Webinar Availalbe On-Demand – Experts Share Real World Insights
By: Eric Luyer, Market Research Analyst
According to the FDA, when it comes to 3D printing, you might say that the future is already here. Due to its versatility, the agency is evaluating the applications of 3D printing in devices, drugs and biologics and to medical applications across the entire ecosystem.
- Thomas Marchand, Co-Founder & CEO of BIOMODEX provided the industry perspective
- Jenny Chen, a trained neuro-radiologist and founder/CEO of 3DHEALS, shared the physician’s perspective
- Stavros Stefanis, leader in Deloitte’s Product Development practice, shared insights on the use of 3D printing across the product development lifecycle
The webinar was held on September 28th and sponsored by Dassault Systèmes (3DS).
3D printing in Life-Sciences is NOT Science Fiction, it is Science FACT
To date, FDA has cleared over 85 applications for 3D-printed medical devices which span across many product lines such as prosthetics and implants and last year, FDA approved the first 3D printed Drug – Aprecia’s Spritam.
3D Printing, (also commonly referred to as Additive Manufacturing) Simulation and Digital Twin technologies are at the forefront of the Precision Medicine Revolution. Using these technologies, Life Sciences and Healthcare companies are accelerating the delivery of next generation products that are personalized, more precise and higher quality than ever before, resulting in improved patient outcomes.
Dr. Jenny Chen, Neurologist and and Founder/CEO of 3D Heals pointed out, “Of all the emerging technologies that we’re seeing right now, I would argue that 3D printing is probably one of the best tools that we have to combat some of the diseases in our generation.”
From an economic perspective, cost savings are getting the attention of healthcare facilities and providers. Saving 20 minutes of time in the operating room, results in an economic value, in terms of how many patients are treated in a day and ultimately, the high quality of care each patient receives.
From a product development perspective, 3D printing can have an economic impact on both quality and the reliability. Accelerated product development cycles, result in shorter lead times when companies are quickly able to assets the quality of the product that’s being designed. This technology is not only used to customize implants for patients, but also to customize surgical tools, as each surgeon is different. Since every surgeon has their own individual way-of-working, tools can be created specifically for them to increase their efficiency in the operating room.
From a broader supply chain perspective, 3D Printing technology can accelerate customer lead times by addressing unique customer needs in an expedited fashion effectively and efficiently.
An example was offered by Stavros Stefanis, Product Development and Practice Lead at Deloitte added, ”….3D printing makes it much easier and faster to fabricate test samples, allowing quality assessment and tests to be performed before design freeze…”
Medical Device companies are training surgeons in using 3D printed models to plan and prepare for complex surgeries. There is a significant presence of 3D printing in education and educational forums, including training with a focus on delivery in the professional field. Thomas Marchand, CEO and Co-Founder of BIOMODEX, added “…Clinical training is a great application for the medical device industry for them to go on the market and to push their new medical devices and the clinical skills of the surgeon that the surgeons need to train on, yes, to be implanted on the patient…”
With benefits, there also risks and companies face hurdles when incorporating new technologies into their operations. 3D printing is no exception considering the industry’s highly regulated environment. The FDA requires proof of safety and efficacy which can be challenging for companies to obtain quick regulatory approvals, while at the same time being be as flexible with 3D printing to meet customer needs and for patients to ultimately gain the benefits of the technology. FDA is currently studying the use of 3D printing when conducting product reviews and has published draft guidelines around technical considerations for additive manufactured devices.
There is significant potential for Bio-Printing in the clinical market. Opportunities include:
- Specifically creating a complex 3D disease model for various drug discovery, pharmaceutical toxicology and other testing processes
- Lowering the overall cost of R&D, as a result of less animal testing
- Shortening the lead-time of clinical trials as result of efficient and data-driven processes
3D Printing technology solutions are being offered by a growing number of solution providers, including Dassault Systèmes (3DS).
Today scientists have developed simulation and 3D models of human cells and organs that can be bio-printed to accelerate clinical trials to support the Precision Medicine revolution.
FDA is correct — “when it comes to 3D Printing, the future is already here!”
We welcome you to access the webinar on-demand here.