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Archive for category: Biopharmaceuticals

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Life Science: Managing Risk throughout the Regulatory Process

Medical device product development is both a complex and highly difficult process. The developer must have a vision of the desired outcome before they conduct research, development and marketing of the product and begin regulatory compliance.

Because of their nature of use, regulation and approval of the product must be met before the product’s release. The FDA’s regulation process can include a number of production “kinks” at first. The public’s safety is the FDA’s number one concern and the efficacy of the device is the second. An approval process can include an evaluation of potential risk, manufacturing processes, potential harm the device may cause, pre-market evaluation and approval, and post market evaluation. The FDA will then classify the product as a Tier I, II, or III. The device then must be put through the IDE and IRB processes. The Investigation Device Exemption allows the device developer to test the unreleased product by using it as it has been intended. The data from this test will then reveal important information which will be evaluated by a review board before entering clinical trials.

After the review board sets up a comparable clinical testing environment, the trials can then begin. The clinical trial process is divided into two sets, pivotal and pilot. The pilot phase is less stringent, testing the basic safety of use of the product. The pilot phase sets the stage for the pivotal trials which use a larger group of testers with a more extensive type of safety testing and use testing.  After the product passes these regulatory phases mass development can begin.

Product launches are a key milestone and require a great deal of risk management strategy for success.  It is important to work with an insurance and risk management firm that is knowledgeable about the life sciences industry and understands how to make risk control an important component of your overall program.  Working with a TechAssure Association member can help your firm stay protected through the rigorous regulatory process of medical device development and a new device launch.  

Please contact us to learn more about developing a comprehensive insurance and risk management program for your product development and launches.

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TechAssure Risk Survey Highlights Challenges in Regulatory and Legislative Risks for Life Science Firms

The 2013 TechAssure Risk Survey highlights the challenges in regulatory and legislative risks for biopharmaceuticals and life science firms.

The Biopharmaceuticals and life sciences sector was also included in the survey. Based on the survey and our research and experience we identified the top risk concerns for firms operating in the sector. The top three risk factors were risk of damage to reputation, brand, and image, potential changes in the corporate governance, regulatory, and legislative environment, and failure to access capital in that order. Our research has also found that increased competition in the global scene, risk of losing intellectual property, risks associated with the supply chain and inability to manage risks with partners and strategic alliances are among the top risk factors for concern in the Biopharmaceuticals and life sciences sector. Other top ranking risks are associated with network, privacy, and security, inability to innovate new products and services, and risks of delays and interruptions in R&D.

To retrieve a full copy of the summary of the 2013 TechAssure Association Risk Survey, please contact a TechAssure member.