Sunday, February 28, 2016

3 Biggest Challenges to Healthcare Innovators

          Medtech companies are used to running into regulatory obstacles during their innovation processes. According to MDDI, these companies are divided into three type of business: large scale medical device innovators and manufacturers; new device innovators (ranging from the surgeon with a good idea to the existing medical device company with a product line of a few products); software technology innovators. It’s true that they all share common challenges, but their primary ones are different according to their role in this complex industry.

Source: MDDI

When talking with each segment; here are the three biggest challenges they all share:
1. Cost and complexity to improve and enhance innovation: large scale medical device innovators have a great overview of the marketplace and the regulatory system, but identifying the best R&D opportunities is not always easy. Big data analytics are expensive and complex to implement. “The more incremental the deployment of any new technology can be made, the more likely you are to achieve final success.”
2. Time and volume of follow-up and tracking data from FDA: it’s very time-consuming to go through FDA notices, recalls and regulatory changes. “Technology now allows you to both take optimal advantage of the level of effort required and increase the quality of the results for you by automating the access to the data.”  
3. “Getting blindsided by regulatory issues is probably the most common complaint from software innovators”. Having access to FDA guidance, regulations and industry best practices can help these innovators avoid this type of problem.

Sunday, February 14, 2016

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.