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Medical device manufacturers might consider outsourcing product development or product testing activities for a number of reasons. In general, if an outsource provider has specific experience that you lack, has more resources available, or doesn’t carry all the overhead of a large corporation, then you may be better off outsourcing. By outsourcing, manufacturers can often eliminate both direct and indirect development costs. These costs can...

You saw the prototype working. The preliminary clinical data looked promising. There was a huge market need for the product. It looked like a sure thing. Then, two years later than anticipated, the product fi nally gets to market. Development costs millions more than expected. Worst of all, because it took so long to get to market, you now have three competitors that didn’t exist...

The complexities of developing a high-tech medical device are so daunting to the inexperienced that it may seem that luck has more to do with success than anything else. Why do companies with similar products sometimes take very different amounts of time to launch new products, and why do they have very different success rates? The performance differences are so consistent that it suggests that...

How do some medical device firms manage to trip over their own feet? Let us count the ways: trying to get away with “good enough,” leaving risk management and verification & validation for later, and earning a reputation for sloppy work.    Since everyone is a patient eventually, no one wants to believe that medical devices are subject to the same design and implementation flaws that sometimes...

Never heard of software safety? Well, get comfortable with it, because it is here to stay. Software safety is a term that originated in the aviation industry to refer to the collection of definition, design, implementation, analysis, and validation activities that are associated with software development for safety-critical software. The medical-device industry is an additional player now leading the charge toward adopting such terminology, as...

How do some medical device firms manage to trip over their own feet? Trying to get away with “good enough” and consequently earning a reputation for sloppy work are not uncommon. But the biggest single mistake is putting risk management, verification and validation at the end of the product development project instead of building it in from the start.   The U.S. Food and Drug Administration regulates...

Medical device manufacturers that use manufacturing or test instruments that rely on software may be required by federal law to validate that software. This may include software that is embedded as part of the instrument, or external, including off-the-shelf, software that interacts with the instrument. This article does not address software that is embedded in a medical device; it relates only to software or software...

Manufacturers of medical devices are required by federal law to validate software that is part of the manufacturing or quality system. But there is confusion about what this means. What software does the FDA regulate? What level of validation is required? There are no checklists available from the FDA. However, an Association for the Advancement of Medical Instrumentation (AAMI) workgroup has been formed to write...

The FDA requires medical-device manufacturers to validate software that is part of production or a quality system. But what does that mean? Those charged with the job are often not software engineers nor do they have backgrounds in validation or regulatory issues. As a result, some manufacturers fall short of validating quality-system software for its intended use.   Production software is part of the “quality system.” It’s...

Validate it? I just want to use it! Sound familiar? Most companies in the medical device industry understand and accept the need to validate software that is critical to the functioning of a medical device. Perhaps not as widely understood or accepted is the regulatory requirement to validate software that is used to automate any process that is part of a medical device manufacturer’s quality...