Are we ready to commit to showing the value of 3D printing? Medical 3D printing is already used in hospitals, but turning individual success stories into systemic healthcare adoption takes more than the technology. Dr. Naomi Nathan, Head of the Healthcare Division at Mobility Goes Additive e.V. (MGA), knows what it will take to bring 3D printing into healthcare systems at scale. Nathan breaks down the challenges standing between innovation and adoption, from reimbursement and clinical evidence to regulation, procurement, and political commitment. Healthcare requires a long-term approach to investment. Europe’s decentralized healthcare systems make adoption particularly complex, and national clinical studies are needed to demonstrate patient and economic value. Nathan discusses MGA’s role in bringing together industry, hospitals, researchers, and policymakers to move medical 3D printing beyond isolated applications and toward broader healthcare adoption.

⚠️ 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.

About Our Guest:

Naomi Nathan is a trained medical doctor, public health specialist and business executive with over eleven years of experience across health policy, health systems strengthening, healthcare innovation, and now 3D printing for healthcare. She currently serves as Head of Healthcare Division at Mobility goes Additive e.V, a leading European network advancing additive manufacturing (3D printing) in healthcare, where she works with experts in working groups on various topics to bolster AM in healthcare, as well as policy positioning, evidence, and strategy, addressing various stakeholders including the European Parliament on their adoption. Previously, a Technical Officer/Consultant at the World Health Organization, she has worked on various health systems governance and policy initiatives with WHO/Europe member states, and stakeholders and served as secretariat member to the Pan European Commission on Health and Sustainable Development chaired by Mario Monti. Her interests centre on access to health innovation, at the intersection of emerging technologies with public health.

Key Topics

Dr. Naomi Nathan’s journey from medicine to public health and health economics

Mobility Goes Additive (MGA) and its expansion from mobility into healthcare

MGA’s European role and engagement with policymakers

Cross-sector learning between healthcare, rail, and additive manufacturing

Why Europe’s nationally governed healthcare systems complicate 3D-printing adoption

Moving medical 3D printing from technical capability to healthcare system adoption

Point-of-care 3D printing and the reimbursement challenge

Building clinical evidence through registries and multicenter studies

Regulation, procurement, and reimbursement as barriers to adoption

Creating pathways for healthcare innovation through the WHO

Policy commitment and investment needed to scale medical 3D printing

Communicating additive manufacturing’s value to policymakers

The reality of bioprinting and why “we are not printing organs yet”

The established role of 3D printing in orthopedic medical devices

MGA’s “collabor-action” approach and vision for the future of medical 3D printing

Timestamps:

00:00:00 – Welcome And Quick Disclaimer
00:01:09 – From Medical Doctor To Systems
00:02:48 – What MGA Does And Why
00:08:37 – Why EU Healthcare Is Complex
00:11:00 – Hospitals And Point Of Care Printing
00:14:04 – Building Registries And Better Evidence
00:16:35 – Reimbursement As The Real Blocker
00:20:13 – When Innovation Outruns The System
00:21:54 – What Policymakers Must Commit To
00:28:38 – Startup Signals Bioprinting Reality Check
00:35:08 – MGA Strategy Collaboration With Action
00:38:36 – Five Year Vision And How To Join
00:42:43 – Closing Thanks And Full Disclaimer

Resources

🔗 Contact Naomi Nathan

• Naomi Nathan on LinkedIn
• Naomi Nathan at Mobility Goes Additive
• Mobility Goes Additive (MGA)
• European Healthcare Forum for Additive Manufacturing (EHFAM)
• Naomi Nathan’s EHFAM Speaker Profile

🔗 Medical 3D Printing, Healthcare Systems & Policy

• Interview with Naomi Nathan: Getting 3D Printing into Healthcare Systems
• Interview with Naomi Nathan on 3DPrint.com
• HealthCapital Berlin: Interview with Naomi Nathan
• CECIMO
• RSNA-ACR 3D Printing Registry
• ACR 3D Printing Registry
• EHFAM and 3D Printing for Life Sciences at 3D Print Basel

🔗 European Additive Manufacturing & Healthcare

• MGA: Reflecting on 2025 and Looking Ahead to 2026
• Talk3D
• WHO Europe Public Health Innovation Platform
• WHO Guidance on Scaling Health Innovations

🔗 Learn More About 3D Printing Regulation from 3DHEALS!

3DHEALS Healthcare 3D Printing Resource Center

Interview with Erik Boelen: Quality Management for Point-of-Care 3D Printing

Episode 127: Lean Compliance for Medical 3D Printing with Erik Boelen

Episode 114: Interview with Brigitte de Vet-Veithen, CEO of Materialise

3D Printing in Hospitals: A Beginner’s Guide

3D Printing in Hospitals: The Road to Reimbursement

Idea to Implementation: Reimbursement, the Elephant in the Room

Exploring Six Policy Areas Impacting Healthcare 3D Printing and Bioprinting

Event Recap: Advancing 3D Surgical Planning

Episode 113: How 3D Printing Explains the Unexplainable with Dr. Tristan Ramcharan

The post Episode #129: Medical 3D Printing Adoption in the EU with Naomi Nathan appeared first on 3DHeals.

Everyone wants to fund the next miracle drug. Jim West thinks differently. In this episode, the Associate Director of BioTools Innovator makes the case that life-science tools and diagnostics are the better risk-adjusted venture bet than many therapeutics: you trade the 100X biotech moonshot for a 5-to-10X return with better odds, little regulatory risk, and a roughly five-year horizon. He backs it with the accelerator’s own numbers: 95% of the companies through its six cohorts are still operating or acquired, out of roughly 2,800 applications — and explains why focus (not technology) is what most tool founders get wrong, what strategic acquirers actually pay for, and why private equity and family offices are reshaping how these companies get funded.

About the Guest: Jim West

Jim West has spent his career at the intersection of health, business, and technology serving as an engineer, advisor, consultant and CEO to early stage and growing companies. Currently he serves as the Associate Director at BioTools Innovator, the world’s premier accelerator for life science companies. As former co-founder and CEO of Clara Biotech, Jim has been pivotal in pioneering patented breakthroughs in exosome purification and sample preparation, helping address some of the most challenging issues in the field. Prior to Clara Biotech, Jim worked on developing medical products from prototyping through manufacturing. Jim’s expertise and leadership were instrumental in securing FDA approval for one of the first mobile medical devices in 2016 using an iPhone as a stethoscope. Jim has dual master’s degrees in Biomedical Engineering (from the University of Kansas) and Entrepreneurship (Nanyang Technological University, Singapore).

TIMESTAMPS:

00:00:00 – Why Tools Can Beat Moonshots
00:01:18 – Jim West’s Nonlinear Path To Startups
00:03:55 – Clara Biotech And The Exosome Problem
00:06:38 – Standards And Sample Prep Bottlenecks
00:08:15 – Inside BioTools Innovator’s Selection Engine
00:12:55 – Focus And Coachability Define Winners
00:16:05 – Mentorship Plus Nonprofit Funding Levers
00:19:32 – What Strategics Want Before They Buy
00:23:28 – Returns Outlook With PE And Family Offices

GUEST’S LINKS

Jim West on LinkedIn: https://www.linkedin.com/in/jim-west-iii/
BioTools Innovator: https://biotoolsinnovator.org
MedTech Innovator: https://medtechinnovator.org
Clara Biotech: https://clarabio.tech

MENTIONED IN THIS EPISODE

2026 BioTools Innovator Capstone (Oct 14, San Diego — $250K finals): https://biotoolsinnovator.org/2026-bti-capstone/
2026 BioTools Innovator finalists: https://biotoolsinnovator.org/biotools-innovator-announces-the-2026-finalists/
BioTools Innovator program overview: https://biotoolsinnovator.org/program/
MedTech & BioTools Innovator BARDA Accelerator Network hub: https://medtechinnovator.org/medtech-innovator-selected-to-lead-the-enabling-technologies-hub-in-the-next-generation-of-the-barda-accelerator-network/
Jim West on the exosome sample-prep bottleneck (Technology Networks): https://www.technologynetworks.com/diagnostics/blog/releasing-the-handbrake-on-exosome-applications-317602
BioTools Innovator featured on Lab to Startup: https://www.labtostartup.com/medtech-innovator-and-biotools-innovator-accelerator-for-medical-device-digital-health-and-diagnos/

FROM 3DHEALS

Investing at 3DHEALS: https://3dheals.com/tag/investing/
Fundraising, Venture Capitalists & Angel Investors in Healthcare 3D Printing: https://3dheals.com/startup-fundraising-in-healthcare-3d-printing/
Pitch3D, connecting startups to investors: https://3dheals.com/pitch3d/
3DHEALS events & webinars: https://3dheals.com/events/

The post Episode #128 | BioTools Can Beat Moonshots with Jim West appeared first on 3DHeals.

Medical 3D printing has come a long way, but the regulations are still catching up. As personalized medical devices move into hospitals, how can labs innovate while staying compliant? Erik Boelen, founder of medical 3D-printing compliance consultancy Qase3D and former Chief Operations Officer of Xilloc Medical, has a solution. Boelen built an ISO 13485 quality system from scratch at Xilloc, which produced the world’s first complete 3D-printed titanium mandible in 2011. Today, he helps newer medical 3D-printing companies and hospital labs navigate the European Medical Device Regulation (MDR), emphasizing that MDR compliance does not necessarily require a full ISO 13485 system. Through Qase3D, Boelen has developed an MDR Management System with Waveland European Lawyers, an online portal that breaks down regulatory requirements into practical steps for custom-made device manufacturers. As hospitals increasingly become manufacturers themselves, Boelen integrates compliance systems that protect patients without creating unnecessary bureaucracy.

⚠️ 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.

Support our show and get premium and archived content anytime:

Subscribe to The Lattice Podcast

About Our Guest:

Dr. ir. Erik Boelen runs his consultancy, “Qase3D” (pronounced Case-three-dee) specializing in medical 3D printing and Quality Management. He assists 3D printing companies and hospital labs with ISO 13485 certification and MDR compliance. Erik served as Chief Operations Officer at Xilloc Medical B.V. for nine years (April 2012 – June 2021), where the company designed and manufactured some of the world’s first patient-specific, 3D printed medical devices. Before that, he held various roles at 3D printing pioneer Materialise NV: Marketing Manager (January 2011 – May 2012), Sales Manager Biomedical Asia- Pacific (February 2010 – January 2011), Product Specialist (June 2007 – February 2010), and Application Engineer (January 2007 – June 2007).

Key Topics

• Twenty years of medical 3D printing and the evolution of regulation
• Medical 3D printing before the MDR and the regulatory gaps of the MDD era
• Understanding the MDR, CE marking, custom-made devices, and ISO 13485
• Xilloc and the world’s first complete 3D-printed titanium mandible
• Patient safety and the shift from self-regulation to formal standards
• The 2017 MDR and its impact on custom-made medical devices
• Building an ISO 13485 quality management system from scratch
• How Qase3D helps medical 3D-printing companies and hospital labs navigate compliance
• Designing a quality management system that engineers will actually use
• Why smaller labs may not need the full weight of ISO 13485
• Where the MDR and ISO 13485 overlap, and where their requirements differ
• Lean compliance, documentation, and reducing the cost of regulatory management
• Implants, Class III devices, and when more rigorous quality systems are needed
• GDPR, lawyers, and protecting patient data in personalized medical devices
• The rise of hospital 3D labs and the future of hospitals as medical device manufacturers

Timestamps:

00:00:00 – Welcome To The Regulatory Reality
00:03:10 – MDR, CE Mark, And ISO 13485
00:06:30 – Making Implants Before Clear Rules
00:08:33 – What Custom Made Really Means
00:10:20 – From Engineer To Quality Builder
00:12:12 – A Lean QMS People Actually Use
00:17:33 – The MDR Portal And Lawyer Support
00:26:45 – Scaling Compliance Without Bureaucracy
00:30:40 – The Future Of Hospital 3D Labs
00:41:05 – How To Contact Erik
00:43:15 – Disclaimer

Resources

🔗 Contact Erik Boelen

• Erik Boelen on LinkedIn
• Qase3D on LinkedIn
• Qase3D
• About Qase3D & Erik Boelen
• Qase3D Quality BluePrint 5D Method

🔗 MDR, ISO 13485 & Point-of-Care Compliance

• EU Medical Device Regulation (MDR)
• Qase3D MDR Management System
• MDR Custom-Made Devices
• Waveland European Lawyers MDR Point-of-Care Platform
• Qase3D Point-of-Care Compliance
• Qase3D Custom-Made Devices and the MDR
• ISO 13485 Medical Devices Quality Management Systems

🔗 Xilloc & Medical 3D Printing

• Xilloc 
• World’s 1st complete 3D-printed titanium mandible in 2011
• Materialise Mimics
• Materialise Medical
• 3D Printing Industry: Qase3D and Waveland Introduce MDR Management System
• 3DHEALS: Updates on 3D Printed Medical Devices

🔗 Learn More About Medical 3D Printing from 3DHEALS!

• 3DHEALS
• Interview with Erik Boelen: Quality Management for Point-of-Care 3D Printing
• 3D Printing at Point-of-CARE with Quality
• Point of Care Additive Manufacturing
• 3D Printing in Hospitals: The Road to Reimbursement
• A World of Regulation: Updates on 3D Printed Medical Devices
• 3D Printing in Hospitals: A Beginner’s Guide
• Strategic Issues of 3D Printing in Hospitals
• 3DHEALS Policy Guide: Six Policy Areas Impacting Healthcare 3D Printing

The post Episode 127: Lean Compliance For Medical 3D Printing With Erik Boelen appeared first on 3DHeals.

Innovation is a chess game. The right move can turn an idea in a university lab into a company, a breakthrough, or even a treatment for patients. On this episode of The Lattice, we sit down with Mark Alan Wisniewski, Senior Director of Biopharmaceuticals at the UCLA Technology Development Group (TDG), to explore how universities navigate the complex game of turning research into real-world impact. Mark Alan Wisniewski makes the argument that a university technology transfer office is an investment thesis, not a cost center. UCLA receives more than $1.5 billion in federal research grants to its medical school each year, generating 300 to 400 invention disclosures that TDG can patent and license. Wisniewski explains how the office converts early-stage faculty research into startups, why it writes “use it or lose it” development milestones into licenses so inventions are not shelved, and how the 1980 Bayh-Dole Act let universities own and commercialize federally funded intellectual property (IP). He cites concrete outcomes: two of the top five prostate cancer drugs, a licensed cure for ADA-SCID gene therapy from Dr. Donald Kohn’s lab, and UCLA’s $1.14 billion sale of its Xtandi royalty interest in 2016.

⚠️ 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.

Support our show and get premium and archived content anytime:

Subscribe to The Lattice Podcast

About Our Guest:

Mark Wisniewski is the Senior Director of Biopharmaceuticals. He is responsible for the life science and biopharma intellectual property developed at UCLA, including managing licensing and marketing staff, financial management of the portfolio and outreach to inventors and industry. His career spanned multiple roles in biotech management, entrepreneurship and product commercialization in both start-up to Fortune 100 companies. Prior to his role at UCLA TDG, Mark was the Head of Special Projects at Prolacta Bioscience, a producer of human milk nutritional products for premature infants in the neonatal intensive care unit, leading the strategic planning and business development functions. He was also a Principal Advisor to the National Institutes of Health and National Cancer Institute’s Commercialization Accelerator Programs which provides business strategy, product commercialization, fund raising and strategic partnership guidance to hundreds of early stage biotech and life science companies. Mark began his career at Baxter Healthcare where he held positions in business development, strategic planning, marketing and R&D. Mark received his MBA from the UCLA Anderson School of Management and his Masters of Immunology and Microbiology at the UCLA School of Medicine.

Key Topics

How a technology transfer office connects academic research to entrepreneurs and industry

The Bayh-Dole Act of 1980 and its impact on university innovation

UCLA’s invention pipeline, from 300 to 400 disclosures to patents, licenses, and startups

UCLA’s prostate cancer drugs and ADA-SCID gene therapy breakthrough

Mark Wisniewski’s journey from immunologist to biopharma dealmaker

Why faculty researchers often become startup founders

The role of technology transfer in patents, licensing, startup formation, and commercialization

Exclusive vs. non-exclusive licenses and how licensing terms are structured

The “use it or lose it” approach to preventing promising research from being shelved

Intentional competitive shelving and how universities respond

UCLA TDG’s proximity effect and the ingredients of a successful innovation ecosystem

Why technology transfer should be viewed as an investment thesis, not a cost center

UCLA’s $1.14 billion royalty sale and the economics of university innovation

Measuring innovation over the long term, from invention to startup to exit

Serial founders, untapped talent, and the potential for the next Amgen in Los Angeles

LABEST and the effort to build Los Angeles into a leading biotech ecosystem

From accelerator to catalyst and the future of university-driven innovation

Timestamps:

00:00:00 – Welcome And The Tech Transfer Mystery
00:00:56 – What A Tech Transfer Office Licenses
00:02:06 – Bayh-Dole And The Innovation Pivot
00:04:59 – Mark’s Chess Like Career Path
00:08:10 – Why Faculty Startups Lead Licensing
00:13:10 – Exclusive Versus Nonexclusive License Strategy
00:15:02 – Preventing IP Shelving With Diligence
00:21:40 – UCLA’s Scale Startups And Proximity Effect
00:27:00 – Tech Transfer As Long Term Investment
00:36:40 – LA BEST And Building Biotech In LA
00:39:50 – The Future Beyond “Tech Transfer”

Resources:

🔗 Contact Mark Alan Wisniewski

• Mark Alan Wisniewski, UCLA Technology Development Group
• Mark Alan Wisniewski on LinkedIn
• UCLA Technology Development Group
• UCLA Technology Development Group Staff
• LABEST
• Amir Naiberg, UCLA TDG

🔗 University Innovation, Technology Transfer & the LA Biotech Ecosystem

• UCLA Sells Royalty Rights Connected with Cancer Drug to Royalty Pharma
• LABEST 2026: Scientific Innovation and the Future
• LABEST, Los Angeles Bioscience Ecosystem Summit
• Los Angeles Bioscience Ecosystem Summit 2021
• The UCLA Research Park
• California Institute for Immunology and Immunotherapy
• Magnify Incubator at CNSI
• California NanoSystems Institute at UCLA
• UCLA Entrepreneurship Hub
• Gilead Sciences Acquires Kite Pharma for $11.9 Billion
• Amgen
• Prolacta Bioscience
• J.P. Morgan Healthcare Conference

🔗 Technology Transfer, Licensing, Commercialization

• From Bench to Bedside, ASH Clinical News
• UCLA Inks Two Research Deals Around Cancer, MS Therapeutics
• Xtandi
• The Future Is Now: Mark Wisniewski of UCLA TDG
• Authority Magazine Interview with Mark Wisniewski
• BCLA’s 10th Annual Bioscience Talent Connection
• Alliance for SoCal Innovation, Research Commercialization
• Baxter

🔗 Learn More About 3D Bioprinting from 3DHEALS!

• 3DHEALS
• 3DHEALS Ultimate Resource Center for Healthcare 3D Printing
• Bench to Bedside: Bioprinting Innovations
• 3D Bioprinting for Drug Discovery and Development
• In Silico Simulation for Medtech and Biopharma
• 3DHEALS Startup Showcase
• The Fabrication of Microfluidics, 3D Cell Culture & Organ-on-a-Chip
• An Introduction to 3D Bioprinting

The post Episode 125: Inside Technology Transfer At UCLA With Mark Wisniewski appeared first on 3DHeals.

For 25 years, humans have continuously manned the International Space Station. Today that same microgravity environment is becoming a laboratory for building human tissue, studying disease, and manufacturing biological products that can be impossible to make on Earth. Dr. Micheal Roberts, Chief Scientific Officer of the International Space Station National Laboratory, explains how on Earth, gravity forces bioprinted tissue to collapse before it can support itself. In microgravity that constraint disappears and biological structures hold their shape with no scaffold at all. This single physical fact has turned the ISS into the proving ground for manufacturing thick, vascularized human tissue. He traces the arc from space-grown protein crystals to Redwire’s BioFabrication Facility and Auxilium Biotechnologies’ nerve-repair implants, which printed eight devices in roughly two hours in orbit. With astronauts supporting 200 to 400 experiments during a typical six-month mission and the ISS approaching its planned end around 2030, Dr. Micheal Roberts makes the case for a new generation of commercial platforms that could turn low Earth orbit into a biomanufacturing hub. Now is the moment.

⚠️ 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.

About Our Guest:

Dr. Michael Roberts is the Chief Scientific Officer of the International Space Station National Laboratory and Vice President at the Center for the Advancement of Science in Space (CASIS). Before joining CASIS in 2013, Michael worked as a microbial ecologist, principal investigator, and research group lead at the Kennedy Space Center. Prior to arriving at NASA-KSC in 1999, Michael completed an undergraduate degree in biology at Maryville College, a doctorate in microbiology at Wesleyan University and post- doctoral research at the Center for Microbial Ecology at Michigan State University. Lowry holds a PhD in biomedical engineering from Tulane University, sits on the 3Rs Collaborative and FNIH Validation and Qualification Network, and has authored 6 patents, 20+ publications, and 100+ scientific presentations.

Key Topics

A microbiologist’s unexpected journey from Kennedy Space Center to the ISS National Laboratory

Why 25 years of continuous human presence in space have made this the right moment for biomanufacturing

Protein crystallization and the origins of biological manufacturing in space

The scaffold problem and microgravity’s unique advantages for 3D tissue printing

Engineering bioprinters for space, from heat dissipation to fluid separation and microfluidics

Redwire’s BioFabrication Facility, Auxilium’s DLP technology, and the move beyond extrusion

What happens to cells, organoids, and tissues when gravity is removed

How microgravity can accelerate models of aging, cancer, and disease progression

NASA’s  vascular tissue challenge and the race to create thick, functional, vascularized tissue

Wake Forest’s liver and kidney bioprinting work and new collaborations emerging from space research

The partnerships bringing together NASA, academia, startups, pharma, and government

Life after 2030 and the transition from the ISS to commercial space platforms

Varda, Starfall, and falling launch costs are reshaping access to low Earth orbit

The potential of space-based research for aging, cancer, longevity, and regenerative medicine

The biggest barriers to space biomanufacturing, including cost, logistics, regulation, and quality control

Orbital Edge, startup funding, and opportunities for the next generation of space entrepreneurs

Timestamps:

0:00 Welcome And Guest Introduction

3:51 From Microbes To Managing ISS Science

6:14 Why Space Biomanufacturing Now

9:55 Protein Crystals And Better Drug Design

15:35 Why Bioprinting Changes In Microgravity

24:24 Engineering Printers For Space Reality

27:59 Organoids And 3D Cell Culture Gains

35:25 Vascularization Challenge And Thick Tissues

39:45 Partnerships That Make The Ecosystem Work

46:06 Post ISS Platforms And Lower Launch Costs

49:34 Biggest Blockers Cost Logistics Regulation

54:35 Orbital Edge And Advice For Builders

56:40 Closing Thanks And Disclaimer

Resources

🔗 Contact Dr. Michael Roberts

• Dr. Michael Roberts on LinkedIn
• Dr. Michael Roberts, ISS National Laboratory
• Michael Roberts at ASCEND
• ISS National Laboratory
• Center for the Advancement of Science in Space (CASIS)

🔗 Space Biomanufacturing, Research & Companies

• ISS National Lab BioFabrication Facility
• Redwire
• Auxilium Biotechnologies
• NeuroSpan Bridge
• Yes, Virginia, There is a National Laboratory in Space
• The New Alchemy of Space: Why We Cannot Leave Public-Private Partnerships Behind
• NASA In Space Production Applications (InSPA)
• NASA Vascular Tissue Challenge
• NASA Vascular Tissue Challenge Winners
• Wake Forest Institute for Regenerative Medicine
• Varda Space Industries
• Orbital Edge Accelerator
• ISS National Lab LEO Economic Development
• Biomanufacturing in Low Earth Orbit: A Paradigm Shift
• Biomanufacturing in Low Earth Orbit: Full Text

🔗 Learn More About 3D Bioprinting from 3DHEALS!

• 3D Bioprinting in Space?
• 3DHEALS 2020: Healthcare 3D Printing in Space, NASA, ISS
• 3D Bioprinting and Organoids
• 3D Bioprinting Vasculatures
• 3D Bioprinting for Regenerative Medicine
• 3D Printing for Cardiovascular Systems
• 3D Printing Organ-on-a-Chip & Microfluidic Devices
• 3D Printing and Microfluidics
• Interview with Elliot McAllister: 3D Printing Microfluidics
• 3D Bioprinting Heart & Cardiovascular System

The post Episode 123: Bioengineering in Microgravity with Dr. Micheal Roberts ISS/CASIS appeared first on 3DHeals.

Graham Craig is Chief Commercial Officer at VoxCell, a Canadian biotechnology company developing high-resolution, vascularized 3D tissue models as New Approach Methodologies (NAMs) for drug development. He leads VoxCell’s commercial strategy, global business development, and strategic partnerships, working to put more human-relevant preclinical models into the hands of pharmaceutical companies, CROs, and research institutions, so teams can generate decision-enabling data earlier and reduce reliance on traditional animal testing.

Graham brings more than 18 years of experience in commercialization and strategic partnerships across the pharmaceutical and biotech sectors. Before joining VoxCell he was Director of Corporate Development at AbCellera and held senior roles at STEMCELL Technologies. Earlier in his career he spent seven years as a commercial strategy consultant at IQVIA, advising pharmaceutical companies across Europe, Asia, and North America.

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

Graham: Like a lot of people, my first brush with 3D printing was seeing it as a neat gadget that my friend had. Watching his printer build a plastic F1 car layer by layer and thinking it was pretty clever. The moment that actually stuck with me came much later, when I first saw a bioprinter at work at VoxCell. Instead of plastic, it was polymerizing bioink, building a piece of tissue with an actual vascular network running through it. That reframed the whole thing for me. This was a way to recreate human biology outside the body, and I immediately started thinking about how that could help preclinical drug development.

What inspired you to start your journey/company/career/research in 3D printing (bio-fabrication/bio-printing)?

Graham: My professional background is commercial rather than at the bench. I’ve spent close to two decades helping pharma and biotech companies bring science to market, at IQVIA, STEMCELL Technologies and AbCellera. Through that period I saw two persistent and frustrating patterns: the struggle with building confidence that a preclinical drug might work in humans, and the subsequent “leap of faith” into clinical trials that often ended in failure. When I came across high-resolution bioprinting and the broader New Approach Methodologies movement, it was the first time I saw a credible, commercially viable path to generating human-relevant data early, before hundreds of millions of dollars and years of work are already on the line. Joining VoxCell was a chance to help move that from a promising idea into something the industry actually adopts.

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.

Graham: Two people stand out. Dr. Karolina Valente, VoxCell’s founder and CEO, is my biggest influence on the bioprinting side, she built Canada’s first high-resolution 3D bioprinter and has been relentless about solving the vascularization problem many in the field thought was too hard. The other is Dr. Vassilis Lefkaditis, a decision science expert who mentored me early in my career and taught me the value of structure and data in decision-making processes –  a discipline that has had a tremendous impact on my career and shaped how I think about problems and opportunities commercially.

What motivates you the most for your work? 

Graham: Two things, really. The first is impact on patients; if human-relevant models can help even a handful of good drugs survive to approval that would otherwise have failed, or spare patients from therapies that were never going to work, that’s enormously motivating. The second is the commercial challenge itself. I’m energized by the work of shifting an entire, understandably conservative industry toward a new way of generating evidence. Changing how an industry makes decisions is hard, and I find that genuinely exciting.

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

Graham: The biggest obstacle on the commercial side isn’t the technology,  it’s inertia. Drug development workflows, regulatory expectations and decades of institutional habit are all built around animal models and it’s a complicated network of internal stakeholders within each player. Even when a human-relevant model is clearly better, buyers reasonably ask whether it’s validated, reproducible and defensible to a regulator. Our answer has been to compete on evidence: generate rigorous, comparative validation data, lean into the growing regulatory momentum behind NAMs  (the FDA Modernization Act 2.0 is a good example) and build partnerships, like our collaboration with adMare BioInnovations, that let partners test the models against real programs and de-risk adoption for the rest of the market.

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)?

Graham: I am biased of course, but for bioprinting specifically, vascularization is still the central technical challenge. Without a functioning network of vessels you can’t keep complex tissue alive long enough for a meaningful experimental window, and you miss the very structure a drug needs to navigate in order to reach its target. That’s exactly the problem VoxCell was built to solve. Beyond that, the field has to crack reproducibility and standardization, so a model printed today matches one printed next month, possibly in in another lab, along with the throughput needed for routine industrial use. And the whole space needs regulators to keep formalizing how these models are qualified and accepted. The solutions are underway on all three fronts: higher-resolution printing of vascular structures, standardized protocols, and regulatory frameworks that are finally catching up to the science.

If you are granted three wishes by a higher being, what would they be? 

Graham: I’m going to assume world peace, lottery numbers in advance and the ability to fly are all off the table. So, more realistically, given this is an industry interview: health and time with the people I love; the big industry players finally taking their own “leap of faith” with NAMs; and animal testing becoming the exception rather than the norm.

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

Graham: Get comfortable working at the edges between disciplines. Some of the most successful people I’ve worked with aren’t the deepest specialists, they’re the ones who can weave between the science and the market, or between the lab and the clinic, and translate. Build real relationships, stay curious outside your lane, and protect your optionality early rather than over-committing to a rigid plan. The advice I’d ignore is the pressure to map out a long-term career path and get married to “where you see yourself in five years’ time”. The most interesting opportunities I’ve had weren’t on any plan I could have written at 22, they came from being prepared and saying yes when something unexpected showed up. Seek good advisors and pay it forward later.

What’s your favorite book you read this year and why? Alternatively, what’s your favorite book of all times you read and why?

Graham: Earlier this year I read An Elegant Defense by Matt Richtel, which tells the science of the immune system through four real patients’ stories. It takes something as intricate as immunology and makes it gripping and human. It resonated professionally as well, much of modern drug development now centres on immuno-based therapies, which we’ve been testing using the models we build at VoxCell. We’re very excited to show the pain points we can address for translational teams working on such novel therapies.

Related Links:

Episode #98 | Meeting the Bioprinting Vascular Challenge: VoxCell CEO Dr. Karolina Valente

Episode 122: New Approach Methodologies (NAMs) with Dr. Lowry Curley


Event Recap: The 3D Bioprinting Frontier

The post Interview with Graham Craig: Vascularized 3D Tissue Model appeared first on 3DHeals.

Not long ago, growing a human brain in a lab was science fiction. Today, brain organoids can test drugs, model neurological diseases, and even play Pac-Man! 89% of drugs manufactured through animal testing fail. That number rises to 94% in neurology, but still, animal testing has remained the industry default for over a century. Lowry Curley, PhD, founder of Luna LifeSci and founder and former CEO of 28bio (formerly AxoSim), argues that the FDA is now at an inflection point where lab-grown human mini-brains and organ-on-a-chip systems stop being a niche and become the way drugs are cleared. Curley built the neural microphysiological system platform that nearly every top-25 pharma company adopted, licensing brain-organoid intellectual property from Johns Hopkins and acquiring StemoniX’s microBrain technology in a 2023 all-cash deal. He explains what New Approach Methodologies (NAMs) are, why the FDA’s April 2025 roadmap and March 2026 draft guidance changed pharma’s posture, and why the open question for investors is who consolidates the space. 

⚠️ 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.

About Our Guest:

Lowry Curley is a scientist-entrepreneur and developer of foundational neural microphysiological systems (MPS) technology that became the core platform of the first company he founded, AxoSim, which is now 28bio. He took AxoSim from a Tulane University spinout to a venture-backed company that counted nearly every top 25 global pharma company as a customer, translating early-stage neuroscience research into a validated, human-relevant platform for neurological drug discovery. As founder and CEO, he built a product pipeline on IP licensed from Johns Hopkins, UC San Diego, and Tulane, and led two acquisitions to expand the platform. He now runs Luna LifeSci, helping pharmaceutical and biotech companies adopt New Approach Methodologies (NAMs) in their preclinical programs and advising life science founders across commercialization and fundraising.

Lowry holds a PhD in biomedical engineering from Tulane University, sits on the 3Rs Collaborative and FNIH Validation and Qualification Network, and has authored 6 patents, 20+ publications, and 100+ scientific presentations.

Key Topics

Why nearly 90% of drugs and 94% of neurological therapies fail despite successful animal testing

Dr. Curley’s journey from academic biomedical engineering to founding AxoSim and Luna LifeSci

The science behind organoids, organ-on-a-chip systems, and human microphysiological systems (MPS)

How New Approach Methodologies (NAMs) are changing the future of preclinical drug development

Why the FDA’s recent guidance is accelerating the adoption of human-relevant testing technologies

How brain organoids are helping researchers model disease and predict drug responses

The challenge of translating promising academic technologies into scalable commercial platforms

How licensing university intellectual property fueled the growth of AxoSim’s technology platform

Why pharmaceutical companies are investing in predictive human tissue models over traditional animal studies

The acquisition of StemoniX and the evolution of the microBrain platform

How advances in tissue engineering are bringing human biology closer to the laboratory bench

The role of AI, automation, and advanced imaging in the next generation of drug discovery

Why commercialization, validation, and industry adoption remain the biggest hurdles for emerging life science technologies

Dr. Curley’s vision for a future where human tissue models reduce reliance on animal testing and improve clinical success rates

Timestamps:

00:00:00 – Welcome And Guest Background
00:01:14 – What NAMs Actually Mean
00:02:56 – Why Animal Models Fail Humans
00:06:24 – A Seizure That Changed Everything
00:10:32 – Funding A Platform With Proof
00:11:36 – Licensing And Acquiring To Scale
00:13:55 – Explaining Organoids To Skeptics
00:16:32 – Electrophysiology Readouts That Matter
00:20:04 – How A Brain Organoid Learns
00:22:02 – Organoid Intelligence And Ethical Lines
00:24:23 – FDA Pathways And ISTAND Momentum
00:32:56 – Startup Playbook For Faster Adoption
00:34:25 – Data Sharing And The Devil’s Case
00:43:21 – Luna LifeSci And Founder Focus
00:46:06 – Milestones To Watch Next
00:48:36 – How To Reach Dr. Curley
00:49:14 – Disclaimer

Resources

🔗 Contact Dr. Lowry Curley

• Dr. Lowry Curley on LinkedIn
• Dr. Lowry Curley Email 
• Luna Life Sci
• 28bio (formerly AxoSim)
• Digitalis Commons Expert-in-Residence Profile

🔗 Technologies & Research Discussed

• The Clumps of Brain Cells That Can Play Pac-Man
• FDA Plan to Phase Out Animal Testing (April 2025)
• FDA Draft Guidance on Alternatives to Animal Testing (March 2026)
• FDA ISTAND Accepts the First Organ-on-a-Chip Platform
• AxoSim Acquires StemoniX microBrain® Platform
• Organoid Intelligence Workshop (Frontiers in AI, 2023)
• Nerve-on-a-Chip Platform (Scientific Reports, 2019)

🔗 Learn More About Organoids from 3DHEALS!

• 3D Bioprinting for Drug Discovery and Development
• Bench to Bedside: Bioprinting Innovations
• The Fabrication of Microfluidics, 3D Cell Culture & Organ-on-a-Chip
• An Introduction to 3D Bioprinting
• In Silico Simulation for Medtech and Biopharma
• VoxCell: Meeting the Bioprinting Vascular Challenge

The post Episode 122: New Approach Methodologies (NAMs) with Dr. Lowry Curley appeared first on 3DHeals.

Absorbable biomaterials have transformed modern medicine, enabling implants, sutures, and drug-delivery systems that safely degrade after completing their function. Dr. Rao S. Bezwada has helped shape the field of bioresorbable polymers for more than three decades. As the inventor of Monocryl®, the absorbable suture that has generated more than $2 billion in worldwide sales, and the holder of more than 150 U.S. patents, his innovations have influenced everything from surgical sutures to next-generation biomaterials. In this episode of The Lattice, Dr. Bezwada joins Dr. Jenny Chen to discuss the science behind bioresorbable polymers, the chemistry that controls how materials degrade, and what the next generation of resorbable biomaterials could make possible.

⚠️ 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.

Support our show and get premium and archived content anytime:

About Our Guest:

Dr. Rao S. Bezwada is a pioneering scientist and entrepreneur with more than 40 years of experience developing advanced absorbable biomaterials for medical applications. After two decades at Ethicon (Johnson & Johnson)—where he invented the globally successful Monocryl® suture and earned the Johnson Medal—he founded Bezwada Biomedical in 2003 to create next‐generation absorbable polymers. His portfolio includes over 150 issued U.S. patents spanning polyurethanes, amino‐acid based polymers, polyester amides, polyoxaesters, controlled‐release systems, and emerging materials for 3D printing of medical devices. His innovations have contributed to more than 10 FDA‐approved products and continue to shape the future of biomaterials and regenerative medicine.

Key Topics

• Dr. Bezwada’s journey from polymer chemist to inventor, entrepreneur, and founder of Bezwada Biomedical
• The invention of Monocryl® and how it grew into a product with more than $2 billion in worldwide sales
• How a single glycolic acid linkage became the key to controlling polymer degradation
• Why bioresorbable polymers can now be engineered to degrade anywhere from 70 days to three years
• How Dr. Bezwada expanded biodegradable materials beyond sutures to absorbable nylon, PET, and polyurethanes
• The chemistry behind bioresorbable polyurethanes and why they outperform traditional polymer systems
• How Bezwada Biomedical’s polymer platform became the foundation for FDA-cleared bone repair products
• Why traditional PLGA materials face challenges with acidic degradation and processing
• How polymer chemistry is enabling new applications in tissue engineering, drug delivery, and 3D bioprinting
• Why does developing new biomaterials often take decades despite strong clinical potential
• Dr. Bezwada’s perspective on why investors rarely fund foundational materials science
• The challenge of balancing mechanical strength, degradation rate, and biocompatibility in medical polymers
• How lessons from biomedical polymers could help address millions of tons of polyurethane waste
• Dr. Bezwada’s vision for the next generation of bioresorbable materials in medicine and sustainable manufacturing

Timestamps:

00:00:00 – FDA Approvals And Vanishing Materials
00:02:10 – Building Better Absorbable Sutures
00:08:20 – The Chemistry Behind Controlled Hydrolysis
00:11:00 – Why He Left Big Medtech
00:14:05 – Surviving Early Funding And Finding Revenue
00:16:10 – Beyond PLGA Toward New Polymers
00:22:15 – Making Fully Degradable Polyurethane Safely
00:29:10 – Abyrx Orthopedic Putty Applications
00:32:45 – How Licensing Partnerships Actually Work
00:36:15 – PEG Bioinks And 3D Bioprinting Needs
00:43:00 – Future Bets And The Funding Problem
00:49:15 – Advice For The Next Generation
00:51:05 – Closing And Disclaimer

Resources

🔗 Contact Dr. Rao Bezwada

• Dr. Rao Bezwada on LinkedIn
• Bezwada Biomedical
• Bezwada Biomedical YouTube Channel

🔗 Biomaterials & Technologies Discussed

• Bezwada Biomedical Polymer Platform
• Monocryl® (Ethicon)
• History of Synthetic Absorbable Sutures
• Polyurethane Waste Review (2024)
• MONTAGE® Settable Resorbable Bone Putty
• MONTAGE® for Cardiothoracic Surgery
• Global Polyurethane Waste Review (2024)
  

🔗 Watch & Learn More from Dr. Bezwada

• Bezwada Biomedical Publications & White Papers
• 3DHEALS Interview: Absorbable Polymers for 3D Printing
• The Story Behind Monocryl® and Dr. Bezwada’s Career
• Going Beyond PLGA
• From Feasibility to GMP Manufacturing
• Quality Systems & Proof-of-Concept Testing
  

🔗 Learn More About Biomaterials from 3DHEALS!

• Bench to Bedside: Bioprinting Innovations
• Biofabrication for Bones
• Biomaterials & Bioinks for Bioprinting
• Interview with Dr. Neeti Srivastava: Absorbable Polymers
• The Lattice Episode #115 with Dr. Paul Dalton

Supplementary Slides:

Glossary of Terms:

There are many technical terms to unpack, so here are some key definitions.

• Absorbable Material: A substance, such as a suture, designed to be broken down and safely absorbed by the body over time, eliminating the need for removal.
• Bioconjugated Drug: A medication chemically linked to another molecule (like a polymer) to improve its delivery, stability, or effectiveness in the body.
• Bioprinting: A 3D-printing process that uses “bio-inks” to create complex biological structures, such as tissues or organ replacements.
• Bone Putty: A moldable, medical-grade material used by surgeons to fill gaps in bone, aiding in healing and growth.
• Caprolactone: A chemical building block used to create flexible, slow-degrading polymers in medical devices.
• Degradation Clock: The chemical design of a material that dictates how long it takes to break down in the body (e.g., from 70 days to three years).
• Glycolic Acid: A chemical compound used to control the degradation rate of medical polymers; it allows chemists to set the “clock” for when the material disappears.
• Hard Segment: The rigid portion of a polymer chain (like in polyurethanes) that provides structural strength; degrading this part is a significant technical challenge.
• Hemostat: A medical agent or device used to stop bleeding during surgery.
• Hydrolysable Linker: A chemical bridge inserted into a polymer backbone that allows it to break down when exposed to water or bodily fluids.
• Hydrolysis: The chemical process of breaking down a material using water; this is how most “absorbable” implants dissolve in the body.
• ISO 13485: An internationally recognized quality management standard for companies involved in the medical device industry.
• MDI (Methylene Diphenyl Diisocyanate): A chemical building block used in making polyurethanes, often needing careful handling due to its toxicity.
• Monofilament: A single, smooth strand of material, often used in sutures to reduce friction and tissue irritation.
• Monomer: A small molecule that can be linked together with others to form a larger polymer chain.
• PEG (Polyethylene Glycol): A versatile, water-soluble compound often used in medical formulations and tissue engineering.
• PGA (Polyglycolic Acid): A simple, stiff, and highly degradable polymer used in early synthetic absorbable sutures.
• PLGA (Poly(lactic-co-glycolic acid)): A commonly used, FDA-approved copolymer known for its adjustable degradation rates, though it can create acidic byproducts.
• Polymer: A large molecule made of many repeating smaller units, forming the basis for plastics and biological materials.
• Polyurethane: A durable, versatile plastic; while often permanent, “absorbable” versions are being engineered to break down safely within the body.
• Scaffolds: Temporary, often 3D-printed structures that provide a framework for cells to grow into, eventually replaced by natural tissue.
• Soft Segment: The flexible portion of a polymer chain that gives the material elasticity or softness.
• Sternotomy: A surgical procedure that involves cutting through the breastbone to access the chest cavity.
• Suture: A medical stitch used to hold body tissues together after an injury or surgery.

The post Episode 121: Absorbable Biomaterials with Dr. Rao Bezwada appeared first on 3DHeals.

Dentistry was one of the earliest healthcare fields to adopt 3D printing. Today, digital workflows touch everything from treatment planning and surgical guides to restorations and personalized patient care. Oral implantologist Nabeel Cajee has spent his career at the center of that transformation. As an educator, faculty member at Torque Academy and Implant Ninja School, and longtime advocate for digital dentistry, Dr. Cajee has helped clinicians integrate emerging technologies into patient care while navigating the challenges of bringing innovation into everyday practice. In this episode, he joins Jenny on The Lattice Podcast to discuss the evolution of digital dentistry over the last ten years from his perspective and what it takes to turn new tools into real clinical solutions.

⚠️ 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.

Subscribe to our show and get premium and archived content anytime:

About Our Guest:

Dr. Nabeel Cajee is on a mission to democratize advanced dental care by combining digital fabrication and personalized medicine. As a specialist in Oral Implantology, he views technology not just as a tool,  but as a bridge to expanding global access to life-changing treatments. As the Dental Ambassador for 3DHeals, he champions the use of 3D printing and digital workflows to create bespoke patient solutions. This purpose-driven leadership has earned him the “Top 40 Under 40” award from Incisal Edge, recognizing him as a leading voice in the future of healthcare. Through his private practice in Newport Beach and faculty roles at Torque Academy and Implant Ninja School, Dr. Cajee is dedicated to equipping the next generation of clinicians with the digital fluency required to provide precision care to patients everywhere.

Key Topics

• How the open-source 3D printing movement sparked Nabeel’s interest in digital dentistry
• The three pillars of a digital workflow: scanning, design, and fabrication
• Why implant planning starts with the final restoration, not the implant
• How 3D printed surgical guides improve precision and predictability
• The shift from analog workflows to fully digital treatment planning
• Why do same-day restorations require workflows closer to 30 minutes
• How AI design tools can automate up to 80% of the design process
• The economics of in-house manufacturing versus outsourcing to dental labs
• Why integrating scanners, software, and printers remains a major challenge
• The material science gap between zirconia (~1,100 MPa) and printed ceramics (~150 MPa), and what does that mean for the industry
• Nabeel’s bold prediction within five years
• Why dentistry remains a “cottage industry” despite growing technological complexity
• What is his vision for expanding access to advanced dental care through technology and education?

Timestamps:

00:00:00 – Why Dentistry Struggles To Scale
00:00:50 – Meet Dr. Nabeel Cajee
00:01:53 – From Hackerspaces To Healthcare
00:04:22 – The Three Pieces Of 3D Printing
00:08:53 – Implantology Explained With End In Mind
00:16:16 – Dental Labs Versus In-House Tradeoffs
00:19:46 – The Race For Same-Day Restorations
00:25:19 – Milling Versus Printing And Materials
00:34:15 – Open Systems Need Real Integration
00:37:43 – Training Pathways With Torque Academy
00:42:13 – Five-Year Predictions And What Dentistry Missed
00:45:35 – Career Advice And Staying Current
00:49:13 – Closing Thoughts And Disclaimer

Resources

🔗 Contact Nabeel Cajee

• Nabeel Cajee on LinkedIn
• Nabeel Cajee on Instagram
• Nabeel Cajee on Facebook
• Torque Academy

🔗 Companies & Technology in Digital Dentistry

• SprintRay, chairside dental 3D printing
• Medit, intraoral scanners and digital workflows
• Shining 3D Dental, scan-design-print ecosystem
• Zylo 3D, automated chairside dental 3D printing solutions
• CEREC by Dentsply Sirona, chairside CAD/CAM and milling system
• Roland DGSHAPE, dental milling systems
• vhf camfacture, dental milling systems
• Glidewell, dental laboratory and chairside solutions
• Periospot, AI-powered dental literature search
• Boston Micro Fabrication (BMF) and UltraThineer veneers
  

🔗 More Media Links on Dr. Cajee!

• 3DHEALS Influencer Interview: Dr. Nabeel Cajee, Clinical Dentist, Adjunct Professor & Dental Ambassador at 3DHEALS
• 3DHEALS Blogs By Nabeel Cajee
• University of the Pacific Feature
• Incisal Edge Top 40 Under 40 Feature
• Dr Bicuspid article: 3D printing in dentistry

🔗 Learn More about Dental 3D Printing from 3DHEALS!

• Dental 3D Printing – The Ultimate Guide (3DHEALS Guide)
• Four U.S. Dental Schools At The Frontier of 3D Printing Education
• Dental 3D Printing (2024 On-Demand Recording)
  
  

The post Episode 119: Where Is Dental 3D Printing with Dr. Nabeel Cajee appeared first on 3DHeals.

Ossiform is on track to bring the first 3D printed resorbable bone implant to the US market. The company’s preclinical data showed full bone regeneration in six months. Monica Wellejus, Chief Commercial Officer of Ossiform, joins The Lattice to explain how a company built to personalize bone implants for craniomaxillofacial surgeries pivoting to mass produced bone implant for foot deformity, and why hospital finance teams, not just the surgeons, may decide whether this technology actually reaches patients.
⚠️ 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

About Our Guest:

Monica Wellejus

Monica Wellejus is a technology commercialization strategist who has spent the past seven years working at the intersection of biomaterials and medical 3D printing. With an MA in Business, Language, and Culture, Monica entered the field from a non-technical angle but quickly became involved in all aspects of bringing bone regenerative solutions to market, from product development and quality control to regulatory pathways, evidence generation, and global commercialization strategies. She has been part of Ossiform® since 2019, where she manages the company’s commercial and go-to-market activities as the Chief Commercial Officer. Ossiform® develops 3D printed bioactive bone substitutes with an aim to improve bone healing outcomes, simplify complex procedures, and reduce complication rates in orthopedics and spine. Its novel 3D printing technology is further used to provide bone-mimicking 3D cell culture systems for improving the physiological relevance of in vitro models in bone and cancer research.

Email: mw@ossiform.com

Timestamps:

00:00 Intro | Why 3D printed bone has not reached patients yet

02:08 Meet Monica Wellejus and Ossiform

05:41 How Ossiform prints bone substitutes using β-TCP ceramics

10:12 The long road to FDA clearance and U.S. market entry

14:03 Why Ossiform moved away from personalized implants

18:26 Listening to surgeons changed everything

23:47 Flatfoot reconstruction and Ossiform’s first clinical products

30:18 Fundraising, commercialization, and building a MedTech startup

38: 54 The hidden decision-makers in healthcare adoption

46:31 The future of bone regeneration, AI, and point-of-care manufacturing

Key Topics

Monica’s pathway to becoming CCO of a deep-tech MedTech startup

Why a 40-year-old ceramic becomes something new when printed into a resorbable bone substitute

How synthetic consistency became Ossiform’s sharpest argument against donor bone

What a pig mandible study revealed about full bone remodeling in six months

Why 95% of surgeons want something off the shelf, not a custom implant

How foot deformity correction became Ossiform’s beachhead, chosen for fit not market size

Why hospital CFOs and value analysis committees are now as important as the surgeon

Why Ossiform pursued FDA clearance before a CE mark

Monica’s vision for point-of-care bone printing and AI-driven customization

Resources

🔗 Contact Monica Wellejus

• Monica Wellejus on LinkedIn
• Ossiform Official Website
• Ossiform on LinkedIn
• Ossiform on Youtube
• Email: mw@ossiform.com

🔗 Ossiform & 3D Printed Bone

• Research Protocols & P3D Scaffolds
• The Performance of 3D Printed Resorbable Implants in the Mandible of Pigs
• Democratizing 3D Bone Printing for Medical Innovations

🔗 Hear More from Monica

• 3DHEALS Interview: From Hope to Breakthrough – 3D Printed Bone Regeneration at Ossiform
• 3DHEALS Bench-to-Bedside Event Featuring Monica Wellejus
• Alpha Sophia Spotlight: How to Print Bone with Monica Wellejus of Ossiform
• LSI USA ’24: 3D Printed Resorbable Bone Implants
  

🔗 Selected Publications

• Ossiform Publications
• Scaffold Material–Architecture Design Rules Linking Mechanics and Early Osteogenesis in PCL/β-TCP Grid, Honeycomb, and Gyroid Lattices (2026)
• Characterization of 3D-Printed β-TCP Scaffolds with Enhanced Microstructure, Mechanical Properties, and Cell Compatibility (2024)
• Comparison of Off-the-Shelf β-Tricalcium Phosphate Implants with Novel Resorbable 3D Printed Implants in Mandible Ramus of Pigs (2022)
• Treating Mouse Skull Defects with 3D-Printed Fatty Acid and Tricalcium Phosphate Implants (2020)
• Simple Additive Manufacturing of an Osteoconductive Ceramic Using Suspension Melt Extrusion (2017)

🔗 Other Relevant Links

• TEDxWarwick: 3D Printed Bones — Why This Is the Future (Casper Slots)
• 3DHEALS Interview with Ossiform Co-Founder Casper Slots
• Materialise Case Study: Ossiform Creates Patient-Matched Bone Implants with 3D Printing
• 3DPrint.com: Ossiform Raises Funding for 3D Printed Bone Implants
• CELLINK × Ossiform: Launch of Ossi Ink
• ABHI U.S. Accelerator Program
• State of MedTech Podcast (Hosted by Omar Khateeb)

🔗 Relevant 3DHEALS Links

3D Bioprinting Bone – One Defect At A Time (Expert Corner)

Interview with Dr. Brad Estes: 3D Woven Bone

The post Episode 117: Monica Wellejus-The Road to 3D Printed Bone appeared first on 3DHeals.