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September 29, 2017 | Digital Science
We run a popular blog series called #FoundersFriday in which we interview entrepreneurs from science and technology businesses. Founders Friday provides a platform for our interviewees to discuss their entrepreneurial journey and their perspective on the industry as a whole.
Priya Bhutani is the Founder of RegDesk and has been its Chief Executive Officer since 2013. Priya drew on her extensive experience in the medical device and regulatory industry to formulate a new way of approaching compliance needs by using a crowdsourcing model that connects clients with experts from around the globe.
What does RegDesk do?
RegDesk helps pharmaceutical and medical device companies answer the most critical market access questions by leveraging the world’s leading regulatory and reimbursement experts. Our approach of peer review coupled with machine learning allows our clients to receive objective and actionable intelligence quickly, and for a fraction of the cost of a consulting company. This allows our clients to make market access decisions faster and with a higher level of confidence. RegDesk essentially provides more accurate market access intelligence, faster and at a lower cost than consulting companies.
How did your background help you to build RegDesk?
I am a Biomedical Engineer by training. I worked as a product development engineer for a leading medical device company where I was responsible for taking a product from concept to launch. I had first-hand experience with the difficulties of taking a finished medical device to market because regulations not only differ by country but also by product and are incessantly evolving. I learned regulatory and reimbursement are the most significant hurdles faced by healthcare companies seeking to expand.
In my role as a regulatory consultant, I helped numerous medical device companies expand their products globally; I learned that regardless of the size of the company, regulatory challenges remain constant.
How do you connect clients with the right experts?
We are a regulatory and reimbursement intelligence engine. We do not simply connect clients with the right experts. We leverage the method of peer review, which entails engaging multiple in-country experts to provide validated actionable insights.
What challenges did you face when building expert communities?
Building our expert community wasn’t too challenging because these experts are looking for ways to market their services and increase their earnings. The real challenge is ensuring the experts are knowledgeable in the product area.
What problems exist in bringing medical technologies to the market?
As many as 80% of all drug and device applications get rejected by regulatory authorities for reasons unrelated to safety and effectiveness of the products.
Lack of understanding of the local requirements, misinterpretation of the guidelines, and misguided advice can all derail drug and device approval. The same reasons also cause companies to become non-compliant, thereby incurring hefty fines and losing credibility in the market.
Commercial and regulatory leaders at healthcare companies are seeking innovative solutions to predict potential risks and escalate speed to market.
What does RegDesk do differently to other consultancies working in this field?
We provide more accurate product & country-specific intelligence faster and at lower cost than consulting companies. Unlike consulting companies, the intelligence we provide is verified (through peer review), more detailed and evidence-based. With RegDesk, clients get full transparency to the experts who contributed to the intelligence.
Consulting practice relies on the advice of a single expert, making it a precarious business practice. Regardless of how experienced and knowledgeable the single source may be, the results are limited by the ingenuity and skills of one person who may misinterpret the nuances of the requirements, possess outdated information, and be biased by their own agenda. There is no transparency to the accreditation of the consultant providing the advice. Furthermore, consulting companies are limited to geographic footprint.
Does a heavily regulated industry limit or encourage development and innovation?
There haven’t been many technology advancements made in the regulatory and reimbursement space. The dynamic nature of regulations makes it challenging. But there is a definite need for innovation.
How do you see RegDesk developing?
We are striving to become the leading platform – the trusted source for regulatory and reimbursement intelligence. We want healthcare companies around the world to use RegDesk to predict potential risks and gain insights into the fastest pathway to market for their products. Our mission is to reduce the rejection rate by 30% and accelerate speed to market.
Find out more about RegDesk and what it offers. Follow @RegDesk for their latest news and more.