The Personalized Medicine Opportunity–Shifting the Business to Regulated Markets


Life science tool companies have traditionally operated in the “research use only” market—selling equipment and reagents to academic labs, research centers and biopharmaceutical R&D. By selling into the research-only market, these companies have been able to avoid the burdens of controls placed on regulated products. However, the line between research and clinical activities is increasingly blurring—which can be seen by the prevalence of regulated products in traditional research areas, and also by the tightening FDA requirements for research-only use. As a result, life science tool companies are aggressively seeking new revenue opportunities that can be found in another regulated market—personalized medicine—which has significant growth opportunities, and 25 percent compound annual growth rates.

In short, unless life science companies plan to limit themselves to niche markets and to low or declining growth rates, they must move into the personalized medicine space with regulated products. While it’s clear that these companies must make this move, the operating model requirements are vastly different for regulated markets, forcing these companies to adapt their models if they are to be successful.

To achieve competitive advantage in the regulated markets, a company needs to implement the following operational approaches.

• Establish the quality system and regulatory capabilities

• Create a regulated product culture

• Hire an experienced regulated markets sales and support organization

To adapt, life science tool companies must implement a quality system across the entire organization with more stringent processes needed for regulated products. FDA Design Controls can be implemented in a manner that is effective for both the research-only products and the regulated products.

The most difficult change for traditional research-only companies is the creation of a regulated product culture. In most cases, research-only companies have a “research mindset” and people tend to be process adverse. To shift the culture to a quality and regulated product mindset requires a new approach—one that showcases overall business value. By making this transition, companies can enjoy the benefits of less firefighting, improved information flow with fewer functional silos, and better manufacturing yields. Companies in today’s competitive market have an opportunity to implement a “business-friendly” quality system, which can become a competitive differentiator.

Finally, the sales, marketing and customer support organization that worked for research sales will simply not be effective in regulated markets. A vastly different skill set is required, as well as new and more stringent processes for managing the customer relationship. For example, every time a customer calls with a question or concern about a regulated product, the customer support group must determine if it could be a valid complaint and investigate the potential issue including determining if there is a need for a Medical Device Report. The sales people must be trained to identify those complaints that need to be reported, as well what can be claimed about a product in sales presentations.

By implementing these three proven operational approaches, a life science tools company is well-positioned to successfully move into regulated personalized medicine markets. As these changes take time, companies need to begin making this transition now. Those companies that begin immediately are those that can reap the benefits of the rapidly emerging personalized medicine market.

Jim Prutow is a partner at global management consulting firm PRTM ( He can be reached at [email protected] Follow @

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One response to “The Personalized Medicine Opportunity–Shifting the Business to Regulated Markets”

  1. Kathleen Dunn says:

    There are resources to help companies transition to regulated products. Perhaps the most helpful will be the FDA itself. Don’t assume that the relationship will be adversarial. It need not be. I’ve done it. You can engage them at an early stage and understand up front the implications from the labeling you will submit for approval. This determines how you can market your product, i.e., what claims you can make. It impacts everything you do. Personalized medicine products for laboratory use will likely fall into the in vitro diagnostic category, although that is not yet clear.