Prior PLM Medical Overview - Presented to: Donal Lyons Lecturer in Engineering School of Engineering and Design IT Sligo Presented by: John Prior ...
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PRIOR PLM MEDICAL 2021
Prior PLM Medical Overview
Presented to:
Donal Lyons
Lecturer in Engineering
School of Engineering and Design
IT Sligo
Presented by:
John Prior – Managing Director
Issue Date: 28 May 2021
2
PRIOR PLM MEDICAL 2021
Who We Are
We support Product Lifecycle Programmes from initial idea
to end-of-life, offering bespoke services coordinated through WE ARE A TEAM OF
specialist business divisions.
“PROBLEM SOLVERS” WITH A
UNIQUE SYNERGISTIC
✓ Product Designers ✓ Metrology Engineers COMBINATION OF SKILLS AND
✓ Mechanical Engineers ✓ Mould Designers RESOURCES.
✓ Electronic Engineers ✓ Toolmakers
- Prior PLM Medical
✓ Automation Engineers ✓ Quality Engineers
✓ Physicists ✓ Project Managers
Lead or assist the scientific and Medical communities to research, develop and launch new devices or technologies that will demonstrate
quantifiable improvements to the quality of personal health and wellbeing.
Stay focused on areas where we can make a genuine contribution to science and medicine and develop our people, resources and knowledge
to insure we achieve continuous improvement.
Strive to achieve the highest possible standards in the quality and reliability of our products and services through dedication, honesty and
integrity.
3
PRIOR PLM MEDICAL 2021
How We Support You
Pugh’s Design Activity Model
Research 2
Design
We support
Prototype
Product Lifecycle
Programmes from initial
Evaluation idea to end-of-life,
offering bespoke
Verification
services coordinated
Industrialisation
through specialist
Business Divisions
Automation
Prior PLM Medical
Sustaining & Improvement
4
PRIOR PLM MEDICAL 2021
What Makes Us Different
Prototype / Pilot Scale Up / Service
Competitors Ideation Design
Testing Manufacturing Industrialisation & Support
Prior PLM Medical n n n n n n
Typical - Product Design Company n n
Typical - Rapid Prototyping Company n
Typical - Tool Making Company n n n
Typical – Metrology Company n n
• We help support our • We are not a blind • Key activities are • Engage specialists
1 clients through all 2 supplier or hired 3 carried out 4 where appropriate
stages of development design time. internally
and commercialisation We are a committed
partner
5 PRIOR PLM MEDICAL 2021 Who we help…
6
PRIOR PLM MEDICAL 2021
How We Have Helped Our Clients
pMDI Metering Valve Variants
Investigational Research into the dynamic functionality of pMDI metering valve variants
Pilot Scale up / Service &
Ideation Design Prototyping / Testing
Participation Manufacture Industrialisation Support
n n n
❑ Requested by client to understand how the dynamics of various metering valve types vary.
• Existing static CT scan images offer no insight
• Research division investigated possibility of carrying out dynamic x-ray tomography of metering
valves during dose release (through device and aluminium can).
• Designed experiment and experimental equipment to work with ESRF synchrotron beam-line.
• 5TB of generated data.
❑ First known dynamic imaging of valve dosing and refill events at 4000fps.
❑ Information used by the client select most appropriate metering valve for formulation.
7
PRIOR PLM MEDICAL 2021
Phase contrast imaging of PMDIs
Stills from high speed video of dosing event within unmodified commercial inhaler
Stem
Flash boiling
of propellant
in sump
Nozzle
orifice
channel
Dosing event 85 ms after dose commencement from 4 different actuators each with 3 canisters containing HFA 227ea and HFA 134a
propellants and capillary retention (CR) or rapid fill rapid drain valves (RF/RD).
8
PRIOR PLM MEDICAL 2021
How We Have Helped
Our Clients
Aqua Tabs flo Water Chlorination Device
To aid developing and disaster-hit regions. Trialled in Bangladesh by Stanford University) Installed in 2000 Kenyan schools.
Has disinfected 30 billion litres of water as of 2018
Pilot Scale up / Service &
Ideation Design Prototyping / Testing
Participation Manufacture Industrialisation Support
n n n
❑ Presented by client with initial 2D concept sketch.
• Developed scope of requirements with client. Simplicity and Cost were major factors.
• Rapidly developed and refined design to reduce part count and simplify manufacture and assembly
requirements
• Generation of SLS prototypes for testing in the field
• Design was refined for injection moulding and recommendations made for moulded material
• Tool manufacture and moulding carried out by third party
❑ Completed design and proof of principal for high volumetric flow version currently being marketed
as Aqua Tabs Inline.
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PRIOR PLM MEDICAL 2021
How We Have Helped Our Clients (#4)
Bonding of Thermoset to Thermoplastic Materials
Investigational Research into the bonding of thermoset to thermoplastic materials for industrial scale up
Pilot Scale up / Service &
Ideation Design Prototyping / Testing
Participation n n n
Manufacture
n
Industrialisation
n
Support
❑ Early stage involvement project to examine process feasibility
• Initial proof of concept testing onsite. (Generic equipment)
• Designed and manufactured test specimens to allow benchmark testing.
• Engaged and coordinated national and international research facilities to examine the
feasibility of using alternative methods for bonding of dissimilar materials.
• Designed bench mark experiments and generation of evaluation report
❑ Gave clear steer to the client on potential risks/rewards with bonding strategy
❑ Currently prototyping tooling to evaluate alternative bonding method (on-going)
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PRIOR PLM MEDICAL 2021
How We Have Helped Our Clients
K-haler- Breath actuated Drug Delivery Device with Dose Counter
From early stage development supporting the introduction of a dose counter mechanism to scale up industrialisation.
Ongoing product development and industrialisation support partner.
Pilot Scale up / Service &
Ideation Design Prototyping / Testing
Participation n n n
Manufacture
n
Industrialisation
n
Support
n
❑ Early stage development partner
• Redesigned device mechanism without compromising the design envelope or the existing 2M/annum assembly
equipment (14 component device)
• Development for robustness and manufacture of dose counter, dose delivery and closure components generating 3
patents in the process for our clients.
• Rapid prototype injection moulded components using cassette tooling in order to fast track development including in
house moulding and metrology.
• Completed design verification testing to support regulatory submission
❑ Production tooling for highly critical and technically complicated dose delivery system
❑ Heavily involved in the specification and validation of high volume automation equipment across multiple sites.
❑ Device launched on the market Nov 2018 and supporting continuous improvement as Design Partner.11
PRIOR PLM MEDICAL 2021
How We Have Helped Our Clients
Point of care device for measurement of Fractional Exhaled Nitric Oxide (FeNO)
Design feasibility of next generation device and development for limited release.
Pilot Scale up / Service &
Ideation Design Prototyping / Testing
Participation Manufacture Industrialisation Support
n n n n n
❑ Carried out device assessment to understand root cause of poor field performance
• User interface was not relaying information to the user effectively resulting in multiple attempts.
• Environmental conditions affecting usability and reliability
❑ Proof of principal prototypes developed for lab and field testing
• User interface redesign and optimisation
• UI POP applications to trial against correct user adherence
• Implementation of touch screen user interface for trials
❑ Technical solution proposed to overcome environmental issues including design for manufacture feasibility
• Preventative measure to ensure robust functionality with minimum impact on existing manufacturing
process
❑ Managed the design file and offshore manufacture of the device components for low volume
commercialisation12
PRIOR PLM MEDICAL 2021
How We Have Helped Our Clients
Glucose measurement device applicator
9 Tool Injection Mould Scale up x 5 replicates
Steel biasing strategy management
9 tool injection mould scale up tooling FMEA and Tooling model generation
Pilot Scale up / Service &
Ideation Design Prototyping / Testing
Participation Manufacture Industrialisation
n
Support
❑ Customer undergoing scale up from 1 - 4 cavity tools to 8 - 32 cavity tools. (60million
devices/annum)
❑ Required ESI to improve tooling capability and reliability.
• Assessed existing tools, tool designs and component metrology and defect data logs.
• Full suite of component moldflows
• Generated recommendation report for tool design and steel-safes used to support DQs.
• Generated tooling models that incorporated steel safe adjustments , steel biasing and shrinkage
along with accompanying reports in order to retain and manage the “tacit” information. “Live”
tooling model supports the tool validation.
• Updated and appended tooling reports to support the product design file.
❑ Helped the client to reduce the tool validation cycle by approx. 3 months per replicate13
PRIOR PLM MEDICAL 2021
Device Projects – Connected Health/smart devices
“FUSION” Closed loop Insulin Delivery
• The “live” data allows a miniature discrete pump to constantly deliver
insulin in a way that better replicates a normal functioning pancreas.
• Glucose levels and insulin delivery are continually monitored and
trended.
• The data can be used by the patient to better understand their insulin
needs and can also be used by GPs to monitor patient compliance.
Smart inhaler and propellant free “active” dose delivery
• Improving on the efficacy of current API formulations
• Taking the onus of the patient and supporting optimum use
• Improving on the delivery of fine particle dose delivery to target
site.14 PRIOR PLM MEDICAL 2021 Problem Modelling Digital Prototyping and Testing Continual design validation is imperative and having these services in-house allows constantly verify our design concepts is a time efficient manner. We use finite element analysis tools throughout the design and development process to continually validate design updates and alterations.
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PRIOR PLM MEDICAL 2021
Test Laboratories
Test Laboratories
• Fully equipped controlled access test labs • Schlieren technique analysis
• Environmental temperature and humidity conditioning • Plume geometry analysis
• Tensile testing • Abrasion testing
• Torque testing • Analytical weighing
• High speed camera analysis • Component metrology and inspection.
We also manage and conduct test batch assembly, root cause analysis, analytical research, localised test programmes and full device
verification testing programmes.16 PRIOR PLM MEDICAL 2021 Prototyping Services Prototyping Testing the moulding process with the production material, so any process or material based design flaws are discovered early on, saving time and money in development. • Fast, low cost tooling solution for producing parts for fit and function testing. • Soft tooling • Cassette Moulds • Pre-Production Tooling
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PRIOR PLM MEDICAL 2021
Prototyping Services
Pilot Tooling
Testing the moulding process with the production material,
components used for de-bugging moulding process, metrology
process and automation equipment, saving time and money in
development.
• High quality tooling
• Built to Production tooling Spec’
• SPI Class 101standard
• Fast, medium cost tooling solution for producing parts for:
o Metrology Studies
o Metal safe assessment
o DVT Testing
o Assembly equipment testing/validation
o Component assembly function testing/assessment18
PRIOR PLM MEDICAL 2021
Production Tooling
Production Tooling
• Maximises reliability and component quality and minimises
cycle time and down time.
• In-depth knowledge in the moulding of sub-miniature and
micro components down to 0.0025g.
• Pre-engineered solutions for most moulding applications
• Fully automation incorporating moulding, de-moulding,
inspection, assembly, finishing and any other ancillary
processes.
• Latest moulding, gating and cooling technologies
Latest technologies include:
• Conformal cooling
• Diffusion Welding
• Pressure Transducers
• Temperature Transducers Guide Wire
introduction
• Safety Sensors device
component19
PRIOR PLM MEDICAL 2021
Metrology department
1 2 3 4
Shrinkage CMM / VMM Smart Metrology Automated In-Line
Charactarisation Fixtures Gauges Inspection Systems
Systems20
METROLOGY SYSTEMS - 2021
PRIOR PLM MEDICAL 2021
M E T R O L O G Y S E R V I C E S:
• First Article inspection/Initial
Sample Inspection Reports.
• Multi-cavity inspection.
• Steel size verification – 3D model
to cavity compliance
• Reverse engineering – plastic/steel
to 3D model.
• Gauge R&R studies.
• DoE Measurements.
• OQ Measurements.21
PRIOR
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G IYC SA YL S 2T 0E 2M1S - 2 0 2 1 Shrinkage Characterisation
Systems
When to Measure
• A flexible design which caters for a wide
range of components.
• System 3R reference system
• Non contact measurement using CCD
Micrometres.
• The control system allows captured data
to be automatically exported to excel for
further analysis.22
METROLOGY SYSTEMS - 2021
PRIOR PLM MEDICAL 2021
Shrinkage Characterisation
When to Measure Systems23
PRIOR
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G IYC SA YL S 2T 0E 2M1S - 2 0 2 1
Metrology Fixtures
Multi Impression Fixtures:
• Multi-impression metrology fixtures are
designed for both Cmm’s and Vmm’s.
• Incorporate a palletised system designed
to suit both integrated 4th Axis rotary
system chuck and a manual This can
make the requirement for multiple fixtures
unnecessary.
• All fixtures are machined accurately to
guarantee consistent component
repositioning for GR&R studies
• The use of Pre-hardened chromium
steels ensures many years of
maintenance free operation.24
PRIOR
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G IYC SA YL S 2T 0E 2M1S - 2 0 2 1
Products
Multi Impression Fixtures:
• Multi-impression metrology fixtures are
designed for both Cmm’s and Vmm’s.
• Incorporate a palletised system designed
to suit both integrated 4th Axis rotary
system chuck and a manual This can
make the requirement for multiple fixtures
unnecessary.
• All fixtures are machined accurately to
guarantee consistent component
repositioning for GR&R studies
• The use of Pre-hardened chromium
steels ensures many years of
maintenance free operation.25
PRIOR
M EP TL R
MO M
LOED
G IYC SA YL S 2T 0E 2M1S - 2 0 2 1
Metrology Fixtures
Multi Impression Fixtures:
• Multi-impression metrology fixtures are
designed for both Cmm’s and Vmm’s.
• Incorporate a palletised system designed
to suit both integrated 4th Axis rotary
system chuck and a manual This can
make the requirement for multiple fixtures
unnecessary.
• All fixtures are machined accurately to
guarantee consistent component
repositioning for GR&R studies
• The use of Pre-hardened chromium
steels ensures many years of
maintenance free operation.26 PRIOR PLM MEDICAL 2021 PRIOR PLM MEDICAL – MRO DIVISION Maintenance | Repair | Overhaul
27 MRO DIVISION 2021 Maintenance Scheduled Maintenance Program The schedule and duration of maintenance activities are agreed with you, the customer, in advance. We guarantee strict adherence to all plans, ensuring minimal disruption to your production runs. A, B, C Service Plan • A = Full Tool Overhaul • B = General Tool Service • C = Daily Tool Service In Press Driven From Mould Shot Counter .
28
PRIOR PLM MEDICAL 2021
M.R.O. Overview
Maintenance
- Scheduled maintenance program
- A.B.C service plan
- Driven from mould shot counter
Repair
- Weld and repair damaged inserts
- Insert damaged areas
- Tool modifications
Overhaul
- Full tool refurbishment to include
• Disassemble mould
• Replace all o seals
• Replace all pillars bushings
• Full part inspection
• Repair any damaged inserts
- Hot Runner service (as
recommended by hot runner
manufacturer)29 MRO DIVISION 2021 Overhaul Full Tool Refurbishment • Dis-assemble mould • Replace all o seals • Replace all pillars bushings • Full part inspection • Repair any damaged inserts Hot Runner Repair • As recommended by manufacturer Lifecycle Planning Data Management
PRIOR PLM MEDICAL 2021 30
MRO DIVISION
Repair procedure
Part Defected
1 6 Repair Insert
Detected during quality inspection
2 Define Cause 7 CMM Report
Tooling engineer To show repaired part in specification
Isolate & Remove Damaged Insert Record All Data
3 8
Tooling engineer Log repair data into MoldTrax Database.
4
Inspect & Compare With Solid Model 9 Issue Tool Report
Prior PLM Medical Metrology to inspect and compare To show all repairs carried out:
damaged insert with solid model • Highlight areas / inserts more prone to damage: data
for investigation
Issue CMM Report • Issue chart to show example of a full tool report
5
To show defected area taken from MoldTrax31
PRIOR PLM MEDICAL 2021
How We Have Helped Our Clients
24 cavity injection mould with persistent problem of core feature breaking.
Pilot Scale up / Service &
Ideation Design Prototyping / Testing
Participation Manufacture Industrialisation Support
n n
Customer presented us with problem:
• One section of an insert kept breaking - entire core had to be replaced.
• Original toolmaker insisted that the insert could not be repaired.
• Cost of new insert – approximately €8,200 each x 30 = €246,000
• Lead time for batch of 4 inserts – 10/12 weeks
• New inserts required validation after being fitted – Cost??32
PRIOR PLM MEDICAL 2021
How We Have Helped Our Clients
24 cavity injection mould with persistent problem of core feature breaking.
Pilot Scale up / Service &
Ideation Design Prototyping / Testing
Participation Manufacture Industrialisation Support
n n
❑ What we did:
• Carried out review of current design.
• Carried out FE analysis on prone area.
• Devised new design with prone area inserted.
❑ Outcome:
• After initial trial on one core, all 30 were modified.
• Cost of repair – €2,700 each x 30 = €81,000
• Lead time for batch of 4 inserts – 3 weeks
• Inserted cores did not have to be validated – Cost saving = ???
• Because of our FE analysis, and subsequent design, our customer is now getting 2x lifetime out of inserted area.33
PRIOR PLM MEDICAL 2021
Metrology and Inspection
Zeiss DuraMax CMM
❑ Metrology reports on gate repairs:
• Gate size
• Roundness
• Parallelism
• Cavity profile
❑ Metrology reports on cavity repairs:
• Cavity dimensions – before and after repair
• Surface profile - in proximity to repaired area.
❑ Visual reports and analysis on cavity repairs:
• Photographs – before and after repair
• High resolution images of repairs – Keyence VHX 5,000
• Component analysis – flash, gate vestige, mismatch, etc -
before and after repair34
PRIOR PLM MEDICAL 2021
Metrology and Inspection
Management of AbbVie
Injection Mould MRO
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Magnification range from 0.1x - 5000x
High-resolution HDR with increased resolution limits
Live depth composition that eliminates the concept of focus
adjustment
Observe, capture & measure capabilities35
PRIOR PLM MEDICAL 2021
Moulding Services
Pilot Manufacture and Test Labs: Micro moulding , 50 Ton, 100 Ton, 120 Ton Machines
• Tool validation, batch samples. Investing in clean room capability
• Undertaking metrology studies
• Device assembly studies and device performance testing.
Results used to establish manufacturing capability and device robustness to mitigate the risks in advance of the customer
committing to full scale industrialisation programmes.
3536 PRIOR PLM MEDICAL 2021 Summary Broad range of specialist services under one roof. Device Design and Development expertise Single point of contact for our customers. Skilled and diverse workforce. Extensive range of manufacturing, test and analysis equipment.
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