Advancements in medical device manufacturing, including additive manufacturing (AM), are converging with advances in cellular biology and advanced biomaterials. And the convergence is paving the way for greater opportunities in tissue engineering and regenerative medicine, which is now primarily focused on cell therapy, gene therapy and tissue engineering products.
Though still emerging, regenerative medical devices have immense potential for exponential growth—so long as proper regulation and workforce development efforts are put in place to support this expansion.
Providers of biomaterials and medical devices like Dimension Inx, FluidForm and Restor3D are poised to profit from that potential.
Today’s implantable medical devices are considered tools to treat a disease or debilitation rather than a means to change the body to be bioactive—meaning moving from an inactive metal implant to an implant designed to repair and regenerate tissue.
“In the regenerative medicine sector, a lot of investment and attention has been placed on cell and gene therapy,” Dimension Inx CEO Caralynn Nowinski Collens said. “There is an inflection point in the regenerative medical device space because we see advances in how we expand and program cells at the same time we see advances in engineering. Now, we are getting into new modes of 3D printing that allow us to print structures that have bioactivity, and that’s because of advances in materials.”
Dimension Inx designs and manufactures biomaterials that are 3D-printed into medical products to repair diseased or damaged tissues and organs. Using the flexibility of Dimension Inx’s biomaterials platform, the company designs and manufactures products with the composition and nano/microstructure needed to elicit a natural biological response to healing in a patient’s body.
Collens added that it is not just about the material’s makeup; the structure of those materials and the design of the implant are also important.
“There is a lot of biofunctionality that we can offer patients through the structure of the implant, and that structure is something we can create because of the advances in materials and manufacturing techniques.”
Researchers at Dimension Inx look at their materials as building blocks to create novel material combinations and new usages of the materials. The commonality of Dimension’s products is how they create a suitable microenvironment for cells to repair.
“We want to create cell-friendly microenvironments,” Collens said. “Cells react to our products in a positive way that leads to tissue repair. It is our job to architect the microenvironment. If we provide the right microenvironment, that will elicit the right tissue response to regenerate.”
All the existing efforts in regenerative medicine are essential. Still, FluidForm CEO Mike Graffeo said, a revolution is coming in this sector.
“The ability to precisely manufacture regenerative devices with native biomaterials, controlling for architecture with anisotropy, will transform our ability to harness the body’s regenerative responses,” he said. “This will dramatically expand the potential of regenerative medicine.”
FluidForm’s FRESH (Freeform Reversible Embedding of Suspended Hydrogels) printing technology can precisely manufacture native biomaterials in complex architectures with controlled anisotropy, using multiple materials. This capability allows FluidForm to expand how to use regenerative devices.
Mass customization predicted
There is currently a big push in load-bearing skeletal reconstruction and other types of reconstruction that involves 3D printed devices.
Restor3D CTO Ken Gall, who is also a professor at Duke University, believes there will be a continued push for 3D-printed titanium and metal devices, as well as 3D-printed biodegradables or 3D-printed tissues.
“Printing has evolved to a point where you can actually make end-parts directly, and they have complex structures and architectures that help with tissue integration, holding or releasing drugs and compatible mechanical properties with tissues,” he said.
The medical field also uses 3D-printed custom or patient-specific devices, which Gall said will be more widespread down the line: “We’ll see mass customization of patient-specific devices that cut across many different types of surgeries and patients.”
New rules, workforce prep needed
New advances in engineering and materials also mean new challenges.
Changes in the tools available in terms of engineering and materials are significant. And that calls for new regulatory guidance and workforce-preparation changes—each of which has complications.
On the regulatory side, the U.S. Food and Drug Administration and governing agencies outside of the U.S. must ensure that these devices are safe and effective.
That means creating new standards and testing methods and validating that these devices are safe to use.
The number of approved regenerative medical products with bioactive profiles is still relatively low in the U.S.
For instance, the Alliance for Regenerative Medicine said 20 tissue-engineered products have been approved and/or marketed in specific regions and countries for particular indications; only eight of these are approved and/or marketed in the U.S.
Regulation “is important and necessary, but also creates some uncertainties that companies like Dimension have to navigate and think about when considering what products to bring to market,” Collens said.
As new technologies enter the market, the current workforce and next generation of talent will require new skills.
So, investment in training that will ensure enough manufacturing workers can handle regenerative materials and tools is key.
For the regenerative medical device sector to grow further, workers—from the technician level through senior scientists and executives associated with regenerative medical device companies—need continual, efficient and effective learning and development guidance.
Digital, AM, automation essential
To prepare for the future, regenerative medical device manufacturers should embrace the roles digital manufacturing and AM will play in the growth of this industry. The ability to create three-dimensionalities to the structure and microstructure is critically important, Collens said.
AM is here to stay, and for the medical field, this technology will be essential in creating scaffolds, for example.
“On the digital side, the automation, reproducibility, and the clean nature of the manufacturing process will be incredibly important, especially when dealing with the handling of cells and tissues,” Collens said. “The more automation we can introduce into the system, the less concerned we have to be about human contamination, which is important from a safety perspective.”
Collens said the world will not have a regenerative medicine manufacturing industry if manufacturers do not incorporate digital and automation in the process.
Newer manufacturing techniques let regenerative medical device providers design devices tuned and shaped to a patient’s anatomy—and add complex architectures in the device that integrate with a patient’s tissue and biology.
“As we do more implants that are patient-specific, digital design will become a bigger issue, where devices are designed more autonomously, using input from each individual patient and rapid design iterations that are based on anatomy, and they come directly from the CT scan of that patient,” said Restor3D’s Gall. “You can do the design work rapidly, but if you don’t have the manufacturing methods to make those in a reliable way, it will be impossible to scale the treatment opportunity to a broader base of patients. It’s also about the speed and reliability of the manufacturing methods.”
Partnerships with scientists key
Strong partnerships between manufacturers and scientists are essential for broadening the acceptance, development delivery and commercialization of new regenerative medical devices and materials.
“Manufacturers must be aware of the latest technologies in biomanufacturing in order to see how new capabilities overlap with their identified market needs,” FluidForm’s Graffeo said.
“When new solutions come along, the best manufacturers will be poised to take advantage of them,” he added.