We've blogged before about firms that are using 3D printing to help the visually impaired "see."  Innovative individuals and businesses have found unique ways to enhance the aesthetic, educational, and medical experiences of people with different levels of blindness.

In Helsinki, designers are 3D printing replicas of famous works of art so that they can be touched and experienced in a way like never before; objects can now be handled by visually impaired students so as to better understand concepts in their education.

A doctor in New Zealand has applied this technology to create an affordable medical device that can help examine patients’ eyesight and diagnose conditions that can be treated and prevented.

In this one field of medicine we in turn can see a global effort to make lives better through 3D printing and its versatile array of applications.

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.

 

 

Thomas Davis, linebacker for the Carolina Panthers, may be playing with a 3D printed brace on his recently broken arm during the Super Bowl today. Davis, who is having one of the best seasons of his career, still wanted to play in the game, and his team wanted him too. After doctors surgically installed a plate and a dozen screws in his arm, the question was how to further protect his healing arm from additional damage. The answer came in the form of a 3D printed arm brace. His arm was 3D scanned which was then sent to engineers to develop the brace. It had to be comfortable, light, breathable, and abide by standards set by the NFL for braces. Since receiving his brace, Davis has been spotted utilizing it in practice and testing its durability. It is still not guaranteed that he will play but if he does then 3D printing may affect the outcome of the Super Bowl this year. 3D printing is revolutionizing the way we approach sports medicine in addition to the myriad other medical applications it has already proven to have.

PrintAlive BioPrinter Process...

Image Credit:  Inside 3DP

Image Credit:  Inside 3DP

Researchers at the University of Toronto have built the PrintAlive Bioprinter which prints skin grafts derived from a host patient's own skin cells.  These cells, used as the material "ink" needed to produce the build, are deposited into strips that contain fewer cells than are typical in the "full continuous sheets" commonly used.  The benefits of this approach are two-fold:  it is faster than using cultured skin cells which take two weeks or more to grow enough to be grafted.  And when skin damage runs deeper than the epidermis, this technique's bioprint pattern allows multiple layers to be applied and still survive.

The team includes Masters students Arianna Mcallister and Lian Lend, PhD student Boyang Zhang and University of Toronto Associate Professor of Mechanical and Industrial Engineering Axel Guenther. To date, their research has been confined to mice, but the researchers reportthe technology has worked to heal "severe wounds" and they expect human trials may be possible in two to three years.

Further south, a research team at the University of Massachusetts Medical school, led by Dr. Jie Song, is using a MakerBot Replicator to print a latticed scaffold implant it hopes will someday promote healing in damaged bones and tissues.  Unlike the traditional filaments used in FDM printers, this 3D printer is fed a combination of "plastic and the therapeutic stem cells or proteins that a patient needs to heal, and the flexible scaffold that emerges could become a kind of patch for use by surgeons."  The lab is also investigating a similar approach to "regenerate the periosteum, a tissue that covers bone."

 

 

 

 

 

 

 

 

Working in the Portland State Accelerator, we are literally down the hall from a number of interesting tech-based companies, so we come across a lot of cool products.  For some residents, we provide engineering support, for others, rapid prototypes, 3D printing, 3D scans, parts, molds/tools, and models.  We thought it would be fun – and informative - if we showcased some.  Two of our neighbors use sensors for monitoring in powerful ways.  Today, we'll showcase the first...

APDM creates movement monitoring solutions for health conditions, biomedical research and athletic training.  Originally designed to collect data from people affected by Parkinson’s, their wearable sensors are widely used in research and have evolved to “include a Clinical Data Management System (CDMS) called Mobility Exchange.”  Three options are available:  sapphire, emerald, and opal which include many features (docking stations, body straps, temperature calibration, and data logging among others). 

Having two relatives stricken by Parkinson’s, it’s excited to see devices that are unobtrusive - imagine a monitor as small as a watch - yet effective enough to gather volumes of data to fuel research demands.