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Areas of Expertise: Medical Device Product Design; Project Management; Regulatory Strategy; Quality Management Systems; Design Control
Eric Kolb has over 20 years of experience in the medical device field, the last 7 as a consultant. Throughout his career he has contributed to large and small organizations, across a variety of cross-functional roles and within a number of medical disciplines including orthopedics, spine, urology, dental, wearable devices, craniofacial, and wound care. As a consultant Eric has provided a range of services including concept development, customer discovery, product design and testing, grant writing, quality system implementation, regulatory strategy, intellectual property strategy, process validation, and much more.
In addition to providing consulting services, Eric is co-founder and CTO of Elidah, which designed and manufactures Elitone, the first externally worn treatment for stress urinary incontinence cleared for over-the-counter use. Through this first-person entrepreneurial experience he has gained insights valuable to clients striving to bring their own medical device products to market. Development and clinical testing of the Elitone device were largely funded by the National Science Foundation, the National Institutes of Health and state based granting agencies. In addition to leading Elidah’s successful grant writing efforts, Eric maintains primary responsibility for regulatory submissions, publication strategy, pipeline product development and maintaining Elidah’s ISO 13485 certification.
Prior to founding Elidah. Eric worked as Director of Engineering for two medical device startups that brought first-in-class technologies through the US regulatory process. At ZetrOZ, the manufacturer of a wearable multi-hour ultrasound therapy device (samrecover.com), Eric led the company through continuous improvement of the device and its manufacturing processes. Eric also implemented broader quality system best practices that were specifically relevant to the startup medical device environment. At Doctors Research Group, the manufacturer of a novel in situ curing polymer which was ultimately acquired by Abyrx (abyrx.com), Eric successfully brought a first line of products through domestic and international regulatory reviews. Eric also built out and validated manufacturing capabilities and developed a pipeline of products that utilized the company’s polymer technology.
Eric started his career with Johnson & Johnson, working within the companies supporting orthopaedic surgery (e.g. J&J Orthopaedics, DePuy Orthopaedics, DePuy AcroMed, DePuy Spine). He spent 10 years with dual responsibilities as an R&D lead and a project manager. The more complex of these projects included multi-site/country teams, thousands of product SKUs and ultimately generated $100s of millions in revenue. Beyond project work, Eric also played a key role in redefining the corporate product development process, and project management tools he developed for his own teams were implemented company wide.
Eric has a BS in Biomedical Engineering from Rensselaer Polytechnic Institute and an MS degree in Mechanical Engineering from Case Western Reserve University. His Master’s thesis investigated failure mechanisms of orthopaedic implants using computer modeling techniques. Eric has 30+ issued US patents and has written 7+ federally funded grant applications that have raised in excess of $3.5MM for his companies and clients.