ARTICLE SUMMARY:
We’ve rebuilt our global Document Depot database to make it easier to find guidance, regulations, proposals, and any number of other items that make the medtech regulatory and market access world tick. Scroll, search, sort, and filter to locate key documents to support your work and monitor trends in policy development.
Medtech regulatory affairs and market access professionals work every day to advance lifesaving products within a defined set of rules. It’s a challenging job, made especially so because those rules and how they’re defined are constantly changing.
When new guidelines and regulations are published, and new laws and decrees are enacted, the on-the-ground context in which a device is operating evolves. Meanwhile, consultations, proposed rules, white papers, and other future-facing missives point to potential near-term opportunities and pitfalls.
This is the field in which Market Pathways plays, working in our articles, interviews, and data analysis to help companies navigate the landscape necessary to bring new products to market and to keep them there. One of the tools we bring to bear is Document Depot, our medtech policy database.
In Document Depot, the new FDA discussion paper on generative AI lives with CMS’ annual Medicare payment rules, last year’s EU proposal to revamp the Medical Device and IVD Regulations, China NMPA’s recent drop of 57 product-specific guidances in one day, a 2021 resolution establishing price monitoring of implantable devices in Brazil, and… Well, you get the idea. Currently, there are 4,000-plus documents from 135 agencies and organizations, representing more than 40 countries and regional authorities, and we update the database continuously.
Now, we are taking steps to make it easier to find what you are looking for amid all this information. As of today, we’re launching a new and improved Document Depot that boasts a cleaner, more straightforward user interface, better search function, and the ability to filter by region, agency, and document type. It allows you to pinpoint which documents have open comment periods so you can weigh in on how they are crafted. It links versions of documents over time, so you can more easily follow their evolution.
Check out the brief video tour below to help get you started. We’d love to hear your feedback and any ideas to improve the offering. (You can reach out to me directly at d.filmore@medtechstrategist.com.)
I hope Document Depot is a valuable tool that you can use to support your day-to-day work along with the rest of what we offer in Market Pathways. Good luck on whatever pathway you find yourself!