Shaping a product’s regulatory strategy in the early stages of development gives companies the maximum flexibility in aligning the product’s technology, marketing claims, and regulatory path. It’s a cost-effective approach that makes it more likely that a company will obtain regulatory approval to market a product sooner, as well as avoid costly disruption and potential adverse publicity down the line.

Often companies will develop products with the best intentions – whether that’s meeting the demand for devices to help with the COVID-19 public health crisis or producing products that are better for the planet. However, it’s easy to fall foul of the regulations as we’ll discover.

Streamlined route to authorization

The opportunity to help medical device companies shape their US FDA regulatory strategy during the early stages of development is what drew Laurie Clarke, JD, MPP to TSG Consulting. As Vice President and Principal, Medical Device Regulatory, Laurie supports clients in achieving US FDA authorization in the most efficient way possible. “A regulatory strategy clearly sets out steps that need to be taken to reach the desired goal,” explains Laurie. “For many medical device companies that are launching products on the US market, this is obtaining FDA clearance for the proposed indication via 510(k) premarket notification. Taking a proactive and premeditated approach from the outset puts the company in the driving seat. It can satisfy any existing FDA requirements for demonstrating that the type of device is substantially equivalent to another, or define those requirements and apply them to its device. Getting this right results in a more streamlined route to authorization.”

These general principles also apply to other types of products. Understanding the potential impact of regulatory constraints from the outset helps de-risk the product development process and avoid costly mistakes.

Importance of due diligence

The COVID-19 pandemic saw a dramatic rise in the number and type of disinfectant products placed on markets around the world. Many businesses rushed in to fill the increased demand for products that can kill viruses such as SARS-CoV-2 (the coronavirus) but did not stop to consider the regulatory implications. This was especially true of smaller companies that don’t have in-house regulatory teams. “Inexperienced companies can easily fail to identify that chemical products intended to kill or control microorganisms will typically meet the definition of a biocidal product under the BPR or an antimicrobial pesticide under FIFRA,” explains Amy Burrows, Head of Biocides & Cosmetics. The BPR is the Biocidal Products Regulation and applies in the EU and UK; FIFRA is the Federal Insecticide, Fungicide & Rodenticide Act and applies in the US.

In the UK, one such business developed a ‘disinfection booth’, essentially a walk-through chamber that sprays people with disinfectant as they pass through. The company claimed that the system reduced the risk of COVID-19 transmission by disinfecting users’ skin and clothes. Had they conducted due diligence on such a product, they would have realized that the disinfectant spray is subject to the BPR and that the practice of spraying people with disinfectants is strongly advised against by public authorities, such as the Health & Safety Executive (HSE), the UK Government’s SAGE committee and the World Health Organization, who note that it could be harmful and is not effective at reducing the spread of the virus. The business was subject to enforcement action by HSE, who required the product to be withdrawn from the market at a substantial cost to the company.

“Consulting with regulatory specialists such as TSG at an early stage would have helped the company avoid making such a costly mistake,” says Amy. “Our biocides experts have many years' experience advising companies across the UK, EU and North America on the permissibility of active substances in products, safe use requirements, and regulatory obligations to help clients develop compliant products from ideation.”

Understanding regulatory obligations

Companies not appreciating the full scope of their regulatory obligations is something that Richard Bishop, Senior Chemicals & REACH Consultant, is familiar with. Richard recently joined TSG from the Health & Safety Executive (HSE) where he was Principal Inspector, responsible for the enforcement of REACH, CLP, PIC, biocides and plant protection products legislation across Great Britain.

With the increased focus on sustainability and protecting the planet, a biodiesel manufacturer saw an opportunity to convert waste cooking oil from catering establishments to produce biodiesel for both heating and to fuel cars. “Despite the company’s positive intentions to recycle a waste product, their business model revolved around manufacturing a chemical substance from waste,” explains Richard. “With no in-house expertise on chemicals regulations and no involvement from external specialist providers at an early stage, they failed to appreciate that they would attract registration duties under REACH.” REACH is the regulation governing the Registration, Evaluation, Authorisation, and Restriction of Chemicals in the EU and UK; and Article 5 means that businesses who fail to register substances cannot legally manufacture or place those substances on the market until they have been registered in full. “Registration isn’t a process that can be achieved overnight. It’s complex and it took the company many months to achieve REACH compliance,” explains Richard. “By involving regulatory specialists at an early stage of the product development process, they would have been able to identify their legal obligations and take action to comply, thereby avoiding costly disruption.”

As these examples show, companies should not underestimate the importance of developing a robust regulatory strategy at the start of the innovation process. Not only will it deliver product and process cost reductions, it will facilitate a smoother authorization/registration process and reduce time to market.

If you have any questions about your own product’s regulatory strategy, do get in touch at [email protected]

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