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There are many processes a medical device company needs to go through in order to bring a new product to market. So much research needs to be done, in-depth reports must be written, regulations must be adhered to… it can definitely take a very long time for a medical device company to start offering a new product. However, one company has helped streamline this whole process: CiteMed. This cutting-edge enterprise is helping companies bring their new medical devices to market much faster!
Home Business Magazine had the opportunity to chat with CiteMed’s Co-Founder and Operating Partner, Ethan Drower, all about his business. Drower was happy to share insight on “The CiteMed Edge ”, his company’s greatest achievement, and the biggest challenge they had to overcome to get to where they are today. He even shares tips on how to bring a business idea to life and the top traits of a successful entrepreneur!
HBM: Tell us all about CiteMed. What is “The CiteMed Edge”?
ED: “CiteMed is disrupting and revolutionizing the European Union Medical Device Regulation (EU MDR) process. Literature Search and Review is the cornerstone of medical device companies’ Clinical Evaluation Report, and CiteMed has made this process more streamlined and optimized than ever. The CiteMed team was formed to deliver a high volume of beautifully written and formatted Literature Reviews on timelines that will enable companies to meet their EU MDR goals. CiteMed’s top goal is to help companies get their medical products to market as quickly as possible, all while maintaining state-of-the-art compliance with European Commission regulations.
CiteMed leverages a software platform that we built in-house to perfect the formatting of uniform and error-free submissions. Humans read and write, while CiteMed’s machines handle the arduous tasks of formatting and error handling. The result is consistency across all literature review submissions.
‘The CiteMed Edge’ has been our ability to bring together amazing technologists and industry-leading medical writers and regulatory consultants. It’s the collaboration between these groups that has allowed us to build tools unlike anything used in Regulatory Affairs and scientific literature review today. ”
HBM: What inspired the founding of CiteMed?
ED: “We saw a massive need to rise with the implementation of the EU Medical Device Regulation in 2020 and 2021. Manufacturers were suddenly buried with work, especially when it came to Clinical Evaluation and Post Market Surveillance. Someone had to come in and innovate the space, because current best practices simply wouldn’t be enough to comply with the new regulation. “
HBM: Tell us about your own business backstory. How did you get involved with CiteMed?
ED: “I was one of the original founders of CiteMed. My contribution to the team was originally to build and lead the software development team in the creation of our first internal tool. ”
HBM: What has been CiteMed’s biggest achievement thus far?
ED: “Externally, it has been and will always be the continued success of our clients. Whether we deliver Clinical Evaluation Reports, Literature Reviews, or continued Post Market Surveillance and Vigilance monitoring, their ease of compliance (and acceptance in Europe) is our proudest achievement.
Internally, I would say it has been the ability to build software products that directly impact the submission timelines (and budgets) of our clients. The more we innovate, the more everyone succeeds ultimately. ”
HBM: What was the biggest challenge CiteMed had to overcome to get to where it is today?
ED: “Regulatory Affairs is a dynamic space. The rules all have different interpretations, and the current accepted ‘best practice’ can be completely overwritten by a newly released guidance document. I’d say that the biggest challenge is maintaining a beginner’s mind, and always being open as a company to change our processes, and understand the various medical device regulations. ”
HBM: What are your biggest tips on bringing an idea for a business to life?
ED: “I would say you have to confirm that there is a market for what you are selling. This sounds overly simple, but most people waste years building a product that no one wants. Find the simplest, cheapest version of what you want to sell, and then go try and sell it! The feedback you get from this initial process is invaluable as an entrepreneur. ”
HBM: What three traits must every entrepreneur have in order to be successful?
ED: “I would say empathy, resilience to rejection, and a love to build useful things.”
HBM: Where do you hope to see CiteMed in 3 years?
ED: “We are in the Regulatory Affairs and Medical Device space for the long haul. We hope to continue to help clients with their Clinical Evaluation submissions, while simultaneously building amazing software platforms that innovate and drive this industry forward. ”
For more info about CiteMed, visit citemedical.com.
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