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Steve Gens is the managing partner of Gens and Associates, a global life sciences consulting firm specializing in strategic planning, RIM program development, industry benchmarking, and organizational performance. Following an early career in industry, across various management positions at Johnson & Johnson, Steve transitioned to consulting and led global healthcare consulting practices for First Consulting Group and Booz Allen Hamilton, before founding Gens & Associates, whose ‘World-Class RIM’ research tracks evolving best practices in regulatory information management. He recently gave a keynote presentation on the theme of ‘people’ considerations in RIM transformation management at AMPLEXOR’s recent BE THE EXPERT event, an annual industry forum which this year took place in France.
Every big shift will stir up dissenters, but these negative forces can actually offer a useful contribution if their concerns are fed into a continuous change program. This could make all the difference in regulatory information management transformation, writes Steve Gens.
However helpful the latest technology may prove, it is people that will determine whether a major transformation project will deliver the hoped-for results - and it’s unrealistic to expect everyone to get on board with change from the outset. Every big shift will stir up dissenters - those who seem bent on resisting change. But these seemingly negative forces can actually offer a very useful contribution – as long as managers feed their concerns into a continuous change program, to improve overall outcomes. It’s an approach that could make all the difference in regulatory information management transformation, says Steve Gens.
The latest advances in technology may offer to solve a big problem for an organization, but these opportunities and the process transformations and cost savings they promise, can quickly become the main focus of any resulting change program. The trouble with this is, unless the teams that will be affected by the shift are receptive to and prepared for the proposed new ways of working, the impact of the project will be compromised and the risks of disengagement and ultimately failure may be high.
It is important, then, to plan for the impact of change on people and to take into account all of the different perspectives and personalities of those involved. That includes those who dig in their heels, apparently resistant to change, determined not to fully contribute or even resist whatever is being asked of them. Those who seem all too willing to spread their negativity by finding plenty about the changes to be skeptical and damning about.
In fact, directly engaging with these ‘Eeyores’ among the target user base should be a positive and proactive mission for project leaders.
In the Pooh Bear books and animations of childhood, Eeyore the doleful donkey was the character that everyone else had to work hard to chivvy along. Never quite able to see the positive in any situation, he could instead be counted upon to worry about all the worst-case scenarios: the “But, what ifs?” At the same time, he was sufficiently self-aware to know he put a downer on things. “Thanks for noticing me,” he would say, not expecting to matter very much to those around him.
Put any group of people together, and there will be at least an Eeyore or two among them: instinctively negative about new scenarios, yet expecting their voice not to be heard. And it would be easy to ignore or try to quieten those voices, in the drive to bring teams along on a change journey. The last thing Regulatory teams needs when striving to update and advance the way they collate, manage and harness information is for dissenters to undermine that momentum.
But what if these resistors to change had a positive contribution to make, and could even become persuasive advocates for change - if they were proactively engaged to provide feedback and had ample space to adapt to the new world?
It’s something my organization has been exploring with clients, as they have sought to realize the tangible benefits of regulatory information management (RIM) transformation in their respective organizations. The point being that regulatory organizations can’t just plough on, focused solely on compliance and efficiency targets, to effect impactful change. They must also address how individuals and teams will be affected: that is, the organizational transition that will be needed to deliver tangible benefits for the business.
I’ve found myself being asked to speak on this theme a lot at conferences recently too, and I have been at pains to start out by considering the importance of an incremental, continuous approach to any improvements.
Vast change programs - where change is seen as a one-off “event” that sees old systems and ways of working switched off on a Friday, and the “new way” come into effect on the Monday - are no longer seen as an effective way to deliver results. Such programs are typically highly disruptive, and not in a good way - because people end up left behind, or struggle to adapt (even if they have been given “training”).
And, of course, big change programs cost a lot of money; they can also be “over-engineered.” Once projects have finally been delivered, there is a risk that tools and ways of working will have moved on again - so the business is continually playing catch-up. By contrast, incremental, continuous improvements allow big changes to be made more gradually: they take people along a journey, allowing for adaptation and building competency as conditions change, and delivering better results along the way.
When I recently looked afresh at Gens & Associates’ 2018 World-Class RIM1 research, it emerged that those life sciences regulatory organizations with a continuous improvement approach to their RIM programs were 26% more likely to have achieved measurable business benefits, and between 16% and 21% more likely to have greater confidence in their regulatory data, real-time reporting facilities, and efficient RIM capabilities generally.
Instead of switching from the old to the new way, without a neutral in-between phase, these regulatory organizations have appreciated and made room for a learning curve for new processes, procedures and systems, and taken the time to build expertise, confidence, and ultimately competency.
To ensure a smooth transition, such organizations will take time to get people on side over time. They will create or appoint advocates, and they will expect and embrace natural resistance. Core change teams will get alongside those who will be affected by the transition, taking steps to understand any negativity, and harness this feedback to make the changes even better. Tactics for addressing resistance, meanwhile, could include providing opportunities to visualize what the new world will look and feel like, and how it will make a positive difference for individuals.
In a global organization, it’s important to recognize too that teams may be dispersed across huge distances, with a successful transition relying on the buy-in of those working for far-flung affiliates. Bridging those distances effectively, to keep people moving in the same direction, might require video meetings, and designated change agents having virtual cultural competence, for instance.
At times of great upheaval, keeping people on side matters more than ever. Or, in the words of Eeyore, “A little consideration, a little thought for others, makes all the difference.” Certainly, effective transformation can’t happen unless the right team is driving the change and looking out for the different dynamics that will need to be addressed head on.
Steve Gens is the managing partner of Gens and Associates, a global life sciences consulting firm specializing in strategic planning, RIM program development, industry benchmarking, and organizational performance. He recently gave a keynote presentation on the theme of ‘people’ considerations in RIM transformation management at AMPLEXOR’s recent BE THE EXPERT event, an annual industry forum which this year took place in France.