You've designed an innovative new medical device and manufacturing is ready to go. Everything is moving as planned, so your product should launch seamlessly, right? Unfortunately, it may not go as smoothly as you think. As a developer of medical devices, it's your responsibility to be aware of all the ins and outs of the regulatory world, but most likely, you haven't yet uncovered all of the complex layers involved in navigating the global regulatory landscape. And it's not because you lack intelligence, but you're lacking regulatory intelligence.
It's not only important to have regulatory knowledge, but to also know exactly what to do with that knowledge - strategically. To reach the ultimate goal of launching your product into the marketplace, it must clear many regulations and standards. In order to achieve this in a timely and cost-effective way, there has to be a regulatory strategy in place to make sure everything comes together. Regulatory intelligence is using all available resources, your experience and knowledge gained through previous interactions with regulatory bodies to predict any potential pitfalls along the way.
You might be able to educate yourself on all of the FDA requirements, or research the regulations in the country in which your product will be launched, but you have to know how best to interpret these regulations and standards in regard to your device and its intended use. This comes with experience. Intelligently devising your product's strategy and seeing it through to completion and beyond - that is regulatory intelligence.
During early development of your medical device, a regulatory strategy should be devised to ensure that when your device is ready to be launched, all global regulations have been met. This should be achieved during design development, prior to distributing the device into your preferred countries. With up-front planning, unforeseen issues are tackled in advance, avoiding delays in selling your device. Your regulatory strategy should also take into account the amount of risk you are willing to accept with different options within your strategy. Understanding the available regulatory paths and the associated risks is crucial in planning your strategy.
Throughout the entire process, your strategy may include engaging with regulatory agencies in order to foster productive conversations that could potentially reduce approval times.
Regulatory strategies need to change as the requirements change. With advancements in technology, medical devices are one of the fastest-growing industries, bringing about rapid changes in regulations. You will need to stay abreast of these changes and implement them as appropriate to your strategy.
Just like you wouldn't dream of representing yourself in a court of law by reading a few law books, you shouldn't navigate alone your product's best interest in the global regulatory landscape. You may want to partner with an experienced regulatory consultant who can gauge the unique regulatory requirements for your particular product and act as your liaison with the regulatory agencies. Keeping up with the quickly changing regulatory landscape could prove to be a daunting daily task that your business may not wish to undertake on its own.
All medical device manufacturers, regulatory professionals and government agencies have the same common goal: to allow doctors and patients access to safe and effective medical devices. You are on your way to making this happen. You just need to make sure it's done intelligently.
A Wright Path is a trusted name in global regulatory compliance and strategy, and could help in navigating your path to FDA and worldwide compliance with successful approvals and registrations.