As you might expect, here at RQS the responsibilities and duties of providing our clients with the support they need often involves traveling for on-site visits. For the time being, most of the travel takes place within the greater metropolitan area of the cities in which we currently have offices: Cleveland and Pittsburgh. Our Pittsburgh team makes rounds to their Pittsburgh-based clients and our Cleveland team makes rounds to their Cleveland-based clients. However, in order to best meet our clients’ needs, there is a fair bit of interchanging resources between our offices. Employees, some more than others, travel within the two metropolitan areas providing support to clients in both regions, as needed. Having been one of our Pittsburgh-based employees who has frequently traveled to Cleveland for client support, I thought I would use this blog post to reminisce on the journey.
Each journey essentially is the same: Head Eastbound on PA Turnpike then the OH turnpike to Cleveland and the reverse when coming home to Pittsburgh. Even for someone like me who doesn't have the best recollection of directions and road names, I have traversed the journey enough times to know how go back and forth ( or at least between the general vicinity of my apartment and a client site in Cleveland ). Although, the road on which I drive physically remains unchanged, no two journeys have been exactly like. A major contributor is that I usually rent a car for these trips, meaning that I get to drive a different car every journey. Aside from the vehicle, there are many other aspects that make each journey unique: traffic patterns, road construction, weather, which rest stops I use, what I listen to in the car, what I eat, and my decision on whether to stop at Sonic on exit 187 or not ( yes, my inner child still craves a frozen blended beverage from time to time).
One day on one of these drives headed to Cleveland, the analogy that sparked this blog post hit me. The road I was traveling on represented the regulatory pathway that medical devices must traverse through to demonstrate safety and effectiveness, the car I drove represented a medical device that a manufacturer hoped to bring to market, and me, the driver represented Regulatory and Quality Solutions navigating medical device companies through the most efficient regulatory path to bring a product to market.
As with the rental cars I drove, each medical device is different. As there is a learning curve for me to adjust to the handling and feel of the car and finding where all the controls are, there is a learning process we instill here are RQS to ensure we are properly and adequately educated to the details, history, and nuances of a medical device company and its medical device and personnel so that we can tailor our services and expertise to best help our clients achieve their goals. As my drives on the roads to Cleveland are distinguished by the traffic, weather, and other factors, the regulatory pathway to clearance or approval is unique for a given medical device. Factors such as the device’s clinical application, technology, predicate, and features to name a few, can yield variations in regulatory requirements. As my driving experience and sense of navigation (supplemented by my trusty GPS of course) allow me to adjust to the differences of each journey , whether it be adjusting to a new car or road conditions, to successfully allow me to arrive to my destination in time, it is the experience, knowledge, and versatility of Regulatory and Quality Solutions that has allowed for its continued success in navigating through international medical device regulations and accelerating success for medical device companies.
Image Credit: Moyan_Brenn_BACK_FROM_ICELAND at Flickr