In yet another example of surgeons using 3D printing to plan complex surgeries, Chinese researchers have begun creating personalized models of patients' hearts. These models are based off of ultrasound scans of the organs which are then rendered precisely so that doctors can see exactly the size and detail of each unique heart. This helps in the planning and execution of surgeries, which can be prolonged and risky without apt preparation. These medical models will be helpful not just to doctors but also to medical students.

Given the resulting health and cost benefits, this application of additive manufacturing is expected to see explosive growth.

Story after story illustrates the power and popularity of 3D printing in the medical field.  Fueled by the ability to customize solutions to specific patients, providers are using the revolutionary technology to create and improve a range of medical devices, surgical guides, designer drugs, and body implants.  The wide adoption of health-related additive manufacturing initiatives has left the FDA scrambling to respond.  In late October, 2014, RapidMade participated in an FDA-sponsored forum of stakeholders to discuss their concerns and consider best practices.  Since then, it appears that the FDA has backed away from implementing industry-wide regulatory guidelines and instead chosen to review and decide each product on a case-by-case basis using existing 510K and emergency use regulations.  

At least one source, Maya Eckstein, argues the current tactic does not sufficiently address an ever-increasing number of issues that are surfacing...

Unanswered questions include:

How will FDA treat non-traditional device “manufacturers,” such as hospitals?
Will FDA regulate 3D printers as medical devices? Or, will FDA only concern itself with 3D-printed products?
Will a manufacturer’s sharing of its design files for a 3D-printed product constitute promotion of the product? If so, will manufacturers be obliged to share risk information whenever they share design files?
When will FDA consider a 3D-printed device to be a “custom device”? Will such 3D-printed custom devices be exempt from premarket approval requirements and mandatory performance standards?
How will FDA execute its inspection program? How will quality systems and good manufacturing practice requirements be applied to the 3D printing of drugs and devices?

Another unknown is whether the FDA will attempt to regulate non-profit organizations like e-NABLE which use a network of unregulated makers to print and distribute low-cost prostheses to needy children and adults.

Clearly the key will be providing enough regulatory oversight to ensure patient safety without becoming overly bureaucratic and cumbersome.

 

 

The prospect of medical teams being able to print replacement body parts is exciting.  As someone who has experienced reconstructive surgery, the idea that surgeons can perfectly recreate an exact match brings great hope.  Patients would no longer have to rely on artistry and good fortune - or repeated surgeries - to obtain symmetrical, life-like results.

New 3D printing technology created by a team at Wake Forest University in North Carolina is showing great promise reliably printing human tissue and organs. Bioprinting, as it is known, is a big leap for medical technology and is now coming into its own as an effective and beneficial means of healthcare and healing. The bioprinter works similarly to other 3D printers, but instead of printing in metals or plastics, it prints hydrogels containing human cells. What is special about this new printer is that the tissue that it prints is able to accept blood vessels and therefore essentially keep the cells alive. This research is especially exciting for the medical community, which is already looking to the future and the potential that this technology has for us.

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AuthorRenee Eaton

Cardiologist Wilson King, who works at SSM Health Cardinal Glennon Children’s Hospital in St. Louis has been using 3D printing to make models of patients’ actual hearts. By using medical images generated from techniques like Heart CT scans and Ultrasounds, King is able to render 3D models of his patients’ actual hearts. This ability enables doctors’ and surgeons’ to anticipate and prepare for diagnoses and surgeries. Additionally by making a model, doctors are able to physically practice placing devices into each individual’s heart. When patients have unique anatomy or particular heart conditions, 3D printing can be used to more comprehensively understand each case.  

As RapidMade has reported before, another benefit is patient and physician education - explaining complex medical procedures is much easier when one can see and touch a replica - and what could be cooler than seeing and touching an exact copy of your own organ.  

This case is jut another great example of why 3D scanning and printing have become so widely adopted in medicine.