Page 33 - Technology and Innovation Journal - 19-1

ADAPTING STAGE-GATE TO MTM CURRICULUM 371

equipment and facility controls, production and Engineering Entrepreneurship Using the Lean
process controls, corrective and preventive LaunchPad Methodology
action (CAPA)). The topic of organizational In 2011, the National Science Foundation (NSF)
structure and responsibilities included man- adopted the Lean LaunchPad methodology of entre-
agement control subsystems, quality policy, preneurial immersion, hypothesis-driven customer
audits, reviews, training, inputs, outputs, discovery, and business model validation (10,11)
verification, validation, transfer, change, risk via the creation of the NSF Innovation Corps (NSF
management, and technical files. The topic I-Corps ) program. The New York City Regional
TM
of production and process control covered Innovation Node (NYCRIN), the third I-Corps node
how manufactured products meet specifi- created through support from the NSF, is led by
cations, including process control, validation, CUNY in partnership with Columbia University and
monitoring, purchasing, acceptance, sampling, New York University and includes a network of over
calibration, vendor assessment, identification, 25 regional institutions (12). Previously, NYCRIN
storage, labeling, installation, and servic- successfully adapted the NSF I-Corps program for
ing. The area of non-conformities and CAPA undergraduate engineering entrepreneurship training
focused on quality policy that strives for con- (13).
tinuous improvement. Topics included col- The NSF I-Corps boot camp is seven weeks long
lecting and analyzing data; identifying and and is taught by seasoned commercialization experts,
investigating product and quality problems; including serial entrepreneurs, investors, and direc-
root cause analysis; identifying and implement- tors of innovation. Each cohort consists of 21 to 24
ing corrective and preventive actions; veri- teams of three: an NSF-funded principal investigator,
fying and validating; providing information for an entrepreneurial lead who is typically a graduate
management review; differences between cor- student or postdoc familiar with the technology, and
rection, corrective action, and preventive an industry mentor. These three-person teams are
action; and customer feedback. Finally, required to develop business model hypotheses about
the topic of medical device reporting included their technology’s value proposition and customer
reporting, recall and vigilance systems (Euro- segments, which together create a product/market
pean Union and Canada), customer complaints, fit, along with the remainder of the Business Model
risk management, internal audit, external audit, Canvas (BMC). The team must test their hypotheses
management review, International Orga- by “getting out of the building” and interviewing
nization for Standardization (ISO) 13485, and at least 100 potential customers during the sev-
differences among U.S. FDA, good manufac- en-week course. Learning the customer pain points
turing practice, and ISO. Guest lectures given leads to insights that can either validate or invali-
by Susan Littlefield, manager for Quality Sys- date the teams’ hypotheses. The methodology favors
tems & Regulatory Affairs at the Georgia Eye experimentation over elaborate planning, customer
Bank, focused on the real-life company feedback over intuition, and iterative design over
approach to quality: how to build quality into traditional “big design up front” development (14).
the process, separate the department for qual- The course is a modified flipped classroom, in which
ity, and introduce quality systems. the pedagogical learning is assigned through vid-
eos in the Udacity series How to Build a Startup to
◉ ISO standards, which are important standards be watched outside of class time. Class sessions are
related to medical devices and drugs, were an used for the teams to present their weekly insights
integral part of the MTM I6100 Intellectual with feedback from the teaching team followed by a
Property, Regulation, and Quality Assurance discussion of the video and corresponding assigned
course material. Relevant standards were dis- text, which covers one block of the BMC each week.
cussed in great detail, including the After sufficient data is gathered, the team can pivot
history of the ISO standards and other norms. as a result of a pattern of invalidations and must con-
tinue their customer discovery process to reach a go