Advances in medical technology are giving amputees more practical and adaptable options
After seven years of war, an estimated 86,000 Syrians are coping with losing a limb to amputation, according to the World Health Organisation and disability charity Handicap International. IRIN recently spent a day in neighbouring Jordan, exploring how 3D printing technology can produce a new generation of replacement limbs that are more comfortable and adaptable than traditional prosthetics.
3D-printed devices such as surgical instruments and implants offer treatment advantages for ASCs and hospitals but also entail liability risks if the device isn’t ‘manufactured’ properly, according to CNA Vice President of Underwriting Ryann Elliott.
The FDA defines a manufacturer as “any person who designs, manufactures, fabricates, assembles or processes a finished device.” Therefore, the FDA may be authorized to regulate and inspect healthcare facilities creating medical devices through 3D printing.
Facilities should implement these five strategies to mitigate risks:
1. Tracking. Implement procedures to track all 3D-printed products brought into the facility. Identify which physicians have the appropriate credentials and privileges to use the products.
Last month, legal practitioners, industry, and academics gathered at The Legal, Regulatory and Business Conference on 3D Printing to discuss the legal, regulatory, and business issues that arise when products are manufactured using 3D printing or additive manufacturing techniques, rather than traditional manufacturing methods.
During the conference, 3D printing was described as the digital revolution, the fourth industrial revolution, a game-changer, and a disruptive innovation. Although the conference focused on all different types of 3D-printed products and uses, it is safe to say that the printing of medical devices falls under each of these descriptors, and may comprise some of 3D printing’s most innovative uses.
Medical technology continues to advance all the time, with life-saving procedures and medicines that were previously unheard of. Now, Global Data believe that 3D printing could be as disruptive to healthcare as the internet has been to retail.
The company initiated a study for its Disruptor Tech database, and the results revealed that 3D printing could revolutionise the supply chain by limiting the gaps between sourcing, production, and distribution. 3D printing has the ability to create ‘clinical trial ready’ devices without the need for expensive tools, computer-aided manufacturing, and computer numerically controlled manufacturing. As a result of this, price is lowered and waiting times are also reduced.
Printing accurate models of organs is reducing recovery time and healthcare costs.
16By taking advantage of 3D printing technology, doctors are presented with tangible, accurate models of organs. This is helping both doctors and students to perform better. Some programs and labs have been started in hospitals to try and adopt 3D printing technology. According to doctors, the program has empowered med students to invent their own solutions to healthcare challenges and helped tighten design cycles. Their products draw from training and experience with actual patients, striving to make a difference in the quality of care for future generations.
The following was derived from an interview from an interview with Todd Pietila, Materialise’s business development manager for hospital 3D printing. He talked about what models are printed, how they help, regulations, and more.
Three-dimensional printers are letting doctors in Minnesota make simulated body parts in a hospital and a Brooklyn startup create rocket engines designed to put satellites into orbit, executives said Thursday at an event hosted by General Electric Co.
The unusual locations for additive printing, highlighted at the first such event GE has organized, showed how quickly the technology is moving beyond plastic prototypes to everyday industrial use.
Companies are now routinely printing titanium engine parts, customizing dashboards of high-end cars, turning out jewelry and eyeglass frames and developing rocket engines.
Medical device designers and manufacturers have many special needs that 3D printing can help meet.
3D printing, also known as rapid prototyping and additive manufacturing, is slowly making the leap from a method of making prototypes to one that can also make functional parts. But even in its current state, doctors and biomedical engineers can make good use of 3D printing in a wide variety of links in the medical-device value chain, according to Stratasys, one of the leading manufacturers of 3D printers and a presenter at the MDTX Show.
For medical R&D. 3D printing does live up to its original name of rapid prototyping. It lets biomedical engineers move more quickly from design to physical object and from verification to validation, and then the final design. They can mock up a non-working version to test the fit and form of instruments and implants. In many instances, 3D printing also lets them build functional parts for testing. The prototypes are created quickly compared to previous times when they were hand-crafted by skilled modelers. This speeds up the design phase by letting the engineering team go quickly through several iterations on a design, incrementally improving it or rejecting different approach. Prototypes can also be given to physicians for feedback, and they intuitively understand 3D prototype faster than by trying to understand how a 2D model on a computer screen will look and feel.
Low-cost, 3D-printed robotic prosthetics have been developed by students at the University of Manchester that could provide a much cheaper alternative for amputees.
The hand’s joints are all fully posable with each individual finger and the thumb being able to move as well as make a fist.
The functionality of the hand allows its user to do simple everyday tasks such as picking up items, eating using a knife and fork, typing and clicking a mouse or opening doors. It can even play rock-paper-scissors.
The students built the hand for just £307 and reckon they can make it even cheaper. In comparison, an advanced robotic prosthetic limb currently on the market can start at approximately £25,000, going up to £60,000 if bought privately.
A trauma center in the Netherlands is using 3D printing technologies to improve the treatment of trauma patients, especially those who are admitted with bone fractures. The technology is being explored at the Elisabeth-TweeSteden Ziekenhuis (ETZ) trauma center by a team of trauma surgeons and researchers.
At the ETZ, one of 11 trauma centers in the Netherlands, PhD candidate Lars Brouwers is testing the effectiveness of 3D printing for trauma treatment. He has been tasked with the job of transforming medical scans of bone fractures into patient-specific 3D printed models. The 3D printed bones are then being used as pre-surgical aids for doctors and as explanatory models for patients.
Brouwers, along with ETZ trauma surgeons Mike Bemelman, MD and Koen Lansink, MD, believe that physical 3D printed models can offer surgeons a better and clearer understanding of a patient’s injury than 3D models visualized on a 2D screen.