GessNet’s mission is to advance medical product safety engineering by providing the industry best practice-based software solutions and expert consulting. It is an extraordinary honor and privilege to have our board members join us on this journey. Together, we will provide our clients with the best-in-class software tools and services.
Mr. Watson is a highly respected regulatory leader in drug device combination products, digital health, human factors, and assurance cases. He has served in executive leadership positions at biotech, pharmaceutical, and digital health companies for the past 10 years.
Prior to his time in industry, Mr. Watson spent nearly 20 years in CDRH at FDA serving as a medical device reviewer, branch chief, and Division Director for a variety of devices, including General Hospital / Drug Delivery Devices. He also serves on industry coalitions, standards organizations, and speaks on topics regarding combination products, human factors, and digital health.
Susan Neadle, a 35-year expert in Combination Products and Medical Devices, holds impressive qualifications, including MS, BS, and has been recognized with Fellowships in both RAPS and AAO. She's been honored with the 2022 ISPE Joseph X. Philips Professional Achievement Award and was a 2021 TOPRA Awards Finalist. Susan also received the esteemed Johnson Medal for her contributions to Johnson & Johnson's R&D.
Post-retirement, Susan is Principal Consultant at Combination Products Consulting Services LLC, offering regulatory affairs, advisory, and design excellence services to biopharma, biotech, and medical device industries. Susan's commitment extends to Chairing the ISPE Combination Products CoP, leading Combination Products Working Groups, teaching courses, and active industry participation. She has recently published “The Combination Products Handbook: A Practical Guide” through CRC Press (www.routledge.com/9781032291628)
With over 39 years’ experience and devotion, and as a ASQ fellow, Mr. Bills has earned himself as a globally recognized thought leader and subject matter of expert in the field of medical product risk management and quality. He has been a key contributor to the development of international standards such as ISO 14971, ISO TR 24971:2020, and AAMI TIR 105 combination products risk management. He also serves on the US national committee for ISO 13485 and IEC 60601s.
Through consulting, authoring, and training programs at AAMI, PDA, institutions such as University of Southern California, University of Washington, Purdue University, Virginia Tech, Mr. Bills has been sharing his knowledge and wisdom on how to make and maintain safe and effective medical products.