Having personally been in the biotech field for some time, it’s interesting to watch how industry discourse is evolving. We couldn’t be more excited to share that in some way, we at A.D.A.M. have foreseen several of the changes in the medical device industry and orthopaedics which are currently being debated at events such as RAPID + TCT.
Therefore, here are few thoughts I’d like to share as a summary of developments in the additive manufacturing industry in healthcare, and a small prognosis for the next few years.
On a grand scale, industrial 3D printing has kicked off, especially in regards to metal. There is no question that supply chains in high-tech production industries will undergo a huge change while the players in the space are figuring out the applications. The assertion that COVID accelerated transformations of various industries has already become quite trivial over the last year. Nevertheless, the digitalization that has impacted people’s everyday lives is about to impact the course of industrial manufacturing. Essentially we are witnessing the very beginning of the cloud or end-to-end manufacturing era.
The logic is applicable to healthcare. In the US, several big players including the Mayo Clinic, the Cleveland Clinic and the Veterans’ Administration Hospital System have launched point-of-care (POC) 3D printing. These are just a few examples that were discussed in the panels at RAPID + TCT. Other renowned hospitals are also looking at ways to establish 3D printing on site. Smaller hospitals would love to have the capability, but most likely will have to accede (connect) to other 3D printing ecosystems or hubs, where the 3D printed product will be delivered to them promptly.
However, these discussions predominantly revolve around how the application of POC 3D printing relates to surgical models and instruments. Rarely are actual orthopaedic implants printed in metal. There is an easy explanation to it; the primary interests of hospitals and large orthopaedic device manufacturers are different. Large orthopaedic companies are not interested in innovating to change their business models, due to the dominant position they currently hold. Therefore, hospitals are forced to innovate themselves, and this has brought some results in a niche, though necessary process such as surgical planning.
This leads to a conclusion that there is clearly a need to bring the point-of-care manufacturing to an evolved level, both from a technological point of view, and it’s scalability- which is ultimately dependent on the ease of use. From the conversations that we’re having, there seems to be a consensus between hospitals and surgeons on the need. However, the business case specifically for hospitals remains to be explored, tested and implemented.
Currently, the biggest impediments to the large scale adoption of 3D printing in hospitals are:
- Cost of printers; there is no average, but in most cases prices range from USD $100k - $400k
- Regulatory burden; individual hospitals are reluctant to pass all necessary certification required by the FDA
- Time; it takes several iterations to reach a desired outcome of implant properties
- Human resource; few hospitals have engineering staff to support the 3D printing infrastructure
- Reimbursement possibility; due to the novelty of the technology there is no unified approach in reimbursement. However, reimbursement of ‘custom devices’ as determined by the FDA seems to have become common practice.
Eventually, this results in the cost of an implant printed on-site to be comparable with a non-customized version (depending on the complexity the range is between USD $20k - $50k per implant). In such a scenario, few people would want to go through the complication of the new process.
However, if there is someone who can bring a cost-effective, turnkey 3D printing solution to the market, it may become a game changer and reshape the way the orthopaedic industry works.
There was an interesting insight from a panel discussion featuring a hospital in the US Department of Defence system, where it was noted that the hospital was “forced” to start doing metal printing on-site themselves a few years ago. The reason was that at the time, there was no one in the industry offering customized implants for the soldiers they were treating.
Perhaps the time has come, when hospitals will not be ‘forced’, but will be provided with a streamlined, end-to-end solution in 3D printing of orthopaedic implants?
A few years ago, when A.D.A.M. started with the vision of a one-stop-shop manufacturing implants on-site, people looked at us as if we were living in a science-fiction world. This is not at all surprising; in the conservative, heavily regulated healthcare industry it usually takes a considerable time to see the benefits of innovating and changing the approach. Now, these needs are being discussed at industry and healthcare events. I’m happy to see the consensus in the industry; that our proposed solution matches the need in full.