bioprinting and pharma companies, academia, and the government policy experts together to tackle some of the tougher problems facing the healthcare 3D printing and bioprinting industry. In theory, the small group format will allow decision makers in each organization to have a multi-disciplinary conversation, outside of the silo they often found themselves in.
There was no sales pitch in this conference. The goal was one and only: Finding out what are the top challenges facing the industry, and have a conversation to initiate solutions. We named this 3-hour event, “3DHEALS: Taming the Wild West of 3D Printing”, and focused on policy related issues for the attendees. While due to inopportune government shut-down no government entity was present (i.e. FDA, DOD, NIH, etc), the conversations were filled with enthusiasms and inspiration. Below is our meeting minute and we think sharing the notes will be beneficial to everyone in the ecosystem. 
Attendees: Mike Tilkin (American College of Radiology), Ankit Saharan (EOS), Robert Weseley (St. Louis Children’s Hospital), Jay Morris (Mayo Clinic), Lee Dockstader (HP), Celeste Letourneau (Reed Smith), John Jameson (Winningconnections), Ben Holmes (Nanochon), Kara Noack (BASF), Rik Jakobs (3DSystems, NextDent), John Hartner (VC/Digital Industrialist LLC), Matt Jacobson (Reed Smith), Jenny Chen (3DHeals), Daniel Ortiz (3DHeals)

Clinical Trials Group: 9:00 – 9:15 pm

(Participants: Jenny Chen, Celeste Letourneau, Rik Jacobs, Ben Holmes)

Topic 1: Challenges for clinical trials on evidence or efficacy of 3D printing in healthcare.

Group Summary:
Costs:

• • There are several ways to get additional funding for clinical trials. Government funding and funding from non-profit organizations are available. If the clinical trial involves routine care, then the trial is often qualified to participate in cost-sharing coverage (by insurance companies).

• • Starting legal advice early (at phase 1 of trial) can de-risk cost of a trial down the line.

• Designing a business model to decrease the risk of trial is important.

Design: Design trial also serves to contain cost. To increase the chance of cost containment, strategies include pairing with larger entities (such as NIH), being beyond phase 1 trial, optimizing the timing of the clinical trial. For example, the trial for a rare disease will take longer (i.e. more costly). A well-known, outspoken research sponsor with a rich network will potentially decrease the timing of the trial.
Communication is the key. Picking a good spokesperson (who doesn’t have to be a PR firm) is important. This person should be a good listener and also able to communicate in multiple different industrial languages that are easy to digest. This is especially important when the audience is the government/legislator.
Benefits of conducting clinical trials: Clinical trial can serve side-goal of establishing a pathway to the reimbursement and educate the communities you will get paid from.
Roundtable Discussion:
– A lot of the scientific work takes 5-10 years before attempts at reimbursement discussion.
– Sometimes trials are attempting to provide solutions to problems that don’t exist or doesn’t actually answer the problem.
– A local insurance company in Minnesota will pay for some 3D prints even though CMS will not (becaused of assumed value added).
– Nontraditional funding exists and can be a good source of funding. 

Manufacturing Potential of Hospitals: 9:15 pm – 9:32 pm

(Participants: John Hartner, Matt Jacobson, Jay Morris, Lee Dockstader)

Topic 2: What is the potential for the hospital to become a 3D printing manufacturer?

Group summary:
It is important to define what is a medical device. In common sense, they can include surgical models, surgical guides, implants, and surgical tools. Depending on who you ask, the definition of “medical device” is different in FDA’s lingo versus that of the law (liability law). Even if a diagnostic model causes harm, it’s still held liable.
Roundtable Discussion:
What should be within the scope of the hospital? What should be okay for hospitals to produce?
Several suggestions:
– Non-diagnostic surgical models are okay for hospitals to produce.
– Common opinion: Class II/III medical devices should not be at manufactured the hospital level.
– Are surgical instruments okay? Depending on the resources of the institution, the manufacturer should be accredited.
– Living tissue like live cartilage in wide geographic distribution is not yet a reality. Some larger institutions will have a GMP. In hospital tissue engineering still seems a future possibility.
Eventually, a system or device production in the hospital would have to be accredited by a regulatory body like the ACR. Although the cost of the device goes down with in-house production, the liability and related insurance will go up.

3D printing process vs end device regulation: 9:32 – 9:43 pm

(Participants: Mike Tilkin, John Jameson, Robert Wesley, Kara Noack, Ankit Saharan)

Topic 3: Should regulation be at the 3D printing process or end device level?

Group Summary:
Although 3D printing process regulation/qualification is eventually needed, we are not there yet. It is still more practical to just regulate end device. The process to be regulated will include regulation on materials, sterilization process, manufacturing environment, documentation, and personnel certification.
FDA reviewer knowledge and efficiency vary from one to another. They can be a novice to that specific device/industry. The industry needs to spend more time and efforts to educate the public, including the FDA.
FDA document  (recent technical guidance) is a step forward but still at the leadership level. It will take awhile for it to trickle down to the reviewer level.
Roundtable discussion:
FDA typical approval/clearance pathways: PMA, de novo process, etc. Default goes to PMA, which is the most stringent pathway. Companies should consider going to de novo process. “Me too” process has funding implications and is widely variable.
General discussion
In the Netherlands, after being encouraged by 3D printing entrepreneur, the local dental school now has 3D printing in the dental school curriculum.
It is very important to ensure education and have diverse collaboratives.
ReedSmith White Paper on 3D Printed Medical Device and Liability Law:
o   3D Printing of Manufactured Goods: An Updated Analysis
o   3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles

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The post Government Shutdown and 3DHEALS: There is a Connection, Believe or Not appeared first on 3DHeals.

“The ‘law of 3D printing,’ if such can be said to exist, challenges those existing specialties and divisions, if only by linking the intangible and ever-changing world of “cyberlaw” to our relationship with manufacturing and manufactured objects.”

Martin Galese is General Counsel for Formlabs, a desktop 3D printing company. Formlabs produces high-resolution desktop 3D printers for engineers and designers. Before joining Formlabs, Mr. Galese worked as an IP litigator at the law firm of Kirkland & Ellis LLP in New York City and pursued his passion for 3D printing after hours. Mr. Galese’s earlier Patent-Able project, turning expired patents into 3D printable models, has been covered by both the NY Times and Popular Science. Mr. Galese has previously spoken about legal and policy issues involving 3D printing at the Annual Corporate IP Counsel Forum, 3D Printshow New York, 3D/DC and before the Intellectual Property Owners Association, the Boston Bar Association, the Harvard Journal of Law and Technology, and the Cardozo Arts & Entertainment Law Journal.

Q: What is your vision on the intersection of 3D Printing and healthcare?

A: Of all the industries benefiting from the 3D printing revolution, healthcare has the potential to be among the most radically transformed. As the pharmaceutical industry moves steadily towards personalized drug interventions, so too will medical devices become increasingly customized for patients and treatment needs. 3D printing is the enabling technology for that transformation.

Formlabs Class I Biocompatible : Dental SG Resin

Q: What do you specialize in? What is your passion?

A: I see my role as General Counsel for Formlabs as providing the integrated approach and broad view of generalist to a field of increasingly focused and silo-ed field-specific legal experts. The “law of 3D printing,” if such can be said to exist, challenges those existing specialties and divisions, if only by linking the intangible and ever-changing world of “cyberlaw” to our relationship with manufacturing and manufactured objects.

Q: What inspired you to do what you do?

A: As a sci-fi fan, I have dreamed about what a post-scarcity world might look like. And as an IP litigator, I have had the opportunity to see the ways in which legal rules shape R&D today and might shape our technological future. I see 3D printing bringing these threads together, providing innovators, scientists, and doctors with tools today to help bring future technologies to everyone more quickly. The chance to work in this industry, help it grow, and provide such powerful tools to our customers is very fulfilling and inspiring for me.

Q: What challenges do you see arising in implementing 3D printing in healthcare sector in the next 5 years?

A: One of the more significant challenges lies in training healthcare workers, who may be largely unfamiliar with any manufacturing technology, in the appropriate use of 3D printing technology. Without excellent resources and support, medical users of 3D printers may lack the tools and skills to provide the full benefits to their patients.

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