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.

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.