“All that is necessary to break the spell of inertia and frustration is this: Act as if it were impossible to fail.”—Dorothea Brande
When the 6,000 life sciences manufacturers market their products to the patients who use them, the healthcare professionals who prescribe them and the insurance providers that pay for them, the words used are heavily scrutinized. That is, each brochure, TV ad, and sales presentation must comply with legal and regulatory guidelines that ensure the marketing messages are consistent with the regulatory approval of the product.
Regardless of their noble objectives to improve the human condition, companies face extreme pressure to sell and distribute products aligned with the cadence of the fiscal year and investor expectations. This ‘need for speed’ creates enormous opportunities for oversight gaps, especially for the industry’s most highly regulated products.
PRC, MRL, MLR, RLM, Ad Promo, A&P…it’s remarkable that 20 years after the FDA clarified what it meant in its 1969 guidance for “adequate provision” and launched broadcast direct-to-consumer advertising of drugs, the industry still doesn’t have a consistent name for the process used to ensure compliance with the guidelines. Since process optimization – any process optimization – is inherently people-driven, it will inevitably mirror the culture and human biases of the process owners and participants. The risk tolerance of an organization, its appetite for change, the degree of tech-savviness, and let’s not forget brushes with FDA, all add variables to how companies approach promotional material review.
If an entire industry must comply with a reasonably consistent set of global regulatory guidelines, and if speed and agility in product commercialization (aka sales and marketing) are central to a firm’s growth and profits, then why are so many companies ignoring obvious opportunities to simplify and expedite their promotional material review?
Here’s my four-part argument on why companies succumb to the inertia of the current state even if it means higher risk, outdated processes and slower commercialization:
- High variability precludes simple one-size-fits-all solutions
- Without simple fixes, inertia rules the day
- Change can be (technically) hard
- Change can be scary
Variability in the Approaches Used Across the Industry Masks Simple Improvements
In contrast to promotional material review, consider a modern manufacturing process or the engineers that design and optimize a production line. Whether LEAN, Six Sigma, or the Toyota Production System, manufacturing process optimization has become a science. Experts scrutinize the sequence of steps, location of components, and study the defects to reveal “optimization experiments” aimed at continuous improvement. Granted, manufacturing is far more mechanized than promotional language interpretation so it is arguably easier to adjust locations of robots and raw materials than it is to teach humans new best practices. Without a clear path to optimization, we’re stuck.
In practice, there is far more global standardization possible than most companies realize. Standard operating procedures (“SOPs”) for governing promotional material review are 90+% the same. You may think you’re a special snowflake, but you’re not – and in fact this attitude is costing you dearly. If our SOPs are nearly the same, it stands to reason that our approaches used to ensure compliance should be nearly the same.
Thus, my second argument for why promotional material review fails to meet commercial objectives.
Without Simple Fixes, Inertia Rules
Our highly variable legacy processes, cultural biases, and lack of obvious silver bullets to improve speed, accuracy, and risk mitigation all lead to organizational inertia.
Perhaps then it comes as no surprise that modern promotional material review is anything but modern. Given the urgency of our work, interdependencies with our colleagues, and the myriad technical, regulatory, and cultural complexities, change is hard. Any change. The end result is that we must work harder to keep up. Upcoming conference and product launch in the same week? There goes your weekend. Regulatory reviewer on vacation next week? Scramble to accelerate the work before she leaves, accept a delayed schedule, or fight through explaining the context to her delegate. And that’s just a change to a set of promotional jobs.
What if we wanted to change the system or the process itself? If you’ve ever tried to convince the person “who’s always done it this way, in this order” that there’s a better way, you know how hard change can be. And even though we know, inherently, in this day and age, that handing a manila blue folder to the next person in the process to get their review and signature is oh-so 1995, at least we know it works.
Change Is Hard
“Yeah but cross-functional enterprise IT projects are complicated. Something like 40% of them fail. Even if we line up appropriate executive sponsorship, adequate funding, and a talented team, the odds are mixed.” (And yes, those critical success factors are minimum prerequisites to a successful digital transformation program). When we work with our customers, we hear a familiar refrain of concerns:
- Technical complexity: system integrations, configuration, quality assurance, ongoing system updates…this is a lot to manage!
- Process and procedures: change the system to meet our processes or change the process to align to the system?
- Data migration: how will we decide what to keep from our current system and then how do we migrate the data and validate the data transfer?
- Maintaining compliance: how will the new system provide continuity of compliance for our legacy data?
- Smooth system cutover: we have an existing system with 1000 users trained globally, routing 100’s of jobs per month. Turning one system off and the new one on must not slow our operations or impact our ability to execute commercially
- Change management: people do not like change, even if it’s an improving change. “This is how we’ve always done it. Why are we changing?”
Change is Scary
As Kim Scott aptly points out in Radical Candor, even changes that are logical and rational are still often met with resistance due to emotional attachment. Hence, argument number four: change is scary.
Making enterprise software selections after analyzing competitive bids and sitting through a few demos puts chills in even the most experienced buyers. Moreover, compliance software is often selected by people who are not frequent buyers with large, year-over-year budgets. Even more stressful, most of our business users who consider Pepper Flow® are spending their boss’s budget or the budget of an adjacent department. That’s a lot of personal capital on the line.
Hey, we get it. So let’s derisk things a bit and help you embrace change.
What if We Guaranteed the Success of a Pepper Flow Implementation?
Change can be good and it doesn’t have to be scary. We can help and we’ll even guarantee your success.
Starting in 2018, Vodori began offering our Implementation Guarantee. In short, if the migration to Pepper Flow fails to pass customer acceptance testing, we will continue to provide additional consulting and configuration support at no additional cost until your Pepper Flow environment meets your needs and your users are successfully routing materials.
We’re so confident in our ability to modernize your approval processes, migrate your legacy jobs, and equip your users to be successful, that we’ll guarantee the implementation.
By design, Pepper Flow eliminates a non-trivial amount of technical risk just by being cloud-based. Where will it run? Check. Who will maintain it? Check. What are the service levels? Done. Gone are the days of hiring a system integrator, consulting partner, software provider, and infrastructure company. Using APIs and configuration, modern applications can be tailored to business needs in a fraction of the time, cost, or risk of legacy systems. Modern like Pepper Flow, of course.
Vodori builds and maintains Pepper Flow. Vodori implements, deploys, and trains users on Pepper Flow. Vodori supports all our customers on Pepper Flow. One team, one platform, one commitment – our customers’ success. Now with a guarantee.
If you’d like to learn how Pepper Flow can streamline your promotional review process, contact us at email@example.com.