Bringing a new product or service to market is a multi-disciplinary challenge.
Not only do you have to be concerned with the design and manufacture of your product, but you also need to consider any intellectual property and patent issues (both protecting your work and ensuring you have freedom to operate). You might need to find a manufacturer, think about how you are going to package and ship your product, deal with returns, servicing and support. In many global markets, you will also have to think about how your product is regulated; whether that’s meeting basic requirements for safety or meeting more specific standards, within a regulated industry such as medical.
At eg technology, we do a lot of work in the medical sector; helping our clients design and transfer into manufacture their medical devices and IVDs. In addition to our core engineering skills, that also means we have a wealth of practical experience in getting medical devices through some of the key regulatory testing, such as the IEC 60601 series for medical electrical equipment, IEC 62304 for medical device software and IEC 62366 for medical device usability.
However, for medical device manufacturers, completing these tests is only part of the story. Meeting the legal requirements for placing medical devices on the market requires a much broader view of the whole product life-cycle, covering not only the development but manufacture, clinical evaluation and post-market surveillance. The exact terminology and requirements may change slightly, according to whether you are targeting the EU, UK, FDA or other global territories – but overall, these different regulatory environments share many more commonalities than differences. Generally speaking, that means that medical device manufacturers must have an ISO 13485 quality system.
Because the requirements of bringing a medical device to market extend well beyond the design and development of the device, we always recommend that new entrants into the medical device market seek additional specialist advice. A good regulatory consultant can help you navigate many of these complex interactions. They can help you put into place a quality system, that meets the regulatory requirements (ISO 13485) and also help you to tailor it to your company. They will be able to provide bespoke insight and expertise in the regulatory pathway, tailored towards different global territories and dependent on the classification of your device. A good regulatory consultant will also be able to advise you on what clinical evaluation (clinical trials) will be needed. If the clinical trials are particularly complex or extensive, your regulatory consultant may in-turn make an introduction to more specialist Clinical Research Organisations (CROs), meaning you are fully supported across every scenario.
At eg, we firmly believe that a successful medical device development should draw on specialist skills when appropriate, whether that’s engineering, regulatory, manufacturing or intellectual property. Partnering with companies with the appropriate expertise ultimately streamlines the development process, increases the effectiveness of your work and reduces the overall time to market.