I am Ethan Drower, Co-Founder and Operating Partner of CiteMed (which is changing the face of the European Union Medical Device Regulation (EU MDR) process). CiteMed has completely sped up the medical device regulation paperwork process so that manufacturers can bring their products to market much more quicker. I wanted to share my brand story with the hopes of inspiring new and aspiring entrepreneurs who are looking to disrupt an entire industry.
My Father’s Observation That Sparked Everything
Prior to co-founding CiteMed, I was a software developer for years. My dad had been in the medical device regulatory industry for three decades and came to me with a problem he thought I could help with: a new regulation (EU MDR) that inflicted big extra costs and required a lot more paperwork was bound to crush the progression of both small and large manufacturers.
The process of certifying a medical device was already a laborious undertaking that required so much time and effort, and the regulation was bound to make it even more strenuous. The requirements were more stringent than ever, and shrinking corporate budgets and focus on sales have also made it difficult for Regulatory Affairs professionals to get Clinical Evaluation Reports (CER) and other documents ready to go.
Both new and established medical device companies felt frustrated over the number of hours needed to just format their CER documents alone, and they couldn’t hire more team members as a way to streamline and speed up the process. My father knew that the medical device regulatory arena was in dire need of innovation, so we set out to see how we could help manufacturers that struggled with the new regulation.
The Beginning of CiteMed
Our vision was to devise a much more streamlined, leaner process of getting all the reports and mountains of regulation paperwork completely ready to go for medical device manufacturers so that they could get their new products to market as quickly as possible (while complying with the European Commission regulations).
We had a team of medical writers ready to handle Literature Search and tackle paperwork, and I thought it would be best to bring specialized, custom-built software tools into the equation — my reasoning was that if our medical writers had targeted software that could help them, their work would be highly optimized. Our clients would then get to enjoy cost-effective and efficient device compliance that was also free of human errors and of the utmost quality possible.
Using my years of experience in software development, I came up with the vision for the software platform that would help our medical writers with their work. My father and I then collaborated on the concept and brought our first client on board. With that, CiteMed was born.
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Disrupting an Entire Industry
Since its founding in YEAR, CiteMed has completely revolutionized the EU MDR process. ‘The CiteMed Edge’ has been our ability to connect stellar technologists with industry-leading medical writers and regulatory consultants. The synergy and collaboration between these parties have enabled us to create groundbreaking tools unlike anything used in Regulatory Affairs and scientific literature review today.
Our company is comprised of veteran Regulatory Affairs Professionals and software engineers who previously made waves in Silicon Valley. CiteMed’s custom-built software platform assists our medical writers in crafting and formatting uniform, mistake-free submissions — the software helps make our writers up to 20x more efficient at their jobs!
The humans on our team read and write, and our software takes care of the labor-intensive task of correcting errors and ensuring everything is properly formatted. The final result is consistency and accuracy across all of our clients’ literature review submissions, without the need to cut any corners or sacrifice the attention to detail that is so crucial for top-tier work.
CiteMed is the answer for medical device companies that are reeling over budget and workload issues stemming from EU MDR regulation. With CiteMed, there is no need to inflate budgets to try to get regulation paperwork completed. Our company will also take away worries about missing critical deadlines — the CER and other paperwork will be high-quality, mistake-free, and timeline-ready!
Our proprietary Literature Search Dashboard is used to look up, process, and keep scientific studies and other literature related to devices. CiteMed also dissects global clinical literature from a vast list of databases like Clinicaltrials.gov and Europa. On top of this, CiteMed gives each client a comprehensive Literature Review document that can be easily integrated into a CER, Post-Market Clinical Follow-up, or Periodic Safety Update Report.
CiteMed does all of this and so much more for our clients! Our team is big enough to complete medical device companies’ certification paperwork before their deadlines and small enough to really care about what every single one of our clients needs to succeed.
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The Process
It is so easy for medical device companies to benefit from CiteMed! Right after a manufacturer reaches out and describes their exact regulation requirement needs, we select a dedicated project manager who will oversee their case and be their main point of contact. The medical device company can then have peace of mind in knowing that their CER will be taken care of in a professional manner and will abide by all timelines.
While our in-house team of writers does the literature review and writes the reports, and while our software handles the formatting and fixes errors, we keep all clients constantly updated on the process so they are never left wondering what stage their paperwork is in.
Then, we present our clients with their documents (faster than other services could), they provide their thoughts and any requests for revisions they have, and we finalize everything and send it all along to their CER submission.
All of our clients enjoy stress-free, painless, and highly efficient automation. On top of this, we save all of the scientific literature, search results, and paperwork in our database and send reminders to clients to update their files as needed.
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Looking to the Future
CiteMed is in the Regulatory Affairs and medical device arena for the long run. We hope to continue to help medical device companies with their Clinical Evaluation submissions, while simultaneously designing and constructing pioneering software tools that innovate the entire industry.
