“The unpredictable nature of the future path of an emerging technology like 3D printing is its most exciting aspect, and probably why I am so fascinated by it.”

Jenny Chen MD, Founder & CEO, 3DHeals

---

Of all the technologies in the digital age, 3D printing is arguably one of the most revolutionary. It has helped to transform product development by optimizing the design and manufacturing process. Product manufacturers can quickly and inexpensively design, produce, and modify their prototypes and then expedite many of the complicated tooling processes needed for mass production.

But perhaps the most interesting advances in 3D printing can be found in the world of medicine, where 3D printing is starting to shake things up, especially as the cost of 3D printing drops and the technology becomes more accessible. Many 3D-printed medical solutions are still in their experimental stages, but first tests are looking promising in a variety of areas.

If we return to the Gartner Hype Cycle as a way to determine the current state of the industry, we can see how Gartner segmented the industry in 2019.

As you can see in the graphic above, Gartner has placed the medical applications of 3D printing at these points in the hype cycle curve:

• Innovation trigger: 3D bioprinted organ transplants
• Heading for the trough: 3D printed surgical implants; 3D bioprinting for Life Sciences R&D; 3D printingbof medical devices; 3D bioprinted human tissue
• On the slope of enlightenment: 3D printing 0f dental devices

Practical uses of 3D printed items continue to expand, with significant growth in the medical device and wearables markets. A critical factor in accelerating adoption will be the ability for healthcare regulation to keep up with the opportunity across geographic regions. 3D printing prosthetic limbs and appendages (for example, ears) and some specific internal valves is progressing rapidly, primarily using various polymers as the material. By 2023, 25% of medical devices in developed markets will make use of 3D printing in Gartner’s prediction.

---

What are the current use cases for 3D printing in health care? – Multiple sectors within the medical industry are benefiting from 3D printing. The technology is offering interesting new ways to provide personalised care and create better-performing medical devices. There are multiple ways to segment the market, and depending upon which research firm you look at, you’ll see a different segmentation methodology. I like to segment the 3D printing medical market this way:

Orthopedic implants – Medical devices used to surgically replace a missing joint or bone — are one of the applications that benefit the most from 3D printing. The technology enables medical professionals to create better-fitting, longer-lasting and higher-performing implants. Today, the technology can be used to make a wide range of implants, including spinal, hip, knee and skull implants. At the end of 2019, it was estimated that over 600,000 implants will have been produced with 3D printing. By 2027, this number could increase to four million.

Patient-specific anatomical models – Anatomical models are currently one of the most widely adopted applications of 3D printing in the medical industry. The accessibility of medical CAD/CAM software and lower-cost desktop 3D printers is increasing, enabling more hospitals to establish 3D printing labs. In such labs, medical professionals can produce high-accuracy 3D-printed models to assist in presurgical planning. 3D-printed anatomical models help surgeons evaluate better treatment decisions and plan their surgeries more accurately.

Enhanced surgical tools – Another area where 3D printing is making an impact is personalised surgical tools. Surgical instruments, like forceps, hemostats, scalpel handles and clamps can be produced using 3D printers. Creating personalised surgical instruments offers many benefits. They facilitate faster and less traumatic procedures, increase a surgeon’s dexterity and support better surgery outcomes.

Medical & Dental devices – Medical and dental devices like prosthetics, braces, dentures, restorations and clear aligners can significantly benefit from 3D printing. Low-cost personalisation is a key benefit, driving the adoption of 3D printing for medical & dental devices. With 3D printing, prosthetic limbs are becoming much more affordable and faster to produce. Furthermore, the technology can be used to create prosthetics tailored to the patient’s anatomy, thereby improving the fit of the prosthetic. Increasingly, 3D printing is being used to create prostheses for children. Children’s rapid growth means that they can quickly outgrow traditional prostheses. As a result, it’s necessary to replace them with a larger size version every couple of years. The lower costs associated with 3D printing make this a far better-suited manufacturing option.

3D printing is predicted to make a huge impact in the dental sector. Clear aligners — invisible teeth straightening devices — are perhaps the biggest use case of 3D printing in dental today. Major clear aligner companies like Align Technology and NextDent use 3D printing to create hundreds of thousands of moulds for clear aligners. Over the next five years, 3D printing is predicted to evolve to the point where it can be used to create clear aligners directly at home.

Bio printing or Body Parts On-Demand – Of all the amazing uses for 3D printing, the ability to print a fully-functional replacement body part might seem the most fantastical. Yet, this technology, known as bio-printing, is actually one of the oldest applications of 3D printing in medicine. In 1999, Dr. Anthony Atala of Wake Forest University successfully used a modified inkjet printer to create the world’s first engineered organ – a human bladder. Since then, his team and numerous other researchers around the world have printed tissues and organs from nearly every part of the body.

It’ll still likely be many years, however, before entire 3D-printed organs will be implanted in patients. Not only do they need to be structurally similar to their native counterparts, but bio-printed organs need to perform all the complex functions of real organs, as well as live in harmony with the rest of the body once they’re implanted. These complexities, as well as the high costs and time it takes to create an organ, will need to be resolved before the replacement organs can become viable. However, functional ears, heart valves, and blood vessels (for a look at 3D bioprinting for vasculature, 3DHeals recently held a webinar on the topic which can be found here) are just some of the simpler parts that researchers have successfully printed over the past few years. Several groups have even developed a special bio-printer that can print new skin cells directly on top of wounds.

Bio printing in the pharmaceutical industry – Bio-printed tissues are already playing an important role in drug development and education. Since 2014, San Diego-based Organovo has offered a line of 3D-printed liver and kidney tissue that can be used to test the toxicity of drug candidates. The major benefit of these bio prints is that products can be tested on human-based tissues without harming animals.

3D printing also has the potential to upend the pharmaceutical world and vastly simplify daily life for patients with multiple ailments. A 3D-printed pill, unlike a traditionally manufactured capsule, can house multiple drugs at once, each with different release times. This so-called “polypill” concept has already been tested for patients with diabetes and is showing great promise. At the TED conference in 2018, Dr. Daniel Kraft presented some of his work in developing 3D printed polypills in his talk titled: “The Pharmacy of the Future? Personalized pills 3D Printed at Home.”

---

What are the current challenges to the wide scale implementation of 3D printing in health care? – Unlocking the full potential of 3D printing for healthcare is not without challenges. Currently, the lack of a comprehensive regulatory framework for 3D-printed medical and dental products is one of the industry’s biggest barriers. Several regulatory bodies, including the FDA, are working on developing standards for 3D printing in healthcare.

Lack of reimbursement can be a major barrier for hospitals thinking about establishing a 3D printing lab. While an FDA-approved 3D-printed joint implant or bone fixator may be reimbursed, 3D models of a patient’s anatomy and professional fees often are not. Fortunately, healthcare organisations are actively working to change that. For example, the American Medical Association (AMA) has recently approved four Category III Current Procedural Terminology (CPT) codes for 3D-printed anatomical models and personalised 3D-printed cutting or drilling tools. The four new codes will allow radiologists and other clinicians to seek reimbursement for 3D printing services. Another driver for using CPT codes is to ensure all of the production steps of a 3D-printed medical device are recorded. The data collected through the codes will be used to support the FDA approval processes. For medical 3D printing, the introduction of the codes represents a key milestone on the way towards widespread adoption of 3D printing in healthcare.

Legal issues in the use of 3D printing in health care can be challenging. Critical issues include intellectual property, medical device liability, and FDA and CE regulations and guidance, focusing both on biological and non-biological devices. Dr. Chen and her organization have created a series of webinars to cover this topic. You can register and access these webinars here.

---

What is the future of 3D printing in healthcare? – 3D printing is set to hold a fundamental position in the future of healthcare.

“I am very excited about the next five years for 3D printing in the healthcare sector, and even more optimistic in the potential positive impact the technology can bring humanity by improving healthcare.”

Jenny Chen MD, Founder & CEO, 3DHeals

Dr. Chen’s organization 3DHeals has been leading the development of 3D printing technology in healthcare since she founded the group in July, 2014. Here are her predictions for 3D printing in health care over the next five years:

• More user-friendly 3D printing product specifically designed for healthcare professionals and healthcare system. This product includes 3D printing digital workflow that is out-of-box ready to use.
• More clarifying guidelines on 3D printed medical device from the FDA.
• Leadership in 3D printing R&D in medical devices by industrial giants will encourage more entrepreneurial pursuits in the area, accelerating overall the industry innovation rate.
• New business models and delivery systems of 3D printing services and products will emerge. For example, hospitals may become primary manufacturers of on-demand devices; or, medical devices company “ship” its product via the internet and 3D printing service bureaus.
• M&A deals will increase because of increasing available innovations.

---

3D printing has the potential to radically disrupt medical technology. While many of its applications have a long way to go before they become mainstream, we’re already starting to see some of the ways it’s making healthcare more accessible, affordable, and personalized for patients.