3D Printing/BioPrinting: Modern Miracle or Danger Zone?

| | Technology & Integration

3D Printing Part II Bio Printing
At RIMS 2016, 3D Printing (or BioPrinting), was up for discussion. In a prior article we talked about 3D printing in the medical industry and referenced common uses such as producing casts and creating anatomical models to help plan and prepare for complicated procedures. One concern about using 3D printing in medical procedures is the time it takes to produce the printed device or apparatus. The turnaround time is a key reason many believe 3D printing will not become common in medical practices. But for many uses, there is plenty of time to plan and model medical devices such that 3D printing is the go-to option. These uses include:
  • Prosthetics
  • Ears
  • Intervertebral discs
  • Cranium replacements
  • Skin
  • Organs – liver, heart, kidney
  • Blood vessels

Other prosthetic type devices include: skulls, noses and facial implants which have all shown success and have been approved by the FDA for human use.

Manufacturing these types of devices by 3D printing seems like science fiction to many, and that’s understandable. But the promise of reasonably priced medical devices, especially in third world countries or underserved areas, is exciting. Many companies experimenting with medical 3D printing (often referred to as bioprinting) are focused on these populations and receive assistance or funding from various organizations. With the reality that comes with war zones, terrorist attacks and other catastrophic events, the need for prosthetics is growing in the areas that can least afford them.

Autodesk Research and CBM Canada are collaborating with researchers at the University of Toronto to produce lower cost customizable prosthetics for Uganda. Not Impossible Labs, located in California, is creating prosthetics for people in Sudan. In both instances the organizations are training local people to operate the equipment and create and fit the prosthetics. As a result, inexpensive prosthetics are increasingly available to a larger portion of the population.

Professor Jonathan Butcher of Cornell University has printed a heart valve for experimental testing in sheep to determine viability. Ultimately, this leads to the question: Can we create human organs?

An article in StreetScape magazine published earlier this year indicated that “bioprinting is capable of printing cells, proteins, DNA and drugs” and anticipates it will happen within 5-10 years. Obviously, there are concerns, but the potential benefit is enormous. Using an individual’s stem cells to create her own transplant organs drastically decreases the risk of rejection and could eliminate the need for immunosuppressant drugs. 3D BioPrinting Solutions successfully transplanted functional, 3D printed thyroid glands into live mice. If this endeavor proves successful, transplanting bioprinted kidneys will be the next test (probably not until 2018). If we can bioprint organs, we will reduce the wait times for people needing organs. Currently, a person waits an average of five years for a kidney.

While the potential is thrilling, bioprinted organs are under close scrutiny, and the FDA is highly involved. It has been about three years since the FDA approved creation of an artificial airway implanted into an infant via bioprinting technology. Over this period of time, the FDA has identified two bioprinting categories: devices and biologics. The FDA treats stem cells as a separate component. Currently, FDA approval is not required for animal testing or in vitro testing (defined as ‘outside of the body’). The FDA maintains the requirement for sufficient data in order to support clinical testing in humans.

What are the dangers?

Stem cell research is still controversial, and there are laws related to stem cell use.

Cells may die before the organ is constructed.

We need more research about toxins related to the biotechnology and plastics.

With the use of 3D devices and telemedicine, imagine what the future holds for medicine. For further reading on bioprinting technology, we recommend: (1) BioPrinting by James Gwinn III, and (2) 3D Bioprinting by Clare Scott.

Karen Atkins

Karen Atkins, Chief Operating Officer with UniMed Direct, is leading the conversation, and the industry, on how to make the utilization review process more efficient for all stakeholders: physicians, insurance companies and, most importantly, patients.