SENIOR MANAGEMENT TEAM

Michael J. Billig
Co-founder & Chief Executive Officer
Mike began his career in the medical device industry 35 years ago with Medtronic. Mike’s entire career has been involved with quality, regulatory, clinical research and general management. He has worked in executive-level positions for the past 20 years at Converge Medical, Timi3 Systems, CardioThoracic Systems, and Cardiometrics. Mike’s role in these early stage start-up companies was to provide overall leadership and strategic direction as a member of the executive staff. Mike has also worked for a number of other successful companies including Guidant, Oximetrix, Abbott and Syntex. Mike has secured regulatory approval for hundreds of medical device products across the U.S., Canada, Central and South America, Asia and Europe. He has been involved with a variety of product areas including both sterile disposable products and electronic instruments. As a vice president of several companies and the former President and CEO of Timi3 Systems, Mike has been instrumental with multiple successful IPOs, as well as substantial fundraising and corporate acquisitions. Mike has a B.S. degree in microbiology from the University of Minnesota.

Darlene Crockett-Billig
Co-founder & President
Darlene started her medical device industry career 33 years ago at Medtronic. She went on to work for Miles Laboratories, CooperVision Ophthalmic Products, and KeraVision, holding senior management positions since 1987. At KeraVision, Darlene was responsible for the regulatory, clinical and quality activities associated with the company’s successful effort to obtain FDA approval of a new Class III Panel Track ophthalmic implant and its associated surgical instruments. During her career, Darlene has directed over 300 successful submissions including PMAs, IDEs, 510(k)s, HDEs, Technical Files and Design Dossiers. She has also provided regulatory and quality leadership for a variety of implantable cardiovascular pacemakers and leads, parental and nutritional IV solutions and administration sets, ophthalmic drugs, contact lenses and contact lens solutions. Darlene is an expert in validation testing including sterilization (ethylene oxide, radiation, steam and dry heat) and aseptic processing. Darlene has developed a fully-customizable, comprehensive Quality Management System for Experien Group clients and is a standout in the field for assessing and securing compliance with FDA’s Quality System Regulation, ISO 13485:2003, the European Medical Device Directive and Health Canada’s Medical Devices Regulations. Darlene received her B.A. degree in Biology from Augustana College in Sioux Falls, South Dakota. She earned her MBA from the College of St. Thomas in Minneapolis, Minnesota.

Russell W. Felkey
Executive Vice President
Russ started his medical device career in 1972 as an FDA Investigator, conducting more than 300 inspections and investigations over his five year term. For the past 31 years, Russ has worked for medical device companies, including 10 years in senior management positions for large companies such as Medtronic and Boston Scientific. In addition, he has over 20 years experience advancing novel device therapies from start-up phases through commercialization. Russ’ experience includes global pre-clinical, clinical, regulatory and quality strategy development and implementation. Russ has provided leadership for significant implantable cardiovascular and neuromodulation systems, laser therapies, drug pumps, heart valves, interventional cardiology products including intravascular ultrasound, drug eluting stents and other complex medical devices. He has supported several companies through successful IPOs and secondary offerings. Russ received his B.S. degree in Chemistry from the University of Iowa.

Kit Cariquitan
Senior Director, Clinical & Regulatory Affairs
Kit joined Experien Group from Boston Scientific where he was the Global Principal Product Manager for neurovascular access products. Kit has worked in the medical device industry for over 12 years predominantly in start-up organizations in clinical research, regulatory strategy development, product development and marketing. He has experience with cardiovascular and neurovascular medical devices. Kit has worked for such companies as Cardiometrics, CardioThoracic Systems, Guidant, Converge Medical and Boston Scientific. Kit has developed strong expertise in designing, managing and supporting FDA IDE and post-marketing clinical trials of Class I, II and III medical devices. Kit has overseen top-level clinical trial activities, conducted clinical trials in Europe and managed O.U.S. clinical research organizations. He additionally has directed IRB submissions, FDA and Notified Body activities, 510(k) submissions and other regulatory projects. Kit received a B.S. degree in Biological Sciences from Pepperdine University in Malibu, California.

Sean P. O'Donnell
Director, Regulatory Affairs & Quality Systems
Sean possesses over 14 years of experience in the medical device industry, both in the United States and Europe. Prior to joining Experien Group in 2009, he held management roles with various medical device companies, including Acuson, Siemens Medical Solutions and Boston Scientific. Sean has specific expertise in the development and implementation of Quality Management Systems that comply with FDA’s Quality System Regulation, ISO 13485:2003, CE Marking (MDD and IVDD), Canada’s MDR (CMDCAS scheme) and other relevant standards. He is highly skilled with Design Assurance and Design Controls for Medical Device hardware and software, including the application of Risk Management ISO 14971:2007 and the IEC 60601 Series of standards. Sean has performed numerous internal audits, supplier audits and management reviews for medical device companies and he has instructed courses in Internal Auditing for DeAnza College’s CACT Program. Sean was a certified instructor on Process Validation for Siemens Medical Solutions and Boston Scientific and he has completed AAMI Certification for Mastery of the Quality System Regulation as well as a Lead Assessor Program for ISO 9000. Sean received a B.S. degree in Chemical Engineering from San Jose State University in San Jose, California.

Katrina L. Christy
Director, Pre-Clinical, Clinical & Regulatory Affairs
Katrina has over 13 years pre-clinical and clinical research experience with medical device companies, including various management level positions at Heartport, Converge Medical, RITA Medical and AngioDynamics. Katrina began her medical device career in pre-clinical research and as a clinical instructor for product training of surgical teams. She has conducted several clinical trials in Europe and possesses substantial clinical trial management expertise in cardiovascular and radiofrequency ablation devices. She has supported 510(k) and other regulatory submissions and is also experienced in supporting companies’ compliance with ISO 13485:2003, the European Medical Device Directive and Health Canada’s CMDCAS. Katrina received a Bachelor’s degree in Biology from Sonoma State University and holds a post-graduate Clinical Trials Design and Management certificate. She is also a Registered Veterinary Technician (RVT) and a Registered Laboratory Animal Technologist (RLATG).

Kara L. Madsen
Director, Clinical & Regulatory Affairs
Kara has over 12 years of professional experience supporting clinical research programs for medical devices, drugs, and combination products from development phases through commercialization. She has worked in clinical and regulatory affairs for several successful start-ups such as RadioTherapeutics (sold to Boston Scientific) as well as established medical device companies like Accuray. Kara has designed and managed feasibility studies, IDE trials, and post-market studies in both the U.S. and O.U.S. and has experience with laser, radiofrequency energy, hysteroscopic sterilization and implantable device technologies. She has overseen regulatory activities such as IRB non-significant risk submissions and 510(k) submissions. Kara earned her B.S. in Physiological Sciences from the University of California, Los Angeles and her M.S. from the University of California, Davis. She is in process for an Executive MBA degree from Pepperdine University.

Kristin S. Crosland
Director, Business Development & Project Management
Kristin started her professional career in 1995 in academia, conducting state and national research projects for the University of Utah, the University of California, Los Angeles and Stanford University. She is an experienced qualitative and quantitative researcher in public policy, having conducted high-stakes outcome assessments for multiple research centers, foundations, and early stage companies. Kristin has performed business development activities and supported fundraising efforts for both public and private entities. She received a B.S. from Duke University in Political Science and an M.S. from the University of Utah. Kristin additionally attended Harvard Law School and is A.B.D. in her doctoral degree in from University of California, Los Angeles.