Canyon Labs’ consulting group is dedicated to the goal of helping medical device professionals go from the concept phase in medical device development, all the way to supporting post-market activities. You may have a novel medical device you’re looking to bring to the market, or simply a “me-too” device which you intend to manufacture. But it may be difficult to determine where to begin in this field.
We hope you’ll begin with us. The sooner you get a regulatory and quality professional involved in the process, the better you’ll understand what requirements you’ll need to meet to legally market your new product.
Regulatory Plan
One of the first steps in bringing a device to market is to understand what the pathway to market is. First, our consultants will begin by determining what classification your device falls under, and therefore what the regulatory pathway to market is. You may have a very simple, “me-too” device which has a clear path through FDA’s 510(k) process. The 510(k) process relies on establishing that there is a predicate device on the market which your device is similar to, while it remains incumbent upon you to provide objective evidence that the design differences with the new device do not raise any new concerns of safety or efficacy. Our consulting team has a long history of successfully utilizing the 510(k) process to bring devices to market.
It could also be the case that your device is significantly novel in its modes of operation and/or indications. In these cases, you may want to consider a presubmission to FDA in order to confirm its classification, or that you’ll need to follow another pathway. We also have experience in preparing these types of submissions. Typically, if a device is sufficiently novel in its modes of operations and/or indications, this would fall under the “de novo” process, or possibly a pre-market approval (PMA).
In any case, you’ll want to establish this regulatory plan at the beginning of the development process, as this plan with affect many decisions which follow.
Testing Plan
The next step in your development process will be coming up with a testing plan. This can sometimes be confusing with all the different types of required performance testing, biocompatibility testing, sterilization validations, packaging validations, figuring out what previous data can be leveraged, etc. Whether it’s FDA in the US, or a notified body in the EU, or numerous other countries around the world, our team has combined decades of experience interacting with regulatory bodies and interpreting guidance documents, so nothing on your project gets missed. Fortunately, not only does Canyon Labs’ consulting group has a long history of helping development teams determine what’s required for a specific product, we also perform a robust set of tests and have experts in-house to assist in determining the best path forward. Whether it’s product sterility experts, biocompatibility experts, or packaging experts, we’ve got you covered.
Submission
One of the biggest milestones of any new product development project is when all the testing is complete and the submission is sent off to the regulatory body. Knowing how to submit to various agencies can be confusing, however this is also right in our consulting group’s wheelhouse. We understand the formatting requirements for various types of submissions, know what pitfalls to avoid, and how to put it all together for success.
We also will interact with regulatory bodies on your behalf. These interactions can sometimes be difficult for the same reasons a submission can be difficult, but fortunately we have a long history of success working with regulatory bodies. Sometimes this can be interactions that require a formal response in a specific format, similar to a submission, or they can be informal interactions over e-mail, or they can be a conference call that we can help facilitate. But the bottom line is: we’ve seen it all, and got you covered.
Post-Submission
One of the greatest feelings in the world is when a regulatory body issues their clearance or approval letter so that you’re able to legally able to market your device. However, the work doesn’t stop there. FDA, for example, has the FURLS database which requires your device to be registered at every facility in which it undergoes a significant step in the manufacturing process, such as if you contract out sterilization. There’s also navigating facility registration and payments, complaint handling, GUDID registration, and more. If you’re marketing in the EU, there may be an annual notified body audit that we can help support. If you’ve never gone through any of these processes, they can seem quite daunting. Fortunately, Canyon Labs’ consulting team has plenty of experience and understanding of what needs to be done to stay compliant with all of the regulations once your device reaches the market.
Conclusion
Canyon Labs has the tools, talent, and experience to help you go from the concept phase of medical device development, through the testing required by regulatory bodies, writing the submission to get clearance or approval, and supporting compliance post-market. That all may seem overwhelming at first glance, but we know how to do it. The sooner we get involved, the better the outcome will be.