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Using Service Design to Drive Value, Speed & Quality in the Regulatory Review Process


Regulatory review teams at biopharma companies are one of the most underappreciated players helping to drive COVID-era innovation. Pre-COVID, these teams already had the challenging job of ensuring compliance with vague FDA guidelines, a responsibility that typically manifests in a conservative, deliberate, measured approach to the review process. In other words, reviews took a lot of time. With the rapidly-worsening impact of COVID at start of the pandemic, time was not an available luxury. They had to find a way to accelerate their processes — processes not particularly suited to speed — without compromising quality, accuracy, or adherence to regulations. And they did so very successfully — from creating rapid patient communication task forces to delivering time-sensitive COVID-related information to helping get three vaccines approved in less than a year — all while being 100 percent virtual. Now that they have proven it can be done, how can this culture be maintained as we emerge from the pandemic? How can it be applied in such a way that it drives value for the organization and improved patient and provider communications, particularly in the era of increased telehealth?

From a business perspective, there is a significant financial benefit to maintaining a faster, more agile approach. On the commercial side alone, one single brand may have 100+ pieces going through multiple rounds of regulatory review in the course of a year, the cost of which is often not clearly visible in corporate financials because the cost drivers are accounted for in two entirely different areas of the corporate budget. Internal labor time sits in the salary line and the agency time comes out of the market budget, neither of which are typically tracked at a granular-enough level for the cost impact to be understood.

However, it is fairly easy for a brand marketer (or any biopharma team member creating materials) to do a quick back-of-the-envelope estimate of the cost by calculating the average per piece review cycle cost (including both internal time and agency time), multiplying it by the average number of review cycles, then multiply the average review cost by the total number of pieces per year.

For example, I ran this calculation on a brand that had 100 marketing pieces — from ads to brochures to websites — going through regulatory review per year. The average cost per review cycle of one piece was $16–$22K, which didn’t even include the cost to create the piece — this was just to put it through review. The pieces averaged six review cycles, resulting in a total cost per piece of $97K–$133K. So 100 pieces per year were costing approximately $970K–$1.33M for only the marketing materials for one brand. If one were to add in the cost of the patient support material review, MSL materials, and even the internal sales training materials, it could easily be argued that close to $5 million dollars were being spent per brand for regulatory review after the initial investment in material creation. Multiply that across two or three brands and companies are looking at potentially $15 million in commercial expense related to regulatory review.

In the context of reducing a multi-million dollar expense, investing in initiatives to maintain and enhance the COVID-era best practices for accelerating the review cycles without compromising material quality or compliance is a pretty compelling proposition. However, decreasing expense, quantifiable as it is, is not the only benefit of investing in improving the process. The other benefit is improving the usefulness and impact of the communication piece on the patient, caregiver, or physician end-recipient. While this is far less quantifiable monetarily, it is arguably more central to the drive towards patient-centricity and the foundational missions of all biopharma companies to improve patient health and well-being.

One example of how a modified review process can improve the quality and efficacy of a piece while still being compliant patient and caregiver stories. I have previously been in charge of creating a caregiver-focused video series containing real-life stories and interviews. Knowing that the more authentically we could allow the people to share their stories, the more the stories would resonate with caregivers we were trying to reach. Asking a caregiver or patient who has never previously worked in media, to read a pre-written script from a teleprompter would have resulted in silted, unengaging, stereotypically pharma content so common in these videos.

Alternatively, filming their story free-form may have resulted in not capturing enough usable information and/or a choppy video. To make it more effective, we worked with the Medical-Legal-Regulatory team to redesign the review process for these videos such that the stories were reviewed prior to filming, concerns were flagged, then the patients/caregivers were shown what words and parts of the story to avoid. MLR attended the filming and listened real time so they could stop the patient or caregiver on any problematic statements and have them restate it so it was captured on film the way it needed to be. This resulted in organic, highly-engaging, interesting stories well-received by the audience.

The above is just one example and reinventing the process on an ad hoc basis is neither efficient nor extensible. To drive value, organizations must take a holistic approach and look at the entire regulatory review ecosystem and all touchpoints within, to design the most optimal experience. But where do you begin? What is the “thing” that needs to be done and who is the right partner to help you do this “thing”?

The “thing” is Service Design. Service Design takes a holistic, strategic approach to evaluating and providing recommendations for delivering a service, in this case regulatory review, using a human-centered perspective. It encompasses the whole service ecosystem — from all of the people involved in the process, to the tools, technologies, and regulations — and orchestrates them to work together to best serve user needs. The human-centered focus of the engagement is paramount for creating viable, enduring solutions because they will be designed around the needs of the people in the process, and they will have an active role in shaping it.

Service Design is different from other Experience Design initiatives because of the orchestration aspect. Imagine if you will, the experience of going to a theatre to see a show. As a theatre-goer, you are the service user who is at the center of the design of the theatre service. To provide you with an optimal experience, all aspects of the theatre have to be taken into account — the ones that are visible to you and invisible to you. These would range from the ticket purchasing process, to the concessions, to the seating, lighting, music, stagehands, performers, and so on. And there would be different flavors of this design depending on the type of show the theatre was featuring for that performance. Some parts of the service delivery would be different for a concert than a ballet or an opera than a play. Using this analogy, the theatre can be considered the overall regulatory review process — the people, technology systems, SOPs, etc. — and the performance types can be considered analogous to the different types materials being developed and reviewed.

Service Design engagement for redesigning the regulatory review process to capitalize on the COVID-era efficiencies and maximize customer benefit would involve these types of activities:

  • Research. Research is the foundational activity to creating a human-centered solution. By involving team members in various capacities in the review process, we can gain their perspective on needs, opportunities, and barriers for enhancing the process. The research can range from 1:1 interviews (to identify explicit needs) to collaborative co-design sessions (to identify latent needs)
  • Northstar/Future Visioning. Utilizing the research, as well as tools such as a Journey map (that identifies user pathways through the service) or a service blueprint (which includes the users’ path and supporting service and systems), we will create a future vision and identify gaps, opportunities, and behavior change interventions necessary to achieve it
  • Experience Playbook. At the conclusion of the engagement, we will deliver a playbook that outlines the vision and the steps needed to get there. This will equip your organization with the information, instructions, and roadmap to implement the new process.
  • Implementation Support Services. Depending on the action items outlined in the playbook, we can also support implementation

Service Design can be a powerful tool to help your organization capitalize on the innovative modifications you may have made to your regulatory review process during the COVID-era to build a sustainable process that achieves cost-savings and improves material quality. If you haven’t yet made improvements, it’s a great starting point to help you do so.

Tiffany Mura is VP Client Experience & Strategy, Health at Mad*Pow.

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