Statistical solutions to help you with 5 FDA medical devices stages

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Ming Dong
Technical Training
Manager
Statistical
Solutions to Help
You with the
5 FDA Medical
Devices Stages
Abbie Wong
Area Marketing
Manager

Statistical
Solutions to Help
You with the
5 FDA Medical
Devices Stages

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

Medical Device Classifications
• Class 1: General Controls
• Pose the least amount of risk to consumers
• GMP, Reporting Adverse Events to FDA
• E.g. oxygen masks or surgical tools
• Class 2: General Controls With Special Controls
• Pose more risk to consumers
• Subject to special controls in addition to general controls
• E.g. heart rate monitors, x-ray systems, and infusion pumps.
• Class 3: General Controls and Premarket Approval
• Support or sustain life or implanted in the body
• Require premarket approval
• E.g. pacemakers, HIV diagnostic tests
• Development process differs depending on the device’s
classification

FDA Drug and Device Development Processes
The 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.
Source: https://www.fda.gov/patients/learn-about-drug-and-device-approvals

FDA Product Development Life Cycle
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

Stage 1
Device
Discovery/
Concept

Goal
• 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.

Case Study
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 Multi-Vari Chart, engineers can quickly
identify the strongest.

Average Pull Force with Variation by Different Formulas and Months
The Method Used
• Source of variation analysis
• Multi-vari Graph
Result
• The manufacturer, therefore,
decides to develop a bonding agent
that is both as reliable and
consistent as product C.
Minitab Tool - Multi-vari Graph

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 - Project Prioritization Matrix

Stage 2
Preclinical
Research –
Design and
Prototype

Goal
• 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.

Case Study 1
Optimizing a Packaging Process
• 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.

Contour Plot of Average Pull Force by Different Front and Rear Temperature
Minitab Tool
DOE

Result
• Through the interaction graph,
you can identify the factor levels
that maximize the pull force.
Interaction Plot of Average Pull Force by Different Front and Rear Temperature
Minitab Tool
DOE

Case Study 2
Predicting the Product Life Cycle with Minitab
• Every medical device must be labelled with an expiration
date.
• Some products, such as implantable medical devices, tend
to last for many years.
• Minitab’s Accelerated Life Testing (ALT): to speed up the
failure process under extreme conditions.
• Methods of acceleration include testing under extreme
temperature, voltage, pressure and so on.
• Failure data is analysed to extrapolate the product life cycle
under normal circumstances.

Stage 3
Pathway to
Approval –
Testing and
Validation

Goal
• 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.

Case Study 1
Reaching 95/99 reliability
• A medical device company needed to show a 95/99 reliability
requirement on the tensile strength of plastic tubing.
• Requirements:
• Confidence level: 95%
• Deviation from the required strength: 12 pounds
• Percentage of the product: 99%.
• Analyzed data using Minitab’s Tolerance Intervals.
accelerated life testing

Minitab Tool
95/99 Tolerance Interval
Result
• The company can be 95% confident that 99%
of the tensile strength deviations will be
between –9.451 and 10.7 pounds.
• The process is following the design
requirements.

Case Study 2
Estimating Process Capability
• A medical device is shipped in heat-sealed packages
with a minimum seal strength requirement of 13.5
Newtons per square millimetre (N/mm2).
• From a DOE study, it is understood that the relationship
between seal strength and other variables is:
• Seal Strength= 9.64 + 0.003*Temp + 4.0021*Time +
0.000145 Temp*Time
• How can we assess the process capability under a
specific manufacturing condition?

Minitab Workspace Tool
Monte Carlo Simulation: A Model from a DOE Study

Capability Report after 50,000 times of Simulations

Simulated Capability Report after Reducing Variations
Suggested manufacturing
conditions:
Temperature: 178.9 degrees
Seal time: 1.99 seconds
Result
Defective probability: ~0

Stage 4
FDA Review and
Deployment

Goal
• 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.

Case Study 1
Monitoring process stability
• Process engineers want to check for changes in
infusion amounts over some time through
intravenous access devices.
• Five intravenous devices are randomly selected from
each lot for approximately one week. The infusion
amount is measured.
• By Reading control charts, engineers can identify
which batches are out of control.
• By checking the log files, they can identify and
eliminate all special cause variation.

Minitab Tool
Control Charts
Result
A successful SPC program helps
manufacturers maintain stable
processes, improve efficiency, and
reduce costs.

Case Study 2
Checking the process capability
• An ostomy pouching system is a medical device used to
collect waste from a surgically diverted biological system,
such as a colon or urinary tract.
• The manufacturer wants to study how capable the
products are to resist external pressure with the lower
specification requirement of 1,500 psi.
• Each pouch bag is tested using a machine that measures
the pressure simultaneously at four fixed locations.
• A total of four samples are tested every 12 hours for 15
days.

Minitab Tool
Distribution Identification
Result
Smallest extreme value
distribution is identified.

Minitab Tool
Capability Analysis
Result
PPM: 10,620 / 1,000,000
PPK: 0.77
Possible improvement methods:
• Increasing average strength
• Reducing process variation

Case Study 3
Controlling outgoing product quality
• An epinephrine injector manufacturer wants to inspect a lot of
5,000 injectors before shipping to customers.
• If the injector chamber is not filled, the product should be
rejected.
• Minitab’s acceptance sampling plan shows that engineers
need to randomly select 439 sample injectors from the batch
and test them.
• According to the plan
• if one or more injectors fail the test, the full batch of 5,000
products should not be released.
• If none of the samples fails the test, the batch can go to
customers.

Minitab Tool
Acceptance Sampling Plan
Average Outgoing Quality Limit
Sample Size 439
Acceptance Number 0
Accept lot if defective items in 439 sampled ≤ 0; Otherwise, reject.
AOQL At Percent Defective
0.073 0.220

Case Study 4
Predicting and reducing failure batches
• 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.

Minitab Tool
Classification Tree
Result
Key sensors are identified
and closely monitored.

Mintab Workspace Tool
Process map
A process map to
illustrate:
• Sequential flow
• Relationship of steps
• Identify key decision points
• Uncover rework loops

Stage 5
Post-Market
Safety-
Monitoring,
Maintenance,
and Support

Goal
• 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.

Case Study
EWMA Control Chart
• A manufacturer of small catheter spigot wants to use
process control charting to monitor the tensile pull
strength, the force needed to pull the spigot apart.
• The manufacturer is concerned about the possibility of
small shifts in the mean.
• Sample spigot is collected every production hour over 5
days.

Case Study
EWMA Control Chart & Complaint Monitor

Final Words
• 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.

Virtual Workshop
Powerful Statistical Tools in the Pharmaceutical and Medical
Devices Industry Workshop
• Date: Friday September 25th, 2020
• Time: 10AM HKT/ 12PM AEST/ 2PM NZT
• Duration: 2 hours
• For more details:
https://info.minitab.com/resources/apacpharmamedicaldevicesworkshop

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:
• Quality as a competitive advantage: How the Lego Group work with Quality and
Product Safety
• The Age of Analytics: Data-Drive Insights in the Services Industry
• Three-part Machine Learning series
• For more details:
https://info.minitab.com/resources/webinars/webinar-wednesdays-apac

Upcoming Training
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our expert statisticians. Upcoming training include:
• Improving Business Processes: Statistical Quality Analysis for Service Quality
• September 14-18
• Predictive Analytics – Machine Learning
• October 12 -13
• Improving Business Processes: Statistical Quality Analysis for Service Quality
• November 2 – 6
See all the details at:
http://www.minitab.com/training/training/

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Statistical solutions to help you with 5 FDA medical devices stages

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