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”.

Medtech Industry needs to build credibility with Hospitals

McKinsey & Co. released a new report, called "Improving healthcare while curbing cost: Med-tech companies offer a solution", showing that the medtech industry has to, not only build awareness of its products and solutions, but also build credibility among hospitals.

MDDI

The McKinsey survey 157-hospital executives in the U.S. and Europe, fewer than half ranked the clinical and technical expertise of large equipment manufacturers as "excellent." The result was even worse for makers of devices and consummables. Only 19% of hospital executives responded that large medtech makers' understanding of the hospital business was "excellent."

"With few exceptions, med-tech companies do not offer to share risk with their hospital customers," the report charges. "They focus on marketing the technical features of their products and price accordingly. Yet providers say they are more willing to work with med-tech partners if they know they share the risks as well as the benefits of the arrangement."

       The report suggests that there is a $44 billion opportunity in the U.S. if medtech companies work with hospitals and provide "beyond the product" solutions.  It also points out that executing contractual agreements where medtech companies share risk would help to build credibility.

Contract Manufactures and Evolving Medtech Needs

According to QMED, besides regulatory complexity and the challenges of handling large companies, healthcare firms' profit margins are falling leading medtech companies to rely more heavily on contract manufacturers – which, in these days, quickly turns into contract development: from early product design to the manufacture of finished products.  

Source: QMED

Since companies are looking for assistance with product development, working with contract firms often signifies cost savings in the long run. “Decisions made early in the design cycle typically end up driving a majority of a finished product’s ultimate cost”. “The earlier you can look at a design, the earlier you can optimize it for manufacturing,” says Tim Hopper, CMO at EG-GILERO.

Such partnerships, between a design and a manufacturing company, bring together the theoretical and practical, according to Betten. “The merger gives the organization the ability to go from A to Z,” Betten said Wednesday at MD&M Philadelphia.