The un-tapped Pool of MedTech Marketing Opportunity: Regulatory Affairs

A profession which has been looked upon as the closest thing to a MedTech company's internal DMV is increasingly becoming a significant & cool source of differentiation.

The medical device regulatory affairs market size was valued at $7.0 billion in 2021, and is estimated to reach $12.2 billion by 2031, growing at a CAGR of 5.8% from 2022 to 2031, according to a new report published by Allied Market Research.

Regulatory affairs (RA) arose from the desire of governments to protect public health by regulating the safety and efficacy of products in areas such as pharmaceuticals and medical devices. The various types of regulations followed in product life cycle of medical devices can be clustered as:

• Regulatory strategy development

• Regulatory affairs consulting & support

• Device classification determination. 

Some other regulations which are required for the approval of medical devices include:

• Pre-market, post-approval & post-market support

• Appraisal & evaluation of technical documentation, gap analyses & desktop audits

• Technical files

• Design dossiers

• Quality management system support

• Authorized representation services

Ever changing law and regulation drive demand for regulatory affairs professionals who can help companies bring medical product to the market as recently seen in Europe since the new Medical Device Regulation (MDR) became effective.

For a long time RA were only seen in context of marketing, when product managers pushed for quicker approval timelines or when a brochure needed to be reviewed. But these are the old days. Current-day regulatory affairs leaders combine their knowledge of existing regulations and future changes with a broader understanding of the specific product's market to enable competitive advantages. Also vice-versa: MedTech marketing leaders with a limited understanding of their devices' regulatory environment are unable to make impactful product development and product marketing decisions as they are just not getting the most out of their market. We need Regulatory-Product-Managers who are just as savvy in the application, customer needs and competitive landscape of their product line, as they are knowledgeable about this specific product line's regulatory environment and trends to see opportunities. This overlap of skills and knowledge is obviously the more valuable, the more dynamic the regulatory environment of a product is.

Yes, this is Regulatory Arbitrage. A term so far mostly used in financial contexts “Financial Arbitrage” is increasingly becoming relevant in other highly regulated industries, just like Medical Devices. This is due to 1) Cost pressure & commoditization on and of standard procedures and 2) The emergence of digital and AI-driven solutions

Regulatory leaders now need to have strong influencing skills in order to shape policy for both internal partnerships with marketing and development colleagues if they want their company to reach its goals. The approach should be proactive rather than reactive when it comes to new regulations being instituted because these changes happen so quickly and pose so many opportunities (not just headaches!).

The entire discussion on RA has to switch from an "issue solving" to an "opportunity creating" view, as regulations apply to all players in the market. Those who can navigate the regulations better (not just quicker) than others, will create sustainable differentiation.

Let's go, Regulatory Affairs!

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