Team

Our seasoned and cohesive team is a proven asset to all of our client companies. We are there when you need us, providing integrated services and flexible resource loading to accomplish your objectives.

Experien_Group-0059RT2

We take tremendous pride in the caliber of our staff. We hire seasoned experts as well as talented
junior professionals to comprise a truly excellent team. Together we deliver custom solutions
for each client and ensure the fulfillment of applicable regulations. We feel most
fortunate to have the opportunity to work with tremendously experienced people
both within Experien Group and our client companies.

– Mike Billig and Darlene Crockett-Billig

Senior team members

Our extensive product exposure and up-to-date technical knowledge ensures our delivery of timely, superior project results.

Our senior team possesses substantial industry experience, having worked for start-ups, mid-sized companies and some of the largest global medical device corporations both prior to and during their consulting careers. We partner with clients’ internal resources, working closely with design teams and functioning as company staff.  As a collective, we have 250 years of experience in:

  • Securing regulatory clearances and approvals for hundreds of submissions
  • Leading client company interface with FDA, Notified Bodies, FDB and other regulatory agencies
  • Supporting client company executives in meetings with Boards of Directors, sales teams and investors
  • Helping client companies to secure relationships with funding sources, test houses, design and manufacturing partners, distributors and key opinion leaders
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Co-Founder & Chief Executive Officer
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Michael J. Billig
Co-Founder & Chief Executive Officer

Mike co-founded Experien Group in 2003 with Darlene Crockett-Billig.

His entire 40+ year professional career has been involved with regulatory affairs, quality systems, clinical research, and general management for medical device companies. Mike has secured regulatory approval for hundreds of medical device products across the U.S., Europe, Canada, Central and South America, and Asia. He is a recognized industry expert in the growing area of FDA de novo submissions. Mike has led regulatory teams for a wide variety of technologies, including sterile disposable products, electronic instruments, robotics, combination products, mobile medical apps, and devices for regenerative medicine. Mike has particular expertise in interventional cardiology and cardiac surgery.

At Experien Group, Mike’s primary role for client companies is to provide strategic regulatory and clinical support, including virtual staff executive leadership. For several clients, Mike functions as the Acting Vice President of Regulatory, Quality and Clinical, representing the companies in Board of Directors meetings, sales meetings, industry symposia, investors meetings, regulatory agency interface, and more. Mike assists small start-ups, mid-sized companies and major public corporations alike, providing advisory and tactical direction for:

  • Complex U.S. and international regulatory and clinical strategies
  • Communications and interface with U.S. and international regulatory agencies
  • U.S. and international regulatory submissions
  • Venture presentations and facilitation of strategic corporate partnerships
  • FDA and international compliance activities (e.g., MDRs, Vigilance Reporting, and field actions)
  • Product labeling and promotional materials

Past companies and experience

Mike entered the device industry in 1973 at Medtronic, setting up the company’s first microbiology laboratory in Minneapolis. He transitioned to regulatory affairs at Medtronic as a Project Regulatory Manager at the time that the U.S. Medical Device Amendments of 1976 were finalized.

Mike went on to work for a number of other large companies and public corporations, including Syntex, Oximetrix, Abbott and Guidant. Mike spent the majority of his time in the industry in senior management for start-ups, holding executive-level positions for 20 years at companies such as CardioThoracic Systems, Cardiometrics, Converge Medical, and Timi3 Systems. In these early stage companies, Mike oversaw the regulatory, clinical and quality teams and provided strategic direction for product development and marketing.

As a vice president of several companies and the former President and CEO of Timi3 Systems, Mike provided overall leadership for strategic business affairs and company growth. He was instrumental with substantial fundraising, multiple successful IPOs, and company sales/corporate acquisitions from both seller and buyer positions.


Education

Mike earned his BS degree in Microbiology from the University of Minnesota.

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Co-Founder & President
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Darlene Crockett-Billig
Co-Founder & President

Darlene co-founded Experien Group with Michael J. Billig. During her 35+ year career in the medical device industry, Darlene has directed over 300 successful submissions, including PMAs, IDEs, 510(k)s, HDEs, de novos, Technical Files and Design Dossiers. She has been responsible for regulatory affairs, quality systems and clinical research activities for a myriad of products, including implantable and active implantable devices, combination products, in vitro diagnostics, and instruments. Darlene is an expert in validation testing, including sterilization (ethylene oxide, radiation, steam and dry heat) and aseptic processing.

Darlene is an expert in interpreting U.S. and international standards and regulations for clients. She additionally provides virtual executive leadership and strategic project support for client companies advancing U.S. Class I, Class II and Class III medical devices and combination products. For several clients, Darlene functions as the Acting Vice President of Regulatory, Quality and Clinical, representing the companies in interface with regulatory agencies, investors, and more. She has developed a fully-customizable, comprehensive Quality Management System for Experien Group clients.  Her work primarily involves:

  • Interface with U.S. and international regulatory agencies for product submissions and facility audits/inspections
  • Quality Management System development
  • Quality Management System compliance support (e.g., FDA’s Quality System Regulation (QSR), EN ISO 13485, EN ISO 14971, the European Medical Device Directive (MDD) and Health Canada’s Medical Devices Regulations)
  • Product testing considerations and pre-clinical research
  • Manufacturing, suppliers and distribution (e.g., validations, technology transfers and supplier quality)
  • FDA and international compliance activities (e.g., MDRs, Vigilance Reporting and field actions)
  • Clinical trial design and clinical trial management

Past companies and experience

Darlene started her medical device industry career in 1975 at Medtronic. She went on to work for Miles Laboratories, CooperVision Ophthalmic Products, and KeraVision, holding senior management positions for medical device companies since 1987. She provided regulatory, clinical and quality leadership for a variety of products, including implantable cardiovascular pacemakers and leads, parental and nutritional IV solutions and administration sets, ophthalmic drugs, contact lenses and contact lens solutions. As KeraVision’s Vice President of Regulatory Affairs, Clinical Research and Quality Systems, Darlene successfully led the company’s efforts to obtain PMA approval for a new Class III ophthalmic implant and its associated surgical instruments, securing unanimous FDA Panel approval for the PMA product. She has been responsible for over 50 medical device clinical trials.


Education

Darlene received her BA degree in Biology from Augustana College in Sioux Falls, South Dakota and earned her MBA from the College of St. Thomas in Minneapolis, Minnesota.

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Chief Regulatory Officer
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Kit Cariquitan
Chief Regulatory Officer

Kit is a highly regarded medical device executive possessing 20 years of industry experience with both start-ups and large public corporations. His professional background includes senior management responsibility for regulatory affairs and clinical research as well as supporting roles in sales and marketing. Kit has successfully led wide-ranging device programs through development and into global commercialization. He has been personally responsible for directing successful U.S. and OUS clinical trials and he has secured numerous device approvals/clearances.

At Experien Group, Kit is responsible for translating client companies’ strategic visions for their products into executable and commercially viable regulatory plans. He manages clients’ regulatory and clinical requirements to ensure alignment with Quality Management System requirements and operational efficiency. Kit is responsible for formal and informal communications with FDA, Notified Bodies and other regulatory agencies as well as all aspects of regulatory submissions. Kit’s primary functions include:

  • Regulatory/clinical strategies
  • Regulatory representative on client companies’ design teams for medical devices and combination products
  • Pre-submission packages and client interface for FDA pre-submission meetings
  • U.S. regulatory submissions (e.g., IDEs, 510(k)s, PMAs, and de novos)
  • Design Dossiers and Technical Files for CE Marking
  • Clinical trial design and oversight (including feasibility studies, pivotal studies for commercial approval and post-market registry studies)
  • Experien Group and client company representative at industry meetings and symposia

Past companies and experience

Kit returned to Experien Group from SentreHEART where he was Vice President of Regulatory and Clinical Affairs. Prior to that, he was Sr. Director of Regulatory Affairs and Global Management and Board member at Acclarent, a Johnson & Johnson company. Kit previously held several senior positions at Experien Group, including Vice President of Regulatory Affairs. Kit’s earlier career involved roles at several successful medical device companies, including Cardiometrics, CardioThoracic Systems, Converge Medical, Guidant, and Boston Scientific. He was Boston Scientific’s Global Principal Product Manager for neurovascular access products. Kit has particular expertise with cardiovascular and neurovascular medical devices.


Education

Kit received a BS degree in Biological Sciences from Pepperdine University in Malibu, California.

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Chief Operating Officer
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Kristin Crosland
Chief Operating Officer

Kristin joined Experien Group in 2007 to formalize the firm’s business development platform and to direct strategic growth initiatives. She works closely with the founding executives on management responsibilities such as planning, hiring and business operations to ensure the delivery of high-value services to all client companies. Kristin has successfully led Experien Group through several expansion cycles. She interfaces with U.S. and international executives, investors, legal representation and clinical and policy advisors to expand industry networks and to deliver meaningful support to the firm’s clientele and partners.

Kristin leads Experien Group’s operations and oversees all business development activities. She coordinates with senior team members for client communications, deliverables definition, resource planning, budget estimates, project accounting, and results tracking to ensure client satisfaction. Kristin delivers industry presentations representing Experien Group and she creates the firm’s collaterals and training materials. Her central responsibilities include:

  • Potential client outreach, introductions and the establishment of new business relationships
  • Ongoing senior team support for meaningful sustainment of the firm’s existing client accounts
  • Legal and business negotiations for the firm, including due diligence for the firm’s growth opportunities and strategic partnerships
  • Allocation and management of internal resources to support client programs

Past companies and experience

Prior to Experien Group, Kristin spent three years consulting for a variety of start-ups, small businesses and not-for-profit entities in business strategy, operations and marketing. She spearheaded successful, high-impact projects in the areas of strategic planning, client recruitment, fundraising, project management, and facilities relocation or expansion. Kristin additionally spent over 10 years in academia. She taught undergraduate and graduate courses and conducted numerous public policy research projects for Stanford University, the University of California, Los Angeles and the University of Utah. Kristin is a published scholar and a named contributor to federal court reports and other public records for law and educational policy. She has received numerous awards and prestigious fellowships from universities and private foundations.


Education

Kristin earned her BS from Duke University in Political Science and her MS from the University of Utah. She additionally attended Harvard Law School and is ABD in her doctoral degree in Educational Policy Studies from University of California, Los Angeles.

Nada Hanafi
Chief Strategy Officer
Nada Hanafi
Nada Hanafi
Chief Strategy Officer

Nada joined Experien Group in 2017 after working 12 years at FDA’s Center for Devices and Radiological Health (CDRH). Since 2010, she had been a CDRH Senior Science Health Advisor, serving as an expert consultant and senior advisor in the Center Director’s office. Nada combines her deep institutional knowledge with innovative approaches to help companies successfully communicate product information to FDA throughout the total product life cycle. Leveraging her years of reviewer experience and broad FDA exposure, she develops actionable premarket strategies to guide programs through successful submission. She also orchestrates compliance activity. While at FDA, Nada led postmarket investigations for ob-gyn devices, wrinkle fillers, tanning devices, breast implants, negative pressure wound therapy (NPWT) devices and metal-on-metal hip implants and she applies this knowledge to help companies effectively manage postmarket requirements.

At Experien Group, Nada helps medical device and combination product manufacturers generate regulatory/clinical roadmaps for success. Building upon her strong engineering background, she helps companies devise and position product performance testing and/or clinical studies to achieve major milestones. Nada’s primary functions include:

  • Product information review and strategic regulatory/clinical assessment to devise long term program and actionable milestones towards U.S. commercialization
  • Pre-submission support and FDA communication, including product positioning for device testing and clinical studies, including patient preference testing
  • U.S. regulatory submissions (e.g., IDEs, 510(k)s, PMAs, de novos, HUD/HDEs, 513(g)s, etc.
  • Postmarket compliance advisory services
  • Experien Group and client company representative at industry meetings and symposia, presenting as speaker or panelist to societies, universities and public/private consortiums

Past Companies and Experience

Nada initiated her career at Biomat Sciences as an R&D engineer supporting dental products. She joined CDRH’s Office of Device Evaluation (ODE) in 2004 and led FDA review teams for first-of-kind (and sometimes controversial) devices, including a silicone gel-filled breast implant PMA, a drug-eluting neurovascular stent IDE and two novel neurological stent HDEs for the treatment of atherosclerotic disease. As a Senior Science Health Advisor at CDRH, Nada led cross-Center and Agency programs for the advancement of FDA’s mission, including the Health of Women (HoW) program, the Network of Experts program and the Patient Preference Initiative. She collaborated with the Center for Tobacco and the National Institutes of Health (NIH) to improve regulatory efficiency and to strengthen data collection and she was the CDRH Liaison and Subject Matter Expert to FDA’s Office of Women’s Health (OWH) and the Office of Minority Health (OMH).


Education

Nada holds an MS in Biomaterials and a BE in Biomedical Materials Science & Engineering from Queen Mary College, University of London. She earned her MPH from Johns Hopkins Bloomberg School of Public Health. Nada is a Certified Quality Improvement Associate (CQIA) and a Certified Quality Auditor (CQA) from the American Society for Quality (ASQ).

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Chief Quality Officer
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Sean O’Donnell
Chief Quality Officer

Sean joined Experien Group in 2009 and possesses more than 20 years of experience in the medical device industry. He has particular expertise in the development and implementation of Quality Management Systems that comply with FDA’s Quality System Regulation (QSR), EN ISO 13485, EN ISO 14971, IEC 60601 electrical equipment series of standards, the European Medical Device Directive (MDD) and other relevant standards. Sean is an expert in software validation for medical devices and Software Lifecycle Management (EN IEC 62304). He has designed and implemented clean rooms for medical device manufacturers (up to Class 10) and he has been personally responsible for large scale projects in quality assurance and manufacturing process validation, including extensive experience with technology transfers.

At Experien Group, Sean manages the Quality team. He holds particular expertise in software-based technologies as well as usability engineering standards (EN 62366) for complex medical devices. Sean supports clients’ regulatory submissions (U.S. and international) and he functions as companies’ interface with regulatory agencies through audits and inspections. His central responsibilities include:

  • Quality Management System development and compliance to relevant standards
  • Manufacturing and distribution considerations (e.g., Supplier Quality, Design Control and Risk Management)
  • Interface with FDA Inspectors, Notified Body Auditors and State of California FDB Inspectors
  • Software Lifecycle Management for stand-alone medical software products as well as devices incorporating software (e.g., wearable technologies, mobile medical apps, sensor-based diagnostics, capital equipment)
  • Internal audits, supplier audits, and management reviews for companies
  • Quality requirements and regulatory submissions for CE Marking

Past companies and experience

Sean’s professional career began in 1982 at Dysan Corporation (sold to Xidex Magnetics) in process engineering for the manufacture of computer information storage products. In 1995, he transitioned to the medical device sector, holding management positions at several medical device companies, including Acuson, Siemens Medical Solutions and Boston Scientific. He has completed AAMI Certification for Mastery of the Quality System Regulation and a Lead Assessor Program for ISO 9000 with emphasis on ISO 13485. He was a certified instructor on Process Validation for Siemens Medical Solutions and Boston Scientific and a course instructor for De Anza College Center for Applied Competitive Technology. He has also performed as a Sarbanes Oxley (CSA) auditor, ISO 9000 certification coordinator and ISO 13485 auditor.


Education

Sean received a BS degree in Chemical Engineering from San Jose State University in San Jose, California.

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Senior Director, Regulatory Affairs
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Valerie Defiesta-Ng
Senior Director, Regulatory Affairs

Valerie joined Experien Group in 2011 with over 20 years of regulatory affairs experience at both small and large medical device companies. Her professional background includes regulatory affairs, regulatory compliance, clinical research, and product development. Valerie has obtained numerous regulatory clearances and approvals from FDA and has actively participated in multiple FDA and State of California FDB inspections. She has secured the CE Mark and international registrations for a myriad of products and she has participated in numerous successful Notified Body audits. Additionally, Valerie has written protocols for clinical trials in support of PMA submissions and she has been involved in U.S. and international clinical studies. In her regulatory capacity, Valerie has worked closely with company Marketing and Business Development teams to ensure that product labeling and marketing materials are compliant to relevant standards.

At Experien Group, Valerie manages clients’ regulatory requirements for product development, manufacturing, clinical trials, submissions, commercialization activities and post-market compliance. Valerie is responsible for formal and informal communications with FDA as well as international regulatory agencies. Valerie’s primary functions include:

  • U.S. and international regulatory/clinical strategies
  • Regulatory representative on client companies’ design teams for medical devices and combination products
  • Clinical trial management
  • Pre-IDE packages and client interface for pre-IDE meetings
  • U.S. FDA regulatory submissions (e.g., IDEs, 510(k)s, PMAs, HUDs/HDEs and de novos)
  • Design Dossiers and Technical Files for CE Marking as well as international registrations
  • Advertising, labeling and promotion compliance
  • Interface with FDA inspectors, Notified Body auditors and State of California FDB inspectors

Past companies and experience

Valerie has experience in all aspects of the medical device industry from product development through commercialization. Valerie has been personally responsible for numerous regulatory clearances and approvals (U.S. and international) and she is an expert in regulatory compliance activities, including QSR and ISO requirements, product complaint evaluation, MDR and Vigilance reporting, and corrective action resolution.

Valerie’s regulatory career began at CooperVision. Two years later, she joined another ophthalmic company, KeraVision. At KeraVision, Valerie worked as a Regulatory Affairs Manager under Darlene Crockett-Billig, supporting the company’s successful PMA approval efforts. Valerie gained cardiovascular experience at Guidant before moving on to a Senior Director position at ArthroCare where she managed all regulatory activity for their arthroscopy, spine and ENT medical devices.


Education

Valerie received her BA degree in Chemistry from San Jose State University in San Jose, California.

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Senior Director, Regulatory Affairs & Quality Systems
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Ramona Migliardi-Field
Senior Director, Regulatory Affairs & Quality Systems

Ramona joined Experien Group in 2009 and possesses over 20 years of experience in the medical device industry. She is an expert in the development and implementation of Quality Management Systems that comply with FDA’s Quality System Regulation (QSR), EN ISO 13485, EN ISO 14971, the European Medical Device Directive, Health Canada’s Medical Devices Regulations (SOR/98-282 and CMDCAS scheme) and other relevant standards. Ramona has been extensively involved in quality assurance for collagen-based technologies, combination products and sterile disposable devices. She is an expert in sterilization validation and aseptic processing. She is highly knowledgeable about product usability/human factors requirements, as well as the IEC 60601 electrical equipment series of standards.

At Experien Group, Ramona works closely with companies’ technical teams. She supports Design Control and Risk Management activities for clients. She regularly performs gap analyses, internal audits, and other quality management system assessments. Ramona performs compliance reviews for a variety of product lines. She leads clean room validation projects and oversees technology transfers in compliance with applicable ISO and QSR requirements. Her additional functions include:

  • Quality Management System development and compliance to relevant standards
  • Biocompatibility and medical device safety testing
  • Product sterilization validation (e.g., EtO and radiation)
  • Cleaning and steam sterilization validation for reusable products
  • Manufacturing process validation (e.g., Installation, Operation and Process Qualifications)
  • Product manufacturing and distribution considerations (e.g., Supplier Quality)
  • Interface with FDA Inspectors, Notified Body Auditors and State of California FDB Inspectors
  • Internal audits, supplier audits and management reviews for companies

Past companies and experience

Ramona has been a professional in the life sciences industry and manufacturing operations since 1985. She has held management roles at Collagen Aesthetics, Inamed Corporation, Allergan, and Aesthetic Sciences. She has overseen Quality Management Systems and project management activities for global product lines, including supplier agreements and the establishment of international product distribution chains. Ramona has directed long-range strategic planning at several companies, including the writing of business plans and determining budget allocations for new technologies. Ramona has earned her ISO 13485 Lead Auditor Certification, Aseptic Processing Certification, and RAB Lead Assessor Certification. She is also accredited by the RAB and IRCA for ISO 9000.


Education

Ramona earned her BS in Business Management from the University of Phoenix in San Jose, California.

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Senior Director, Regulatory Affairs
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Ron Warren
Senior Director, Regulatory Affairs

Ron joined Experien Group in 2014, bringing 30 years of successful experience in Regulatory Affairs, Clinical Research and Quality Systems. He possesses a strong track record of developing and implementing successful regulatory strategies that have led to timely product approvals worldwide. Ron’s background includes a wide variety of medical devices, IVDs and biologics, including tissue-based products, wound care devices, cardiovascular devices, insulin pumps, and electrosurgical devices and instruments. He has secured numerous FDA product clearances and approvals through CDRH and CBER and has secured international approvals for a wide array of technologies.

At Experien Group, Ron is responsible for the translation of client companies’ strategic goals into executable and commercially viable regulatory plans. He oversees clients’ regulatory requirements through product development, manufacturing, pre-clinical and clinical research, submissions, and post-market compliance. His primary functions include:

  • U.S. and international regulatory/clinical strategies
  • Formal and informal communications with FDA (CDRH and CBER) as well as Notified Bodies, Competent Authorities and global regulatory agencies to secure clinical and commercial approvals
  • Regulatory representative on client companies’ design teams for medical devices and combination products
  • Pre-submission packages and lead interface for pre-submission meetings
  • U.S. regulatory submissions, including IDEs, 510(k)s, PMAs, HDEs and de novos
  • Design Dossiers and Technical Files for CE Marking and Health Canada submissions
  • Interface with FDA inspectors, Notified Body auditors and State of California FDB inspectors
  • Submissions for study authorizations (e.g., Institutional and Independent IRBs and Ethics Committees)

Past Companies and Experience

Ron initiated his career in clinical research in 1983 at the Institute of Biological Research and Development (IBRD). He transitioned to clinical and regulatory at Edwards Cardiovascular Surgery Division of Baxter Healthcare, followed by Sorin Biomedical where he supported the company’s complete line of cardiovascular and cardiopulmonary products. In 1995, Ron joined Advanced Tissue Sciences (ATS), securing PMA approval for human tissue-based chronic wound and severe burn therapies and achieving HDE approval for a genetic connective tissues disorder therapy. Following ATS’ acquisition by Smith & Nephew Wound Management, Ron led Regulatory Affairs & Quality Systems functions for all human cell-based tissue engineered dermal products. In 2006 Ron became a Director of Regulatory for MDCI, a medical device consultancy later acquired by Aptiv Solutions. During his seven year tenure there, Ron assisted U.S. and international companies with regulatory strategy formation, FDA negotiations and pre-submission meetings, commercialization applications and post-market compliance. At Tandem Diabetes Care, Ron led the Regulatory Affairs department, working on the company’s line of insulin infusion pumps.


Education

Ron holds a BS in Biology from the University of California, Irvine and an MBA from California State University, Long Beach.

Naghmeh Nouri
Senior Director, Quality Systems & Regulatory Affairs
Naghmeh Nouri
Naghmeh Nouri
Senior Director, Quality Systems & Regulatory Affairs

Naghmeh joined Experien Group in 2016 after spending 20+ years working in the medical device industry. Prior to her hire, Naghmeh served as the Vice President of Quality and/or Regulatory Affairs for four companies and she held management roles at both startups and established corporations. Naghmeh holds an advance degree in Electrical Engineering. She is highly experienced with medical device software, including software as a medical device (SaMD). Naghmeh is an expert in FDA’s Quality System Regulation (QSR), EN ISO 13485, EN ISO 14971, the EU Medical Device Directive (MDD), the EU Active Implantable Medical Device Directive (AIMDD) and Health Canada’s CMDCAS for medical devices. She possesses ISO 13485:2016 Lead Auditor Certification from BSI.

At Experien Group, Naghmeh works closely with companies’ technical teams. She helps companies generate device Design History File (DHF) documentation for product development and is an expert in risk management, performance testing, electrical safety testing and usability studies. Her additional functions include:

  • Quality Management System (QMS) implementation and/or documentation upgrade activities
  • Quality representative responsibilities for phased Design Control, including support for Risk Management, Software Life Cycle Management, Supplier Quality, etc.
  • Quality lead for client interface with external regulators (e.g., FDA and State of California FDB inspectors, Notified Body auditors, etc.)
  • Gap assessments, internal audits, supplier audits and management reviews—as well as follow on support to address findings as needed
  • FDA and OUS regulatory submissions for pre-market clinical testing and commercial clearances/approvals (e.g., IDEs, 510(k)s, de novo, Technical Files, Design Dossiers, etc.)

Past Companies and Experience

Naghmeh spent the first decade of her career at Siemens Medical Systems performing quality engineering for capital equipment product development. She has subsequently worked in a variety of product areas at different device companies, including Ventritex (implantable cardiac defibrillators), Aradigm (drug delivery combination product), Radiant Medical (Systematic Body cooling system), Health Hero Network (patient monitoring software), Asante Solutions (insulin pump system), and AirXpanders (breast tissue expander). She successfully obtained CE Mark and U.S. and OUS clearance/approvals for numerous medical devices.


Education

Naghmeh earned her BS and MS in Electrical Engineering from Rutgers University/New Jersey Institute of Technology in New Brunswick, New Jersey.

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Senior Director, Clinical & Regulatory Affairs
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Brad Solberg
Senior Director, Clinical & Regulatory Affairs

Brad joined Experien Group in 2009 and possesses over 15 years clinical research experience working in medical device companies. He has been employed by large device companies as well as successful start-ups, and he possesses particular expertise with cardiovascular and spinal orthopedic devices. Brad has extensive experience in designing, managing and supporting U.S. and OUS clinical trials, including feasibility studies, IDE trials and post-market studies.

At Experien Group, Brad directs clinical and regulatory activities, including clinical trial design and study management for U.S. and international trials. He supports regulatory submissions, including U.S. IDE submissions as well as OUS Notified Body, Competent Authority and Ethics Committee submissions. Brad performs analyses of marketed products’ compliance to U.S. and international regulatory reporting requirements and he implements changes to bring products into compliance, as needed. Brad’s primary functions include:

  • Clinical strategy development
  • Clinical protocol development, including Informed Consent, Case Report Forms, trial agreements, etc.
  • Clinical trial management, including budgets, timelines, site coordination and monitoring
  • Clinical study documentation for regulatory submissions (e.g., IRB or Ethics Committee packages)
  • Formulation and facilitation of Data Safety Monitoring Boards (DSMBs) and Clinical Events Committees (CECs)
  • Independent core lab selection and management
  • Clinical report writing
  • U.S. and international regulatory submissions and compliance activities

Past companies and experience

Prior to joining Experien Group, Brad held management positions at Medtronic and Abbott Vascular. He also worked for start-up companies, including Conor Medsystems and PharmaSonics. As a clinical study director for several companies, Brad has presented at investigator meetings and conducted Clinical Advisory Board meetings. While he has been primarily involved with clinical research for medical device companies, Brad has also supported R&D, manufacturing, marketing and sales departments. He orchestrated post-acquisition activities for cross-functional teams at Medtronic following the purchase of Kyphon and he helped CryoVascular develop both public and physician information campaigns to increase market penetration.


Education

Brad received a BS degree in Environmental Studies from San Jose State University in San Jose, California.

Serena Brewster
Senior Director, Finance & Administration
Serena Brewster
Serena Brewster
Senior Director, Finance & Administration

Serena joined Experien Group in 2005 with a broad background in accounting and business administration. Serena manages the firm’s Accounting Department and directs Human Resource activities, including staff hiring and training. She works closely with the executive team to establish and maintain operating budgets and she communicates with clients on invoicing and project budget tracking. Serena additionally oversees Experien Group’s administrative functions, including office coordination and facilities maintenance.


Past companies and experience

Serena began her professional career as an Office Manager at Rankin, Landsness, Lahde, Serverian & Stock. She was hired by Fox Paine in 1999 as an Executive Assistant to the Chief Financial Officer and also assisted with the private equity firm’s bookkeeping duties. Serena transitioned to the medical device industry in 2000, where she was hired as an Office Manager/Bookkeeper for Timi3 Systems. At Timi3, Serena met and worked with CEO Mike Billig. Serena later worked with Mike at Converge Medical, and then finally, at Experien Group where she has been an instrumental part of the firm’s growth.


Education

Serena earned a BA in Humanities from San Jose State University and additionally completed coursework at the University of San Francisco School of Law.

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Director, Pre-Clinical, Clinical & Regulatory Affairs
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Katrina Christy
Director, Pre-Clinical, Clinical & Regulatory Affairs

Katrina joined Experien Group in 2007 and possesses 20 years of pre-clinical and clinical research experience at medical device companies. She has conducted numerous clinical trials in the United States and Europe for U.S. Class II and Class III devices and she possesses substantial clinical trial management expertise for cardiovascular and radiofrequency ablation devices. She has supported successful regulatory submissions for a wide range of products and she is highly experienced in directing companies’ pre-clinical activities (including cadaver and animal testing).

At Experien Group, Katrina directs and manages pre-clinical, clinical and regulatory projects with particular expertise in GLP animal studies and clinical trial management. She participates on multiple client companies’ design teams as the Clinical and Pre-Clinical representative. In addition, she is experienced in compliance procedures for ISO 14155 and the European Medical Device Directive. Katrina’s primary responsibilities include:

  • Comprehensive pre-clinical and clinical operations from site selection through study close-out activities
  • Clinical study documentation and interface for regulatory submissions and study approvals (e.g., IDEs, Institutional and Independent IRBs, and Ethics Committees)
  • Pre-clinical study documentation (including protocols and data collection forms) for IACUC submissions
  • Management of international CROs responsible for OUS clinical site monitoring
  • Clinical protocol development, including Case Report Forms, Informed Consent, and trial agreements
  • Clinical report writing
  • U.S. regulatory submissions support (e.g., pre-IDE packages, IDEs, 510(k)s and PMAs)
  • Clinical and regulatory support for Design Dossiers and Technical Files for CE Marking

Past companies and experience

Katrina began her career in veterinary medicine at the University of California, Davis as an emergency care nurse and as a veterinary anesthetist for large and small animals. After seven years, she transitioned into the medical device sector to support pre-clinical research and to serve as a clinical instructor for product training of surgical teams. She held management positions at Heartport, Converge Medical, RITA Medical and AngioDynamics, and she maintained responsibility for all aspects of pre-clinical and clinical programs, including laboratory studies, (site selection, study management and oversight), clinical protocol development and investigator training.


Education

Katrina earned her BS in Biology from Sonoma State University. She holds a post-graduate Clinical Trials Design and Management certificate and is also a Registered Veterinary Technician (RVT) and a Registered Laboratory Animal Technologist (RLATG).

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Director, Quality Systems
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Brian Fisher
Director, Quality Systems

Brian joined Experien Group in 2013 and possesses nearly 10 years of experience in the medical device industry. He has held several Quality Engineering and Quality Systems roles and is a certified lead auditor. Brian serves as the Quality Representative for multiple client companies and he leads Quality Management System activities for both premarket and commercial product lines. He is highly knowledgeable about compliance to FDA’s Quality System Regulation (QSR), EN ISO 13485, EN ISO 14971, IEC 60601 electrical equipment series of standards, the European Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), and other relevant standards.

At Experien Group, Brian is responsible for Quality Management System implementation, assessment and auditing for a number of client companies with diverse product lines. His additional responsibilities include:

  • Phased Design Control projects for U.S. FDA Class II and Class III traditional medical devices, combination products, capital equipment and mobile health technologies
  • Risk Management support, including generation of FMEAs and Hazard Analyses from a Quality Engineering perspective
  • Interface with FDA Inspectors, Notified Body Auditors and State of California FDB Inspectors
  • Interface with Nationally Recognized Testing Laboratories, contract design and manufacturing firms and other critical suppliers
  • Internal audits, supplier audits, and management reviews
  • Technical review for U.S. and EU regulatory submissions, including IDEs, 510(k)s, PMAs, Technical Files and Design Dossiers
  • Design verification testing activities, including: determining requirements (including statistical analyses to determine adequate sample sizes), writing master validation plans, generating test protocols, supporting verification testing (including interfacing with contract manufacturers and testing laboratories) and producing final reports

Past companies and experience

Brian’s professional career began at Abbott, where he was involved with several divisions, including Abbott Vascular, Abbott Bioresearch Center, Abbott Molecular and Abbott Diabetes Care and he was selected for the parent corporation’s national management development program. Brian transitioned full time to Abbott Vascular in 2010, functioning first as a Quality Engineer of Product Performance and then earning a promotion to Senior Quality Engineer of Incoming Quality Assurance and Manufacturing. Brian joined Experien Group in a Senior Quality Engineering capacity but has earned several promotions, being named Director of Quality in 2015.


Education

Brian earned his BS in Molecular Biology from the University of Illinois, Urbana-Champaign.