Sean Chen

Founded Kreate Medical to create a new generation of medical products for soft tissue repair and wound healing. Two FDA 510(k)-cleared product families, a growing body of peer-reviewed publications. ISO 13485 and MDSAP-certified manufacturing facility. A growing IP portfolio in tissue repair & regeneration, and controlled drug delivery.

Lead next generation products design and development. Technical Leader responsible for the all technical aspects of new products. Plan, budget, execute the key development activities to meet program timeline, including preclinical studies to support FDA pre-submission and submission.

1) Program leader of several key biomaterial development programs including understanding the unmet need, completing technology screening and transfer, conducting IP landscape research, feasibility lab research. Built and managing an effective R&D team, and successfully completed the feasibility, scale-up, and technology transfer to business units. 2) Material expert in solving complicated problems. Solved key technical problems impacting products with $ billion revenue. Recognized multiple times by BU teams and co-filed 6 patents.

Material expert in failure analysis, material identification and selection, vendor and process changing, supply continuity, yield improvement, new product development, regulatory approval, competitive analysis, technical due diligence etc.