MCADCafe Industry Predictions for 2024 – Synopsys

By Kerim Genc, Product Manager, Synopsys Simpleware Product Group

Kerim Genc

1. More and more Medical Device companies that have tried to build/deploy their own AI-enabled automation for their current patchwork of patient specific workflows are going to start realizing their inefficiencies and turn to third-party companies that specialize in delivering AI solutions.

• • Since patient-specific workflows are set to drive the growth of the global 3D printing medical device market , the biggest bottleneck, image segmentation, needs to be addressed at scale. Companies can no longer afford to rely on an army of technicians clicking away at images to manually segment them. Therefore, they will turn to AI solutions to automate the process, and will run into the “build or buy” dilemma.  Some can build and deploy internally, but many have been at it for a while and are struggling to realize the promise of a fully automated, single-click image segmentation solution.

It takes more than simply hiring a few AI developers to build robust AI-enabled solutions that are accurate, repeatable, and scalable to their specific workflow, all the while being deployed quickly and able to pass regulatory approval. Many are two to three years into “building it themselves,” and although their internal solutions may be able to automate 60-70% of the cases, the last 30% is proving elusive; they are realizing that, although they are a Medical Device company with sophisticated software capabilities and very talented developers, extracting the full potential value of AI needs a specialized partner.  I think we will see an acceleration of companies ceding control of their workflow development in exchange for faster and more robust deployment of AI solutions.

2. We will see a continued steady growth of simulation being used in the Medical Device and clinical space, which will set the stage for long-term upsides.

• The use of simulation-based tools (think FE, CFD etc.) for Medical Device R&D will continue to grow at a steady pace. This continued proliferation of simulation will be the basis in silico Clinical Trials, whereby the digital human twin will be leveraged to speed up traditional Clinical Trials and the regulatory approval process, which in turn allows for a faster time-to-market. However, despite the massive potential upside and value in the long run, in silico trials are very complicated and need significant resources, validation and buy-in to deploy effectively, so this will continue to be a slow burn as companies slowly dip their toes into this area over the next year.
• We will also continue to see more startups gain traction in the Simulation-as-a-Medical Device domain.  Companies like HeartFlow and FEOps are showing some success after years/decades of work, and new startups like ViTAA Medical are gaining visibility, so we will likely see more startups coming out of the woodwork.

3. POC 3D Printing will continue to grow slowly, but with reimbursement a long way off, and despite some surgeons swearing by its utility and clinical relevance, it will continue to struggle towards that promised inflection point.

• Service providers like Ricoh USA and Insight Surgical are continuing to slowly gain traction and visibility towards implementing truly point of care 3D printing manufacturing facilities at or near hospitals.  However, the regulatory burden, costs and barriers of uptake remain high. With the elevation of CPT codes to level I for reimbursement continuing to be a long way off, I think this market is still in the early phases and is likely not ready to scale in 2024.  Longer term, I still think that the market will hit an inflection point, but a lot of things need to fall in place first.
• I also predict that we will continue to see a growth in the use of AR and VR technologies to supplement and enhance 3D prints, they are certainly not mutually exclusive!  Once the hardware is purchased, there is no materials to worry about, no large and sometimes messy hardware to maintain and you are good to go!  However, VR/AR technologies seem to be running into similar reimbursement barriers as 3D Printing.

About Author:

Dr Kerim Genc is a Product Manager for the Synopsys Simpleware Product Group. He received his BS and MS in biomechanics from the University of Calgary and the Pennsylvania State University respectively and completed his PhD in Biomedical Engineering at Case Western Reserve University.

Categories: 3D printing, Predictions

This entry was posted on Monday, January 8th, 2024 at 5:23 pm. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.