Consultants

KEN BLOCK
President and Founder

Background:
BS Physics + 20 years professional experience in regulatory affairs, quality systems, R&D, product and process improvements, medical device manufacturing, validations, testing, and lasers.

Certification:
Kenneth L. Block has earned the Regulatory Affairs Certification (U.S.) from the Regulatory Affairs Professionals Society (RAPS). The RAC (U.S.) is earned through professional examination regarding comprehensive knowledge of FDA and related U.S. regulations, policies, and guidelines in the areas of medical devices, drugs, and biologics. The RAC (U.S.) designation is a mark of distinction for regulatory professionals dealing with FDA products and issues including strategic planning, design and development, pre-market and regulatory review, manufacturing quality systems, marketing, post-approval, and FDA interfacing.

DIANE RUTHERFORD
Submissions Manager

Diane Rutherford is responsible for oversight of all submissions related activities for Ken Block Consulting. Her efforts focus on the successful outcomes of submissions to FDA, such as premarket applications.

As a trained engineer, she entered the medical device industry in product development, finally transitioning to Regulatory Affairs. This experience has contributed to her successes in assisting clients to receive marketing clearance for their devices. In addition to submissions related activities, she also assists with: development of regulatory strategy; presentation of seminars in the U.S. and Japan; development and improvement of quality system documents; product testing and validations; research reports on various client requested topics.

Ms. Rutherford holds a Bachelor of Science in Mechanical Engineering from the University of Texas in Arlington and a Master of Science in Materials Science Engineering from the University of North Texas. Prior to joining Ken Block Consulting, Ms. Rutherford spent ten years in a senior product development position with a medical device manufacturer of single use, disposable, safety sharps devices. In addition to her experience in design control and quality system regulations, she has a background in sterilization and packaging.

To keep up to date on the rapidly changing medical device industry, Ms. Rutherford attends seminars and conferences and maintains membership in several professional organizations including Regulatory Affairs Professionals Society (RAPS), American Society for Quality (ASQ), American Society for Testing and Materials (ASTM), Institute of Electrical and Electronics Engineers (IEEE), Association for the Advancement of Medical Instrumentation (AAMI), Society of Plastics Engineers (SPE), and American Society of Mechanical Engineers (ASME).

PAUL SWAIN
Senior Consultant

In 24 years of quality system experience, Paul Swain has planned, executed and reported multiple customer and supplier/vendor in-depth system and process assessments, primarily to 21 CFR Part 820, ISO 13485 and ISO 9001, in the U.S., Canada, Japan, and China. He has also planned, executed, and reported multiple pre-FDA-inspection assessments and 21 CFR Part 820/ISO 13485 gap analyses, and planned, executed, and reported multiple quality-system assessments (FDA, ISO 13485, and ISO 9001).

Mr. Swain has created, corrected, or improved all FDA, Health Canada, and ISO 13485 quality system documents/elements for multiple customers, advised multiple customers on FDA Form 483, Warning Letter and Untitled Letter responses and remediation, prepared facilities for FDA re-inspection including after Warning Letter remediation, and designed and conducted multiple training seminars related to FDA and quality system requirements.

Mr. Swain began working in quality systems in 1991 and held various quality-management positions, including at a Class II (implantable) medical device company, before starting consulting in 2004 and joining Ken Block Consulting in 2009. Mr. Swain has been educated in the U.S. and in Japan, and worked as a quality system manager for ten months at Japanese medical device company in Japan. Mr. Swain is a native English speaker and has a working knowledge of verbal Japanese. He holds professional certification in regulatory affairs (RAC).

ISOKO HIRASE
FDA Regulatory Consultant

A native of Japan, fully fluent in English and Japanese, Isoko Hirase joined Ken Block Consulting in 2007. Since then, she has been involved in a variety of consulting projects, including FDA inspection support, quality system improvement, gap analyses, quality audits, and training and seminars. Ms. Hirase has also honed her interpretation and translation abilities over the course of her involvement in regulatory affairs, and has served as interpreter during audits, FDA inspections, negotiations, and more. Some of the tasks that she manages while working out of KBC’s Dallas headquarters include the creation of responses to FDA Warning Letters or Form 483 observations, review of quality system procedures, and teleconference interpretation and mediation. Ms. Hirase has represented KBC at numerous international events. She was invited as a guest speaker to conferences at MEDTEC 2012, Fukushima Innovation Beyond, and Fukushima Medical Industry Integration Project 2014.

Ms. Hirase holds professional certification in regulatory affairs (RAC).

AKIKO DOHI
Regulatory/Research Specialist

After more than 10 years in biomedical and neuroscientific research, Dr. Dohi joined KBC as a regulatory and research specialist. Dr. Dohi is currently involved in the preparation of 510(k) submissions, as well as design control and design history file (DHF) remediation. She also works with clients on scientific thinking and applies her biomedical research expertise in numerous ways while generating solutions.
 
Dr. Dohi is native Japanese and is bilingual in Japanese and English. She holds a Bachelor of Science in Biology, with a minor in Chemistry, from the University of North Texas and earned her Ph.D. in Biomedical Sciences, with an emphasis in Pharmacology and Neuroscience, from the University of North Texas Health Science Center. The topics she focused her studies on include steroidal hormone regulation of the GABAergic system, the neuroprotective effect of steroidal hormones, and the neuromodulatory effect of obesity on baroreflex. 

LACEY HARBOUR
Validation Specialist

As Ken Block Consulting’s Validation Specialist, Lacey Harbour utilizes her ten years of science academia and industry experience to develop robust risk-based software and process validation procedures. Ms. Harbour has assisted numerous clients with the goal of creating in-house validation specialists. Her efforts have included the training of client teams on how to approach validation, as well as all applicable supporting subjects. Ms. Harbour performs tailored seminars, workshops, and one-on-one training in areas such as current Good Documentation Practices, calibration, installation, and others. Ms. Harbour holds a Bachelor of Science in Biology and a Master of Science in Biology (focus on molecular biology) from the University of Texas of the Permian Basin (UTPB). Her background in experimental design, calibration, and instrumentation is built upon years of academic research at UTPB and the University of Texas Southwestern (UTSW). Ms. Harbour has a keen interest in Japanese language and culture, studied Japanese while in Japan, and is able to read, write, and speak Japanese on a conversational level. Ms. Harbour also taught English to Japanese students during her tenure in Japan. Prior to joining KBC, Ms. Harbour continued her validation and regulatory experience, working in a high-complexity, high-throughput, CAP/CLIA-certified Laboratory Developed Test (LDT) laboratory.

To keep current with the most recent validation techniques and FDA validation matters, Ms. Harbour attends training seminars, reads relevant publications, and studies FDA releases.

BRENDAN FRAYNE
Software Specialist

Mr. Frayne’s consulting focus is in software documentation. He leverages his software validation experience in the creation and implementation of test plans and documentation to support FDA submissions and quality system compliance. He has overseen the creation of software design, requirements, validation, and risk-related documents in numerous successful 510(k) submissions. Fluent in Japanese and English, Mr. Frayne also has 15 years of professional translation experience, which have been a particular advantage in working with KBC’s Japanese clients.

He holds a Masters in Business Administration from the University of Texas at Dallas, with a focus in IT systems and strategy, and has also accumulated three years of professional and volunteer classroom experience as an ESL (English as a second language) instructor.