In this episode, Alyssa Huffman, CEO and co-founder of Allumin8, shares the six-year journey behind a first-of-its-kind 5.5 mm porous, 3D-printed pedicle screw. We discussed how Allumin8 earned FDA clearance and why design details matter for fatigue, fixation, and fewer revisions. We also map a path toward “therapeutic hardware” that integrates orthobiologics without slowing surgeons down. Join us as we explore the challenges, triumphs, and vision behind Allumin8’s mission to change lives.

⚠️ Disclaimer:
This podcast is for educational and informational purposes only. The views expressed do not constitute engineering, medical, or financial advice. The technologies and procedures discussed may not be commercially available or suitable for every case. Always consult with a qualified professional.

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Key Takeaways:

Why does a 5.5 mm screw matter?
How does Gaussian topography support bone ingrowth?
What are some of the lessons from fatigue testing and post-processing?
What are the additive vs milled manufacturing trade-offs?
What was Allumin8’s FDA journey and strategy?
When and how do orthobiologics add value?
How did Alyssa build a purpose-aligned team and investor base?
What are some practical founder advice on equity and boards?
What is on Alyssa’s wishlist for the future of orthopedic implants? 

“I saw catastrophic failures occur in the OR, but then I saw the ripple effects of what those catastrophic failures meant for patients.”

Recourses/Links:

Scientific papers and technical resources

• Trabecular bone geometry and curvature (Zadpoor group–style 2020 work, matches what you discussed):“The local and global geometry of trabecular bone” (bioRxiv): ​
• Complex curvature and bone cells (Nature Communications)
• Gaussian curvature–driven bone regeneration (hyperboloidal scaffolds)​
• “Meta-biomaterials” (RSC review including Gaussian curvature & bone):
• Gaussian curvature and geometry pattern of the bone
  • The “gaussian geometry pattern” in bone refers to the use of Gaussian curvature as a mathematical tool to characterize the complex, sponge-like microarchitecture of trabecular bone. It is not a visible physical pattern but rather a descriptor of the bone’s intricate, highly curved surfaces. 

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Regulatory and clinical

• FDA 510(k) (ALLUMIN8 INTEGR8™ Porous Pedicle Screws) https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242827​
• Example MIS pedicle screw 510(k) summary (template-style reference):
  https://www.accessdata.fda.gov/cdrh_docs/pdf10/K100605.pdfaccessdata.fda​
• FDA Technical Considerations for Additive Manufactured Medical Devices (3D printing guidance):
  HTML summary: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/technical-considerations-additive-manufactured-medical-devicesfda​
  PDF: https://www.fda.gov/files/medical%20devices/published/Technical-Considerations-for-Additive-Manufactured-Medical-Devices—Guidance-for-Industry-and-Food-and-Drug-Administration-Staff.pdffda​
• FDA AM program overview (cleared 3D‑printed devices): https://www.fda.gov/medical-devices/medical-device-regulatory-science-research-programs-conducted-osel/additive-manufacturing-program-research-medical-devicesfda​
• FDA spinal system 510(k) guidance (pedicle screw context):
  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-and-fda-staff-spinal-system-510ksfda​
• FDA / NIH perspective on additively manufactured medical products:
  https://pmc.ncbi.nlm.nih.gov/articles/PMC6027614/pmc.ncbi.nlm.nih​
• Orthobiologics / regenerative medicine regulatory + patient info (AAOS hub):
  AAOS Biologics hub: https://www.aaos.org/quality/biologics/aaos​
  AAOS orthobiologics FAQ for patients: https://orthoinfo.aaos.org/en/treatment/orthobiologics-faq/orthoinfo.aaos
• ​FDA Guidance: Spinal System 510(k)s

Orthobiologics and spine surgery background

• Plain-language explainer on orthobiologics (PRP, BMA, stem cells) – OrthoInfo:
  https://orthoinfo.aaos.org/en/treatment/orthobiologics-faq/orthoinfo.aaos​
• Additional AAOS orthobiologic resources (patient-focused):
  https://www.aaos.org/quality/biologics/biologics-resources/aaos​
• Patient-friendly overview of hip resurfacing & metal ion complications:
  https://orthoinfo.aaos.org/en/treatment/hip-resurfacing/orthoinfo.aaos​
• Clinician-level review of metal‑on‑metal hip implant complications (metal ions, tissue effects):
  https://pmc.ncbi.nlm.nih.gov/articles/PMC4865716/pmc.ncbi.nlm.nih​

For spinal fusion/pedicle screw revision as context:

• Example meta-analysis of pedicle screw accuracy & revision:
  https://pmc.ncbi.nlm.nih.gov/articles/PMC9109561/pmc.ncbi.nlm.nih​

Tools, books, and founder resources

• Google Scholar search for “Gaussian curvature spinal trabecular bone Zadpoor 2020”:
  https://scholar.google.com/scholar?q=Gaussian+curvature+spinal+trabecular+bone+Zadpoor+2020biorxiv​​
• Book: “Slicing Pie” by Mike Moyer
  • official equity split model site:
    Model/book landing page: https://slicingpie.com/mike-moyer-slicing-pie-author-equity-splits-for-startups/slicingpie​
  • Author homepage: https://mikemoyer.commikemoyer​

Event and ecosystem links

• “Life in 3D: Invest in The Next Frontier” JPM 2026 (3DHEALS))

Allumin8/Press

• ALLUMIN8 (Illuminate) – company website
• FDA 510(k) – A8 INTEGR8 Porous Pedicle Screw System (ALLUMIN8)
• News coverage: ALLUMIN8 gains FDA 510(k) clearance (VoxelMatters)
• St. Louis Magazine – feature on ALLUMIN8 spine screw clearance
• Video: Alyssa Huffman on better pedicle screw systems (YouTube)
• Video: Game‑changing therapeutic 3D‑printed pedicle screw implants (YouTube)
• Instagram reel: Tackling spine revision issues with ALLUMIN8
• ALLUMIN8 at NASS 2025 Annual Meeting

About Our Guest:

Alyssa Huffman

Alyssa Huffman is an award-winning MedTech entrepreneur, inventor, and thought leader focused on advancing orthopedic and spine care. Highly regarded in the industry, she was the first Commercial Representative appointed to the North American Spine Society (NASS) and is a respected voice in global spine innovation, championing evidence-based strategies at major conferences. Her initial inspiration came in 2009 while working as a distributor, when she witnessed the devastating complications of failed spine surgery on family members. This led to the first sketch of the A8 INTEGR8™ Porous Pedicle Screw System—the cornerstone of her company ALLUMIN8’s Therapeutic Hardware™ platform—which integrates biomechanical support with regenerative potential.

Under her leadership, ALLUMIN8 has achieved global recognition, including the “Best Technology in Spine” Award from Orthopedics This Week, the Global Impact Award 2025 from WashU in St. Louis, and significant funding from organizations like the Missouri Technology Corporation and St. Louis Arch Grants. Beyond her entrepreneurial endeavors, Huffman has contributed to clinical scholarship as a co-author on topics such as innovations in spine surgery and analgesic effects for trigeminal neuralgia. Her two decades of consulting experience span a wide range of MedTech areas, from medical devices to stem cell therapies. Her mission is to solve problems for patients, physicians, healthcare organizations, and payors by merging rigorous clinical evidence with cost-conscious innovation to accelerate the future of patient care.

Past interview podcasts

The post Episode #101|Therapeutic Hardware: Can Implants Also Heal? With Alyssa Huffman Allumin8 appeared first on 3DHeals.

On April 17, 2019, we had our first 3DHEALS Brazil conference at Inovabra Habitat, hosted by community managers Dr. Mayra Vasques and Fabio Sant’Ana.

About 150 participants and 15 speakers were part of this event, which has the objectives to 1) discuss the directions of healthcare 3D printing in Brazil and 2) connect experienced users, new enthusiasts, and companies.

In the first part of the event, specialists spoke on various panels focusing on dentistry, medicine, bioprinting, and regulation. They also discussed the current status and future directions of the industry in both Brazil and the world on respective panels. The format was very engaging, and the experts and the audience were able to interact and exchange ideas freely.

After some networking among the participants during a coffee break, we started the second part of the event began, a Startups Competition (#Pitch3D), an unprecedented event in this area in Brazil.

Four companies, including  3DBiotechnology Solutions, BabyHipCare, Prótesis, and BioEdTech pitched in front of a renowned panel of evaluators. Jorge Vicente Lopes da Silva (CTI Renato Archer), José Claudio Terra (Albert Einstein Hospital), Fernanda Jabour (Dental Factory), Samanta Lopes (social entrepreneur) and Jack Cavalcanti (Unipartners / Inovabra) were the competition judges and concluded that Prótesis – represented by Thiago Jucá, was the winner of the competition. He will receive a mentorship with Dr. Jenny Chen (3DHeals USA) and Fabio Sant’Ana (Farcco Tecnologia) and R $ 1000,00 in 3DSystems products (imprima3d.com.br). The second place in the competition was with BabyHipCare.

The organizers are grateful for the support of the following sponsors: Inovabra Habitat, Farcco Tecnologia, Smart T Digital, 3DSystems, and 3DCmed.

You may also want to read:

Interview: Rafael Vidal Peres, Founder of Aditiv and RealDent

Interview: Andrea Son, 3D Printing in Dental Surgery

Interview: Luiz Fernando Michaelis, Co-founder & CEO of Hefesto Med Tech

Interview: Doris Canen, 3D Printing Tax Law Expert

The post 3DHeals Brazil: Healthcare 3D Printing Next Generation! appeared first on 3DHeals.

Sean Boatright is a Certified Prosthetist, practicing in the East Bay.  He studied prosthetics at Cal State Dominguez Hills and has been working in the field of Orthotics and Prosthetics since 2006.  He has been with Diablo Prosthetics & Orthotics in Walnut Creek, CA for the past 6 years. Had one of the first patients to walk on an entirely 3D printed prosthesis and continues to utilize the technology to better provide for his patients.

Mr. Boatright will be speaking at the San Francisco event!

Jenny: When was the first encounter you had with 3D printing? What was that experience like? What were you thinking at that moment?

Sean: My first encounter with 3D printing, which was actually two events that happened almost simultaneously, was around 2014.  The first of the two happened as I came across a movie on Netflix called “Print the Legend.” Very shortly after I was introduced to Jeff Huber, CEO of Standard Cyborg.  Both had immediately opened my eyes to the capabilities of this technology.

Jenny: What inspired you to start your journey in 3D printing (bio-fabrication/bio-printing)?

Sean: My excitement of how I could apply this technology into my field inspired me to get more involved in 3D printing.

Jenny: Who inspired you the most along this journey in 3D printing ? This can be a mentor, a patient, a celebrity, anyone basically. You can name more than one as well.

Sean: I was most inspired by Jeff Huber of Standard Cyborg.  His passion not only for the technology but how he approached the application of 3D printing to help the amputee population was very impressive.

Jenny: What motivates you the most for your work?

Sean: Having a positive influence on my patients’ lives and being able to help them along their journey to attaining their goals.

Jenny: What is/are the biggest obstacle(s) in your line of work? If you have conquered them, what were your solutions?

Sean: Each patient of mine presents with a very unique situation.  There is never one solution that works for everyone so my job is to understand what certain obstacles may be and why they are happening.  Then create a plan to rectify the problem and enhance how the patient’s prosthesis or orthosis functions/fits for them.

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)?

Sean: The biggest challenge has been getting other practitioners that have been in the field longer than myself, to actually learn this technology and put it into practice.  Also, issues with material strength and cost-effectiveness are a common theme.

Jenny: What advice would you give to a smart driven college student in the “real world”? What bad advice you heard should they ignore?

Sean: I still feel very fortunate to have begun my career in O&P at a time where hand casting and plaster modifications were the only methods of fabricating prostheses and orthoses.  My advice would be to students would be to not completely discount those hand skills. Dedicate some time to learn and put into practice those skills. For me having that experience has enhanced my ability to translate the core principles of socket design from a plaster model to a computer screen.

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?

Sean: We have things to do.  It’s time to get up and do them.

Jenny: What were/was the best/worst investment you made in 3D printing/bio-printing/bio-fabrication?

Sean: Committing the time to learn and now continue to use the scanning and modeling software has been the best investment for me as a practitioner.

I can’t say I have made any bad investments so far.  I will say that we, as a company, had looked into purchasing 3D printers for our offices and if we did that a few years ago I don’t think that would have been the best decision at the time.

Jenny: What do you enjoy in your spare time? What are you passionate about outside of your work/3d printing?

Sean: I enjoy traveling and spending quality time with my wife.  I also compete professionally in BBQ competitions throughout the year.

Jenny: What is your favorite quote? Why?

Sean: “Progress is not achieved by luck or accident, but by working on yourself daily.”

Jenny: What does the word “3DHEALS” mean to you? =)

Sean: 3DHEALS to me represents passionate individuals who want to make a significant impact in the medical field and patients’ lives.

The post Interview: Mr. Sean Boatright, Certified Prosthetist at Diablo Prosthetics and Orthotics appeared first on 3DHeals.

(What does the word “3DHEALS” mean to you?)

“An amazing group of people coming together to improve the quality of life for those in need.”

Lee Dockstader is the Director of Vertical Market Development of HP’s new 3D printing business.  He is engaging the global product development process to grow additive manufacturing across verticals including Aerospace, Automotive, Medical, Dental, Life Sciences, Consumer and Retail. Emphasis is on developing production applications for HP’s Multi Jet Fusion 3D printing technology.  Before HP, Lee held several positions during his 18-year career at 3D Systems including VP of Business Development, VP and General Manager of the Stereolithography Products Business Unit and VP and GM of the Asia Pacific region. Before 3D Systems, Lee worked for three years at 3D/EYE Inc, a leading-edge 3D software company as a sales and distribution manager. For 11 years he held a variety of sales and marketing positions at Hewlett-Packard. During this period, Lee spent three years as program manager for HP’s Asia mechanical engineering CAD business, based in Hong Kong. Lee attended the West Point Military Academy and received a Bachelor of Science degree in Engineering from UCLA.

Lee Dockstader will be speaking at the Seattle event!

Jenny: When was the first encounter you had with 3D printing? What was that experience like? What were you thinking at that moment?  
Lee: I had just joined 3D Systems in 1997 and on my first day at work at a trade show I met a person who was setting up a 3D printing facility at an automotive company in Malaysia.  He ended up buying two 500mm size machines that were powered by an argon gas laser tube that output a whopping 250mW. Two machines cost $1.4 million dollars. Today you can get a Formlabs system that outputs that power for under $5K!!
Jenny: What inspired you to start your journey in 3D printing (bio-fabrication/bio-printing)?  
Lee: I joined 3D Systems to start up their direct operations in Asia with the HQ in Hong Kong.
Jenny: Who inspired you the most along this journey in 3D printing?   
Lee: Chuck Hull, the pioneer of 3D printing hired me. That was pretty inspiring at the time.
Jenny: What motivates you the most for your work?
Lee: I like to see the end to end solutions put into production.  
Jenny: What is/are the biggest obstacle(s) in your line of work? If you have conquered them, what were your solutions?
Lee: There just aren’t many examples of true production for low volume applications.  HP’s second generation color 3D printer has over 140 unique parts inside that are 3D printed and even with HP, it was hard to implement and justify.

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)?  
Lee: Education on how to implement 3D printing for low to medium volume plastic parts is still one of the biggest obstacles.
Jenny: If you are granted three wishes by a higher being, what would they be?  
Lee:

1. Always be happy
2. Good health to the end for my wife and I
3. Able to fly

Jenny: What advice would you give to a smart driven college student in the “real world”? What bad advice you heard should they ignore?
Lee: 

1. Work Hard / Play hard
2. Do more than you are asked
3. Make your boss look good
4. Ignore most things HR say you have to do to advance your career.  I told my kids a career is like kids picking teams for a ball game at recess.  Two kinds of kids get picked. The ones that can hit the ball out of the park and the ones you like to play with.  Companies are just the same. Whenever there are new projects or reorganizations those are the two types of people who get picked.  

Jenny: What were/was the best/worst investment you made in 3D printing/bio-printing/bio-fabrication?
Lee: I bought pre-IPO stock for Align Technology at around $10 and sold 10 years later for a bit more than $20.  Today it closed at $380!! (Ouch)
Jenny: What was/is the biggest risk you took in your career?  
Lee: Left the 3D CAD business in the USA and moved to Hong Kong for 3D printing with 3D Systems.  At the time they only had resins that went limp in humid environments.
Jenny: What do you enjoy in your spare time? What are you passionate about outside of your work/3d printing?
Lee: Woodworking, Tennis, golf, and skiing
Jenny: What is your favorite quote? Why?  
Lee: You can’t 3D print stuff without 3D data.  3D printing isn’t about hardware. It is all about the parts and the applications.  
Jenny: What does the word “3DHEALS” mean to you?  =)
Lee: An amazing group of people coming together to improve the quality of life for those in need.  

You may also be interested in these interviews:

Interview: Professor Alshakim Nelson, Chemistry, UW

Interview: Dr. Jing Jianlong, Dental 3D Printing, China

Interview: Dr. Shweta Agarwala, Bioprinting

The post Interview: Lee Dockstader, Director of Vertical Market Development of HP appeared first on 3DHeals.

马丹军，中科院生化细胞所博士，美国韦恩州立大学博士后，助理研究员，蛋白质组实验室主任。2016年回国创建清紫生物科技（深圳）有限公司，2017年获得深圳市科创委国际合作项目资助（压电陶瓷材料增材制造的关键技术研发）。入选深圳市孔雀人才计划，担任“上海巴斯德麒麟众创空间”创业导师。发表文章二十余篇，专利8项。
Danjun Ma, Ph.D., Shanghai Institute of Biochemistry and Cell Biology,  Postdoctoral Fellow, Research Assistant Professor, Director of the Proteomics Laboratory at Wayne State University, USA. In 2016, Dr. Ma returned to China to establish Qingzi Biotechnology (Shenzhen) Co., Ltd., and in 2017, he was funded by the Shenzhen Science and Technology Commission International Cooperation Project. The key technology research and development of piezoelectric ceramic materials additive manufacturing). To be selected “the Shenzhen Peacock Talent Program”, and as the “Shanghai Pasteur Kirin Zhongchuang Space” entrepreneurial mentor in 2018. Dr. Ma has published more than 20 papers in peer-reviewed journals and submitted 8 patent application.

Dr. Danjun Ma will be a speaker at the Shanghai event!

Jenny: 您第一次接触3D打印是什么时候？在什么情况下？那一刻的感受是什么？
When was the first time you touched 3D printing? under what conditions? What was the feeling at that moment?
Danjun: 2015年，参观深圳的3D打印创业公司，感受是新鲜，好玩。
In 2015, I visited the 3D printing startup company in Shenzhen. It was new and fun.
Jenny: 是什么因素促使您开始研究或从事3D打印（生物制造/生物打印）？
What prompted you to start research or engage in 3D printing (biological manufacturing/bioprinting)?
Danjun: 在生物系统中有一些复杂的东西是不容易实现的，例如一些植入物，支架等等。但是3D打印有可能比较容易的实现。
Danjun: There are some very complex biological systems that are not easy to replicate or design for, such as implants, stents, and the like. But 3D printing may it easier to implement.
Jenny: 在从事3D打印（生物打印/生物制造）的过程中，谁对您的影响最大？是导师、病人、名人，还是其他人？您可以说出一个或多个。
Who is most affected by you in the process of 3D printing (biological printing / bio-manufacturing)? Is it a mentor, a patient, a celebrity, or someone else? You can say one or more.
Danjun: 更多的是看文献。
Danjun: I learned the most from the works of literature.
Jenny: 激励您从事3D打印的因素是什么？
What are the factors that motivate you to engage in 3D printing?
Danjun: 能对传统的生物医学的研究有帮助。
Danjun: It can help with traditional biomedical research.
Jenny: 您工作中最大的障碍是什么？如果您已经克服了这些障碍，您用的是什么方法？
What is the biggest obstacle in your work? If you have overcome these obstacles, what method do you use?
Danjun: 技术手段还是比较单一。
Danjun: The technical means are still relatively monolithic.

Jenny: 您认为“3D打印/生物打印”的最大挑战是什么？应对这些挑战的潜在解决方案是什么？
What do you think is the biggest challenge of “3D printing / bio-printing”? What are the potential solutions to these challenges?
Danjun: 具有功能的类器官或大器官的打印。更好的，更多的交叉研究，将3D技术手段和生物学结合，现在从事这个方面的工作还是太初级。
Danjun: Printing of functional organs or large organs. Better, more cross-disciplinary research, combining 3D technology with biology. The current works in this area are still too primitive.
Jenny: 针对“现实生活”，您给大学生的建议是什么？您觉得什么样的建议是不可取的，是他们不应采纳的？
What are your suggestions for college students for “real life”? What kind of advice do you think is not advisable, they should not adopt it?
Danjun: 多尝试，不要被学科束缚，未来大概率属于懂得更多学科的交叉型人才。
Danjun: Try more, don’t be bound by the discipline, and the big probability in the future belongs to the cross-discipline talents who are not monolithic.
Jenny: 如果您有机会通过一个巨大的广告牌，向我们这个行业（如：医疗3D打印和生物制造）的数百万人，甚至数亿人宣传一个理念，您会在这个广告牌上写一条什么样的信息？
If you have the opportunity to promote a concept to millions of people in our industry (eg medical 3D printing and bio-manufacturing) through a huge billboard, what would you write on this billboard? Information?
Danjun: 生物制造在未来的场景吧。那个场景应该很震撼。应该拍一个在未来的短片。
Danjun: Bio-manufacturing in the future. That scene should be impressive. You should take a short film in the future.
Jenny: 您职业生涯中曾遭遇的最大风险是什么？
What is the biggest risk you have encountered in your career?
Danjun: 最大的风险总是在明天。
Danjun: The biggest risk is always tomorrow.
Jenny: 您的业余爱好是什么？在您的工作/3D打印之外，您对什么最有兴趣？
What is your hobby? What are you most interested in outside of your work/3D printing?
Danjun: 旅行，锻炼。工作之余陪家人最重要。
Danjun: Travel, exercise. It is most important to spend time with your family after work.
Jenny: 您的人生格言是什么？为什么?
What is your life motto? why?
Danjun: 没有人生格言。有道理的话太多。
Danjun: There is no life motto. There are too many wise words out there.
 

The post Interview: Dr. Danjun Ma, Qingzi Biotechnology (Shenzhen) Co., Ltd. appeared first on 3DHeals.

Daisy Zhu是3D Science Valley的联合创始人，这是一个专注于增材制造的评论媒体平台。她负责在牙科行业，整形外科行业以及康复器具行业出版3D打印白皮书。她是“汽车工业技术与发展报告中的3D打印”和“3D打印与工业制造”一书的作者之一。她曾在多个医学论坛，创业沙龙和科普活动中担任主讲人。
Daisy Zhu is a co-founder of 3D Science Valley, a commentary media platform focusing on additive manufacturing. She is responsible for the publication of a white paper of 3D printing in the dental industry, orthopedic industry as well as rehabilitation appliances industry. She is one of the authors of the book ‘ 3D Printing in Automotive Industry Technology and Development Report’and ‘3D Printing and Industrial Manufacturing’. She has been the keynote speaker at several medical forums, entrepreneurship salons, and popular science activities.

Daisy Zhu will be a speaker at our upcoming Shanghai Event!

Jenny: 你第一次遇到3D打印的時候是什麼時候？那是什麼經歷？那一刻你在想什麼？
Jenny: When was the first encounter you had with 3D printing? What was that experience like? What were you thinking at that moment?
Daisy: 初次接触3D打印是在2013年，那时我还在德国机床企业DMG 工作，当时在媒体上看到对3D打印的报道，仅是一台工业级3D打印设备就可以直接制造出塑料零件。这对于在机械加工行业工作的我来说触动很深，因为在传统制造中，需要通过复杂的模具制造以及注塑生产才能够制造出塑料零件或产品。而3D打印技术无需通过模具，就可以进行直接制造，无疑是具有颠覆性的。这引起了我对3D打印技术与其应用的兴趣。
Daisy: My first encounter with 3D printing was in 2013 when I was working at the German machine tool company DMG. That’s when I saw reports on 3D printing in the media, and only one industrial-grade 3D printing device could directly manufacture plastic parts. This was very exciting news for the machining industry because, in traditional manufacturing, complex plastic parts or products can be manufactured using complex tooling and injection molding process. However, 3D printing technology can be directly manufactured without going through the mold injection method, which is undoubtedly disruptive. This has piqued my interest in 3D printing technology and its applications.
Jenny:是什麼促使您開始3D打印（生物製造/生物打印）的旅程/公司/職業/研究？
What inspired you to start your journey in 3D printing (bio-fabrication/bio-printing)?
Daisy: 2014年，我跟随3D科学谷的创始人Kitty Wang 一起运营3D科学谷。3D科学谷专注于工业3D打印/增材制造，专注于对增材技术及其产业化应用的洞察。在这个愿景的基础上，我们通过发布应用白皮书与专业评论性文章来跟踪增材制造技术的应用发展，医疗行业是3D科学谷关注的重点应用领域之一，也刚好是我工作中主要负责研究的领域。
医疗行业为增材制造技术提供了产业化的应用土壤，其中骨科植入物、牙科的隐形矫正器都是已经实现商业化的3D打印应用，相信未来，无论是康复辅助器械，还是组织工程领域还会出现更多有产业化潜力的3D打印应用。
Daisy: In 2014, I co-founded 3D Science Valley with Kitty Wang. 3D Science Valley specializes in industrial 3D printing/additive manufacturing, focusing on insights into additive technology and its industrial applications. Based on this vision, we track the application development of additive manufacturing technology by publishing application white papers and professional articles. The medical industry is one of the key application areas of 3D Science Valley, and it is also the main research responsibility in my work.

The medical industry provides solid ground for the industrialized application using additive manufacturing technology. Among them, orthopedic implants and dental Invisalign appliances are successful commercial 3D printing applications, and in the future, rehabilitation aids or tissue engineering. There will also be more and more 3D printing applications with large industrial potential.
Jenny: 誰在3D打印的這一旅程中為您帶來了最大的靈感？這可以是導師，病人，名人，基本上任何人。您也可以命名多個。
Who inspired you the most along this journey in 3D printing? This can be a mentor, a patient, a celebrity, anyone basically. You can name more than one as well.
Daisy: 3D科学谷的创始人Kitty Wang, 和她一起探索3D打印技术的发展，是一件非常酷的事情，她对于增材制造和商业总有独到而令人意想不到的见解。
Kitty Wang, the founder of 3D Science Valley. She is very passionate about exploring the development of 3D printing technology. She has unique insights into additive manufacturing and commerce.
Jenny: 你工作的最大動力是什麼？
What motivates you the most for your work?
Daisy: 我工作的动力来自多方面，比如说通过对3D打印医疗应用发展的观察，我能切身感受到这个领域在不断的发展，在3D打印技术支持下，骨科、牙科等医学学科的的治疗方式会越来越个性化、精准化，能够切身感受到这些发展是令人兴奋的。而我的一些工作成果，比如说白皮书、文章、书籍等等，对于推动3D打印技术在制造中的应用是出了一份力量的，也受到了应用端读者的认可，这是一件有成就感的事情。
Daisy: The motivation behind my work comes from many aspects. For example, through the observation of the past development of 3D printing medical applications, I can feel there is large potential future development of this field. With the support of 3D printing technology, the treatment methods of orthopedics, dentistry and other medical disciplines will be more and more personalized and precise. It is exciting to be able to feel these developments. Some of my past works, such as white papers, articles, books, etc., have contributed to the application of 3D printing technology in manufacturing, and have been recognized by the application readers. This makes me feel I have achieved something meaningful. 
Jenny:你工作中最大的障礙是什麼？如果你已經征服了他們，你的解決方案是什麼？
What is/are the biggest obstacle(s) in your line of work? If you have conquered them, what were your solutions?
Daisy: 希望能够更好的协调各项工作的安排，未来与医院、医疗器械制造商等3D打印潜在用户进行更多的互动与沟通。
Daisy: I hope that I can multitask better. In the future, I hope I will have more engagements with potential users of 3D printing such as hospitals and medical device manufacturers.

Jenny: 您認為3D打印/生物打印的最大挑戰是什麼？您認為潛在的解決方案是什麼？
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)?
Daisy: 中国并不缺乏具有医疗器械增材制造能力的企业，但是3D打印医疗器械产业化的难点在于如何能够申请到增材制造医疗器械的注册证。CFDA 已经在完善增材制造医疗器械审批指导原则了，相信监管审批方面会越来越成熟。但对于企业来说，特别是研发骨科植入物这样的三类器械的企业来说，如何满足CFDA 对报批器械的documentation 的要求是具有难度的，这一点国外的先进企业借助了生产过程执行管理软件（MES）的力量，对于增材制造这一面向规模化定制的数字化技术来说，利用好MES 软件则更为重要，这一点可为国内企业所借鉴。
Daisy: China does not lack enterprises with the ability to manufacture medical devices. However, the difficulty in industrializing 3D printed medical devices is how to apply for the registration of medical devices for additive manufacturing. CFDA has already improved the guidelines for the approval of medical devices for additive manufacturing and believes that future regulatory approvals will become more mature. However, for enterprises, especially those who develop instruments such as orthopedic implants, it is challenging to meet the CFDA’s requirements. Foreign companies have done better, relying on the advanced companies. The power of software (MES, Manufacturing Execution System). For scalable digital/additive manufacturing, the use of good MES software is very important. I think domestic (Chinese) enterprises can also use this strategy.
Jenny:如果你被授予三個願望，他們會是什麼？
If you are granted three wishes by a higher being, what would they be?  
Daisy: 获得更多时间去充电、学习；在工作中遇到更多有能力、有趣的人；多和孩子分享我在工作中所获得的对于科技、社会发展的认识。
Daisy: Having more time to recharge and learn; Meeting more capable and interesting people at work; Sharing more of my insights on technology and social development with my child.

Jenny: 您對“現實世界”中聰明的大學生有什麼建議？你聽到了什麼不好的建議他們應該忽略？
What advice would you give to a smart driven college student in the “real world”? What bad advice you heard should they ignore?
Daisy: 建议大学生朋友们除了专业方面的学习，还可以多涉猎一些商业、科技发展趋势方面的知识，成为一名跨界人才。此外，无论是在学习中还是未来工作中，始终与卓越的人同行。
Daisy: I would recommend the college students that, in addition to professional studies, they should also learn more about the business and technology development trends, and look to becoming a cross-border talent. In addition, either in the process of learning or at work, try to always stay close with outstanding people.

Jenny: 如果你有一個巨大的廣告牌來向我們社區中的數百萬甚至數十億人宣傳信息（即醫療保健3D打印和生物製造），那會是什麼信息？
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?
Daisy: 3D打印和数字化技术为医疗带来更加个性化、便捷的制造解决方案，使得治疗更精准，生命更有尊严，在世界范围内需要增强医生、3D打印硬件、软件商、服务商的交流，以推动技术的发展和商业化进程行业。
Daisy: 3D printing and digital technology bring more personalized and convenient manufacturing solutions for medical treatment, making treatment more precise and life more dignified. It is necessary to enhance the communication between doctors, 3D printing hardware, software vendors and service providers worldwide. Promote the development of technology and the process of commercialization.
Jenny: 您在3D打印/生物打印/生物製造方面的最佳投資是什麼？
What were/was the best investment you made in 3D printing/bio-printing/bio-fabrication?
Daisy: 在医疗3D打印领域我做的最好的投入是花了大量精力去跟踪这一技术的应用发展。
Daisy: The best investment I have made in the field of medical 3D printing is to spend a lot of energy to track the application development of this technology.
Jenny: 你在業餘時間享受什麼？你對工作/ 3d打印的熱情是什麼？
What do you enjoy in your spare time? What are you passionate about outside of your work/3d printing?
Daisy: 在工作之余与家人在一起健身、读书、旅游，分享快乐。
Daisy: Stay fit, study, travel and share happiness with family after work.
Jenny: “3DHEALS”這個詞對你意味著什麼？
What does the word “3DHEALS” mean to you?  =)
Daisy: 3DHEALS是一个非常有活力的国际化3D打印医疗社区，在3DHEALS，任何对于3D打印医疗技术感兴趣的企业、个人都可以在这里获得前沿的信息，寻找志同道合的伙伴。
Daisy: 3DHEALS is a very dynamic international 3D printing medical community. In 3DHEALS, any company or individual interested in 3D printing medical technology can get cutting-edge information and find like-minded partners.

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A New York native, Dr, Nima Massoomi is a Board Certified Oral and Maxillofacial Surgeon who attended the University of Pennsylvania where he received his Dental and Masters in Education. He then attended Medical school at Vanderbilt University where he also completed his Oral Surgery residency in 2007. This was followed by a Cosmetic surgery fellowship in 2008 at Ohio State alongside Dr. T. William Evans, fine-tuning his skills in the management of the soft-tissue and skin. He is currently a clinical instructor at the Department of Oral Surgery at the University of Pacific in San Francisco and maintains two practices in San Francisco and Cupertino. He has lectured nationally and internationally on the use technology in oral surgical procedures, with a goal of improving surgical outcomes using CBCT technology. Most recently, he was part of the team that brought to market the first FDA-approved robot “Yomi” for Dental Surgery in January 2017. This was after many years of collaboration with a team of scientists and engineers at Neocis in Miami, Fl. The Yomi robot will have the capabilities of performing a wide variety of oral surgical procedures, based on 3D CBCT data, being able to provide same-day surgery from start to finish. Dr. Nima Massoomi will be a speaker at the #3DHEALS2018 conference on April 20-21st, 2018. 
Jenny: When was the first encounter you had with 3D printing? What was that experience like? What were you thinking at that moment?
Nima: Approximately 15 years ago, I became involved in 3D printing when I was in medical school as we prepared to remove a tumor from a patient’s lower jaw.  We worked with a company called “Medical modeling” who 3D printed a model of the patient’s skull with the tumor anatomy and vital structures such as nerves, in order to plan our surgical approach.  This allowed us to pre-bend the plates that would be required during the tumor resection surgery.  This was only made possible creating a surgical template using CBCT imagery.  Even back then I thought this was so cool and revolutionary, to preplan surgeries prior to even making an incision.  Today, many companies are even pre-printing custom-made plates for these types of cases!       
                                             
Jenny: What inspired you to start your journey in 3D printing (bio-fabrication/bio-printing)?
Nima: Honestly, it was the ability to provide better and more precise care to my patients.  It is my belief that if technology can be used to better patient outcomes, then it should be employed to its fullest extent. 
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.
Nima: It really wasn’t a particular person, but I have to thank my the chairmen of my OMFS surgery department, Dr. Samual McKenna, and Dr. Scott Boyd, who was back then even willing and open to such ideas. 
Jenny: What motivates you the most for your work?
Nima: Improving my patient’s lives and making them smile. This can range from the simplest form of dental injury which can include the loss of a front tooth, to the more devastating injuries from extensive facial trauma. 
Jenny: What is/are the biggest obstacle(s) in your line of work? If you have conquered them, what were your solutions?
Nima: Data. I think all of us in the 3D printing field have to generate data to validate the use of this technology.  I have been working closely with the faculty at University of Pacific Dental School to publish 2 papers on the accuracy of 3D printed material and how it affects outcomes.  More papers are in the works.
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)?
Nima: For the practitioners that are interested in using this technology, the expense of the equipment and the materials to start down this journey can be overwhelming. Additionally, it’s the lack of “cross-breeding” of ideas.  For instance, I am currently working on solving a problem for an oral surgery procedure and need something printed in 3D printing using metal.  However, I have no idea who has done this in the other fields and if they have, is it FDA approved to use in the surgical realm?
Jenny: If you are granted three wishes by a higher being, what would they be?
Nima: Make 3D printing universal, cheaper and faster. 
Jenny: What advice would you give to a smart driven college student in the “real world”? What bad advice you heard should they ignore?
Nima: To make AI, 3D printing a part of their schooling.
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?
Nima: “Got 3D? We do!”
Jenny: What were/was the best investment you made in 3D printing/bio-printing/bio-fabrication?
Nima: The treatment planning software that I use on a daily basis to create surgical guides/templates to perform surgery
Jenny: What were/was the worst investment you made in 3D printing/bio-printing/bio-fabrication?
Nima: I don’t think I have made one yet….time will tell?
Jenny: What was/is the biggest risk you took in your career?
Nima: Again, I think its too soon to answer that. Ask me in 10 years!
Jenny: What do you enjoy in your spare time? What are you passionate about outside of your work/3d printing?
Nima: Mission trips and volunteer work here in the US and internationally.  Also trying newer adventures, such as robotics in the oral surgical procedure. 
Jenny: What is your favorite quote? Why?
Nima: Mahatma Gandhi “live as if you were to die tomorrow, Learn as if you were to live forever.”
Jenny: What does the word “3DHEALS” mean to you? =) 
Nima: 3D can heal.

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The post Interview: Dr. Nima Massoomi, Board Certified Oral and Maxillofacial Surgeon appeared first on 3DHeals.