November 14, 2014

Managing Risk: A Key Challenge for Medical Device Development

Helix ALM
After analyzing the results of this year’s State of Medical Device Development Survey, we identified three key challenge areas in the industry: managing risk, working with documents, and overcoming barriers to improvement. Over the next few weeks, we’ll take a closer look at each of these challenges and explore how TestTrack can reduce or eliminate these pain points. Managing risk is the first key challenge we identified as we analyzed the survey results. We asked several questions exploring how medical device developers control risk during the development process, including:
  • How do you manage risk identification, analysis, and mitigation?
  • What types of risk management methods do you use?
  • At what point in the process do you start documenting risk?

Risk Visibility Is a Key Challenge

Risk visibility is limited for a majority of the industry. “Risk Controls” is one of the top three areas identified by survey respondents as needing better visibility. When risk control assets have limited visibility, it impacts development costs, time to market, and product safety.   The majority of survey respondents manage risk documentation through shared files on a network (47%) or in a document control system (43%). Only 10% said that they break down risk into individual artifacts and track them from the very beginning of the development lifecycle. manage-risk 600

What’s Wrong with Documents?

The problem with both shared files and document control systems is that they don’t provide the visibility risk controls need to be effective. Risk assets can easily get overlooked as the team focuses on implementing product features. The longer the development process, the more easily risk controls are misplaced. When development efforts span several months or years, the reasons why certain safety requirements even exist may be forgotten. When risk controls get overlooked, bad things happen. Costs go up. Safety levels go down. Development work may need to be re-done if risk control assets are discovered late in the process, delaying the product’s release and increasing overhead. When issues are found after release, the result could be a damaging recall or even patient harm. There’s also the issue of legal compliance. Increasingly stringent regulatory requirements have added complexity and cost to medical device development, leading companies to seek better risk mitigation techniques and tools.

TestTrack Increases Risk Visibility

One solution to improving risk visibility and tracking is Seapine’s TestTrack. TestTrack enables teams to conduct risk analysis and mitigation within a comprehensive, end-to-end, wholly traceable system, capturing and recording all relevant data throughout development. Over 60% of the top medical device manufacturers use TestTrack, in addition to many smaller medical and biotechnology companies. TestTrack provides the configurability to adapt to a company’s individual needs, ensuring the right people see the right risk controls at the right time. Assuring regulatory teams, management teams, and investors that automatic notifications and escalations, auditing, and electronic signatures are incorporated into the daily development and quality assurance processes lessens the exposure to risk. With TestTrack, teams can create an intuitive and effective development and quality assurance process by centrally managing requirements, risk artifacts, feature requests, source code, digital assets, issues, test cases, test runs, and automated tests. One major advantage and value Seapine can deliver is end-to-end traceability of all artifacts—the vague requirement the FDA is auditing on a more frequent basis. In order to be effective, risk mitigation artifacts must be highly visible to everyone involved in the development and testing of the product. TestTrack allows teams to reduce the time spent on risk management by focusing on traceability between requirements and corresponding risk controls. Learn more about Seapine’s solutions for the medical device industry.