Katie Weimer has been working with advanced 3D software and additive manufacturing (AM) technologies for more than ten years. Her career began at Medical Modeling but she moved over to 3D Systems when the company was acquired in 2014. Today, she is vice president of the medical devices—healthcare division that focuses on a holistic ecosystem approach to improve healthcare for individuals by providing medical professionals with the tools and customization that improves individual patient outcomes. Disruptive Insight editor Rachel Park caught up with Katie to find out more about her work and day-to-day insights on the AM ecosystem for medical applications—past, present and future.
Disruptive: Could you start by giving us more insight into your history and experience with AM technologies?
Katie Weimer (KW): I have been involved in the digital and precision healthcare space for over 10 years. I started my professional career out of college at Medical Modeling, which was acquired by 3D Systems in 2014. My early work involved applying medical image processing to a range of anatomical structures. At the time, anatomical modeling was the main application for 3D printing in healthcare, but we soon started to grow the field.
We went on to develop a service-based workflow that allowed for pre-planning surgical procedures online with the surgeon before printing any anatomical models. By doing this, we essentially created the digital process to support what we had already been doing up to that point. This evolved into virtual surgical planning (VSP), which became my first project and expanded the role of 3D printing in healthcare through the ability to create patient-specific 3D models, templates and guides. I spent five years interacting with surgeons and developing VSP solutions before moving into product development and, as of two years ago, I head up 3D Systems’s medical device organization.
Today, the 3D Systems's Healthcare Technology Center is a 70,000 square foot (21,336m2), state-of-the-art facility in the USA’s Denver area, comprising both 3D printing labs and office space. We have a team of 140 people and a full portfolio of professional 3D printing technologies, including direct metal printing (DMP), stereolithography (SLA), selective laser sintering (SLS), as well as MultiJet and ColorJet printers. In addition to the Denver healthcare headquarters, we have centers of excellence in Leuven, Belgium, and Tel Aviv, Israel, which focus on metal applications and surgical simulation, respectively.
Disruptive: Since you started working with AM, many new developments and capabilities have emerged. In your opinion, which do you believe are the most significant in general and specifically for the medical/healthcare sector, and what difference(s) have they made?
KW: There has been a remarkable evolution in software over the last 10 years across precision healthcare applications. Many precision healthcare solutions start with medical imaging data, and the image processing software involved has become more efficient. VSP has become more streamlined and the design of patient-specific devices has become more automated. These advancements have allowed dramatic improvements for concierge planning services and are also creating opportunities for precision healthcare software to be accessible and successful at the hospital level.
With 3D printers and materials, there is a continued drive to develop new materials, specifically materials that are biomimetic. We want anatomical models of bone to act more like the hard and soft tissues in the human body. For example, we are working to print heart models that simulate real heart tissue so a surgeon can simulate the surgery with cutting and suturing and the model behaves just like a real heart. This will open up opportunities in advanced anatomical modeling and expand the use cases for 3D printed models from visual references to practice models for teaching, training and pre-surgical simulation. It will also expand non-patient-specific surgical simulation models by allowing life-like models to be printed that represent complex and unique anatomy that is often times very difficult to train on before a clinician sees his or her first case in the operating room (OR). This ultimately allows for a whole new level of specificity and repeatability in training.
The Figure 4 platform for high-speed, production-ready plastics is another tremendous advancement in the field. The level of automation that is possible with this technology, along with the precision and speed it offers, makes it a frontrunner for incorporation into local hospital and dental labs that want to bring device design and manufacturing on site. This application is still in development but I believe it points to an exciting opportunity in healthcare and beyond.
Disruptive: The work that you do with AM in the healthcare sector has an indirect and sometimes direct impact on the lives of people who have suffered trauma through illness or accidents, with the potential to improve them. Does this influence your approach?
KW: In healthcare, every case or project is actually a patient—somebody who has suffered disease, deformity, injury or trauma and is in need of care. Many of our patients are children as well. As such, every case is an opportunity for us to improve somebody’s life. This changes your approach to customer service, workflow accuracy and quality control. We have a world-class team of engineers, designers and technicians who work with drive and passion every day using 3D printing software and hardware technologies to transform lives.
The human element of our work affects every part of our workflow from when we answer the phone about an incoming case down to how we check parts before they ship because we know there is a patient on the other end who is relying on us to be perfect at what we do. Whether it is an anatomical model, a patient-specific surgical guide for facial reconstruction or a spine implant, contributing to someone else’s wellbeing through our work affects the seriousness with which we approach the quality of our parts. In that sense, it is really the people on the receiving end of our products and services that drive the technologies we push ourselves to invent and optimize.
Given that each of our projects is a patient with a unique anatomy, standard instrumentation often is not helpful in transferring the surgical plan to the operating room. There is really no other manufacturing technique that offers the same time and cost efficiencies for unique parts as 3D printing.
Disruptive: Could you provide one example of the knowledge and expertise transfer from an engineering discipline into the operating room?
KW: The basis of all our VSP services is the patient. We start by processing the medical imaging data that we receive from the clinical team and converting it into a 3D digital model. Once we have a CAD file of the anatomy, we can work with the clinical team to perform cuts and movements just as they are planning to do in the operating room.
As an example, we have assisted with cases of fibrous dysplasia, where scar-like tissue develops in place of normal bone. In these types of instances, the patient may need skeletal and soft tissue reconstructions to rebuild missing anatomy, so our biomedical engineers get online with the presiding surgical team and run simulations of possible surgical procedures under the surgeon’s instructions. From these exercises, we can create models of what the patient’s skull would look like without extraneous bone, for example, which can be helpful to the surgeon in identifying necessary processes and procedures. Throughout these meetings, we are not making any medical decisions or diagnosing in any way; we simply use our software system to simulate the most accurate representation of the surgeon’s desired surgical plan.
Once the surgeon has determined the best surgical plan, our team transfers that plan to the operating room through 3D printed patient-specific anatomical models, guides and templates. After a rigorous final quality check, they are shipped to the clinicians for use in the operating room. This workflow is what we do in VSP, but the same steps would apply in designing a long-term implant.
Disruptive: One of the indirect applications of AM in the healthcare sector is that of anatomical models—can you explain how AM technology has dramatically changed this discipline?
KW: Anatomical models are the oldest use case for 3D printing in healthcare, going back to the 1980s. I believe the healthcare field—specifically the craniomaxillofacial specialty— gravitated to use cases in reconstructive bone surgery because most of the materials for AM lend themselves well to hard tissue applications. So, things like bone-born cutting guides, drilling guides and positioning guides offer a compelling application, and the adoption rate has grown significantly over the last 10 years. Now we are seeing anatomical modeling being adopted by many other surgical specialties such as cardiologists and urologists for things like teaching and education, surgical planning and—increasingly as material capabilities grow— for advanced anatomical models. This loops back to the biomimetic materials I mentioned earlier and the push for new applications that will help drive development.
We are also seeing hospitals advocating for 3D printing anatomical models locally with on-site print labs. 3D Systems is supporting this transition by enabling a workflow that helps practitioners create patient-specific 3D models without time and expertise barriers. DICOM-to-Print (D2P) is one example—it is specifically developed software to facilitate the creation of digital anatomical models from medical imaging data for applications ranging from visualization to CAD to 3D printing. Putting this capability into the hands of surgeons is a major advancement, especially when combined with complementary hardware, software and service offerings. Whether clinicians are self-sufficient from start to finish, or if we supplement their process with our ISO-13485 certified design and manufacturing facilities, this holistic approach enables a powerful, productive and highly adaptable workflow.
Disruptive: The healthcare industry is highly regulated and can be a challenging environment to operate in. How does this impact your work with AM and is it getting any easier now that AM is being more widely accepted and adopted?
KW: 3D Systems’s Healthcare Technology Center produces medical devices regulated by the FDA, and as such, it is our obligation to ensure that everything we produce is safe and effective for use in the treatment of patients. Regulations continue to advance as more knowledge about this technology is gained. This ever-changing regulatory landscape is difficult to navigate. That being said, I do not believe easier is better and we welcome this change in regulation to keep 3D printed medical devices safe and effective.
From a logistics perspective, there is more work involved now to get FDA and other regulatory clearances, but as a business with a very strong quality and regulatory knowledge base, we are well-positioned to continue to grow, even as regulations become more complex.
Disruptive: Most recently, 3D Systems has acquired NextDent. This fits in your division so I wondered if you could explain how it aligns and expands 3DS strategy and intent within the healthcare sector.
KW: NextDent’s products are a very new addition to our portfolio, but we are excited to bring their materials suite into our healthcare applications. Especially exciting is the combination of NextDent’s 3D printing materials and our Figure 4 platform, which gives us a strategic foothold in digital dentistry in both expertise and capability. We believe that by leveraging and advancing digital workflows, we can improve productivity, efficiency and cost-effectiveness for our customers and ultimately enable better care and outcomes for their patients.
The NextDent team we have brought on board is very knowledgeable in both the dental industry and material science, so as a company we are excited to use that expertise to advance our solutions across healthcare and other verticals.
Disruptive: What do you think are still the most challenging issues associated with the adoption of AM within the healthcare sector? How can these be overcome?
KW: The lack of reimbursement codes for anatomical models and VSP continue to pose challenges. These are two key growth areas in precision healthcare, but because they are new patient-specific applications, many do not correlate to anything on the institutional backend. For many of the implants, however, where the majority is still stock or non-patient-specific, it is different. For example, the billing code for an off-the-shelf spinal implant is the same whether it is 3D printed or manufactured with traditional milling. Because many reimbursement codes do not go into the manufacturing process for existing devices, we are seeing an increased adoption in metals for device design and manufacturing. It is in the applications that did not exist before, mainly patient-specific devices, that we are seeing the biggest challenges.
Another challenge is making the technology easier to use and bringing it closer to the point of care. By enabling a digital healthcare workflow that clinicians can navigate as easily as an engineer, we are trying to make precision healthcare solutions more local and responsive.