The development of new drugs and medical devices follows well-established approval paths to make sure that they are safe when they reach the public. The U.S. FDA recommends five stages for the medical device and pharma development process, and some Asia Pacific countries' regulators suggest similar steps. In this virtual hands-on workshop, Minitab Technical Services Manager Ming Dong will walk you through the Minitab Statistical Software and Minitab Workspace quality and visual tools that can be used in each stage. He will also take you through the common challenges faced by pharmaceutical and medical device manufacturers.

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Powerful Statistical Tools in
the Pharmaceutical and
Medical Devices Industry
Workshop

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• 15+ years of
experience
• Masters in Applied
Statistics
• Masters in Computer
Science
Meet the Presenter:
Ming Dong
Technical Training Manager

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FDA Drug and Device Development Processes
FDA
• Reviews research data and information about drugs
and devices before they become available to the
public.
• Watches for drug problems once drugs and devices
are available to the public.
• Monitors drug information and advertising.
• Protects drug quality.
https://www.fda.gov/patients/learn-about-drug-and-device-approvals
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FDA Product Development Life Cycle
4
1
Stage 1: Device Discovery/ Concept
2
Stage 2: Preclinical Research – Design and Prototype
3
Stage 3: Pathway to Approval – Testing and Validation
4
Stage 4: FDA Review and Deployment
5
Stage 5: Post-Market Safety Monitoring, Maintenance and Support

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Stage 1
Device
Discovery/
Concept
• Research an unmet medical need
• Create a concept or an idea for a
new device
• Determine the concept is
workable
• Practical concepts that move to
the later stages of development.

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Case Study Stage 1: Device Discovery/Concept
Develop the Best Bonding Agent
• An adhesive bonding agent manufacturer is
looking to develop a new product to compete with
the current market leader.
• The engineers collected three popular bonding
agents and measured their pull force every three
months to assess strength degradation.
• Using Minitab’s Quality Tools  Variability Chart,
engineers can quickly identify the strongest.

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The Method Used
• Rank potential projects by both
their weighted benefits and their
relative ease of completion.
Result
• Prioritize and choose the best
projects to work on
Minitab Workspace Tool Stage 1: Device Discovery/Concept
Project Prioritization Matrix

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Stage 2
Preclinical
Research –
Design and
Prototype
• Translate user needs into technical
requirements.
• Test the prototypes in controlled
laboratory settings.
• Understand the prototype and
attempt to reduce the risk of harm to
people.

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Case Study Stage 2: Preclinical Research – Design and Prototype
Optimizing a Packaging Process
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• U.S. headquartered medical devices manufacturer Boston
Scientific’s manufacturing facility in Heredia Costa Rica
• Evaluated its pouch-sealing process to determine optimum
process conditions.
• Applied Minitab’s DOE tools by simultaneously changing and
assessing more than one input variable at a time.
• Applying the optimal packaging manufacturing conditions,
Boston Scientific Heredia substantially increased cost
savings and achieved desired sealing strengths.

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Stage 3
Pathway to
Approval –
Testing and
Validation
• Verify that the device is both safe
and effective.
• Test the product performance
relative to specifications.
• Show evidence that the
processes will consistently
produce the specified outcomes.

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Case Study Stage 3: Pathway to Approval – Testing and Validation
Active Ingredient
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• The active ingredient in a tranquilizer has a
target active ingredient amount of 150 mg/ml.
Each batch of sedatives is tested to detect
significant deviations from the target before
shipment.
• 12 samples are taken at random from 12
different batches, and the amount of the
active ingredient is measured.
• Hypothesis Testing

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Stage 4
FDA Review
and
Deployment
• File an application with the FDA to
market the device to the public.
• To provide continual assurance
that the process remains in a state
of control and a validated state
during commercial manufacture.
• To meet a set of requirements
defined by specification limits
• Be sure of shipping good batches
of medical products to customers.

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Case Study Stage 4: FDA Review and Deployment
Dissolution of Oral Tablets
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• A sustained-release pharmaceutical drug was
developed to have a 50% dissolution time (T50) of at
least 150 minutes.
• To evaluate the capability of this process, a quality
engineer measures dissolution time to show that a
high proportion of tablets can meet the lower
specification of 150 minutes.
• Capability Analysis non-normal data

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Minitab Workspace Tool Stage 4: FDA Review and Deployment
Process map
A process map to
illustrate:
• Sequential flow
• Relationship of steps
• Identify key decision points
• Uncover rework loops

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Stage 5
Post-Market
Safety-
Monitoring,
Maintenance,
and Support
• File an application with the
FDA to market the device to
the public.
• Provide continual assurance
that the process remains in a
state of control.
• Meet a set of requirements that
are defined by specification
limits.

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Case Study Stage 5: Post-Market Safety Monitoring, Maintenance and Support
Predicting and reducing failure batches
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• A medical latex glove manufacturer installs 57
sensors/signals on the production line to collect different
production conditions.
• temperature,
• moisture level
• machine speed.
• Engineers had collected data from 4,601 batches of
products that had a 39.4% batch failure rate.
• After applying Minitab’s CART classification tree
techniques, researchers discovered the key sensors
related to high risk of failure batches.
• Actions were taken to monitor key sensors closely.

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• Classification and Regression
Trees
• Python Integration

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Minitab Virtual Launch Event
Research shows that leaders globally are making digital
transformation a priority. Hear from Minitab experts including
Jennifer Atlas and Mikhail Golovyna on how organizations
can bring about, impact and accelerate digital
transformation.
• Date: Thursday, October 22
• Time: 1030am HKT / 1130 am KST /
130pm AEDT / 330pm NZDT
• Register for free here now:
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launch-event-acceleration-digital-transformation
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Final Words
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• By applying Minitab statistical tools, manufacturers
can ensure the quality and durability in each stage of
the product life cycle.
• Record all necessary information for future reference
or inspection by regulators.
• Workspace contains essential visual tools, forms, and
templates all in one application to assist
manufacturers record details of every step.

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Upcoming Training
Virtual Training
Take our Minitab Signature Trainings virtually now from anywhere and learn directly from
our expert statisticians. Upcoming training include:
• Predictive Analytics – Machine Learning
• October 12 -13
• Improving Business Processes: Statistical Quality Analysis for Service Quality
• November 2 – 6
• Improving Manufacturing Processes
• November 30 – December 2
See all the details at:
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On-Demand and Live Webinars
Webinar Wednesdays
Live Webinar Highlights
• Gaining a Competitive Advantage: Using Analytics to Optimize Your
Digital Marketing
• October 14th at 10am HKT/ 1pm AEST
On-Demand Webinar Highlights:
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Quality and Product Safety
• The Age of Analytics: Data-Drive Insights in the Services Industry
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