“Never doubt that a small group of thoughtful, committed citizens can change the world; indeed, it’s the only thing that ever has. – Margaret Mead.   I love this quote because it gives me the courage to work on big problems with small teams and the confidence to know that our efforts can have an impact.”

 
Gray Chynoweth serves as Chief Membership Officer for ARMI | BioFabUSA where he oversees membership development and marketing activities and acts as a catalyst for the emerging biofabricaition ecosystem.
Prior to joining ARMI | BioFabUSA in January of 2018, Gray was an executive at multiple information technology companies.   As an early executive at Dyn (acquired by Oracle), Gray helped scale the company from less than 20 to more than 450 employees, raise $50,000,000 in venture capital funding, grow revenue 30x and establish global operations, with offices in the US, the UK, and Australia.
Gray holds a J.D. and M.A. in Public Policy from Duke University and was awarded a B.A. in Political Science from the University of California at Berkeley, where he graduated magna cum laude.

Mr. Gray Chynoweth will be presenting at our upcoming 3DHEALS Boston event.

Jenny: When was the first encounter you had with 3D printing? What was that experience like? What were you thinking at that moment?
Gray: My first experience with 3d printing was on a tour at DEKA with Dean Kamen when we visited the machine shop.  This occurred many years prior to starting my work with Dean at ARMI. What captured my attention about the technology was the design flexibility and innovation enablement that it offered to engineers and entrepreneurs.
Jenny: What inspired you to start your journey/company/career/research in 3D printing (bio-fabrication/bio-printing)?
Gray: Over my career, I’ve been able to scale companies and build commercial and community ecosystems.  It was exciting to think that I could deploy these skills, which had been focused in and around the IT industry, in an industry where products the save lives and help wounded warfighters.
Jenny: Who inspired you the most along this journey in 3D printing (bio-printing/bio-fabrication)? This can be a mentor, a patient, a celebrity, anyone basically. You can name more than one as well.
Gray: Dean Kamen’s vision that engineering breakthroughs and a diverse ecosystem of collaborators could act as the catalyst for rapid innovation and commercialization of engineered tissues and organs inspired me to join ARMI | BioFabUSA.
Jenny: What motivates you the most for your work?
Gray: From improving lives to reducing healthcare costs, to developing a next-generation manufacturing industry that provides quality job opportunities, the potential impact of ARMI | BioFabUSA’s work are deep, broad and profound.
Jenny: What is/are the biggest obstacle(s) in your line of work? If you have conquered them, what were your solutions?
Gray: ARMI’s mission is to make practical the large-scale manufacturing of engineered tissues and tissue-related technologies, to benefit existing industries and grow new ones.  To do this we’ll have to overcome many obstacles. Tissue and Organ manufacture need new manufacturing tools. They need better and better understood, regulatory pathways and standards frameworks.  They need capital. They need the costs of their therapies to be reimbursable. They need hospitals and clinicians that are ready, willing and able to deliver their therapies to patients.
Jenny: What do you think is (are) the biggest challenge(s) in 3D Printing/bio-printing? What do you think the potential solution(s) is (are)?
Gray: 3D bio-printing is only one part of the tissue and organ manufacturing process.   For 3D bio-printing to truly enable the manufacturing of engineered tissues and organs, these printers must be effectively integrated into an automated manufacturing process, not simply be suitable to stand-alone or prototyping activities.
Jenny: What advice would you give to a smart driven college student in the “real world”? What bad advice you heard should they ignore?
Gray: I’ve valued the lessons I learned from reading The 7 Habits of Highly Effective People (Covey) and the 48 Laws of Power (Greene) and doing completing the StrengthsFinder workbook.
Jenny: What was/is the biggest risk you took in your career?
Gray: I left a promising partner-track career as a lawyer to join a small IT startup.
I left a set of deep connections and history of proven success in operations and IT to work in business development and BioTech.  
Jenny: What do you enjoy in your spare time? What are you passionate about outside of your work/3d printing?
Gray: I love New Hampshire and trying to make it a better place for people to stay, work and play.
Jenny: What is your favorite quote? Why?
Gray: Never doubt that a small group of thoughtful, committed citizens can change the world; indeed, it’s the only thing that ever has. – Margaret Mead.   I love this quote because it gives me the courage to work on big problems with small teams and the confidence to know that our efforts can have an impact.
 

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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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