Regulations tend to put a stranglehold on innovating, setting up roadblocks that require more work, more capital investment, and more time. However, innovation leadership entails seeing the opportunities that lurk within an intricate regulatory framework. By taking a step toward complexity as others shy away from it, enterprises stand to turn regulatory changes into a competitive advantage.
When an international personal care company decided to create a new line of combination contact lenses, it entered uncharted regulatory waters. The intention was to create a contact lens that administers allergy medicine, eliminating much of the discomfort of contact-wearing allergy sufferers.
It was a revolutionary idea that had never been done before. Consequently, the FDA had no idea how to handle it. For one thing, the product would fall under two regulatory bodies — the device division and the drug division.
The product’s technical challenges ranged from production to packaging, but they were not insurmountable. But before it could even address those issues, the organization had to navigate through complex FDA approvals.
Fortunately, the process did not sway the company’s intentions, and they implemented innovative strategies to communicate and educate the FDA about the new product. To some degree, they were creating new definitions of compliance.
Every organization must submit to regulations, whether they’re internal or external. Oftentimes, regulatory parameters bind innovation by restricting movement. But it doesn’t have to. In fact, new regulations can kick start innovation.
How do you perceive new regulations — as obstacles or opportunities?
