About Us
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Meet Class 5 Inc. Our professional staff is comprised of senior medical sales and marketing professionals, financial analysts, regulatory affairs and engineering professionals, clinical specialists, and marketing communications experts. We bring together a unique set of skills and experience to assist your company in attaining financial, marketshare, and operational goals in a cost-effective manner while solving problems in innovative ways. |
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| Commercialization
& Distribution |
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 Scott
Vierke, PhD, President & CEO, Class
5 Inc.—Scott has 25 years of senior sales and marketing experience
with national sales forces, dealers, distributors, and manufacturer's
representatives. During his career, Scott has successfully commercialized
over 25 medical devices ranging from single-use products through complex
medical systems. He brings real-world experience to your global product
launch, market research project, competitive analysis, or strategic
plan. Scott has held the position of Director of Marketing for hospitals,
as well as Vice President of sales and marketing for medical manufacturers.
He is a frequent contributor to medical trade publications serving
as a writer, publisher, and editorial advisory board member. During
his career, Scott has received the following merit awards: International
Award of Excellence, Medical Marketing Association, Category: "Trade
or Professional, and Technical and Instructional"; Best of Show, Medtrade,
Category: "Large Company Exhibits"; President's Special Merit Award,
Ohmeda Medical Systems, Inc., Category: "Market Turnaround"; Presidential
Medical Staff, The Whitehouse, Air Force One, Category: "Corporate
Product Placement and Clinical In-service. Scott holds an MS degree
from the Rehabilitation Institute and a PhD in Healthcare Administration
from Southern Illinois University. He is also a graduate of the Medical
Marketing Education Program, The Anderson School at UCLA, Los Angeles,
CA. |
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 Tom
Vollmer, MA, CPMR—Tom Vollmer is
the President of Provision Associates, a medical products distribution
and sales company with over 25 years of medical industry experience
in a variety of markets including acute care, sub-acute care, homecare
and extended care facilities. He is also former President of the Health
Industry Representatives Association (HIRA). HIRA is a trade organization
of sales representatives, distributors, allied manufacturers and service
providers. Tom has held senior-level management positions with several
medical manufacturers and served for four years as a Naval Officer.
He graduated with a BA from Denison University, Grandville, Ohio and
has an MA from the University of Wisconsin, Madison. He received his
Certified Professional Manufacturers Representative degree from Indiana
University in 1994. |
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 David
Smith has
over 35 years in medical products design, systems development, distribution
chain enhancements and marketing strategy. Working with FDA licensure
and regulations, he has brought numerous products to market from conception
to brand acceptance and specializes in developing sales representative
organizations, both direct and manufacturers representatives throughout
the USA. Dave has acted as a Consultant to major device manufacturers
in support of expanding product lines, new distribution channels,
marketing networks, and strategic planning and brings extensive knowledge
of medical products development concept to brand acceptance. |
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| Financial
& Technical |
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 Cheryl
Rochford,
BA, CPA—Cheryl
offers senior financial planning and forecasting expertise from the
healthcare, banking, manufacturing and training industries. In developing
effective planning and forecasting tools, she works closely with many
key contributors, including senior management, finance, operations,
research and development, marketing, sales, quality assurance and
human resources. Her extensive career includes development of comprehensive
financial models that have satisfied bond-rating agencies, provided
the financial framework for corporate mergers, and met the scrutiny
of venture capitalists. Her strategic plans include financial analysis
and decision models for new product development, product launches,
and sales programs. She has the ability to translate comprehensive
financial models into useful, understandable, and scalable formats.
Cheryl recently raised $800,000 in capital funds for a nonprofit organization
through a combination of senior management meetings and grassroots
networking. Cheryl holds a BA from Augsburg College in Minneapolis,
MN and is a Certified Public Accountant in the state of AZ. |
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 Thomas
Kroenke, BS,
MS—Tom has more than 20 years of experience in the medical
device and defense industries. He has held senior research, manufacturing,
quality and regulatory positions at a variety of companies. Tom's
extensive experience in strategic regulatory affairs has enabled US
and international medical companies to quickly obtain market access
for their products, and maintain that market access through compliant
products and services. He has assisted companies designing and manufacturing
products including aesthetic body contouring equipment, anesthesia
and drug delivery systems, catheter accessories, in vitro diagnostic
devices, patient monitoring equipment, surgical instruments, and X-ray
therapeutic and diagnostic systems. Tom earned a bachelor's degree
in electrical engineering from the University of Nebraska, Lincoln,
and a master's degree in engineering management from the University
of Colorado, Boulder. He is a Senior Member of the American Society
for Quality (ASQ), an ASQ Certified Quality Engineer, is Regulatory
Affairs Certified by the US Regulatory Affairs Professional Society
(RAPS) and trained as an ISO 9000 Lead Auditor.
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 Karen
Copeland,
PhD—Karen is an applied statistician with more than 15 years
of experience applying statistical methods in a variety of industries
including medical device, medical diagnostics, ophthalmology, pharmaceutical,
chemical, environmental, and consumer products. She has experience
designing studies, calculating sample sizes, and determining the appropriate
analysis technique for the data at hand. Karen is skilled at presenting
statistical analysis results such that they are accessible and meaningful
to all involved. Karen has co-authored technical publications including
two statistical texts, journal articles, and JMP software articles.
She holds a BA from St. Olaf College in Northfield, MN, and a MS and
PhD in mathematical sciences from Clemson University in Clemson, SC. |
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 Kevin
Morningstar, BS—Kevin
has over 20 years of experience in the medical device industry as
an engineer, manager, and entrepreneur. He is a co-founder of Silverglide
Surgical Technologies, Inc., a manufacturer of innovative electrosurgical
instruments. From start-up to acquisition, Kevin actively participated
in product development, operations, regulatory affairs, marketing,
sales, and corporate management. He is the principal architect of
the company's quality management and design control systems. Before
that, Kevin founded and managed his own five-person regulatory consulting
practice serving medical device manufacturers worldwide. At these
and other companies, Kevin successfully developed his own brand of
pragmatic, hands-on problem solving aimed at "getting the water to
the end of the ditch." He is a seasoned regulatory affairs professional
with extensive experience in FDA and European regulatory requirements
for medical devices, including international technical standards.
Currently, he consults for medical device firms from offices in Colorado
and Germany. Kevin earned a bachelor's degree in electrical engineering
from Michigan State University. He has received Regulatory Affairs
Certification by the US Regulatory Affairs Professional Society (RAPS)
and is a BSI Certified ISO 9000 Lead Auditor. He was also granted
registration as a Professional Engineer in Colorado and is professionally
certified in Production and Inventory Management by the Association
for Operations Management (APICS). |
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| Engineering & Project
Management |
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 Chris
Crowley, BS—Chris
has been a medical equipment R&D Engineer and Project Manager
for more than 20 years. His direct design experience includes pulse
oximeters, breath gas monitors, patient sensors, high volume disposables,
drug delivery devices, ruggedized handheld electronic devices, fluid
filtration, shock/vibration mechanical packaging, plastic injection
molds, and numerous other aspects of engineering. He has interfaced
with FDA inspectors in design control audits, and managed UL, CSA,
CE and country specific regulatory submissions. He is published in
American Society for Artificial Internal Organs [1999], and Proceedings
of the International Snow Science Workshop [1998]. His clinical exposure
includes six years as a Colorado volunteer EMT/B, and hundreds of
work-related hours in the OR, ICU, PACU, NICU, ER, and Transport areas
of the hospital. He also completed the University of Colorado four-day
“hands on” anesthesia course. His core experience is getting
products “out the door”—from prototype to customer
release. Chris holds a Bachelors of Science in Engineering Mechanics
from the University of Wisconsin at Madison. Additional coursework
includes Boothroyd-Dewhurst Design for Manufacturability workshop,
Practical Negotiation Skills, and several Project Management courses.
He is available for design reviews, project management consultation,
and other engineering related consulting. |
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| Clinical & Research |
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| Dr. Kevin Farrell, Medical Advisor—Dr. Farrell has over 25 years of experience in health care, including working with some of the nation's largest health plans and hospital systems. He has also served as a clinical and product design consultant to a number of medical device manufacturers. Dr. Farrell currently operates a large medical practice in Kansas City, MO. Prior to completing medical school, Dr. Farrell was a paramedic and critical care nurse. | |
 Jane
K. Dickinson,
RN, PhD, CDE—Jane's clinical expertise covers a broad spectrum
of specialty areas and includes writing and reviewing publications;
program development, implementation and evaluation; qualitative and
quantitative research; management; consulting; and public speaking.
Her patient care experience includes pediatrics, oncology, medical/surgical,
diabetes patient education. Jane has worked with health care facilities
and organizations of various sizes in a variety of locations across
the United States. Jane earned her BA in biology from St. Olaf College,
Northfield, MN; her Master of Science in Nursing from Yale University;
and her PhD in Nursing from the University of Connecticut.
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 Steve
Hilley,
R.N.—Steve has over 28 years of pre-hospital and nursing
experience. He brings extensive clinical experience to your organization
in areas such as pre-hospital, critical care, flight medicine and
emergency medicine. With seven years as the Trauma Coordinator and
Hospital Preparedness Coordinator for a Level III trauma Center, Steve
has extensive experience in developing and implementing hospital policies,
procedures and quality management in trauma care. In developing training
programs, Steve has an excellent working relationship with many medical
and volunteer disciplines, including water rescue teams, fire/EMS,
search and rescue and law rnforcement. He has hours of experience
developing and marketing training material. His career includes training
core competencies for water rescue teams, flight programs, ambulance
services and public health. His experience in the development of comprehensive
training programs for mass casualty drills is unsurpassed. Steve's
most recent experience has been covering sixteen counties as the West/Northwest
Colorado Regional Training Coordinator for Public Health in All Hazard
and Bioterrorism Preparedness. He has been active as a Board Member
of the Steamboat Springs Rural Fire Protection District, RETAC and
EMS councils. |
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 Jennifer
Halcome, BA—Jennifer has been a
molecular biologist in the biotechnology and pharmaceutical fields
for over 9 years. Her experience includes development of molecular
biology research products and reagents, as well as development and
publishing of applications for these products. She has extensive experience
in evaluating molecular biology technologies and products for technical
feasibility and performance. She has managed projects that ensure
that the products meet marketing and technical specifications, which
requires experimental design as well as analysis of data from the
Research and Development teams. Jennifer has conducted product field
testing that requires identifying and contacting participants, creating
all relevant documentation, analyzing all returned data, and determining
if the data meets established acceptance criteria. She has also conducted
competitive analysis in the molecular biology field and determined
performance of products to key competitors. Jennifer has spent a number
of years managing the day-to-day activities of research scientists
and documentation specialists. Jennifer has demonstrated success in
managing cross-functional teams including marketing, R&D, sales and
manufacturing. Jennifer graduated from the University of Colorado
- Boulder with a Bachelor of Arts degree in Molecular, Cellular and
Developmental Biology. |
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| Marketing
& Technical Communications |
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 Janice
Vierke, Vice
President, Class 5 Inc.—Janice has considerable experience in
both medical marketing and technical communications. She has worked
with Market Insights, Inc., a provider of information and analysis
to the healthcare industry, to develop various sales strategies and
marketing collateral, including user manuals and multimedia product
demos. She has also worked extensively with IBM Global Services to
develop customer communications for Fortune 500 clients, including
presentations, sales proposals, and sales collateral. She has developed
proposals ranging in size from small grants to multi-billion dollar
projects. Janice has developed business and strategic plans, marketing
communications materials, grants, and sales proposals for companies
ranging in size from startups to multinationals. As Director of Marketing
for a publishing company, she had an extensive opportunity to handle
all aspects of the publishing business, from sales and marketing program
development and implementation (with an emphasis on direct marketing),
to customer account management. In addition to over 25 years of hands-on
experience, she has completed a graduate-level program in Applied
Communications at the University of Denver. She is a long-standing
member of the Society for Technical Communications.
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MEMBER AFFILIATIONS
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Health Industry Representatives Association
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HIRA Ambassador Program
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Healthcare Communication & Marketing Association
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VGM Consultant
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The Institute for Orthopaedics
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American Association of Neuroscience Nurses
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American Academy of Opthalmology
- Global Medical Alliance
Class 5 Inc.
Medical Marketing Solutions
Medical Marketing Solutions
27355
Whitewood Drive East, POB 772930, Steamboat Springs, CO 80477-2930
Office: 970-870-0576, Mobile: 970-620-0350
Office: 970-870-0576, Mobile: 970-620-0350
© Copyright 1998-2011 Class 5 Inc. All rights reserved.
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