WIMAS 2015: International Workshop on Additive Manufacturing for Healthcare

WIMAS (International Workshop on Additive Manufacturing for Healthcare) took place in Campina Grande, Brazil from November 18-20^th. The event gathered together representatives from several different sectors interested in applying additive manufacturing (commonly known as 3D printing) in healthcare. Among the guests, there were people from the academy like researchers from IME  (Military Institute of Engineering) from Rio de Janeiro, NUTES (Center of Strategic Technologies for Health) and the team from the Sao Paulo-based Renato Archer Institute. There were also representatives from regulatory bodies like ANVISA (Brazilian Health Surveillance Agency) and the FDA; public institutions like the Ministry of Health and the SENAI Innovation Institute. Besides people from the private sector and companies like URI Medical and Biokyra.

      During the event, it was discussed relevant strategic issues for the application of the technology in healthcare as the development of protocols throughout the model building process, from segmentation of the medical image, i.e. regulate programs that make this process, until the manufacturing process used for materialization of the implant or biomodel, besides the form of sterilization and the risk ratings for each 3D printed product.

In addition to the round discussions, Biokyra had the opportunity to present the surgical cases that have recently been done and the products that are being developed within the company.

The future of medical device startups

The panelists from a Tuesday panel of Silicon Valley–based medical device entrepreneurs at BIOMEDevice San Jose conveyed the clear message that the venture funding for medical devices has dried up, but opportunities abound in the medical device space. One of them is Kathy Stecco, the co-founder and chief medical officer of Panthera Medtech, a startup acquired by Avantec Vascular Corp. (Sunnyvale) – that had 20x return without any venture capital backing.

“I am pushing people away from the VC route. The more you can bootstrap and look for alternative funding, the better it tends to be for the long-term growth of your company,” said Stecco.

According to Kathy Stecco, many medical devices could be developed by small teams of self-financed rogue entrepreneurs working with a team of consultants. “If you have a 510(k) device, you can often self-fund your device. Go shopping at Fry’s Electronics, build your prototypes, do your testing on your own—do whatever you can on your own,” she said. “It is doable to get a 510(k) by yourself—especially if you don’t need clinical trials. You can either use your own financing or apply for grants to help with funding.”

Tom Ross, CEO of Pontis Orthopaedics, suggested that medical device startups grow their team based on how far the technology is from commercialization. More established companies might need more full-time support. The route of a startup can change, requiring more consultants than full-timers.

It is beneficial to frequently look for third-party insights from people who are not personally interested in the startup’s growth.  

Brenneman, CEO of Rox Medical, recommended that startups look for funding overseas. “There is a lot of money coming out of China right now,” he says. “It comes with big strings attached, but there’s a lot of funding there. ... There’s also some off-shore money coming from Europe into the U.S. market. If you are going long and have a PMA device, you might consider that.” When considering Chinese money, it is a great idea to get Chinese patents, says Joel Harris, senior director of intellectual property at InCube Labs (San Jose). “It used to be that people didn’t take the Chinese patent system seriously, but it is increasingly important. China is now part of the WTO. Any Chinese partners are going to want to see that patents are filed there,” he said. “Just keep in mind that when you file in various foreign jurisdictions, it can get very expensive.”

Biokyra is a medical device company based out in Brazil that started off as a startup. It develops minimally invasive medical devices, from the idea/need to the pre-series production.

3D printed realistic brain model assisting complex brain surgery

In the past few years, we have seen 3D printing helping medical procedures and surgeries around the world.  Based on CT scans, printed bones to organs such as hearts have all been made to assist physicians. It can be applied to just about any medical field and Dr. Ivar Mendez, head of surgery at the University of Saskatchewan, proved that by 3D printing a brain replica for a complex deep brain stimulation procedure.

3ders.org

The procedure involves opening the skull and inserting electrodes into toe brain folds and a small error can do permanent damage. So Dr. Mendez always carefully prepares using computer simulations, but this time the technology failed him. The limitations of the software became apparent as it could not predict how the tissue would react. That’ why the Canadian physician contacted the University’s school of engineering and assembled a team of experts: engineers, a radiologist, MRI specialists and neuropsychologists. All with the purpose of translating complex brain MRI data into 3D printable files.

             After about seven months of work, they 3D printed an initial prototype in rubber, but that didn’t accurately display the necessary smaller features. Just now, Mendez and his team completed a larger, more detailed model he can work with. ‘You can actually do the surgery. You can actually put the needle in the brain,’ he said of the surgical model. ‘You can get really lost, because you really don’t know. But when you have the model it lets you see exactly where you want to go,’ he adds. 3D printed in transparent synthetic rubber, this brain replica even matches the consistency of an actual brain.

New Method for Customised 3D printed Medical Devices

A new 3D printing technology enables the creation of medical devices such as catheters for premature newborns customised to each patient. These devices will be stronger and lighter than existing models.

Gadgets360

"If you can print a catheter whose geometry is specific to the individual patient, you can insert it up to a certain critical spot, you can avoid puncturing veins, and you can expedite delivery of the contents," said Randall Erb, assistant professor at Northeastern University in US.

“Using magnets, Erb and Martin's 3D printing method aligns each minuscule fibre in the direction that conforms precisely to the geometry of the item being printed. The researchers "magnetise" the ceramic fibres by dusting them very lightly with iron oxide, which, Martin notes, has already been approved by US Food and Drug Administration (FDA) for drug-delivery applications.”