Putting processes in place to break down the “us vs them” mentality with regulatory teams will help you get your digital pharma products approved.
The “us vs them” narrative between those in commercial roles and their colleagues in regulatory compliance is longstanding within the world of healthcare and pharma. When it comes to digital products or services, it’s no different.
Product teams can feel constricted and frustrated by regulatory requirements — as if the end result will be a compromise that won’t live up to expectations. Regulatory teams can feel like they’re not being listened to or have been left out of the decision-making process.
Strict compliance guidelines are a fact of the sector we work in, and rightly so. Rather than constantly fighting against them, put processes and ways of working in place to break down the “us vs them” mentality, involving regulatory teams as early as possible in the product development process to enhance understanding and buy-in.
A high-pressure environment
Let’s think about the pressures that regulatory teams are under. A small oversight on their end can have huge consequences — digital products being pulled, significant fines or lawsuits, or damaged relationships with industry bodies, for example.
The constant awareness of the potential negative impact of them overlooking something undoubtedly causes stress. It’s important to keep this context in mind when working together and have empathy for where they’re coming from.
How to build positive relationships and create approvable digital solutions
Involve regulatory teams early
This is something we always come back to, knowing from 12+ years of experience working with clients in the sector that it’s key for success. A good relationship — where you understand each others’ needs, perspectives, and communication styles — can take time to establish.
Involving regulatory teams as early in the design process as possible will improve understanding and help them feel more involved and invested in the long-term success of your product. Ensuring that they know the purpose and end goal of your digital product from outset is key.
Regular check-ins and updates
Not only should communication with your regulatory teams start early, but also happen regularly throughout the product design process. We usually recommend check-ins take place at least bi-weekly, or whenever there is a new iteration of your design to discuss — don’t leave weeks to go by where multiple changes have been made.
These regular sessions will mean that the level of change to be reviewed remains manageable, and will also strengthen relationships as you spend more time together and get to know each other better.
When you meet, make the most of the face-to-face time to make sure both parties are completely clear on what the other is advising or requesting, eliminating room for later misinterpretation. If your compliance team request a change, ask questions and make sure you are 100% clear on the detail of the change whilst you’re in the room together — or on the Zoom call — so that you can go away and implement it in your design.
Utilise your data to explain design decisions
When you’re talking through your designs or specific changes between iterations, it’s helpful to explain the ‘why’ behind your decisions using real data — whether qualitative, such as comments from user research interviews, or qualitative, such as data from heatmapping software about how users navigate your website.
For example, “We moved this button here because in our user testing, 90% of users said that they didn’t notice it in the previous position, and our heatmapping showed that the majority of users navigated to this part of the page first”.
Explaining your design decisions with real data shows regulatory teams that you’re priotising user needs and making evidence-based decisions.
Keep up to date on compliance guidelines
Ensure your cross-functional teams are familiar with regulatory requirements and any recent updates or additions that effect your digital products. This applies to your entire cross-functional product team, including designers and developers. They don’t need to know the guidelines inside out, but a decent understanding of core requirements and good practice will reassure your regulatory teams, building trust and confidence that they’re in a safe pair of hands. If they have to point out obvious issues that should have been picked up before coming to them, this can lead to frustration and a harsher assessment of subsequent designs.
Pre-empt questions and have answers ready
Before presenting a set of designs or features, put yourselves in the shoes of your compliance team. Think about what might stand out to them or be of concern. What will they want to know more about?
Try to pre-empt questions and make sure you have clear answers and explanations prepared. This will help check-ins go smoothly, and also further improve relationships by showing you’ve tried to acknowledge their potential concerns.
Having some examples to hand of how others in the sector have implemented new features or overcome design challenges may be useful to help communicate and evidence your points.
Educate, don’t assume knowledge
Throughout the process, it’s important to remember that your compliance teams are coming from a completely different world and background to you.
Don’t assume a high level of knowledge around design best practices, UX, accessibility and so on. Pharma as an industry is still in relative digital infancy, so regulatory teams are unlikely to have an in-depth understanding here. They might suggest a change that seems like a clear win, not realising it’s detrimental to the overall UX of your digital product.
Take the time to educate your compliance teams and explain the rationale for things clearly. Whilst this may be a little more time-consuming initially, you’ll feel the benefits of this enhanced cross-departmental understanding in the long run.
Want more on designing approvable digital pharma products? Look out for our follow-up article for more practical steps and processes to implement with your teams to ensure your digital solutions are approved.