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.
From Charles Goulding at 3dprint.com
I had the privilege of attending a two-day Future of 3D Printing in Medicine and Dentistry conference on January 22nd and 23rd in Washington, D.C. at the Army and Navy Club. The Additive Manufacturing Strategies summit was sponsored by SmarTech Markets Publishing and 3DPrint.com.
3D Printing Medical Devices
Day one was entitled 3D Printed Medical Devices. The opening keynote speaker was Lee Dockstader, Director of Vertical Market Development at HP Inc., whose thorough presentation set the stage for the entire conference. Dockstader wants to develop additive manufacturing in industries including Aerospace, Automotive, Medical, Dental, Life Sciences, Consumer and Retail.
Scott Dunham, Vice President of Research at SmarTech Markets Publishing, gave a comprehensive presentation that was particularly informative on the large production volumes occurring with certain non regulated low entry barrier products. The consensus estimate is that 300,000 low barrier medical devices are now 3D printed per day. Dr. Roger Narayan, Professor of Biomedical Engineering at UNC, gave a detailed presentation on the technical and regulatory aspects of additive medical markets. 3D printing has the potential to revolutionize business models and provides access to custom and functional prosthetic and orthotic medical devices.
Where you live should not determine whether you live or die, to quote Bono, lead singer of the rock band U2, but, sadly, it often does. I was reminded of Bono’s phrase as I was reading about the contribution that Silicon Valley–based 3D-printing technology company Carbon (Redwood City, CA) made to the development of a low-cost, easy-to-use in vitro diagnostic (IVD) device to test for tuberculosis (TB).
Of the 10 million people that contract TB globally each year, more than 40% go undiagnosed or unreported, the vast majority of whom live in the developing world, according to the World Health Organization. To address this issue in countries with limited healthcare infrastructures, the Global Good Fund (Bellevue, WA) got to work. A collaboration between Intellectual Ventures (IV; Bellevue, WA), a private enterprise involved in the development and licensing of intellectual property, and Bill Gates, the Global Good Fund spearheaded the development of an easy-to-use, affordable early TB diagnostic device. Carbon brought its expertise to the project, which resulted in the manufacture of hundreds of these devices for use in field trials.
South African biotech startup Akili Labs has developed FieldLab, an accurate, affordable and portable 3D printed diagnostics lab that can cost as little as $1,500, or one-tenth of similar equipment.
The FieldLab was created by Akili Labs co-founders and Rhodes University Biotechnology Innovation Centre (RUBIC) graduate students Charles Faul and Lucas Lotter. Their aim is to give doctors and scientists a rapid and accurate means of identifying disease outbreaks on the spot.
The FieldLab in a box
FieldLab is a rapid field-testing “lab-in-a-box.” It allows medical professionals in remote areas and conflict zones to access equipment typically found in state-of-the-art diagnostic laboratories. By testing for certain viruses, bacteria, and fungi on site, they can quickly identify an outbreak of disease and take the necessary measures before it spreads and becomes an epidemic.
3D printing offers “a tantalizing step toward changing the manufacturing processes” for personalised medicines says a US FDA scientist.
FDA today offered a clearer picture of how it plans to regulate the 3D printing of medical devices – including in non-traditional settings such as medical facilities and academic institutions.
“In order to help ensure the safety and effectiveness of these products, we’re working to establish a regulatory framework for how we plan to apply existing laws and regulations that govern device manufacturing to non-traditional manufacturers like medical facilities and academic institutions that create 3D-printed personalized devices for specific patients they are treating,” FDA Commissioner Scott Gottlieb said in a statement.
Gottlieb also highlighted new guidance that clarifies what the FDA in the U.S. would like to see in submissions for 3D-printed medical devices. The guidance includes FDA regulators’ thinking on device design, testing of products for function and durability, and quality system requirements when it comes to 3D printing. FDA is describing the document as a “leapfrog guidance” because it offers initial thoughts on technologies emerging in the industry.
As medicine advances, technology is playing an ever-increasing role. The development of CT and MRI scanners to see inside patients, pacemakers to keep hearts beating, and prosthetic limbs that interact with the nervous system, have proved how valuable technology can be for our health. Has technology got our backs again, this time with an organ transplant crisis?
There is a severe need for new organs for transplantation around the world. In the last decade, nearly 49,000 people have had to wait for a life-saving organ transplant, in the UK alone. Of those, over 6,000 people have died whilst waiting – all possibly preventable if organs had been available. The issue is, with an ageing population and a safer environment, there are fewer organs available for transplant, and more organ failures requiring a transplant. The vast majority of the demand is for kidneys, with over 5,400 on the current UK waiting list.
Patients could benefit from printed body parts in just five to 10 years, according to Reza Sadeghi, chief strategy officer at Biovia group of technology company Dassault Systemes.
Bioprinting first generated media buzz several years ago, when researchers showed videos of ears grown in a lab and 3D-printed skin.
Since then, the bioprinting sector has been developing at light speed, thanks to computer models, lab experiments and animal trials. The major progress today is the successful development of biomaterials that can actually be used for bioprinting, Sadeghi told PE at the Manufacturing in the Age of Experience conference currently underway in Shanghai, China. He also predicted that human trials are now less than half a decade away.