The old school of serial planning for medical device regulatory, quality and reimbursement thinking has historically resulted in many products failing to get to market. To begin looking for a FDA regulatory classification via product code, once you have your Intended Use or Indication of Use identified, is a high-risk and low ROI approach.
FDA regulations serve to validate your product is safe and effective for patients. It is at the ideation phase that you need to take into consideration many factors impacting your design, testing, manufacturing, quality systems, and reimbursement. The earlier you start, the better you can plan your trajectory for the shortest path to market.
What you need well before finalizing Indication of Use, is comprehensive product information of those similar to your idea. Now imagine comparing such products side-by-side for up to 80 different fields, such as Indication of Use, Usage, standards, clinical trials, and potential reimbursement -- in seconds flat!
We know almost all higher risk devices (PMA) require clinical trials, but did you know that over 9,300 510k devices have conducted clinical trials? Clinical trial data is not always for FDA clearance. There are times trials are conducted for reimbursement justification, or performance tracking with which to better market the devices. So just looking at FDA data is insufficient in assessing what similar products have done.
This matters as you embark on ideation and plan your fundraising rounds.
Thus, FDA, or product classification is only one part of the equation to successfully market your device. You also need to ensure you have the right level of detail in your Indication of Use language, the right amount of test and clinical data to plan your reimbursement and quality system.
Ideally you want to contact FDA directly as early as possible using their DICE line [1(800) 638-2041 or (301) 796-7100], and for products targeting Medicare patients CAGInquiries@cms.hhs.gov . Yet, you also want to go in having some idea with which to have an intelligent and thorough conversation, which means you need to do your homework.
Expensive and not so easy, right? Not anymore. We built ClearRoadmap™ so you can quickly Search, with unprecedented precision and accuracy, and find device information, with which to conduct Comparison side-by-side. Once you have the devices identified you can save the details, with the URLs to the source documents, to a Report, at cost effective prices.
If you're not even familiar with regulations or reimbursement ClearRoadmap™ can help you come up to speed and reduce your risk. Almost a dozen step-by-step Pathways, such as mHealth, FDA 510k, PMA, DeNovo, Quality Systems, can accelerate your knowledge.
We believe in empowering innovators with precise and accurate information, so you can plan your strategy with intelligent information.
ClearRoadmap™ Introductory Offer gives you exceptional value. Register for an account to subscribe to the application, when and where it is most convenient to you. ClearRoadmap™ is a web based platform build on Azure cloud services and available around the world, to put you in the driver's seat.
-- Vizma Carver, Founder and CEO, Carver Global Health Group LLC and ClearRoadmap™