“This
grant is important for many reasons,” explains
Jess Niebuhr, Director of ARCC Continuing
Education and Customized Training. “First,
it is Anoka-Ramsey’s first NSF-ATE
grant, which is the most comprehensive
grant available to non-research institutions.
Secondly, it greatly diversifies the
options for students in the biomedical
field. And finally, the biomedical industry
has made their demand for these programs
clear, and we want to be the first to
fill that need with well-trained professionals.”
The new programs will be developed during
the next three years to meet the rigors
of medical device manufacturing, product
development, regulatory approvals and regulatory
compliance. Individual courses will be
offered at ARCC and other MDIEC member
campuses as soon as they are developed,
possibly as soon as August 2007. Programs
in their entirety will be offered as soon
as they are completely developed. The Medical
Device Quality Systems program will be
rolled out first, possibly as soon as January
2008. To better meet their career goals,
ARCC students will be able to choose the
certificate option or complete an associate’s
degree.
Program Development
ARCC is initiating the three new certificate
programs by leading the development of
a consistent methodology for all three
colleges to follow to identify competencies,
learning objectives and evaluation criteria
for each course.
“We [ARCC] took the lead here because
we have such an active business community
that is willing to give their time to the
development of these programs,” says
Niebuhr.
Once the methodology is set, each college
is primarily responsible for the development
of one of the three programs. ARCC began
curriculum design of the Medical Device
Information Management program in December.
The program will likely include coursework
in regulatory affairs, quality assurance,
document management and document control,
technical writing and database management.
St. Petersburg Community College will develop
the Medical Device Quality Systems program
and Edmonds Community College will develop
the Clinical Data Management program.
Due to the global demand for biomedical
professionals, a national advisory committee
has been formed to guide development, curriculum
and strategic direction for these specific
programs. The committee includes representatives
from businesses and industry associations
representing a variety of medical device
technologies, firm sizes, market focuses
and geographic locations. Minnesota representatives
include: David Herridge, Vice President
of Engineering, Incisive Surgical, Inc.;
Mary K. Cronin, Director, Learning and
Development, Boston Scientific; Jane Stoner,
Manager Administrative Services, Minco;
and Don Gerhardt, President/CEO, Life Science
Alley. ARCC staff and Minnesota representatives
will attend a national meeting in St. Petersburg
Fla. in March 2007.
Minnesota’s advisory representatives
and more than 25 businesses have been invited
to ARCC to help identify the knowledge
and skills necessary for document management
specialists. A senior curriculum specialist
with extensive experience in designing
curriculum for advanced science and engineering
programs will assist curriculum development.
Options for teaching techniques and assessment
methods will also be explored.
Biomedical Demands and Employment
Minnesota has more than 520 FDA-approved
medical device manufacturers in the state
and is second only to California in the
nation in the industry.
ARCC recognized the increasing demand
for trained biomedical personnel early
and became the first community college
in the nation to provide academic programs
that specifically prepare students for
entry into the medical device industry.
In 1999, working with business and industry,
ARCC’s rolled out its first three
biomedical programs: Biomedical Technologist,
associate science; Biomedical Technician,
certificate program; and Clinical Research
Professional, certificate program. Since
1999, 466 students enrolled have enrolled
in Introduction to the Biomedical Device
Industry, ARCC’s core class for all
three programs.
Through pursuit of grants, such as the
one from NSF, active advisory committees,
industry workshops and training and workforce
development partnerships with more than
20 Twin Cities-area medical device companies,
ARCC continues to strive to remain a leader
in the education of biomedical professionals.
Most recently this meant identifying the
need for the system-oriented training that
the three new programs will provide.
"Both small start-ups and the Fortune
500 companies need the right mix of talent
for successful new product introductions,” says
Herridge. “The medical device industry
in Minnesota is blessed with many creative
clinicians, innovative engineers and astute
marketers, but what can be harder to identify
and recruit are disciplined, systems-oriented
team members with the training to gather,
maintain and analyze the clinical data,
quality data and product data. Well trained
team members from these new certificate
programs will boost productivity, cut weeks
off schedules, make smooth regulatory audits
and keep the broader team focused on the
product."
More about MDIEC
MDIEC was established in 2005 to develop
and deliver industry-endorsed solutions.
MDIEC focuses on providing education and
training for technicians involved in quality
control, research and development, product
development, manufacturing, biological/chemical
analysis, compliance-related data management
and technology-related sales occupations.
As a founding MDIEC member, ARCC is one
of 10 community and technical colleges
that comprise the current consortium members.
Other community and technical colleges
include: Alexandria Technical College,
Alexandria, Minn.; Benjamin Franklin Institute
of Technology, Boston, Mass.; Edmonds Community
College, Everett, Wash.; Gateway Technical
College, Kenosha, Wis.; North Orange County
Community College District, Anaheim, Calif.;
St. Petersburg College Largo, Fla.; Shoreline
Community College, Seattle, Wash.; Galway-Mayo
Institute of Technology, Galway, Ireland;
Hamlet College, Denmark.
MDIEC’s board consists of 15 industry
experts from around the nation who guide
education and training program development,
endorse program distribution (when programs
meet the board’s quality requirements)
and provide strategic advice.
For more information on Anoka-Ramsey
Community College current biomedical programs
or to stay abreast of the programs being
developed, visit www.Anoka-Ramsey.edu.
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