A biodegradable, 3D-printed pigtail stent for gastric leaks can be a valuable teaching tool for medical 3D-printed device entrepreneurs. This mental exercise with a recent novel design shows the reimbursement logic every device team should learn before they fall too deep in love with their own inventions. Medical device reimbursement in the United States often rewards factors other than clinical performance. A recent preprint makes the gap easy to see. It describes BRIDGE, a 3D-printed, biodegradable double-pigtail stent for draining gastric leaks after sleeve gastrectomy. The design is clever. Its lattice mid-section is built from a triply periodic minimal surface (TPMS). It bends around a radius that is roughly seven times tighter than that of a commercial biliary stent, without kinking. It drains about twice the fluid. And because it is printed from a biodegradable resin, it is designed to dissolve on its own rather than be removed during a second endoscopy.¹

So it is better.

However, the question that decides whether it becomes a product is a different one. What gets paid, and to whom? In the United States, clinical superiority and payment are only loosely related. The space between them is where most device companies get their education. An endoscopic leak drain is a good place to learn the lesson. Here are some of the steps to reason it out.

What the procedure pays today

Start with the problem the device treats, because the money follows the problem. Gastric leak occurs in 1% to 3% of primary sleeve gastrectomies and as many as 10% of revisions. It is the complication surgeons fear most. It turns a routine bariatric case into weeks of drainage, repeat procedures, and sometimes an intensive-care stay. The mainstay treatment is endoscopic internal drainage with double-pigtail stents. It closes most leaks. And it does so with stents designed for the bile duct and pressed into service off-label because nothing better is available.¹

Here is the first thing to absorb. Medicare pays the physician for the procedure, not for the stent.

And the procedure it covers depends on how the pigtail is placed. If an interventional radiologist places it through the skin into the collection, the claim is a percutaneous drainage code with its own predictable payment. If an endoscopist deploys it transluminally across the leak, the claim is coded as an upper-GI endoscopy code. That is the route BRIDGE is built for, and the coding gets murkier. The closest listed option, 43240, is written for draining a pseudocyst.² A post-surgical leak is not a pseudocyst. So many of these cases land on 43499, the “unlisted” upper-GI code a payer reviews and prices by hand.³ That invites delay and denial.

Either way, the stent itself is a supply. Its cost is buried inside the facility payment for the procedure. That is an outpatient APC. Or, for the septic inpatients, most of these are DRGs. A percutaneous drain runs a hospital somewhere between $28 and $55 apiece.⁶ A fancier printed device might cost more to make. But the hospital’s payment does not move to cover it. Build a better version of a bundled supply, and it inherits the price of the thing it replaced.

(See Glossary section for all abbreviations.)

What actually changes the payment

If a superior device does not automatically earn more, what does? Three things, from the flimsiest to the most durable.

The first is a temporary top-up.

Medicare will pay a little extra for a while. Outpatient, this comes through pass-through. Inpatient, it comes through the New Technology Add-on Payment (NTAP). The price of entry is the same for both. The device has to be new. It has to be expensive enough that the existing bundle can’t absorb it. And the hard part is that it has to be a substantial clinical improvement over what’s already in use.⁴ There is a gate hidden inside the word “new.” CMS also asks whether the device is already adequately described by an existing payment category. This is where a genuinely new design earns its keep. A better plastic pigtail looks like every other pigtail and gets waved into the bundle, but a device that dissolves in the body is harder to call the same thing you already pay for. Even after clearing the bar, the money is just temporary. Pass-through runs up to three years. Then the device drops back into the bundle.⁵

The second is a dedicated device code. A new CPT code is the more durable move. But it follows a new service, not a better instrument. That is the quiet opportunity here. Endoscopic internal drainage of a leak has no code that actually fits it. That is why the field is stuck between a pseudocyst analogy and an unlisted code. A device built specifically for the procedure gives the device maker something to hang a Category III code on. That is the emerging-technology tier. It records that the procedure is happening. With utilization and outcomes data behind it, that code can grow into a paying Category I code. The process is slow, measured in years. Like it or not, it will help the competitors too. It is the only lever that fixes billing for the whole field rather than renting a payment for one product.

The third isn’t a billing lever. For a device like this, it is often the one that matters most. A leak admission is expensive and long. Under a fixed DRG, the hospital swallows every extra day and every repeat scope. A device that empties the cavity faster, keeps the patient off a second or third procedure, or shortens the septic stay puts real money back in the hospital’s pocket. No code change required, but value is added. This lever sells on a spreadsheet the hospital keeps.

Which features carry weight

Sorting BRIDGE’s advantages against the clinical-improvement test is a useful exercise, but it doesn’t weigh them equally.

Biodegradability can be a strong one. Today, a patient undergoes roughly three endoscopies over about eight weeks. A stent designed to dissolve in six to eight weeks eliminates the need for a retrieval trip entirely.1 “One fewer procedure per patient” is a true improvement, and it is easy to measure.

That said, there is a potential wrinkle to the economics. The retrieval the new device deletes is a procedure the endoscopist currently bills. Innovation improves the system’s economics, partly by reducing a provider’s revenue. That is exactly why early adopters will be integrated systems and bundled-payment programs, not fee-for-service proceduralists. (Remember what Charlie Munger’s theory behind “incentives” is.) Less migration comes next. Every stent that stays put is a retrieval, and a failed-drainage rescue that the hospital doesn’t have to do. Better flow and easier placement are real but soft. “Easier for the endoscopist” isn’t something Medicare rewards unless it results in a shorter procedure or fewer complications that can be easily measured.

There is a catch a reviewer will find first and can sink the thesis. Once a device can’t be removed, its degradation timing is its safety profile. Dissolve too early, and it fails while the leak is still open. Linger too long, and it becomes the source of granulation, obstruction, or a fragment that drifts somewhere you can no longer reach it. So the elegant “no removal” story and the “less migration” story have to be proven together. The evidence that carries weight is the degradation curve’s reliability. Not just its average, but how much it varies across real patients. That is where the clinical dollars go. It is also where a printed polymer either earns trust or loses it. The industry has learned expensive lessons on resorbable stents very recently. 8

The 3D printing angle

The 3D printing that enables the lattice and patient-specific fit does not qualify for a reimbursement category. Nobody pays more because a device was printed. What changes with 3D printing is the regulatory road. A biodegradable, architected, possibly patient-matched implant probably won’t slide through on a 510(k) predicate. It is more likely to face a de novo or PMA review. That costs time and money. And, awkwardly, it also strengthens the payment case. Devices that clear the more rigorous regulatory pathways have historically fared better when they request a separate payment from CMS. The higher bar and the better lane turn out to be the same door.

Conclusion

For a device like this, here are some potential strategies to think about. Sell to hospitals on avoided cost now, while collecting the migration, reintervention, and length-of-stay numbers. Take those numbers into a pass-through or add-on application next. Aim at a moving target. CMS has proposed requiring even breakthrough-designated devices to demonstrate substantial clinical improvement again, starting with 2028 applications.7. Finally, go earn a real code. It is the only step that changes billing for good rather than borrowing it.

The lesson under all of it: better is the price of admission, not the final payout. In US device reimbursement, the money follows evidence of a difference a patient and a payer can both feel.

Which lever is your particular improvement actually pulling?

This piece is an educational illustration of US reimbursement concepts for new medical devices, not legal, coding, or reimbursement advice. Codes, rates, and CMS policies change; confirm current figures against primary CMS sources before relying on them.

Glossary

• 510(k) FDA clearance route for a device shown to be substantially equivalent to an existing (predicate) device. The fastest, lowest-burden pathway.
• Additive manufacturing / 3D printing: Building a part layer by layer. Enables lattice geometries and patient-specific shapes that extrusion can’t produce.
• APC (Ambulatory Payment Classification): The bundled unit Medicare uses to pay hospitals for outpatient procedures. Devices used are packaged into it.
• Bundled supply: A device whose cost sits inside a broader procedure payment instead of being reimbursed on its own.
• Category I / Category III CPT codes: Category I codes are established procedure codes with set payments. Category III codes are temporary for emerging services that track usage before potentially becoming Category I.
• CMS (Centers for Medicare & Medicaid Services): The federal agency that sets Medicare payment rules and rates.
• CPT (Current Procedural Terminology): The AMA code set that identifies procedures for billing. The code, not the device, usually drives payment.
• De novo FDA: pathway for novel low-to-moderate-risk devices with no predicate, creating a new device classification.
• DPS (double-pigtail stent): A drainage stent with curled ends that anchor it. Used off-label for endoscopic internal drainage of leaks.
• DRG (Diagnosis-Related Group): The bundled unit for an inpatient stay. The hospital receives a fixed amount regardless of individual supply costs.
• EGD (esophagogastroduodenoscopy): Upper-GI endoscopy. The procedure family under which transluminal leak drainage is coded.
• EID (endoscopic internal drainage): Placing a pigtail across a leak so one end sits in the cavity and the other in the GI lumen, draining internally.
• FDA (Food and Drug Administration): The agency that authorizes devices for marketing. Clearance is separate from payment.
• HCPCS Level II (C-code): Codes that can identify a specific device for tracking or pass-through. They do not by themselves add payment.
• NTAP (New Technology Add-on Payment): A temporary inpatient add-on above the DRG for qualifying new technologies.
• Pass-through (Transitional Pass-Through, TPT): A temporary outpatient add-on (up to three years) for qualifying new devices before they are folded into the APC.
• PMA (Premarket Approval): The most rigorous FDA pathway for high-risk devices. Requires clinical evidence of safety and effectiveness.
• SCI (substantial clinical improvement): The CMS test asking whether a technology meaningfully improves diagnosis or treatment over existing options. The gate for add-on payments.
• TPMS (triply periodic minimal surface): A class of mathematically defined lattice geometries (for example, the Gyroid) used here to tune a stent’s flexibility and flow.

References

1. Phowarasoontorn P, Ko Y, Makhambetova Z, et al. Biodegradable Architected Stents for Endoscopic Internal Drainage. bioRxiv; posted May 12, 2026. doi:10.64898/2026.05.08.723751. Preprint. Not peer reviewed.
2. American Society for Gastrointestinal Endoscopy / American Medical Association. CPT code 43240: Esophagogastroduodenoscopy, flexible, transoral; with transmural drainage of pseudocyst (includes placement of transmural drainage catheter[s]/stent[s], when performed, and endoscopic ultrasound, when performed). ASGE EGD Coding Sheet. asge.org
3. American Gastroenterological Association. Coding Corner (Clinical Gastroenterology and Hepatology): where no specific CPT code exists for an endoscopic procedure, report the unlisted code 43499 and verify coverage with the carrier in advance. cghjournal.org
4. Centers for Medicare & Medicaid Services. New Medical Services and New Technologies (NTAP eligibility: new, costly, and a substantial clinical improvement over existing technologies). cms.gov
5. Gettysburg Healthcare Consulting. Medicare Transitional Pass-Through Payment (criteria; up to three-year duration before bundling). policypros.net
6. IndexBox. Percutaneous Drainage Catheters Price in the United States, Market Insights (2026). indexbox.io
7. Kelly S. CMS proposes repeal of add-on payment path for breakthrough devices. Healthcare Dive / MedTech Dive; April 17, 2026. healthcaredive.com
8. https://www.tctmd.com/news/fda-warns-risk-major-adverse-cardiac-events-absorb-bvs

The post Better Isn’t Billable: How a New (3D-Printed) Medical Device Actually Gets Reimbursed appeared first on 3DHeals.

As the end of 2024 approached, a group of groundbreaking pitch 3D startups took the lead in healthcare 3D printing, bioprinting, and tissue engineering. This article highlights key emerging themes in the space and the startups we have featured on our pitch3D platform. We want to raise awareness of these startups’ cutting-edge technologies and investment potential. Also, please mark your calendar and join us live at the upcoming virtual Pitch3D Demo Day to meet some of our investors, founders, and ecosystem operators.

Key themes that emerge from the pitch decks in the “Pitch3D 2024” folder include:

Innovation in Medical Devices: 

Many of the startups are developing novel medical devices or improving existing ones, often using advanced technologies like 3D printing and bioengineering. Examples include Castomize’s 4D-printed casts, Icarus Medical’s 3D-printed knee brace, and ReConstruct Bio’s personalized breast implants. (See specific company info below.)

Improved Patient Outcomes and Quality of Life: 

The startups emphasize the potential of their technologies to improve patient outcomes, reduce complications, and enhance quality of life. This is evident in CytexOrtho’s focus on restoring joint function, Cellular Vehicle’s aim to make cell and gene therapies more accessible.

Deep Tech:

The 2024 Pitch3D cohort highlights the use of advanced technologies, such as 3D printing, bioengineering, and AI, to create innovative solutions. This is seen in Axolotl Biosciences’ focus on 3D bioprinting, DicomDirector’s use of AR/VR for medical imaging, and Castomize’s use of 4D printing for orthopedic casts.

Personalized Medicine: 

Several startups are developing solutions tailored to individual patients, such as ReConstruct Bio’s and BellaSeno’s personalized breast implants.

Addressing Unmet Needs: 

The startups are targeting areas where there is a significant unmet need, such as knee osteoarthritis (Icarus Medical), breast reconstruction (ReConstruct Bio), and cell and gene therapy delivery (Cellular Vehicle).

Focus on Accessibility and Affordability: 

Some startups emphasize their commitment to making their technologies accessible and affordable, as exemplified by Castomize’s aim to create cost-effective orthopedic casts.

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Pitch3D 2024 Cohort:

Cytoink:

Medical research has many challenges, such as the high cost and lengthy timelines for drug development, with a significant failure rate in clinical trials due to reliance on inaccurate animal testing and significant drug assays. Cytoink offers a solution to these challenges through its human-relevant 3D tissue models, which can accelerate and improve biomedical R&D. These models can lead to significant cost savings and faster time-to-market for new drugs.

Allumin8

There is a high rate of complications in spine fusion surgeries, particularly screw loosening. Allumin8’s technology addresses this issue by improving bone fixation and promoting bone growth. Allumin8’s proprietary technology is a Porous Pedicle Screw System, a 3D-printed orthopedic and spine hardware that mimics bone and can deliver therapeutics directly to the patient.

Castomize: 

Current orthopedic casts can be heavy, uncomfortable, and not very strong. Castomize is a med-tech startup based in Singapore that uses advanced manufacturing techniques to create orthopedic casts that are lighter, stronger, and more comfortable for patients.

Axolotl Biosciences: 

Axolotl Biosciences, located in British Columbia, Canada, recognizes the potential of 3D bioprinting to transform healthcare. However, the field is still developing and requires specialized expertise. Currently the startup offers a suite of products and services, including bioinks, 3D tissue models, and consulting, to support research and development in 3D bioprinting, to advance human health.

Akita Bio: 

Drug development and research are often slow, expensive, and can yield unreliable results. This is partly due to limitations in traditional cell culture and animal models. Akita Bio, based in Helsinki, Finland, has developed scalable organ-on-chip platforms that offer a more physiologically relevant model for drug development and research. These platforms aim to accelerate research, improve cost-efficiency, and generate more reliable results.

Icarus Medical Innovations: 

Knee osteoarthritis is a widespread and debilitating condition, and current treatment options often fall short of providing adequate pain relief and restoring mobility for a large patient population. Icarus Medical Innovations has developed the Ascender Knee Brace, a custom, 3D-printed brace designed to alleviate pain and improve function in patients with knee osteoarthritis. The brace is adjustable and can unload significant weight from the knee joint.

CytexOrtho: 

Osteoarthritis is a common joint disease that causes pain, stiffness, and disability. Current treatments are often limited in their ability to restore joint function and prevent disease progression. CytexOrtho is developing a 3D woven bio-textile implant for joint repair in osteoarthritis patients. Their product aims to restore joint form and function and has shown promising results in preclinical studies.

Cellular Vehicle: 

Cell and gene therapies (CGTs) are promising to treat many diseases, but their manufacturing and delivery are complex and challenging. Based in San Mateo, California, the company is developing the Odyssey System, a technology that standardizes and automates the preparation and administration of CGT doses. This aims to make these therapies more accessible to healthcare providers and, ultimately, to more patients.

ReConstruct Bio: 

Breast reconstruction and augmentation often involve invasive procedures and carry risks associated with artificial implants or tissue flaps. ReConstruct Bio, a venture from Harvard’s Wyss Institute, is developing personalized, regenerative breast implants using a patient’s own fat tissue. This approach aims to offer a safer, more natural, and longer-lasting solution for breast reconstruction.

PathKeeper Surgical: 

Spine surgery can be complex and carries risks of complications, including inaccurate screw placement and suboptimal spinal alignment. PathKeeper Surgical offers radiation-free, accurate, and cost-effective optical navigation and robotic technology for spine surgery. Their technology aims to improve surgical precision and patient outcomes.

ALM Ortho: 

Complex orthopedic implant cases can lead to limb loss or impaired limb function. Current solutions for limb lengthening and reconstruction are often limited by old technology platforms. ALM Ortho uses advanced technology to develop enhanced product solutions, including a bone-anchored prosthetic for amputees and custom products for complex orthopedic implant cases. These solutions aim to salvage limbs and restore limb functionality.

Z-Polymers: 

Traditional super-polymers often rely on toxic chemicals and have high greenhouse gas emissions during manufacturing. Z-Polymers has developed Tullomer, a new super-polymer that is strong, lightweight, inert, recyclable, and made with significantly less energy than traditional super-polymers. Tullomer aims to offer a more

Bellaseno: 

The breast implant industry has a large market size with significant medical needs due to breast surgeries for post-cancer reconstruction, congenital defects, and silicone implant complications. There are high complication rates with silicone implants, including encapsulation, rupture, pain, and breast implant illness, leading to high removal and revision rates. BellaSeno has created a resorbable scaffold using the patient’s fat tissue to regenerate natural breasts. This addresses the safety issues of silicone implants and creates natural-feeling breasts. Over 40 patients with follow-ups of up to 4 years are very satisfied with the results. There have been no removals, infections, capsular contractures, or other major complications related to the scaffold.

DicomDirector: 

A significant and expanding market for advanced medical imaging and AR/VR technologies suggests substantial commercial potential for Intravision XR. DicomDirector is transforming 2D medical images into 3D holograms viewable in AR and VR, with applications in surgical planning, patient education, and medical education. The company operates on a subscription-based business model and has already secured contracts with major companies and healthcare providers.

NOVUS Life Sciences Ltd.: 

NOVUS Life Sciences Ltd. is a Hong Kong-based startup focusing on biomaterial research, development, and manufacturing established in 2014. The company focuses on pioneering 3D printing solutions for biomaterials and medical technologies, aiming to improve human health globally. Its flagship bioactive bone cement is Bonlecule. They also provide medical 3D printer filaments and related design, printing, testing, and sterilization services. By 2024, NOVUS had served over 50 corporate clients in 25 countries.

Related links:

Healthcare 3D Printing Innovations: Pitch3D 2023 Highlights

Pitch3D 2022: Newborns, Warriors, and The Changing World Order

Exploring Six Policy Areas Impacting Healthcare 3D Printing, Bioprinting- Guide
The Ultimate Resource Center for Healthcare 3D Printing

Angel Investor in Life Sciences: Putting Our Money Where Our Passions Lie

Newborns, Warriors, Unicorns, Winners: Commercialization of Healthcare 3D Printing In 2020

The post Pitch3D: Most Innovative Medical 3D Printing Startups 2024 appeared first on 3DHeals.

— Innovation at A Time of Crisis

Crises come in many different shapes throughout human history, but a pandemic is unique as it affects every individual, every company, and every industry. It draws our attention to our personal health and our healthcare systems in an intense fashion that no other crisis can. For many people, there are at least two simultaneous battlefronts: one physical, and one financial. Larger companies slow down due to supply chain disruption and market contraction, but things are even worse for smaller companies that cannot effectively launch, fundraise, pivot, or even survive. However, to quote John F. Kennedy, “The Chinese use two brush strokes to write the word ‘crisis’. One brush stroke stands for danger; the other for opportunity. In a crisis, be aware of the danger – but recognize the opportunity.”

No pun intended.

The silver lining of this devastating pandemic is that this moment could be a turning point of 3D printing, and what it represents for the future of manufacturing and medicine. In the last few weeks, the optimists have welcomed 3D printing into their toolbox to combat the pandemic, as an individual, and as companies. Existing 3D printing companies, large or small, have sprung to the frontline and removed many barriers and fear of working together on both solutions and distribution networks. Companies with 3D printing capabilities but no prior healthcare experiences are now in direct conversation with hospitals, healthcare providers, and other first responders. Hundreds if not thousands of private citizens with desktop 3D printers and knowledge of CAD design have demonstrated creativities not commonly witnessed before. Hundreds of designs for components of PPE, ventilators, test swaps appeared overnight. For the longest time, 3D printing industry has struggled with finding the killer app, as the lack of creative use of the technology is considered one of the major barriers to healthcare adoption. However, this pandemic has given us a good opportunity to reflect upon this.  

Construction continues though the #CoronavirusUSA #pandemic to increase our #3Dprinting #pointofcare manufacturing capability @MayoClinic @MayoRadiology pic.twitter.com/0DaRgKJgym

— Jay Morris (@JayMorris_MD) April 22, 2020

Some good questions to ask include the following:

1. Is the usefulness of 3D printing limited to be a stopgap in the current medical device supply chain?   
2. Will 3D printing find more killer apps through this crisis against humanity?
3. Can 3D printing deliver what it promises to healthcare, ranging from an agile supply chain to mass customization?
4. Will society embrace more automation (3D printing or other digital manufacturing technologies)?

There is no easy way to answer the above questions, but what is clear is that like any other emerging technology, 3D printing needs innovations to continue to grow. This blog explores how the COVID-19 pandemic can potentially positively accelerate healthcare 3D printing innovations.  To summarize, there are five factors that are at play, both in short and long terms: time pressure, social distancing, positive messaging, social mission, experimental culture (or organizational flexibility).

Time Pressure

If we could spur creativity using time pressure, a lot more companies will do so. The reality is that innovative companies often play the long game, and extreme time pressure is in general not beneficial to innovating big ideas, based on one HBR article. [1] Examples of successful companies playing the long game in innovation include the Bell lab/AT&T, 3M, Google, where employees have protected explorative time for years, aiming for world-changing ideas.

However, some may be reminded of lesson learned from the Apollo 13 crisis in 1970, where raw brain power figured out a creative solution for air filtration crisis on board to save the lives of the astronauts under extreme time pressure. [1, 2] Right now, we are on Apollo 13, and we are witnessing raw creative power at play in 3D printing. One could consider a new term “pandemic innovation” to describe the current situation, where a combination of time pressure, existential thread, ability to focus (as a result of social distancing) encourages innovations. [1, 2] However, this kind of innovation aims to solve a singular problem, and not enough for those who want to change the post-COVID world.

Therefore, “time pressure” alone is not enough for a more sustainable long-term innovative culture.  

Social-Distancing

Many now have heard of the story how quarantine time during the Great Plaque of London in 1665 allowed Issac Newton, at the time a student, became a turning point of his career. [3] While in isolation, Newton was able to have long stretch of time to work alone and had not only breakthrough regarding the nature of motion and gravity, but also other vital early theories in optics and calculus, all of which made him a professor in Cambridge in 1667. [3]

For those who are fans of Carl Newport’s Deep work, this should not be a surprise. Quarantine is a great time for innovators to focus and explore. The usual daily interruptions/distractions in our personal and work lives are now significantly less due to quarantine. In contrary to our pre-COVID professional activities, a study has shown that meetings and group collaborations are not effective in encouraging innovation, rather alone time or working with one other person is more effective. [1] Drawing from personal examples, I have finally set up a podcast for 3DHEALS and hosted several webinars, discovering alternative, equally if not more effective communication methods to promote conversations in healthcare 3D printing and bioprinting space that I believe deserve an audience. I really enjoyed doing the interviews I conducted with our 3DHEALS2020 speakers, learning things I would not otherwise about their perspectives, life journeys, values to society. I also signed up for many online courses that I previously wish I could have time for, which includes several how to be on camera, CAD design, and 3D printing courses. If you are a student, as we all should be students for life, this is a great time to learn, think deeply, experiment, and innovate more.

Positive Messaging

Life is not easy in a pandemic. I often use the analogy of surfing (though admittedly a terrible surfer myself), as this is the time to hold your breath, stay low, stay deoxygenated, and wait for the big ugly wave to pass us by, uncertain when and how. However, the way communities, companies, and individuals came together around 3D printed solutions for this pandemic is lifting our moods in our often negativity-filled days. Among the daily numbers of infected and died, we are also sensing hope and relief when major manufacturers divert resources to 3D printed solutions, moving 3D printing towards mainstream manufacturing one step closer. These “quick wins” encourage innovations and inspire our next generation to learn, and therefore innovate more, in healthcare 3D printing. [4] These positive messages also allow more curiosities and re-evaluations from the world external to healthcare 3D printing, and perhaps a 10-20 years investment return is not such a bad deal if some of these technologies are the only life-savers in crisis, or even better, mechanisms that prevent another crisis.

Social Mission

Impact investing, social innovations, sustainability, environmental friendliness are not enemies of a healthy capitalistic society. They can co-exist with the right innovations, which require us to think with social impacts in mind. The current pandemic is certainly shifting individual and corporate behaviors, especially on their innovation focus. Not to be ageist, however, our interviews with various speakers, it is my observation that the term “sustainability” appears more in younger speakers. The next generation of CEOs, designers, engineers, and healthcare providers is already different from the previous generation, and this pandemic will surely inspire many to think of alternatives way of living and producing. Many of the crises today are results of bad planning and short-term vision of our past.  While many recent innovations in 3D printing focus on solving our immediate problems, like me, many are also thinking about what role 3D printing, and related technologies like bioprinting, tissue engineering, can play in healthcare post COVID19.  

Experimental Culture

In highly regulated industries like healthcare and manufacturing, implementing innovations often takes a long time. In this pandemic, however, previously more guarded organizations and companies in these industries are a lot more open to experimenting new solutions, vaccines, treatments, devices, and even business models. Within weeks, companies and organizations have opened up more direct communication channels with individual healthcare organizations and creative individuals online and offline to tackle COVID19 related unmet needs. Many of these channels did not exist before. The word “collaboration” becomes a lot more meaningful in this pandemic. I am hoping this open-mindedness to experiment with new ideas can stay with us even after this pandemic, as we are simply reacting to the virus. The big world-changing idea is more likely to come after this pandemic. [5]

There is also an acceleration to lowering regulatory barriers so that we can race against the virus more effectively as an emergency measure. I am not suggesting we should not have any regulation, but if we can find innovative ways to decrease the paper works and personnel involved without sacrificing safety and efficacy, why not? This is a great time to experiment at all levels of a government, society, and organization.

Therefore, this pandemic is certainly going to change our world and the future of healthcare 3D printing (and bioprinting). This is also a time for you to learn and think deeply, probably alone, what you want those changes to be.

Thanks to all of our amazing volunteers, we have delivered 1850 face shields this week (and 3650 total!) to @UCSF hospitals. Here are some behind-the-scenes photos of the hard work being done @ucsflibrary, and these are not even all of them! #UCSFProud #ucsf3dshield pic.twitter.com/yzmaQSkhFB

— UCSF Makers Lab (@ucsfmakerslab) April 18, 2020

“Man does not simply exist but always decides what his existence will be, what he will become the next moment. By the same token, every human being has the freedom to change at any instant.”

― Viktor Emil Frankl, Man’s Search for Meaning

References:

1. Creativity Under the Gun

2. Innovation Loves Crisis

3. How Issac Newton Made Social Distancing Work for Him

4. The Value of Innovation at a Time of Crisis

5. Innovating During a Crisis

About the Author:

Hui Jenny Chen, M.D.

Jenny Chen, MD, is currently the Founder and CEO of 3DHEALS, a company focusing on education and industrial research in the space of bioprinting, regenerative medicine, healthcare applications using 3D printing. She is trained as a neuroradiologist, Dr. Chen holds degrees in both medicine and radiology from the David Geffen School of Medicine at UCLA and completed fellowship training in neuroradiology at Harvard Medical School. She currently serves as Adjunct Clinical Faculty in neuroradiology at Stanford University Medical Center. With a focus on health technology, Dr. Chen also serves as a startup Mentor to IndieBio EU and French Tech Hub, tech accelerators that help IT and life science companies launch and expand their product offerings, identify customers, and manage operations. Her interests lie in the applications of emerging technologies (especially in the field of 3D printing and bioprinting), automated biology, and has a vision of a decentralized and personalized healthcare delivery system for our near future.

Related Articles:

3D Printing Design for COVID-19 Show Notes and Recordings

The Agility of 3D Technology for Medical Institutions: In Time of A Pandemic

Webinar Recording: Can 3D Printing Save Us From COVID19 Crisis?

Not Another Podcast: The Lattice

Interview with Shannon Walters, Stanford 3D Lab (Video)

Interview with Stefan Leonhardt, Kumovis (Video and Podcast)

The post Is COVID-19 Pandemic Re-Shaping Healthcare 3D Printing? appeared first on 3DHeals.

Want to write a piece for 3DHEALS Expert Corner? Email us: info@3dheals.com

Originally published on “Two Cents”

When the co-founders of Airbnb first approached Paul Graham (a famous Silicon Valley VC who co-founded Y Combinator), they were right out rejected from the accelerator program. However, after Paul heard the story about how the team survived on money generated from selling boxes of cereal during the Obama/McCain campaign, he accepted Airbnb into his program. Airbnb is now a well-known unicorn. When Airbnb was founded, it was in the midst of an economic recession. Things cannot be harder for startups, and investors were also timid. What first convinced Paul to take the risk to invest was the team behind Airbnb rather than the actual business idea behind Airbnb. Paul believed that the founders had an incredible ability to “hustle” and amazing “grit” to stand the nuclear winter of startups.

Healthcare 3D printing is still a very young industry, but a few names quickly show up in mind as great examples of “hustle and grit”: Rik Jacob from NextDent, Paul D’Urso from AnatomicsRx, Nick Dechev from Victoria Hand Project, Jae Yoo from Aprecia, and many more. Their fights last decades long, and they are not done yet.

Another group of people with an incredible ability to “hustle” and amazing “grit” is very close to home. In the past two years, I have worked with more than 20 3DHEALS community managers, who are unpaid volunteers. Their only drive is to realize a shared vision that 3D printing can re-invent healthcare and the need to network in a cross-disciplinary fashion, breaking down the traditional industrial barriers. Often our community managers have to run a one-person show, from catering to sending out hundreds of emails, to put on amazing educational programs and social activities for our members. A shout out to our 2018 community event managers:

· Jess Charlap (Boston)

· Sam Lindsay (Boston)

· Fernanda Valentina (Chicago)

· Aida Kafai (London)

· Sarah Fink (Melbourne)

· Hannah Riedle (Munich)

· Ben Salatin (Albuquerque)

· Annabelle Drault (Paris)

· Mayra Vasques (San Paulo, Brazil)

· Collrane Frivold (Seattle)

· Lisa Zeng (Shanghai)

· Mahendran Reddy (Singapore)

· Jana Waldes (San Francisco)

· Kate Clancy (Toronto, Canada)

· Kuan-Lin Chen (Taipei, Taiwan)

· Tyler Scherr (Nebraska, Omaha)

· Ben Holmes (Washington, D.C.)

· Dan Ortiz (Washington, D.C.)

· Pedro Martinez Seijas (Vigo, Spain)

Many of our community managers and our past event speakers have served as my personal inspirations when the time becomes tough with 3DHEALS. That’s when I remind myself:

“Sell cereals if you have to, great businesses are not built in 3 years, they are measured in decades.”

Happy holidays! & I wish you a productive and satisfying 2019.

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

Clinical Trials Group: 9:00 – 9:15 pm

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

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

Group Summary:
Costs:

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

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

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

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

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

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

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

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

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

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

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

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

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As a closet introvert, I surprised myself with attending and organizing a dozen conferences and events in 2017. The goal of my journey was not only to continue to build 3DHEALS community but also to figure out how 3D printing startups can take off in healthcare. WSGR’s 2017 Medical Device Conference on June 21st, 2017 was memorable. An array of VCs, investment banks, and entrepreneurs with different strategies and styles participated in discussions that most medical device startups and investors should care about. At the end of the day, it seems to be an artful balance of risk assessment, mining opportunities, and occasional contrarian behaviors.
(My memory is biased and my knowledge is limited, so please read with caution.)
Some bullet points to take away:

1. Current Investment Environment for Medical Device Startups:

(Photo: 3DHEALS2017)
It is tough.
·     Not much funding: While digital health is receiving increasing venture money, medical device industry is at the nadir of its fundraising. Many investors have gotten burned in the past with investing in early-stage medical device and therapeutics because these startups typically require overcoming regulatory, clinical, and reimbursement hurdles, and therefore, an extended period of financing.
·     Pre-regulatory approval and pre-data-stage startups. There is a trend that many medtech investors have shifted away from pre-regulatory approval or pre-data-stage medical device companies. However, this may not universal to all investors, according to NEA partner’s recent interview. [Ref]
·     Upside: The other side of the coin is that this could mean less risk to future investors by getting better deals and higher quality of companies to invest in.

2. “Seedable” Characteristics of a MedTech Startup:

(Photo: 3DHEALS2017 Pitch competition)
Some obvious (even to me), others not.
·     Strong Patent (IP): The importance of strong IP is worth stressing since this will dictate the “seedability” and valuation of a medical device company. Some investors mentioned that if the IP is strong enough to be licensed to other companies, that would add credibility to the underlying technology of the fund seeking startup. International IP is also important since it will allow wider market opportunities. Companies need to know different IP agencies work with different efficiencies and styles. (i.e. Apparently, getting an IP in Europe is super slow.) An important term to know for startups, “free to operate”, is written here by WIPO.
·     Regulatory approval/clearance: Many investors at the conference expressed the importance of having one regulatory box checked before considering funding a medical device startup. Some investors are also open to seed a company based on a well-defined regulatory approval strategic plan and reimbursement plan. This regulatory requirement for funding is particularly challenging to healthcare 3D printing startups, where the regulatory path remains unclear since the technology is so new. Also, typically 3D printed medical device involves a combination of new software, hardware, and materials. None of which are well known to the regulatory agencies. A recently finalized guideline on 3D printed medical device from FDA is a very positive step forward, and you can read it here. 
·     Self-financing: Under a tough fundraising environment, a clear reimbursement plan will be helpful, but the world “self-financing” is now on the table, which could make one cringe. Some companies survived because they could self-finance through many years of research and development and the long process of getting regulatory clearance. In our space of healthcare 3D printing, I know of one such company as a success story. This could lead to the next point.
·     Platform based product rather than single-product company. This goes back to the investors’ preference to de-risk as much as possible. Therefore, a portfolio of diverse products and a platform for growing partnership and vertical integration mean a larger future market share and a better investment opportunity.
·     Market product fit.
·     Prototype (MVP) ready.
·     Clear exit strategy. IPO or M&A.
·     Good (>50%) profit margin.

3. Where to Find Money:

(Photo: 3DHEALS2017, Anatomics 3D printed medical models)
Angels.
·     Angel: seems to become a major funding source for early stage medical device companies. It should be an important early discussion to have about the prospect of the angel’s investment, that is, it may never generate any return. Many existing angels invested in medtech companies on emotional and humanitarian bases. Needless to say, it is worthwhile for early-stage companies to spend time on curating a network of high net-worth individuals.
·     Venture Capital funding: Again, tough but not impossible. Some investors made an analogy between investor/company relationship and “marriage”, which is not inappropriate.
·     Government grants: Getting a government grant also establish credibility.
·     Corporate financing: There is a trend of increased investment from established companies and large healthcare systems to invest in early medtech companies. The motivations behind these investments may include:

1. Increasing market share at a lower cost
2. Solving unmet clinical needs
3. Lowering cost to operate

·     Incubators and accelerators: surprisingly, some panelists did not think of these as “valuable”. They think that incubators and accelerators’ main role is to put entrepreneurs in front of other investors.
·     Strategic partners: Having strategic partners can be very beneficial to an early-stage company. Partner companies can obviously leverage each other’s marketing and sales force. This is especially favorable to the smaller company of the two in the partnership. But several things to remember:

1. If the win-win situation is not glaringly obvious to both partners, then the partnership will fail down the line.
2. Larger corporate partners don’t always clearly know what they want from partnerships. So perhaps, it is up to the startup to define a clear vision, timeline, and milestones.
3. Majority of medtech companies exit by merger and acquisition, which often occur after strategic partnership.

·     Self-financing: It is true that I don’t need to write this section, but the devil is in the details. It is fun and worthwhile to study how other companies “self-finance” to survive the rough waters before an exit. Creative business plan to generate a steady revenue from existing businesses to support R&D is way one I have observed to work, but I suspect there are others and would like to learn about them. 
AfterThoughts:
·     Don’t be depressed. I can’t think of anyone who succeeded without challenges. At the end of the day, innovations in healthcare aim to achieve the most meaningful goal in life. 
·     Healthcare 3D printing (H3DP) companies belong to a different species, but most investors (me included) don’t have enough insights or data to understand it well. The word “3D printing” and “medical device” give people the impression that these startups are all about hardware and physical devices, but I suspect that a good H3DP company should also have a robust software solution, sound material selection (i.e. biocompatibility), and well-defined manufacturing process underlying their physical product if there is one. The digital and material solutions can very well be the new “platform” technologies that investors are looking for.
·     The risk in investing H3DP is “infinite” because most of us (including the policymakers) are still in search of a reasonable regulatory pathway. One that is not overly strict to kill most startups and one that is safe and effective to the patients. The map is getting clearer as I observed some efforts from the government, companies, and organizations in better defining the risks and solutions of these risks. 
Join this year’s 3dheals startup pitch competition and 3DHEALS2018.

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This piece may seem offbeat to my normal discussion on the field of healthcare 3D printing, but if I don’t share this, then I am not living what I preach.

Recounting a casual conversation recently (last night) with a friend who is also the senior engineer at Twitter on the interview process at Twitter for new engineers, the hiring process at large tech companies is apparently more gruesome than one can imagine. The process is both complex and frustrating equally for the companies and the engineers. Not to mention the recent diversity controversy starting from Google, the stories from the employer side shed light not just on strategies in talent management but also vision and business strategies of the companies.

Apparently, hiring a new engineer takes a whole day after hours of interviews with different shareholders in the company. The end result, the new hire, still may not work out and having to let go of people sucks. What is the most trait that can forecast a good engineering hire?

It’s not necessarily an Ivy League degree, or certificates, or even good recommendations. Yes, those help and may have a degree of quality assurance, but the most important trait is how well-rounded the engineer’s knowledge is. Is he/she only capable of solving the current problem, or is he/she capable of stay adaptive and competitive to a constantly changing technological business landscape? This not only requires a depth of knowledge in a single vertical, but also a good understanding of ALL the elements in the software development ecosystem. One might even argue that the ecosystem can be as wide as what life presents.

As a business, I don’t think it is practical or even effective to try to learn about everything in healthcare 3D printing, but staying narrow minded to focus only on one or two business endpoints or strategies is doomed to fail if one is to stay in the game for the long run. Staying open-minded, encouraging curiosity, facilitating cross-industry conversations are visibly what existing successful companies like Google, Facebook, and Twitter are doing. When it comes to learning, I always try to learn from people who are successful. Just saying…

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By Eric Barnes, AuntMinnie.com staff writer

This article was originally published on AuntMinnie.com on April 21st, 2017.

VC Panelists @ Startup Pitch Competition, 3DHEALS2017, San Francisco

April 21, 2017 — SAN FRANCISCO – Start-ups are hard enough in any field, but medical device start-ups — including 3D printing hopefuls — require extra helpings of dedication and persistence to succeed, according to experts speaking April 20 at the 3DHeals 2017 conference.
Advice about entrepreneurship in 3D printing was dispensed throughout the day from people who had mostly succeeded in their own goals of establishing firms that offer 3D printing services and products that are now in demand. The products include everything from customized breathing masks for sleep apnea patients to replacement limbs for amputees to engineered biological tissues for drug testing.
Dr. Yan Chow, who served as national chief innovation medical officer with Kaiser Permanente for eight years before joining the pharmaceutical firm Amgen, spoke about 3D start-ups from the viewpoint of an equipment buyer interviewing a new technology developer looking for customers. Based on his experience, Chow said he had identified some common patterns and problems with the developers’ approaches.
Getting the question right
“What problem are you trying to solve?” is a key question for entrepreneurs, Chow said. “In the 2,000 start-ups we saw, a lot of them didn’t know what problem they were trying to solve.”

Showing your prowess
The team behind the start-up is important, and it needs to show its healthcare prowess. Are there critical gaps in the team makeup? Maybe the start-up boasts a great team that includes a medical school professor and an engineer from a top-flight university such as Stanford — but its potential customer comes from the University of California, Berkeley.
You can’t know your customer too well, Chow said. And human skills are extremely important for success.
“When you go to meet somebody, a lot of it is decided in 10 minutes,” he said. “Do they like you and trust you?”
The start-up won’t have or be able to afford all the expertise it needs. But does it have resources in place to scale up quickly, if needed?
Evidence matters
Technology buyers also ask whether there is evidence to back up claims. Maybe your tiny firm hasn’t found a sponsor for a clinical study yet; however, the executive team must prepare for the question by doing its homework. That means at least talking to potential study sponsors and taking definitive steps toward getting evidence to support the product.
Evidence matters “because in healthcare the stakes are very high — life or death, in fact — and the regulatory barriers are formidable,” Chow said. “Many healthcare start-ups underestimate the barriers. New technology poses a couple of problems: one, that there’s no track record, and two, that there’s no agreement on what constitutes success and how it should be measured. These are not small issues.”
Is your product HIPAA compliant? Do you have 510(k) clearance from the U.S. Food and Drug Administration (FDA) to demonstrate your product’s safety and efficacy? With regard to electronic records and signatures, are you compliant with FDA Title 21, Code of Federal Regulations (CFR) Part 11? Are you protecting your patents at every stage of product development?
Along with the layers of formal regulation are the informal ones, such as community standards of practice and peer-reviewed literature, that cannot be overlooked, Chow said.
Finally, who’s going to pay for your technology? Has the company lined up insurers ready to reimburse for its use pending 510(k) clearance? Offering an example from the pharmaceutical industry, Chow said one manufacturer is offering a risk-sharing scheme, wherein patients and payors can get their money back if a drug doesn’t work.
What are other ways to reduce downside risk? Prepare the answers before the pitch, he said.
Find the star players
As for team building, panelist Leslie Karpas, founder and CEO of custom medical 3D design firm Metamason, said an important win for her firm was securing a principal at a leading healthcare firm to serve as medical director.
This individual “knows all of the major players in the space, all the major points of sale, and all the former executives from all the big companies that are in retirement mode that we’re now trying to hit up for funding,” he said.
Another key hire was a former director of clinical affairs from another large firm, who is writing Metamason’s clinical protocols.
“You can hang yourself with clinical protocols really quickly if you’re not careful,” Karpas said. “We ended up scrapping ours and rewriting them a number of times because once you are in a trial, whatever you test is what you get. So if you don’t frame the questions in a really neutral way, you can try to prove something that’s unprovable, even though there are a lot of other quality elements to what you’re doing, and then trap yourself. ”
How does a small start-up face the monumental tasks of sorting out regulations, building a team, and trying to obtain financing?
Get a doctor on your team who has a friendly relationship with an institutional review board (IRB) and is able to get approval to try prototypes in patients, Karpas said. Having a doctor who knows doctors who can help in arranging prototype testing can save a lot of time.
Your team should also have an experienced grant writer, which can be contracted out, and your doctor should be experienced in writing clinical trial proposals, preferably from an academic setting, Chow said. This is important because the protocols for the trial, once submitted, are set in stone.
“For us, we had to look at what we needed and what we could afford. We needed a lot, and we had almost nothing,” said Dr. Chris Hart, founder of Australia-based 3D firm Oventus.
Spending precious money on consultants with network contacts can be a smart move if they save you time and effort — and you can take their advice or ignore it, Hart said. Spending on intellectual property patents can also be a wise use of scarce resources. When you need far more than you have, you can also hand out stock options to get the people you need.
All of the panelists agreed that very small firms can save a lot of grief by partnering with a big player.

Collage: 3DHEALS2017

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Authors : Jenny Chen, M.D. and Adele Wang

3D printing[1] (3DP) has become a key driver in the progress of healthcare technologies in recent years. Along with other high-valued, high-complexity, one-off manufacturing such as in defense, aerospace, jewelry and automobile parts, the production of medical models, implants, prosthetics, surgical guides and even live tissue are becoming increasingly viable with the advent of 3D printing technology.
Despite the struggles experienced by public 3D printing hardware companies like 3D Systems and Stratasys, the adoption of 3DP is continuing its strong trend. Terry Wohlers, the leading 3DP industry analyst, estimated in the 2015 Wohlers Report that the additive manufacturing (AM) industry, consisting of all AM products and services worldwide, grew 25.9% YOY to $5.165 billion in 2015. The report also estimated 13% of the market[2] to be in medical, which puts the size of the healthcare 3D market at about $671M….

This white paper will provide insights on current health care 3D printing market estimation and prediction, as well as current investment strategies and patterns. 

Ms. Wang has over 10 years and $200+ million in M&A experience. Previously, Ms. Wang served as Senior Manager of Corporate Development at EFI, Inc., where she helped develop and execute the Company’s acquisition growth strategy. During her tenure, Ms. Wang successfully managed and closed numerous M&A transactions, representing over $100 million in aggregate value. Her efforts enabled EFI’s target of $1 billion revenue in 2016. As part of the Wells Fargo Corporate Development team, Ms. Wang executed strategic acquisitions of asset-backed loan portfolios and aircraft leasing JV’s, representing over $110 million in aggregate value. Prior to, Ms. Wang was part of the Wells Fargo Corporate FP&A group, focusing on forecasting, budgeting and analysis for the Wholesale Commercial Banking division. She was instrumental in the post merger integration of the Wachovia Bank acquisition, as well as in the implementation of key company-wide finance initiatives.

Jenny is trained as a neuroradiologist, founder/CEO of 3DHEALS, a company focusing on curating healthcare 3D printing ecosystem. Her main interests include medical education, 3D printing in the healthcare sector, and artificial intelligence. She is also a current adjunct clinical faculty in the radiology department at Stanford Healthcare.

The post 3DHEALS White Paper: Healthcare 3D Printing Investing – Are We At the Tipping Point? appeared first on 3DHeals.

Hui Jenny Chen, MD and Michelle Gabriel, MS, MBA

(This blog is adapted from our A Roadmap from Idea to Implementation: 3D Printing for Pre-Surgical Application: Operational Management for 3D Printing in Surgery)

Research firms generally agree that the healthcare sector of the 3D printing market is about 15%. But 15% of “what”? For example, Research Beam[1]estimates the total global 3D printing market to be at $2.8 billion, which would value the healthcare sector at $420 million. According to Wohlers Report 2016, the additive manufacturing (AM) industry grew 25.9% (CAGR — Corporate Annual Growth Rate) to $5.165 billion in 2015 — which would value the healthcare sector at $774 million[2].

Many market research firms report on specific numbers for the healthcare sector of the 3D printing market, and once again, the results vary significantly. As shown below, Allied Market Research forecasts a market twice as large and growing at twice the rate as the Orbis Researchprediction.

Given this range of numbers, it is likely the market researchers are not measuring the same items. Thus, if you are willing to invest in buying a market research report, it will be important to understand what is and is not included in the report, and if it applies to your requirements.

The market for 3D printers for all sectors is growing even faster. In September 2015, Gartner predicted that the worldwide shipments of 3D printers would reach 496,475[5]in 2016. Again in October 2016, Gartner reported that the worldwide shipments of 219,168 3D printers in 2015 would more than double to reach 455,772 printers in 2016.[6] Although the forecast numbers have decreased by approximately 50,000 units, the rate of growth is still spectacular. The growth in 3D printers has been accelerated by the expiration of several major 3D printing patents, and rapid technological innovations and quality improvements. The added abilities of printers increase the end-use market, thus driving the demand for printers and the overall market size.

What is driving this growth in the healthcare sector?

Allied Market sees the primary demand growth coming from the need for customized external wearable devices for a growing geriatric population who are experiencing osteoporosis, a growing number of amputations, auditory loss, and dental problems.[7] Technological advancements driving market growth include printers able to use multiple materials, the ability to print in multiple colors, and an increasing set of available biocompatible materials. Orbis sees different growth drivers, such as the growing need for medical device manufacturers to produce automated products, the increasing number of cost-curbing initiatives, and the rendering of simulations to perform or prepare for medical procedures.[8]

Where is the healthcare market?[9][10]

Market researchers agree that the major market is currently in North America, with a market share ranging from 35–40%. This is due to the growing presence of high patient awareness levels, increasing healthcare expenditure, sophisticated healthcare infrastructure and increasing investments in R&D facilities pertaining to the development of 3D technologies based products. However, there are discrepancies around which sector is predicted to have the most growth. Allied Research sees the most significant growth is coming from Asia-Pacific. Orbis finds that Europe is expected to be the fastest growing regional market over the forecast period due to the presence of a large number of R&D funding programs, and the increasing demand for customized medical devices in this region. It is expected to drive market growth over the next six years.

Who are major market players?

The 3D printing healthcare market is largely consolidated. Majority of the market share is governed by the two leading players, 3D Systems Corporations and Stratasys Ltd. In addition, the key market players have adopted strategic partnerships to accelerate the product development process.[11] However recently, these companies are having difficulties.[12]Fox Business reports that Stratasys and archrival 3D Systems (NYSE: DDD) have struggled to grow revenue since early 2015 due to a widespread slowdown of 3D printer purchases among enterprise customers. Stratasys posted a year-over-year revenue decline of 6.2%, driven by a 20% drop in 3D printer sales. Adjusted earnings per share — the most important earnings metric — declined from $0.01 to nearly $0.00. 3D Systems has had a rough 2016 — discontinuing their entire desktop 3D printer line and management changes including a new CEO and CFO in April, and the resignation of both the CMO and COO in June 2016. [12][13][14]

At the end of 2016, a tough year for most, the Motley Fool Investor published an in-depth analysis of the two market leaders and events affecting the companies.[14] A key takeaway is that increased competition is on the way from HP and Carbon3D who are entering the polymer 3D space. GE is also making an aggressive entry into the industrial metal market with the purchases of Arcam and Concept Laser, while their attempt to purchase SLM Solutions fell through.

Other important companies involved in the healthcare sector include EnvisionTEC, Materialise NV, and 3D Systems Software. Companies specifically involved 3D bio-printing include[15]: Organovo, Cyfuse Biomedical, Ekso Bionics, BioBots, Aspect Biosystems, 3D Bioprinting Solutions, and Rokit.

What are the analysts’ materials and methods?

Allied Research and Orbis both agree that polymers are the most preferred materials in the 3D printing healthcare market, but once again they differ on the market share — Allied at 50% and Orbis at 35%. This is driven by the high usage rates in bio-medical models. Both agree that the ceramics segment is projected to be the fastest growing due to its use in the manufacturing of teeth and jaw bones. For technology, the firms agree that laser/electron beam melting is the fastest growing due the growing demand in manufacturing orthopedic implants and hip stems.

What are the market challenges?

The 3D market in healthcare still faces significant challenges to growth. First, there is a shortage of sufficient clinical data to justify expenditures and insurance reimbursements. Second, there is a lack of structured regulatory frameworks. For example, in the US, the FDA has issued a guidance paper but no rules. Legal precedent regarding liability, patents and copyright is still murky. In general, the high costs associated with advanced 3D printers is also a barrier to entry.

In conclusion, the outlook on the healthcare 3D printing market is bright. This is not only supported by analysts, but also by the recent growth of a vibrant 3D printing market as a whole. Given the multi-trillion-worth total U.S. manufacturing market, the upside potential of market growth for the healthcare 3D printing sector (currently <1 billion) is tremendous. Multiple organizations, companies, and government agencies are now organizing themselves to create manufacture standards, regulations, and laws specific for healthcare 3D printing to meet the challenges the market faces.

References:

[1] https://www.whatech.com/market-research/it/229633-worldwide-3d-printing-market-is-in-the-progressive-phase-of-its-life-cycle-valued-at-2-811-8-million-in-2014-and-is-growing-at-a-cagr-of-21-during-2015-2020

[2] http://www.forbes.com/sites/tjmccue/2016/04/25/wohlers-report-2016-3d-printer-industry-surpassed-5-1-billion/#18694ae97cb1

[3] https://www.alliedmarketresearch.com/3d-printing-healthcare-market

3D Printing Healthcare Industry — Market Size, Analysis Jan 2016

[4] Http://www.medgadget.com/2016/11/global-healthcare-3d-printing-market-analysis-share-trends-and-forecast-by-2020-market-research-report-2016.html

[5] http://www.gartner.com/newsroom/id/3139118

[6] http://www.gartner.com/newsroom/id/3476317

[7] https://www.alliedmarketresearch.com/press-release/3d-printing-healthcare-market.html

[8] http://www.medgadget.com/2016/11/global-healthcare-3d-printing-market-analysis-share-trends-and-forecast-by-2020-market-research-report-2016.html

[9] https://www.alliedmarketresearch.com/3d-printing-healthcare-market,

[10] http://www.orbisresearch.com/reports/index/healthcare-3d-printing-market-analysis-by-application-surgical-guides-implants-surgical-instruments-bioengineering-by-technology-electron-beam-melting-stereolithography-droplet-deposition-manufacturing-by-raw-material-metals-biological-cells-polymers-cera

[11] https://www.alliedmarketresearch.com/3d-printing-healthcare-market

[12] http://www.foxbusiness.com/markets/2016/11/16/stratasys-earnings-3d-printer-sales-drop-20-stock-plummets-12.html

[13] http://www.fool.com/investing/2016/11/23/3d-systems-vs-stratasys-which-3d-printing-company.aspx?source=djc&utm_campaign=article&utm_medium=feed&utm_source=djc,

[14]http://www.fool.com/investing/2016/11/25/the-7-top-happenings-in-3d-printing-in-2016.aspx?source=djc&utm_campaign=article&utm_medium=feed&utm_source=djc

[15] https://3dprint.com/88792/3d-bioprinting-companies/

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