Interview: Dr. Todd Maiden, ReedSmith LLP, Regulation on AM Produced Medical Device

Todd is a partner with more than 30 years of experience helping clients identify and mitigate risks associated with environmental and related business issues. He particularly prides himself on understanding his client’s motivations and risk tolerances to provide cost-effective and practical guidance. His work ranges from regulatory counseling to negotiating corporate and real estate transactions, as well as resolving disputes through litigation and mediation. He regularly represents clients before federal and state agencies on a variety of hazardous waste, water, air and environmental impact/land use issues. Todd participates in several trade associations that monitor and help to shape proposed federal and state environmental legislation and regulatory developments. He has co-authored and contributed to several books focused on international environmental issues and is a frequent speaker on a variety of environmental subjects. He is counsel to the Board of Directors for the Pacific Basin Consortium for Environmental and Health Studies at the East-West Center, University of Hawaii. He will be a speaker at #3DHEALS2018.

Jenny: When was the first encounter you had with 3D printing?
Todd: A client approached me seeking advice regarding the application of some environmental laws to their proposed 3D printing manufacturing process.
Jenny: What was that experience like? What were you thinking at that moment?
Todd: Candidly, the experience was a bit unnerving at the time, since back then I was thinking, “what the bloody hell is 3D printing?”
Jenny: What inspired you to start your journey in 3D printing (bio-fabrication/bio-printing)?
Todd: When I reviewed some studies and spreadsheets showing that 3D printing could be valuable not just at a prototype level but profitable at a scaled-up production level.
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.
Todd: I will punt on the names for the moment but say my clients who are taking gambles to create 3D printed products (both in and outside of medicine) that will make our lives healthier and more exciting.  At the moment, I am working with a client looking at 3D printing in a microgravity environment for future uses outside of earth.
Jenny: What motivates you the most for your work?
Todd: I really enjoy the application of otherwise generic legal concepts to evolving engineering and scientific endeavors; advising people who are doing new things in new ways.
Jenny: What is/are the biggest obstacle(s) in your line of work?    
Todd: Poor communications – between people. between businesses.  with government regulators.
Jenny: If you have conquered them, what were your solutions?
Todd: “Conquering” may be too strong a word, but where I have been successful in solving problems, it was by learning the facts, understanding people’s goals and risk tolerances, and then presenting them with options (most of which have trade-offs).  Helping people make educated decisions that benefit not only themselves but also their counter-party.
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)?
Todd: This technology is evolving so fast with various competing technologies seeking to achieve similar goals.  The business community would benefit by filling gaps in certain voluntary industry standards that would enable businesses to work with each other more fluidly and with less business risk.  Failure to do so may not only limit business opportunities but invite more government regulation which could stifle creativity and growth.
Jenny: If you are granted three wishes by a higher being, what would they be?  
Todd: 

  • affordable healthcare for all;
  • moderate decision-making by our government leaders (at every level); and  
  • better ability to improvise on the saxophone (admittedly a bit selfish on this last one and based on past performance not sure it will be any easier to achieve than the first two)

Jenny: What advice would you give to a smart driven college student in the “real world”? What bad advice you heard should they ignore?
Todd: Good advice:  have a one year, three years and five-year plan – not just of goals but an implementation strategy that is realistic for you.  Then be flexible enough to modify those plans without guilt when new opportunities arise.
Bad advice:  “you have to love what you do” is sub-optimal advice if it implies that’s all it takes to be successful.  They forget to tell you to look for that sweet spot where skillset, passion and opportunity overlap.
Jenny: If you could have a giant billboard to promote a message to millions and even billions of people in our community (i.e., healthcare 3D printing and bio-fabrication), what message would that be?
Todd: “The pursuit of happiness by following the Golden Mean was not limited to Aristotle:  check it out some time.”
Jenny: What were/was the best investment you made in 3D printing/bio-printing/bio-fabrication?
Todd: Time.  Simply investing my time to learn about the technology and the business/risk issues for entrepreneurs utilizing 3D printing in their various ventures – a necessary continuing investment, I might add.
Jenny: What was/is the biggest risk you took in your career?
Todd: Probably moving back to California after having moved away for a number of years.  Between the regulatory environment and the real estate prices, this is definitely a “different market than most.”
Jenny: What do you enjoy in your spare time? What are you passionate about outside of your work/3d printing?
Todd: Too many loves of life to list, but at the moment, I am re-exploring sailing, something that I enjoyed many years ago and took too long a hiatus from.
Jenny: What is your favorite quote? Why?
Todd: “It is not because things are difficult that we do not dare . . .
 It is because we do not dare that they are difficult.”
Seneca the Younger
Keep expanding your capabilities.
Jenny: What does the word “3DHEALS” mean to you?  =)
Todd: Opportunity + relationships.
 

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