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.
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,
Vollmer, MA, CPMRTom 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.
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.
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.
Kroenke, BS, MSTom 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.
Copeland, PhDKaren 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.
Morningstar, BSKevin 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).
|Engineering & Project
Crowley, BSChris 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 , and Proceedings of the International
Snow Science Workshop . 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 doorfrom 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.
|Clinical & Research
|Dr. Kevin Farrell,
Medical AdvisorDr. 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.
K. Dickinson, RN, PhD, CDEJane'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.
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
Halcome, BAJennifer 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.
& Technical Communications
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.