Why we need an Elon Musk in healthcare

   2016 is not even over yet but it has already been a fantastic year for billionaire businessman Elon Musk: Tesla Motors revealed its Model 3 car in March and in April SpaceX was finally able to land the reusable Falcon 9 rocket on a platform at sea. Musk has brought his ambition, innovative ideas and hard work to everything he touches: besides the electric vehicle company and the private spaceflight firm, Elon Musk also cofounded Paypal and has plans to colonize Mars by 2014. However, healthcare is probably the sector in which his golden touch is needed the most, with the aging population and medical costs going out of control.

   One important reason why Elon Musk has been able to drive breakthrough changes in the areas he’s been working with is that he’s not afraid to aim high and it’s time for that kind of big thinking in healthcare. “Instead of treating cancer, we need people set on eradicating it”, states Jamie Hartford - MD+DI's editor-in-chief. How inconceivable is it really to think we can’t wipe out this disease by the time we see the first generation of men on Mars?

   Another great thing about Musk is his realization that he cannot achieve everything by himself: SpaceX’s open-sourced design and Tesla’s open patents are an example of this – as Musk explained in 2014, “sharing intellectual property benefits not just his companies but the entire world”. Our industry players need to start thinking outside of their own organizations if we want to solve many of the healthcare problems we face today.

   Elon Musk’s ability to fascinate has truly inspired his followers to go on to launch their own groundbreaking companies – here’s to at least one of them come to disrupt healthcare…

FDA’s initial thoughts on 3D printed medical devices

The U.S. Food and Drug Administration (FDA) has recently released a draft guidance for the 3-D printed medical devices sector. The agency took into consideration inputs from device manufacturers, 3-D printing companies, and academics who testified at a 2014 hearing. According to QMED, the document covers device design, manufacturing, and design testing and for the purposes of the draft, FDA identified four main types of 3-D printing—powder fusion, stereolithography, fused filament fabrication, and liquid-based extrusion.

Source: QMED

3D printed medical device producers would have to “clearly identify every step in the 3-D printing process, and might need to submit a ‘high-level summary of each critical manufacturing process step,’” the guidance says. They would also have to record each step’s risk, and describe how they would lessen those risks. “The type of testing data needed would depend upon whether the device is an implant, load-bearing, and available in standard sizes or custom-made for each patient, or as FDA put it ‘patient-matched.’”

The implications for 3-D printed devices are enormous – therefore the draft guidance is the agency’s initial thoughts on the technical considerations surrounding the design, manufacture and testing of 3-D medical devices, which have few precedents. “While this draft guidance includes manufacturing considerations, it is not intended to comprehensively address all considerations or regulatory requirements to establish a quality system for the manufacturing of your device,” the agency said.

The draft guidance “provides a solid basis for medtech innovators to understand what is needed to prove safety, efficacy, and consistency to growing on-demand components for the human body,” said Derek Mathers, an adjunct professor of 3-D printing at the University of Minnesota and business development manager at Worrell Design in Minneapolis.

     “Standard-sized 3-D printed devices are offered in discrete sizes, and include features that are too complex to be manufactured with traditional processes like machining and molding,” he explained. “Patient-matched 3-D printed devices are devices that are digitally scaled (manually or by using an algorithm) to match a patient’s specific anatomical features. The FDA identifies that these bespoke devices will require significantly more validation work across every step of the ‘scan-to-fit’ design process.”

Computer simulation on biomedical products: a true possibility?

Computer simulation is broadly used during the development of several critical products such as civil aircraft or nuclear power plants. However, the healthcare industry still mainly rely on long and complex experiments in vitro, on animals, and then on patients, which causes a deep cost pressure – investment that could be used on innovation. The technical term is ‘in silico clinical trials’, which refers to: “The use of individualised computer simulation in the development or regulatory evaluation of a medicinal product, medical device, or medical intervention.”

According to researchgate, Avicenna Action, funded by the European Commission, has engaged 525 experts from 35 countries, including 22 of the 28 members of the European Union, in an 18-month consensus process, to produce this research and technological development roadmap. Providing an overview of where in silico clinical trials technologies are already used; where else they could be used; highlighting barriers that prevent wider adoption.

Research funding agencies, stakeholders, private companies, the academy, the government itself with its regulatory bodies across the world should embrace innovation and write a framework of standards and protocols required to meet safety and efficacy for this type of technology. The European Commission is certainly taking the first step towards a broad conversation inviting experts for several different countries to the table.

Brazil’s trend on the healthcare industry

While ABIMO (Brazilian Healthcare, Medical and Dental Equipment Industry Association) doesn’t have the final numbers of the Brazilian healthcare industry for 2015, we can analyze the sector’s trend until the previous year. The industry of medical and dental equipment grew by 9.1%, in comparison to 2013; while the job market grew by 2.3%.

Source: European Medical Device Technology

Due to Brazil’s large population and increase spending on healthcare, the country’s imports on medical devices passed the US$ 1 billion mark. The exports, however, reached US$70 million only. The United States is both the main origin of imports and destination of exports. Followed by Germany, China and Japan in the origin side and Argentina, Mexico and Belgium on the destination side. There’s a huge gap on the sector’s average revenue per unit between imports (US$ 114.99) and exports (US$33.04) - which makes the trade balance even worse.

The bottom line is that Brazil continues to be a great buyer of healthcare products due to its inability to meet its own demand. On the other hand, the country can be a great source of exports due to competitive prices, strong regulatory and intellectual property system.

Trend report: Top 10 Medical Device Technologies Market by Type

Research and Markets has announced the release of their new report called "Top 10 Medical Device Technologies Market by Type (IVD, Cardiology, Diagnostic Imaging, Orthopedics, Ophthalmology, Endoscopy, Diabetes Care, Wound Management, Kidney/Dialysis, and Anesthesia & Respiratory Care Devices) - Global Forecast to 2020".

These global top medical device markets are expected to reach more than USD 400 million by 2020, growing at a CAGR of 5.5% during 2015 to 2020. The trend is mostly driven by the rising incidence of chronic diseases and increase in disability-adjusted life years (DALYs), technological advancements in medical devices, and growing aging population.

In this report, the top 10 medical device markets are segmented by type and region: in vitro diagnostics (IVD) devices, cardiology devices, diagnostic imaging devices, orthopedic devices, ophthalmology devices, endoscopy devices, diabetes care devices, wound management devices, kidney/dialysis devices, and anesthesia & respiratory care devices.

In 2014, North America was responsible for the largest share of the market, followed by Europe, Asia-Pacific, Latin America, and the Middle East & Africa.  The U.S. is a major market due to the “easy access to advanced medical devices through well-established distribution channels, high patient awareness on medical device technologies, and presence of advanced healthcare infrastructure”. Asia-Pacific is the fastest-growing region because of “the large population and rising healthcare needs, increased spending capabilities of consumers on healthcare, improving healthcare infrastructure in the region, and increasing investments by leading players and respective government agencies”.

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.