Medical Device Quality

RICHARD D. HEBERT

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A senior level position in Operations/General Management in an environment that demands sound leadership and

management abilities, drawing upon a unique and diverse background of operations, quality, regulatory affairs, and

engineering management, creativity and measurable productivity.

Summary:

A results-oriented, hands on executive with experience in the high technology and medical device industries. Employs a

team-based management style that encourages and supports continuous improvement and innovative risk taking. Extensive

experience leading and managing cross-functional teams. General management and P&L experience. A skilled problem

solver with a proven track record in managing crisis and turn-around situations. Extensive growth in progressively

responsible positions in operations, quality and engineering management. Expertise includes:

• •

ISO 9000 Continuous Improvement

• •

ISO 13485 Quality System Remediation

• •

ISO 14971 Engineering

• •

21 CFR Part 820 Quality Assurance

• •

Health Canada Medical Devices Regulation Regulatory Affairs

• •

Medical Device Directive 93/42/EEC Supplier Quality Agreements

• •

Class I, II, and III medical devices Document Control

• •

QSR/cGMP Multi-plant and international experience

• •

CE Marking Design and Change Controls

• •

Yield optimization Gap Analyses

• •

Cycle time reduction Sterile Disposables

• •

Lean Manufacturing 6-Sigma

3 Professional Experience:

QRO Consulting Services 2005- present

Principal & Founder, Consultant

Operations, quality, and regulatory consultation to medical device and medical device related companies. Provides operations,

quality systems and regulatory services to medical device companies for efficiencies improvement, validations, regulatory

submissions, quality system remediation, quality system implementation, and quality audits.

Recent assignments include:

• Providing Manufacturing Operations consultation to a development-stage radio-oncology implant medical device

company to build sufficient quantities of class III devices in support of human clinicals.

• Providing leadership to a leading medical device company under a Warning Letter from FDA to establish adequate

design and process validation methodologies which also significantly improved production efficiencies.

• Preparing a regenerative medicine medical device company whose ISO 13485 certification and CE Mark were in

jeopardy to pass its ISO 13485 audit, thereby preserving its ISO 13485 certification and CE Mark.

• Acting Global Director of Quality for a multi-billion dollar Fortune 500 medical device company and having a key

role in selecting the new Global Director of Quality.

• Preparing for and hosting ISO and supplier audits for medical device companies.

• Leading the effort to obtain CE Marking for various medical device companies.

• Obtaining FDA medical device establishment registration for an IVD manufacturing facility in Eastern Europe.

• Identifying and correcting inadequacies in a leading IVDD medical device company’s quality system.

• Interim Director of Regulatory Affairs & Quality Assurance for a multi-billion dollar Fortune 500 medical device

company, driving manufacturing process validations and efficiencies, preparing for FDA inspection readiness, and

improving change control and risk assessment methodologies.

Richard D. Hebert

Page 2

IntraLuminal Therapeutics 2004 – 2005

1 Vice President, Operations

2 IntraLuminal Therapeutics manufactured and distributed capital equipment and guidewire devices that

utilize optical coherent reflectometry, enabling the interventionalist to cross Chronic Total

Occlusions (CTOs). Responsible for the development and manufacture of a Class II medical

device. Responsibility for Engineering, Manufacturing, and Materials & Purchasing functions.

Through my leadership and utilizing Lean Manufacturing and 6-Sigma methodologies, the

organization improved disposable yields from 55% to 77%, improved 1 st pass capital equipment

burn-in yields from 20% to 95%, reduced material scrap from 61% to 35%, and double capital

equipment and disposable production capacity.

Inadequate sales forced the closure of the company, and its assets were sold.

TRANSURGICAL INC. 2002 – 2003

3 Vice President, Operations

Corporate Officer

Responsibility for Engineering, Manufacturing, Quality, and Materials & Purchasing functions.

Responsible for the development and manufacture of a Class III medical device. Lead program

to utilize High Intensity Focused Ultrasound (HIFU) for the treatment of atrial fibrillation

(AFIB). Spearheaded effort to make necessary design enhancements to transition from

pivotal animal studies to human clinicals. Established manufacturing and built class 100,000

cleanroom. Built a cohesive, multidisciplinary team through participatory management,

collaboration and consensus building. Helped to plan and execute European pilot study.

Transurgical’s CEO, formerly my CEO at EndoSonics, recruited me to remotivate his team.

The pilot human clinical study indicated that the device worked much better with canine

anatomy than with human anatomy, necessitating a complete redesign. Thus, the company had

a greater need for a gifted catheter designer than an operations professional, so I helped to hire

a catheter engineer with the required skill-set prior to leaving Transurgical and returning to

California.

ENDOSONICS CORPORATION 1998- 2002

Vice President, Worldwide Quality Assurance/Regulatory/Clinical Affairs Corporate Officer

Assessed the state of the organization through intensive external/internal auditing. Partnered with Human Resources and the

Employment Training Panel (ETP) and secured $200,000 towards corporate-wide quality training. Passed previously failed ISO

9000 audits in the U.S. and Europe. Responsible for regulatory submissions and quality assurance of Class II and Class III

medical devices. Achieved 510(k) clearance for disposable pullback device, CE marking for Vintage™ line of PTCA catheters,

IDE clearance for Brigade radiation catheter. Engaged governing officials, England and the Czech Republic ISO 9000

Standards, in on-going Best Practice Review.

Jomed, a European medical device company, acquired EndoSonics in September 2000, and as a member of EndoSonics’ senior

staff, my Change of Control agreement took effect. As part of the agreement, I continued providing the company with

consultation on an “as needed” basis.

BIOSURGICAL-BIOINTERVENTIONAL 1997 - 1998

Vice President, Operations and Administration Corporate Officer

Created and implemented standard operating procedures and Quality Manual for QSR, ISO 9000, and OSHA compliance.

Devised the corporate strategy to obtain CE marking in the shortest time and most cost-effective manner. Tracked cash flow and

implemented actual vs. budget reporting for the entire company to monitor burn rate. Planned for limited and high-volume

manufacturing of fibrin sealant and collagen delivery devices for wound closure, given various business scenarios. Built

cleanroom certified to Class 100,000.

In 1998, EndoSonics’ CEO asked that I return to the company as Vice President of

Worldwide Quality Assurance/Regulatory Affairs/Clinical Affairs, to correct issues with

compliance to quality systems and regulatory submissions.

Richard D. Hebert

Page 3

ENDOSONICS CORPORATION 1993-1997

Vice President, Operations and General Manager Corporate Officer

• Started as Director, Quality Assurance, promoted to Vice President, Quality

Assurance, then Vice President, Operations.

• Responsible for the development, manufacture, and quality assurance of Class II

medical devices.

• Successfully turned-around a fully autonomous, high-volume, catheter-based

ultrasound, PTCA catheter, drug delivery catheter, and stent delivery system manufacturing

facility staffed by 118 employees.

• P&L responsibility, growing revenues to from $4,000,000 to $11,000,000 EBITA.

• Led company out of a serious backorder situation.

• Responsible for Manufacturing, Quality Assurance, Materials, Engineering, and

Human Resources.

• Interfaced with Sales & Marketing to establish production forecasts, and with Finance

for cost-of-goods objectives.

• Reduced employee turnover from 30% to 3%.

• Led team towards JIT and TQM goals. Utilizing Lean Manufacturing and 6-Sigma

methodologies, realized greater than 200% increase in gross revenues while improving gross

margins from single digits to greater than 50%, resulting in profitability.

• Re-engineered production lines to minimize scrap and improve yields from 30% to

90%.

• Reduced product cost by 50% while enhancing product designs, lowering costs by an

additional 15%.

As Director of Quality:

• Successfully corrected or rebutted 53 observations of non-compliance on a Form 483

from an FDA audit performed six months prior to joining the company.

• Managed Customer Service, and implemented processes to improve responsiveness.

For the two years prior to leaving the company, I had the role of Vice President of Operations

and General Manager with responsibility for the business unit in the San Francisco Bay Area.

The CEO decided to consolidate the company’s U.S. operations under one roof, in

Sacramento, California, necessitating the shutdown of my facility. I had the option of

remaining with EndoSonics or taking a package, and I opted for the latter.

RESONEX 1991-1993

Manager, Quality Assurance

Responsible for FDA, UL, and TUV compliance. Assured the safety and reliability of MRI systems prior to shipment. Created

Quality Council to involve managers from all departments that had an impact on the quality of products and services. Ensured

GMP compliance.

Education:

Bachelor of Arts Degree in Physics, minor in Mathematics, from San Jose State University, San

Jose, CA.

Associate in Arts Degree from Diablo Valley College, Pleasant Hill, CA.

Successfully completed various Computer Science courses at California State University,

Sacramento, CA.

Professional Organizations:

Member of the American Society for Quality (ASQ).

Member of the Association for the Advancement of Medical Instrumentation (AAMI).

Member of the American National Standards Institute (ANSI).

Member of IEEE Magnetics.

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