In the first of a new regular series from NSF International, Howard Broadbridge, principal – client relationships, Europe, argues that it’s never too early to make friends with compliance.
Bringing a medical device or in-vitro diagnostic product (IVD) to market from early concept to full commercialisation is a complex task, whether it be within a start-up or a corporate giant. Apart from needing input from different areas of expertise, it requires the developers to consider the multiple factors which will influence the process and ultimately shape the product and the way it is presented to the customer or end user. These may include engineering (device and software), sales and marketing, finance, quality assurance and manufacturing – but will definitely require input from a regulatory perspective. The key question is: when’s best to address the regulatory issue?
The answer to the question posed above is that it’s never too early. Whatever the product, it will need to comply with the regulations of the jurisdiction in which it is marketed, whether it be FDA, CFDA, MDR or IVDR. The earlier compliance is built in, the lower the likelihood of a product coming up against a regulatory hurdle at a stage in the development process when design changes would be far more costly. A simple example would be the use of certain chemicals within a product. Via the MDR, the European Commission will soon regulate the use of certain chemicals within medical products due to their toxicity if they come into contact with human tissue. For instance, phthalates are known to be endocrine disrupters and a full risk-benefit assessment is required if they are used. A decision to remove them at, say, design transfer stage would be disastrous for the product development process, causing long delays and potentially a loss of budgeted revenue.
For IVDs, there are stringent new requirements for performance evaluations laid down within the IVDR which will be applied fully in May 2022. These must demonstrate that the product will provide clinical benefit for the IVD to be regarded as compliant. Undertaking the evaluations as early as possible in the development cycle will avoid the manufacturer going back to the drawing board – and again, incurring additional costs and delays. Robyn Meurant, Executive Director at NSF commented: “Regulation is there to ensure the patient benefits from the use of an IVD. Understanding patient and user needs from the beginning of design and development means you can have an IVD that is both wanted (meaning easier to sell) and should face fewer regulatory barriers (meaning faster to market)”.
Although it is not something marketing managers would normally focus on when developing strategy (indeed, regulatory affairs is often regarded by some as a hindrance), compliance with standards can also be turned into a valuable product feature. A manufacturer can use thorough and consistent adherence to product standards and regulations to differentiate its product from others in the market. By developing products that have compliance built-in and nurturing a culture of regulatory compliance within an organization, a manufacturer can build the trust of both end-users and other links in the supply chain such as distributors and importers. This can not only encourage sales growth, but will also protect margins by avoiding costly quick fixes when a compliance issue is highlighted in an audit. It will also contribute to protecting human health by reducing risk.
I have described how building in compliance can speed up commercialization of an idea, avoid unnecessary, costly re-designs and be used as a product differentiator. Adaptation to a changing regulatory landscape can become second nature, making it easier to react. So, in the end, regulatory compliance can be your friend, rather than being seen as an irritating intruder, hell-bent on disrupting the launch of your beautiful new product.
