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.

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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 in 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 40+ 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 21 CFR Part 820, ISO 13485, EN ISO 14971, ISO 10993, the European Medical Device Directive (MDD) and 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.

Experien Group Richter web -9773 (1)
Chief Operating Officer
Experien Group Richter web -9773 (1)
Jessica Richter
Chief Operating Officer

Jessica joined Experien Group in 2017 to expand the firm’s business development activities and to direct strategic growth initiatives. She works closely with the founders and executive team on thoughtful expansion and management responsibilities such as planning, hiring, business operations and performs due diligence for scalability that ensures the continued delivery of high-value services to all clients. 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.

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

  • Client outreach, introductions and the establishment of new business relationships
  • Ongoing senior team support for meaningful sustainment of the firm’s existing client accounts
  • 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
  • Strategic marketing of the firm’s capabilities, while maintaining strict confidentiality standards protecting client information.

Past companies and experience

Prior to Experien Group, Jessica spent six years in leadership roles within Medtronic, where she led sales and market development activities within the West Area of the Early Technologies division. While at Medtronic, she spearheaded successful, high-impact projects in the areas of strategic sales planning, physician education, collaboration with patient advocacy groups and corporate project management.  Previous to that experience, Jessica dedicated 10+ years to driving commercial sales activities within the medical device, software and communications arena.  She concentrated on driving adoption of paradigm shifting platforms and remains passionate about patient-centric commercial advancement. Jessica is a health care leader with experience in both medical devices and diagnostics, specializing in surgical, oncology, aesthetics and gastroenterology. She has received numerous achievement and recognition awards from employers, universities and philanthropic foundations.


Education

Jessica earned her BA in Communications and Business Administration from the University of California at Berkeley.

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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 in cardiovascular and neurovascular medical devices.


Education

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

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 road-maps 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 21 CFR Part 820, 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 Life Cycle 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 Food and Drug Branch (FDB) Inspectors
  • Software Life Cycle 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.

Genice_crop2
Chief Clinical Officer
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Genice Gallegos
Chief Clinical Officer

Genice possesses over 20 years of experience in Clinical Affairs.  Genice joined Experien Group in 2019 to expand the firm’s Clinical Department with her experience in managing all aspects of clinical studies from study strategy and design through data analysis and clinical report generation.

At Experien Group, Genice oversees the Clinical team by supporting clients with both setting strategic direction and evidence pipeline as well as detailed tactical planning and execution for converting a company’s goals into actionable pre-clinical and clinical studies for medical devices and combination products. Her central responsibilities include:

  • Participates on design teams throughout the product lifecycle.
  • Provides clinical strategy development expertise to assess the optimum clinical strategy for the client’s study goals.
  • Directs clinical elements and generates clinical study documentation required for FDA submissions to support clinical research, including pre-submission packages and Investigational Device Exemption (IDE) applications, as well as final clinical study reports for De Novos, 510(k)s, PMAs, and EU technical files.
  • Leads clinical study operations from enrollment planning to close-out in accordance to projected timelines, including study/site activation activities, management of clinical study databases, formulation and facilitation of Data Safety Monitoring Boards (DSMBs), Clinical Events Committees (CECs) and core labs with the study sponsor to ensure study success.
  • Provides clinical functional expertise and support for business development opportunities, including managing the Clinical-related requirements, deliverables, and oversight associated pre-acquisition and investment due diligence efforts.

Past companies and experience

Prior to Experien Group, Genice spent fifteen years with Medtronic in roles of increasing leadership capacity in the Clinical Affairs discipline of various divisions. Genice garnered product experience with significant risk technologies, non-significant risk (NSR) technologies, active implants, capital equipment, implantables, software as a medical device, medical instrumentation and combination products, including shunts for hydrocephalus (cerebral spinal fluid shunts), cranial repair products, navigation/imaging and robotics for spinal and cranial applications, pain ‘dressing’ for tonsillectomies, sleep apnea products, nasal valve collapse products, and laser ablation for neurosurgical procedures.  During this tenure, Genice gained broad and invaluable experience serving as a member of the Medtronic Global Clinical Council, a governance council comprised of executive Clinical leadership from targeted businesses and geographies of Medtronic, was the Executive Sponsor of the EU MDR Clinical Workstream overseeing global enterprise-wide (across Medtronic) implementation of cost-effective, harmonized, strategic solutions to meet the new EU MDR requirements, and received the Medtronic Global Clinical Excellence Award twice for her leadership.  Prior to that experience, Genice held Clinical positions at McGhan Medical (now Allergan), Computer Motion (now Intuitive), and Quintiles CRO (now IQVIA).


Education

Genice earned her BA in Kinesiology with a Minor in Psychology from Westmont College in Santa Barbara.

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Vice President, Regulatory Affairs
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Valerie Defiesta-Ng
Vice President, 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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Vice President, Quality Systems
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Ramona Migliardi Field
Vice President, Quality Systems

Ramona joined Experien Group in 2009 and possesses over 30 years of experience in the medical device industry. She is an expert in the development, implementation and successful management of Quality Management Systems for Class I, Class II and Class III medical devices that comply with FDA’s Quality System Regulation 21 CFR Part 820, EN ISO 13485, EN ISO 14971, the European Medical Device Directive (MDD) and transition to the European Medical Device Regulation (MDR), Canada’s Medical Devices Regulations SOR/98-282, including specific requirements of medical device regulatory authorities participating in the Medical Device Single Audit Program (MDSAP), and other relevant standards. Ramona has been extensively involved in quality assurance for collagen-based technologies, capital equipment, software driven medical devices, combination products and sterile 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 FDA’s Quality System Regulation requirements. Her additional functions include:

  • Quality Management System strategic planning and partner alliances
  • Quality Management System development and compliance to relevant standards
  • Biocompatibility and medical device safety testing (including interfacing with contract manufacturers and testing laboratories)
  • Product sterilization validation (e.g., EtO and radiation)
  • Cleaning and steam sterilization validation for reusable products
  • Manufacturing process validation risk-based approach (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 Food and Drug Branch (FDB) Inspectors
  • Technical review for U.S. and EU regulatory submissions, including IDEs, 510(k)s, PMAs, Technical Files and Design Dossiers
  • Quality requirements and regulatory submissions for CE Marking
  • 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.

Naghmeh Nouri Portrait 2
Senior Director, Quality Systems & Regulatory Affairs
Naghmeh Nouri Portrait 2
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 advanced 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 21 CFR Part 820, ISO 13485, EN ISO 14971, the European 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 Food and Drug Branch (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 Novos, 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.

Hattie-Crop-5n
Director, Project Management
Hattie-Crop-5n
Hattie M. Liversidge
Director, Project Management

Hattie joined Experien Group in 2017 and quickly demonstrated competency in operational organization, project management, and strategic thinking.  She has contributed to numerous successful regulatory submissions, both with FDA and International Agencies.  Hattie works closely with the founders and Executive Team to ensure all projects are completed in accordance with Experien Group’s premium-standards, including accuracy and consistency of work product.

In her current role, Hattie provides project management support for complex projects, to ensure efficiency, excellence and maintenance of client satisfaction.  She is responsible for overseeing both project budgets and deliverables, as well as working closely with our CEO on key client endeavors.  Hattie’s central responsibilities include:

  • Managing and proactively tracking budgets for client projects
  • Reallocation of internal resources, as required, to support client programs
  • Routinely interacting with clients and internal project teams
  • Interfacing with FDA and International Agencies to manage regulatory submissions
  • Supporting Experien Group with strategic and operational initiatives
  • Working closely with the Executive Team and Administrative staff

Past companies and experience

Prior to joining Experien Group, Hattie provided Executive support and managed corporate events for ChemoCentryx, a biopharmaceutical start-up focused on orally administered therapeutics to treat autoimmune diseases, inflammatory disorders and cancer.  She facilitated high-level meetings and worked closely with Company executives and their Board of Directors on key company initiatives.  Hattie first joined at Experien Group in 2017 as the Executive Assistant and Project Coordinator to our Chief Executive Officer.  She has contributed to numerous U.S. and International Regulatory Submissions and supported our project teams with her superior organizational prowess and keen attention to detail.  In 2018 Hattie was promoted to Executive Project Manager where she thrived at providing project oversight and also developed robust leadership skills, while working closing with our CEO and Executive Team.


Education

Hattie earned her BA in Psychology from California State University, Channel Islands.

Experien Group_Sarah-N2
Director, Quality Systems & Regulatory Affairs
Experien Group_Sarah-N2
Sarah L. Canio
Director, Quality Systems & Regulatory Affairs

Sarah is an experienced medical device professional with over 15 years of experience in Quality Management Systems and Regulatory Affairs.  Throughout her career, Sarah has worked with many medical device companies, both large and small, from product design and regulatory submissions to global product distribution.  She is skilled in the development, implementation and successful management of Quality Management Systems for Class I, Class II, and Class III medical devices that comply with FDA’s Quality System Regulation 21 CFR Part 820, EN ISO 13485, EN ISO 14971, the European Medical Device Directive (MDD) and evolving Medical Device Regulation (MDR), Canada’s Medical Devices Regulations SOR/98-282, and other relevant standards and requirements.  Sarah has been extensively involved in quality assurance for medical instrumentation and non-significant risk technologies.

At Experien Group, Sarah is responsible for Quality Management System implementation, assessment, and auditing of companies with diverse product lines.  She supports Corrective and Preventive Action (CAPAs), Complaint Handling, Medical Device Reporting to regulatory authorities, and regularly performs gap analyses, internal audits, and other quality assessments.  Her additional functions include:

  • Phased Design Control projects for U.S. FDA Class II and Class III traditional medical devices, combination products, capital equipment, mobile health technologies, and software driven medical devices
  • Project management activities for clients with multiple ongoing projects, including tracking of project deliverables, budget management, and coordination of resources across project teams
  • Quality Management System activities, including Document Control, Design Control, product labeling and specification development, CAPA-related activities, and Risk Management activities
  • Interfacing with FDA Inspectors, Notified Body Auditors and State of California Food and Drug Branch (FDB) Inspectors
  • U.S. and EU regulatory submissions, including 510(k)s, HDEs, PMAs, IDEs, Amendments, Supplements, Annual Progress Reports, Technical Files, Design Dossiers, Change Notices for CE Marking, and Notified Body responses
  • Reviewing medical device labeling and marketing materials, in cluding websites, to ensure compliance

Past companies and experience

Sarah began her career at Experien Group in Regulatory Affairs & Quality Systems.  In 2015, Sarah joined Willow, an early stage medical device company, where she worked cross-functionally developing an electromechanical consumer-focused medical device with a companion mobile app, from prototype through FDA 510(k) clearance to full commercial launch.  Sarah rejoined Experien Group in 2019 as our Director of Quality Systems & Regulatory Affairs where she has successfully applied her experience working with a lean start-up company.  Sarah holds several accreditations, including an ISO 13485 Lead Auditor Certification.


Education

Sarah earned her BA in Sociology from San Francisco State University.

MZ 2020 crop
Director, Clinical Affairs
MZ 2020 crop
Marc Zimmermann
Director, Clinical Affairs

Marc possesses over 11 years of industry experience supporting clinical research programs for medical devices.  Marc joined Experien Group in early 2020 to support the firm’s growing Clinical Department with his experience in managing all aspects of clinical studies from clinical strategy, study design and development, through data analysis and clinical report generation.

At Experien Group, Marc supports clients by directing and managing clinical projects, including U.S. and international clinical study programs from First-In-Human (FIH)/Feasibility Studies (FS) to large randomized controlled pivotal trials in pursuit of medical device commercialization.  His central responsibilities include:

  • Participating on design teams throughout the product lifecycle.
  • Providing input on clinical strategy development to optimize the client’s clinical evidence goals.
  • Directing clinical elements and generating clinical study documentation required for FDA and Outside the U.S. (OUS) regulatory agency submissions, including Pre-Submission packages and Investigational Device Exemption (IDE) applications, as well as final clinical study reports for De Novos, 510(k)s, PMAs, and EU technical files and design dossiers.
  • Providing clinical study operational leadership, oversight and support from study planning through close-out and analysis in accordance with projected timelines.  This includes study/site activation activities, management of clinical study databases, formulation and facilitation of Data Safety Monitoring Boards (DSMBs), Clinical Events Committees (CECs) and core labs with the study sponsor to ensure study success.

Past companies and experience

Prior to joining Experien Group, Marc spent 2 years at Santen, leading their medical device clinical operations department and global clinical programs to support their PMA submission, OUS submissions, and EU post-market clinical follow-up requirements for a novel ophthalmic implant to treat primary open angle glaucoma.  Marc spent nine years within various divisions of Medtronic in roles of increasing leadership capacity in the Clinical Affairs discipline.  Marc garnered product experience with significant risk (SR) and non-significant risk (NSR) technologies, capital equipment, implantables, medical instrumentation, including nerve integrity monitors, robot-assisted surgery systems, MRI-guided laser ablation systems, surgical navigation systems, sinus surgery tools, ophthalmic implants, hydrocephalus shunts, external ventricular drainage and monitoring systems, cranial fixation systems and neuro-endoscopes.  Marc has extensive experience in influencing design and development from a clinical perspective and he is a patent co-author on a novel Foley Catheter design.


Education

Marc earned his BS in Cell and Developmental Biology with Honors at the University of California, Santa Barbara.

Taras headshot (3)
Director, Regulatory Affairs
Taras headshot (3)
Taras Bouzakine
Director, Regulatory Affairs

Taras possesses over 15 years of strategic and tactical regulatory experience with U.S. and international regulatory bodies.  Taras has successfully obtained numerous clearances, approvals, and registrations in major world markets (U.S., EU, Canada, Japan, China, Australia, and Brazil), as well as in developing markets (Mexico, Russia, South Korea, Singapore, Taiwan, and Thailand). Taras’ prior leadership of small, medium, and large regulatory teams enables him to work effectively with both nimble start-ups and mature medical device organizations to achieve their regulatory objectives.  Taras is skilled at developing and negotiating pre-clinical and clinical testing strategies and has an impeccable reputation for delivering timely and high-quality results.

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

  • U.S. FDA and international regulatory strategies in Europe, Asia Pacific, Latin America, and the Middle East
  • Regulatory representative on client companies’ design teams for medical devices and combination products
  • Pre-Submission packages and client interface for Pre-Submission meetings
  • U.S. FDA regulatory submissions (e.g., 510(k), IDEs, Breakthrough Designations, PMAs, and HUDs/HDEs)
  • Design Dossiers and Technical Files for CE Marking, as well as international registrations
  • Advertising, labeling and promotion compliance review and support
  • Regulatory representative for audits and inspections
  • Support regulatory objectives for significant risk technologies, active implants, capital equipment, and implantables
  • Regulatory compliance activities for FDA’s Quality System Regulation, ISO 13485:2016 requirements, product complaint evaluation, and Medical Device Reporting

Past companies and experience

Taras has successfully authored more than 20 U.S. and international regulatory submissions, including PMAs and 510(k)s.  He is skilled at analyzing international regulatory requirements, prioritizing target markets, preparing standardized technical documentation, and communicating with regulators and qualified international agents.

Prior to joining Experien Group, Taras served as the Global Director of Regulatory Affairs at Adhesys Medical, Inc. where he obtained multiple FDA Breakthrough Device Designations and lead all U.S. and European regulatory efforts for their Class II and Class III novel polyurethane-based medical adhesives.  Prior to this role, Taras held leadership positions at Clinivation, Inc., Genzyme Corporation and Abiomed.  Taras is a dedicated regulatory professional with expertise in percutaneous catheter based ventricular assist devices (VADs) and associated controllers, hyaluronic acid (HA) based injectables, and biodegradable surgical sealants and topical adhesives.  He co-authored an editorial on Global Harmonization in the Regulatory Focus RAPS magazine and routinely lectures on various international regulatory topics.


Education

Taras received his Master of Engineering and Bachelor of Science in Biomedical Engineering from Worcester Polytechnic Institute in Worcester, Massachusetts.  Taras also holds a Regulatory Affairs Certification (RAC U.S.) from the Regulatory Affairs Professional Society (RAPS) and is a Certified Quality Process Analyst (CQPA) by the American Society for Quality (ASQ).

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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Senior Advisor, Business Strategy
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Kristin Crosland
Senior Advisor, Business Strategy

Kristin joined Experien Group in 2007 to formalize the firm’s business development platform and to direct strategic growth initiatives.  She successfully led Experien Group through several expansion cycles and provided both strategic and tactical guidance to the firm throughout her 11 years with the company.  In January of 2018, Kristin transitioned from leading Experien Group’s operations and business development activities to take on a senior advisory role for the firm.

In her advisory position, Kristin continues to instill her institutional insight and executive knowledge onto Experien Group’s staff to contribute to the sustained achievements of the organization.  Her responsibilities include:

  • Ongoing senior team support for meaningful sustainment of the firm’s existing client accounts
  • Counsel the firm on performance metrics and future expansion initiatives
  • Conduct legal and business review for the firm, including due diligence for growth opportunities and strategic partnerships

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.

Mark Experien Group-8888_crop3
Senior Advisor, Clinical Affairs, Data Management & Biostatistics
Mark Experien Group-8888_crop3
Mark J. Holdbrook
Senior Advisor, Clinical Affairs, Data Management & Biostatistics

Mark possesses over 40 years of experience in clinical research, biostatistics and data management. He has supported Experien Group’s clinical and data management activities since 2009, transitioning from a Vice President to Senior Advisor in 2014.  Mark has directed comprehensive activities in clinical trial design, execution and analysis for a wide range of medical devices, and he has additionally conducted large scale trials for pharmaceuticals, biotechnology products, and epidemiology research. Mark has designed and installed hardware and software systems for numerous clinical trial databases, incorporating wide-ranging database requirements, including electronic data capture (EDC).

Mark works in partnership with Experien Group’s team and our client companies’ senior management to direct data management and biostatistics projects.  Mark is involved in first-in-human and early feasibility studies as well as large pivotal trials for PMA applications and other regulatory submissions. Mark’s additional functions include:

  • Strategic review of study designs, including statistical requirements
  • Development and execution of Statistical Analysis Plans
  • Study documentation review (e.g., protocols, Investigator Brochures, and Case Report Forms)
  • Comprehensive oversight of data management, from database development through data lock and data analysis
  • Clinical reports and statistical analysis reports

Past companies and experience

Mark initiated his clinical research career in 1977 at University of California, San Diego. He joined Syntex in 1982 as a bioanalyst and then moved to Genentech a few years later. Mark went on to work for other successful medical device, pharmaceutical, and information systems companies including MAJARO InfoSystems, Medco Research, and Celtrix Pharmaceuticals. At the start-up ophthalmic company KeraVision, Mark directed critical data management activities in support of the company’s pivotal clinical trial and he worked as a member of the senior team that secured FDA PMA approval for the product. Beginning in 2000, Mark joined Santen, a multi-national ophthalmic company, where he worked in the area of global clinical development.  Mark functioned as Santen’s Vice President of U.S. Clinical Affairs until 2009, when he joined Experien Group as the Vice President of Clinical Affairs, Data Management and Biostatistics. He has published several clinical research articles in prominent medical journals and he has presented papers at international conferences for biostatistics and data management.


Education

Mark graduated with a BA in Biology from the University of California, San Diego.