Establish the Safety of Your Medical Device with IEC 60601 Compliance
In our experience, the most frequently forgotten aspect of medical device development and commercialization from emerging companies is establishing a safety profile of a product. While clinical data or clinical trials may be necessary for establishing safety for some products, many Class II devices that follow a 510(k) clearance pathway require minimal, if any, clinical data to support safety claims. Once the need for clinical data is either planned for or eliminated, establishing the safety of a medical device through additional testing tends to be less of a priority.
Depending on the technology incorporated into your medical device, applicable safety standards need to be identified during the design stages of the product. The most widely accepted benchmark for establishing safety for electrical medical devices is a standard called IEC60601-1, where compliance has become an acceptable means for satisfying electrical safety requirements for the commercialization of electrical medical devices in the European Union.
60601-1 has undergone revision recently. The third edition is enforced now in the EU and the second Edition is currently applicable in the U.S. The FDA will require the use of the third Edition of the standard for new devices as of June 30, 2013. In this new edition of the standard, there is strong emphasis on risk assessment, ISO 14971 and, in the U.S, a focus on device usability as an important factor contributing to the safety of the device.
Product testing to 60601-1 is a very technical exercise that involves laboratory testing against the standard by a test house, such as Underwriters Laboratories. If you are complying with the third Edition, there is the additional task of demonstrating safety through extensive, component-by-component, risk assessment.
While complaints about the complexity and cost of safety testing in general and 60601-1 in particular have many sympathetic ears, safety testing has significant benefits. Meeting the demands of safety testing is a necessary step for electrical medical devices in the commercialization process. Through test house examination and risk assessment, it forces a very deep understanding of your product, which can be invaluable for product improvement, market positioning and sales and exit strategies.