The development of new medical devices is arguably one of the few areas in industry where resources continue to be invested, almost at odds with challenging market conditions. This ongoing determination to improve design has led to increasingly complex solutions. However, a new report has raised concerns that device testing isn’t as far reaching as perhaps it should be.
The report, carried out by the Medicines and Healthcare products Regulatory Agency, and supported by the Academy of Medical Sciences, has called for the industry to take note of the engineering model for assessing safety, which has been built through dialogue between industry and regulators.
At Dawson Shanahan, we work closely with our customers, regulators and quality control bodies. We’re approved to ISO 9001 and follow the discipline of cGMP. At all stages of a project, such as that recently carried out with Zogenix to develop a needle-free drug delivery system, we carefully monitor and control every step of the manufacturing process to ensure 100% reliability in the finished product and total safety for the user.
The medical device report makes a number of important points and raises several vital areas for discussion. In particular, the need for all sectors of industry to share both knowledge and best practice is crucial if we are to continue to exploit new technologies and practices safely and to best effect for medical device manufacturers, health professionals and patients alike.