3D printing has already revolutionized the medical device industry. Devices can be produced more efficiently, and creating patient specific devices has already started to improve healthcare outcomes.
While the idea of 3D-printed parts that can augment the human body may still seem like a headline from the future, the industry is already onto the next frontier – bioprinting. Like 3D printing, bioprinting utilizes 3D printers to create multiple 2D layers. In aggregate, these 2D layers eventually form a dimensional structure. The difference in bioprinting are the materials used, including actual cells and biochemicals.
Sterilized polymers, nylon, stainless steel, and other traditional materials are significantly different from living tissue. How current FDA regulation could or should apply to bi-printing is unclear for several reasons.
Should current regulations simply be augmented, or do we need an entirely new framework to address the ethical challenges of bioprinting?
Let’s exam the issues.
- Issue 1: Current classifications that determine regulatory scope don’t include bioprinted devices
- Issue 2: It is unclear who would regulate the overall process
- Issue 3: Philosophical concerns
Issue 1: Current Classifications are Out of Scope
Check out the FDA’s current classification system for medical devices. How stringent the regulation is depends on the medical device’s class rating, determined by potential for harm, how invasive the device is, and purpose. There are currently only three classes:
- Class 1
Class 1 covers the most simply designed medical devices that present a very low potential of harm to the user. It includes products like elastic bandages and enema kits. This accounts for 47% of all medical devices.
- Class 2
Class 2 is the most common category of medical devices. It includes products like powered wheelchairs and pregnancy test kits. This accounts for 43% of all medical devices.
- Class 3
Class 3 covers devices that present the highest risk of injury or illness to the user. They are commonly implanted, and they typically either sustain or support the user’s life. It includes products like pacemakers.
Obviously, the closest class that could govern bioprinted organs is Class 3. However, because organs are vascularized and potentially different from devices manufactured with synthetic materials, there are clear differences. The FDA recognizes this in the Technical Considerations for Additive Manufactured Medical Devices document. In the introduction, it specifics the limited scope of the FDA’s regulatory sovereignty over bioprinted devices:
In addition, this guidance does not address the use or incorporation of biological, cellular, or tissue-based products in AM. Biological, cellular or tissue-based products manufactured using AM technology may necessitate additional regulatory and manufacturing process considerations and/or different regulatory pathways. Therefore, AM questions pertaining to biologics, cells or tissue products should be directed to the Center for Biologics Evaluation and Research (CBER).1
Issue 2: Unclear Ownership
In addition, it’s not clear who would manage regulations, or how many government players would need to be involved (like CBER as mentioned by the FDA above). For now, the FDA only regulates human cells, tissue, and tissue based products (HCT/Ps). However, they do not regulate organ donation, as that responsibility belongs to the Health Resources and Services Administration via the National Organ Transplant Act (NOTA).
Furthermore, the principles of NOTA were created in 1984, well before bioprinting was an emerging technology. In fact, bioprinting stands to solve many of the issues NOTA was created to tackle, including the availability of transplants, equity in access, donation efficiency, safety, and patient outcomes.
Now for the fun part. If bioprinted organs cloned from a patient’s actual body improve to the point where they are indistinguishable from the source, are they any more of a device than the actual organ itself? Perhaps the fact it was “manufactured” is enough to classify it as such, but the question is still worth considering.
An Unsatisfying Conclusion
The existing framework does not adequately provide oversight for this emerging field, and the principles in NOTA are outdated.
If the Maintaining American Leadership in Artificial Intelligence executive is any indication, it’s possible that regulations may be more lax than strict in order to avoid inhibiting ingenuity.
One thing is certain. Penrod is here to take your business processes to the next level, regardless of what comes to pass over the next year. We’ll have more information as this story develops.