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Gallup defines company culture as "how we do things around here" emphasising the actions shaping an organisation day to day. But taking the medical technology industry as an initial example we see how leaders must balance these actions between flexibility and structure when innovation meets regulatory compliance. Expanding our view into other areas we go on to explore how our upcoming Workshop will help you understand and utilise this tension as it plays out in your own organisation.

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Gallup has explored company culture for many years, defining it as "how we do things around here." This functional approach emphasises the "how" and "do" – the actions that stem from and shape an organisation’s culture.

As leaders, you might ask: How should our teams operate? The challenge arises when different teams require contrasting approaches, or even when the same team needs to adapt its style throughout a project.

A key version of this tension involves structure vs. flexibility. Flexibility thrives and finds value in environments with constant change and new opportunities, such as those delivering innovation. However, structure excels and is celebrated when the path is clear and deliverables are well-defined, such as those pursuing compliance with regulation.

Gallup lists both innovation and compliance as performance goals that can be improved through culture.

These requirements were particularly evident to me at a recent trade show for the medical technology industry. I had many conversations with exhibiting organisations about how innovation and regulation must harmonise.

Do their stories here remind you of your own industry? I’ll look at other examples in later updates.

Flexible Work Activities: Designing New Products

When it comes to designing new medical devices, flexibility is paramount. This stage requires creative brainstorming, iterative prototyping, and responsiveness to emerging market needs and technological advancements. Teams might use Agile methodologies, where the focus is on adaptability and quick feedback cycles.

Example: Innovative Medical Device Development

Consider a team working on a new wearable health monitor. This team benefits from a flexible culture that allows them to experiment with different sensor technologies, user interface designs, and integration with mobile health apps. They regularly assess progress and pivot as necessary based on user feedback and technological feasibility. The emphasis here is on innovation, requiring a culture that supports risk-taking and dynamic change - a culture that celebrates exploration and trying new things.

Structured Work Activities: Ensuring Regulatory Compliance

Conversely, as a product moves closer to the market, the pressure builds from the increasing reality of impact on people’s lives. Ensuring regulatory compliance to maintain safety and trust requires a structured approach. This involves meticulous documentation, adherence to stringent standards, and thorough validation processes. Regulatory teams must follow established procedures to meet the requirements set by bodies like the MRHA, FDA or EMA.

Example: Navigating Regulator Approval

When the same wearable health monitor looks at its needs for approval, the approach becomes highly structured. The team must follow a predefined pathway that includes detailed testing, comprehensive reporting, and rigorous quality assurance. This phase demands a culture of precision, consistency, and accountability. The success of regulatory compliance efforts hinges on a well-structured, disciplined approach to meet all necessary guidelines and regulations.

Challenges We’re Currently Seeing

I heard how recent increases in digitised products have brought a digital culture to the traditions of an industrial sector. While a rise in the desire for personalised health interventions has increased market expectations of personalised product experiences. These have exacerbated tension between the creative and compliance requirements.

And this isn't the only industry affected by such adjustments.

  • Anyone experimenting with AI has to be aware of developing regulations - which isn’t always comfortable when those regulations are behind the technology, and so the rules for your product are created after you’ve built your first, second or even third version;
  • The construction industry has great potential to digitise and adapt working methods, but progress comes up against existing health and safety regulations and the constant need for process efficiencies; and
  • Games makers who release interactive media out to an audience need to support its long term business sustainability with downloadable content and merchandise. But as their player base commits time to shared experiences, emerging cultural structures can formalise what content will be accepted in the future.

Balancing Flexibility & Structure - How is that done

So, a question arises: How can a functional approach to culture accommodate and correctly balance both structure and flexibility?

The answer lies in understanding the distinct needs of each process style, fostering a culture that supports both flexibility and structure as complementors, and facilitating transition between them.

Leadership plays a crucial role in recognising when to switch gears and how to support teams across this diversity and through the transitions.

To support this need, we’re going to be launching a culture leadership workshop in the next couple of months that will help you navigate this tension to increase productivity across your teams, while supporting their unique voices within the company.

Initial areas to focus

  • Identify the times and spaces in your development projects that require flexibility versus those that require structure;
  • Create strategies to transition seamlessly between these without compromising efficiency or morale;
  • Foster a culture that respects the necessity of both flexibility and structure, ensuring your teams can thrive across both areas; and
  • Share experiences and best practices with peers in the industry, learning from real-world examples.

Next steps

If these challenges resonate and the workshop interests you, let us know and join in the shaping of culture around your experiences and needs.

Together we can create a balanced culture that promotes both flexible benefits such as groundbreaking innovation and structured rewards including stringent compliance - driving success in your teams and organisation.

And keep an eye out for future examples of how this tension is playing out in our complex world of change and a natural desire for stability.

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