February 2nd, which is affectionately known as Groundhog Day in the US, has special significance for me. It marks the anniversary of my entrance into the world of IVD regulatory consulting. Which is why I've chosen it to officially re-enter the regulatory blogosphere and launch my dazzling new website!
Those that were faithful readers of the old Myraqa blog (RIP) will know what to expect. For those not yet indoctrinated, I'll be touching on a variety of current regulatory affairs topics. Some blogs maybe controversial, others wonky and mundane. But all will have a pinch of snark and (hopefully) a dash of witty insight to help keep you from wandering over to Facebook.
My goal is to post a blog at least once a week, or more often if something exciting happens in the regulatory world. And no, that's not a contradiction in terms. In the coming weeks I will talk about the recent changes at FDA, what the EU has been up too (hint: a lot), and maybe even take one last look at what went wrong in Palo Alto. I also hope to have a celebrity guest blogger on occasion, so it's in your best interest to check back often.
All that said, for this first blog I thought I'd wax poetically on how the world of medical devices and in vitro diagnostics has changed over the past few years, and what we can (perhaps) expect in the future. By the way, for those new to working with regulatory people, "perhaps", "maybe", and "it depends" are some of our favorite words.
To say that a lot has changed since 2014 - when I moved back into the corporate world - is frankly, an understatement. In the EU they decided to up their game in 2017 and introduced some of the toughest device regulations in the world. Here in the US we decided to let a reality TV star have a go at running the country, which has had an interesting effect on the FDA (more on that in a subsequent blog). Over in China, things are still a bit in flux, save the fact that CFDA really does seem to prefer working with companies in China over those that...aren't.
Meanwhile South Korea adopted LDTs, which they claim to have modeled after the US system (god help them). India has decided to dive into the world of medical device regulation; Canada is requiring MDSAP (another future blog topic); Britain has left the EU but might yet follow IVDR; and Russia is, well, Russia. And everyone is frantically trying to figure out what to do with next generation sequencing and the terabytes of data it produces.
So what does this all mean. Well, it depends (I did warn you). For sure it means that the days of following a US-centric regulatory strategy are probably gone, at least in the near term. No longer can you develop a product around a US filing strategy and expect to just re-format it for the rest of the world. Even with the global harmonization efforts of IMDRF and MDSAP, each country seems intent on putting their own adorable spin on device regulation, particularly when it comes to IVDs.
What is certain is that now - perhaps more than in ever in the history of device regulation - you absolutely need a global regulatory strategy. Unless of course you're not interested in marketing your product outside your borders. You'll also need to keep a watchful eye on what's happening in places like the US and the EU to see whether regulation takes a more innovative approach, or whether it retreats to a more conservative path, or if some hybrid model emerges. Regardless, the next 5 - 7 years promises to be some of the most interesting of my career.
I can't wait.