Regulatory Information or Regulatory Intelligence? What About ROI?

Regulatory Information or Regulatory Intelligence? What About ROI?

The following commentary explores the responsibilities of consultants and clients to achieve an effective partnership.

A session at the 2015 RAPS’ Regulatory Convergence in Baltimore discussed the differences between regulatory information and regulatory intelligence. Which are you paying for when you hire a consultant? And as a consultant, which service are you providing?

Given the ease of the internet in finding regulations, guidance and historical information, regulatory information should be easy for anyone to find. However, baseline knowledge of regulations is sometimes necessary in order to even begin the search.

Regulatory consultants typically strive to stay up to date on changing worldwide policy and emerging technologies. This can be a daunting task, but this knowledge base is exactly what the client often needs to begin to address complex questions without having to spend exorbitant amounts of time mining the internet. But knowing where to find the applicable regulation is not a consultant’s only service; they are hired to interpret those requirements—aka regulatory intelligence. Regulatory intelligence can be gained through experience working with regulatory agencies and companies developing novel products. Consultants, who spend a lot of time talking with regulatory agencies, understand current agency thinking. They also likely have gained useful knowledge from past projects contributing to reduced risk for the current client project.

Regulatory intelligence also might stem from scientific or engineering expertise. A background in device development as scientists and engineers helps regulatory consultants understand the set-backs and challenges often encountered during product development. A consultant who understands the underlying technology might be able to challenge the clinical utility of a client’s product and thus suggest alternative pathways to market.

Finally, regulatory intelligence requires an understanding of the client’s risk tolerance so regulatory strategies are proposed to seek the shortest possible time to market while weighing the likelihood of success.

What Do You Need?

When selecting a consultant you should consider the scope of service and be clear when communicating this. Do you want a fact finding team to present you with data on predicate devices or do you need strategies specific to your unique device?

The return on investment for solid regulatory strategies early on will save development time and submission costs. These strategies should be part of every project Phase I product development.

First interactions with FDA should not strictly be fact finding missions or a forum to ask open ended questions of the agency.  Any interaction should be a combination of information sharing and trust building. Use experienced consultants to be sure you are representing your ideas completely and in a favorable way to FDA.

Like the product design process, regulatory strategies may need to change over the course of development as indications for your product change or the safety profile of your device changes. Your strategy needs to be revisited throughout the product lifecycle.

Consultants can play an important role to mentor and support new regulatory professionals with the education to gather information, but may not have the ability to convert information into regulatory intelligence.

What Can You Do?

As a consultant, the best way to serve a client is to understand the client need. We need to be focused on the task requested with an eye to the end goal the client hopes to achieve. Is the company looking for an IDE approval to raise capital? A clearance letter to sell their technology? Is the client an established company in this space for the long haul? These need to be considered when implementing a strategy.

As a client, you need to spend time with your consultant to ensure a thorough understanding of the device technology and regulatory history and testing to date. You need to be clear about what you need and what your future goals are. Use consultants you trust to educate your staff on what they need to know. As priorities change, stay in contact with your consultants to prevent a breakdown in communication and a loss of understanding of the project development.

We need to challenge the paradigm relationship between service providers and companies. Obtaining services from regulatory professionals is not like purchasing an off the shelf part. It is similar to purchasing a customized critical component. The relationship needs to be a partnership for continued success of both parties.

Access to safe and effective products to improve the lives of patients is the ultimate goal for consultants and clients alike. By strategizing early and often in the process, needless delays to market can be prevented which will allow earlier access for patients to life altering medical products.

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Christine Nichols

Christine Nichols, RAC, works as a regulatory consultant for Boston Biomedical Associates, a CRO in Marlborough Massachusetts. She has more than 28 years of medical device experience, which includes roles as scientist, clinical trials manager, quality affairs manager, and regulatory affairs manager.


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