How to Conduct Your Assessment of Products and Systems ......12/11/2012 1 Confidential Material 1 How to Conduct Your Assessment of Products and Systems Before Purchase Lab Quality

12/11/2012

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Confidential Material1

How to Conduct Your Assessment of Products and Systems Before Purchase

Lab Quality Confab San Antonio, TX November 7, 2012

Argent Global Services2

Background

• Steve Stone, Managing Director, Argent Global Services

• Process-Engineering and Management Consulting firm

• Argent pioneered many engineering services for the Diagnostics Industry - 20-years Health Care experience

• Skill Set & Methodology include:– Industrial Engineering

– Lean Enterprise & Six Sigma

– Data Collection & Information Gathering

– Facility Design & Layout

– Management Tools & Software

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Disclaimer

• Argent works for many diagnostic and pharma vendors

• We are third-party and not biased

• We have studied systems in most laboratory environments

• Presentation will not focus on specific systems but general examples



Time to Choose

You’re on schedule to purchase and you want to lean more about your options

This is a process you have done many times

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How You Learn

• Traditional ways to learn – Ask your vendors for information

– Ask your colleagues for input

– Ask you vendors for access to systems

– Read surveys or publications

• Accessibility to all of the systems you are considering can be an issue

• Rely on vendors for information and data


What Does the Data Mean?

World’s Most Accurate Pie Chart


Data and information from vendors is accurate,but, is it helpful, is it useful?

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The Set Up

• Vendors and laboratories have intimate knowledge of their testing systems

• Understanding the assessment methodology could give you more insight on which questions to ask and what information is useful for your needs

• When you do get to see systems you may look at them differently


Engineering Methodology

• Vendors and laboratories utilize engineers to perform assessments of testing systems in actual laboratory settings

• Many advantages to this methodology and to using third-parties


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TEEA ModelSM

Testing Equipment Engineering Assessment

The TEEA Model is a comprehensive analysis of testing systems utilizing industrial engineering methodologies with focus on how systems integrate with and impact laboratory operations.


TEEA ModelSM Components

Need Performance Workflow Cost

Decision


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TEEA ModelSM

Testing Equipment Engineering Assessment

Methodology

• Engineers conduct assessment through direct observation

• Time and motion studies and data collection

• Conducted in real labs with actual test mix and volumes

• Assessments look at metrics, features, workflow, configurations, strengths & weaknesses, etc.


Conducting the Assessment

• Study protocol is developed

– Based on desired outcomes of study – how the information is used

– Specific to testing environment

• Assessment outputs fit into the four components of the TEEA ModelSM


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Need



Decision

What Do You Need?

Need• The most important factor to consider when

selecting automation is to determine what you really need

• Separate needs from wants

• Part of need is also knowing your limits or restrictions

• Try to avoid assumptions or pre-conceived ideas based on lab size or volumes


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Weighing Needs

• Assay performance or other clinical considerations are usually what a laboratory will base decisions on when selecting testing systems

• If assay performance is close then other factors should be considered

• Factors that will impact cost, labor, efficiency and performance of the lab


What are Needs

Examples of Needs

• Test menu

• Labor reduction or improved staffing

• Faster results or more capacity

• Reduce operating costs (cost per test)

• Handle volume increases

• Better space utilization


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Understanding Needs

• Study and understand the specifics of your lab’s workflow before selecting automation

• Engineering Adage:

“never automate a bad process”

• Don’t assume new equipment will solve all of your issues


Performance



Decision

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Performance

• Automation Cycle Time – Time to first result

– Time for all results (rack or batch)

• Total Cycle Time– Entire process – prep to results


Total Cycle Time

• True time to results with prep, waiting and automation time.


Spin

Resumespecimen,control &standardpreparation02:00

ManualPrep

ManualPrep Freeze pellets


IncubateManualPrep


ManualPrep Incubate Incubate Incubate Incubate Incubate

AddAmplifierWorkingReagent23:28

AddLabelWorkingReagent24:15

Start specimen,control & standardpreparation00:00(hh:mm)

AddSubstrateWorkingReagent25:19

Testingcomplete26:32

BeginSubstrateincubation25:28

BeginLabelProbeincubation24:16

BeginAmplifierProbeincubation23:29

BeginPre-amplifierProbeincubation22:42

AddPre-amplifierReagent22:41

BeginCapture &Target Probeincubation06:41

Begindry bathincubation04:04

Place samplesin freezer02:29

Centrifugesamples01:00

Post-detectionanalysis26:12

Day 1 Day 2

LaborWaiting

Automation

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Performance

• Throughput– Tests per hour

– Batches per day/shift

– Slides per hour/day

• Test Menus– Available and future

• Open vs. Closed Systems – ASR, LDA


Performance

• Equipment reliability– Downtime and repairs

– Mostly anecdotal, may be design issues, may be random and isolated

– Many new systems have bugs to work out

• Assay performance– Not typically part of an engineering

assessment but important


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Workflow



Decision

Workflow

• How does the equipment impact the laboratory processes, staffing and flow?


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Workflow

• Labor– Hands-on time

– Attentive time – how you staff

– Walkaway time

– Wait time

• Maintenance Time– All requirements


Operator Interaction

• Anytime an operator is required to interact with testing, there is an opportunity for delays

Molecular Example


Operator intervention required to:

Load universal tubes to RCS

Legend: Hands-on Time Load all required consumables & inspect

Instrument Run Time microwells after Hybridization Automation

Move reaction wells to reader

1-

2-

3-

Manual Specimen Preparation Time Hybridization Automation Hybrid CaptureSignal

Amplification Washing Detection ReadingPost

readerDaily

M aintenance

1 32

Interaction

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Workflow

• Specimen Preparation Requirements– Test from primary

– Transfer steps

– Is pre-quot required

– Propriety labels


Workflow

• Reagent preparations steps– Thaw time

– Premix or mix

– Pour-off or self-contained


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Workflow

• Testing Capacity– Queue size, loading capacity

– Batch size

– Flexibility of batches

– Menu flexibility

– On-board reagents capacity

– Multiple assays at one time

– Support continuous flow - Lean


Capacity

Batch Sizes

• Bigger is not always better

• Batch sizes should match your overall workflow and meet your needs

• Look for batch sizes that support continuous flow and reduce waiting


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Capacity

Bigger is not always better

Vs.


Workflow

• Parallel Processing– Do testing steps/components run

independently and in parallel or linear?

– Single box or multiple

• Modular Automation vs. Integrated– Integrated systems tend to have smaller

footprints


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Workflow

• Reagent packaging configurations– Flexibility of batch sizes for kits

– Storage requirements

– Thaw times

– QC to kit ratio

• Storage space for consumables– Ambient, refrigerated, frozen


Workflow

• User-friendly, Ergonomics, Mistake Proof

• Any Workarounds –– Open covers on instruments

– Spin STATs off-line

– Manually move specimens from track

– Tricks to disable lock-outs

– Etc.


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Workflow

• Size / Footprint – Includes all peripherals and workbenches

– Clearance

• Facility Requirements– Water requirements

– Drains

– Multiple rooms (e.g., molecular)


Cost



Decision

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Cost

• Cost should be an obvious factor

• More often labs are required to cost justify decisions

• Cost Outputs

– Total Cost of Ownership (TCO)

– Return On Investment


TCO

• Total Cost of Ownership is a way to estimate the real operating cost of equipment

• Goes beyond just the contract pricing (i.e., cost per test)

• Becoming a common tool in this industry


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TCO Example

Typical factors utilized for TCO calculations


Determinate X Factor = Cost

Cost per Test (rental) x Volume = _______

or, Capital Cost x Terms = _______

Reagents x Volume = _______

Consumables, Supplies x Volume = _______

Labor x Wage = _______

Utilities x Rates, Time = _______

Lab Space x Value of Ft2 = _______

Supply Storage Space x Value of Ft2 = _______

Multiply by Number of Years = _______

TCO = _______

ROI

• Almost all new equipment will promise some savings, improvement or ROI.

• When looking at benefits of new equipment ask yourself if you could get the same improvements yourself

• Equipment may only be the catalyst for improvement but not the direct factor– E.g., labor reductions, layout improvements, reduced

steps, improved capacity, etc.


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Summary

• TEEA ModelSM Components



Decision


Conclusions

• Understand your need

• Follow typical avenues for information

– Vendors, colleagues, surveys or pubs

• Ask new questions based on the TEEA ModelSM and engineering approach

• Consider how the automation will integrate with your laboratories workflow

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Training Thoughts

Remember…

“Learning is not compulsory, neither is survival”

- W. Edwards Deming


End of presentation

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How to Conduct Your Assessment of Products and Systems Before Purchase Copyright 2012Argent Global Services Lean Training ServicesArgent Global Services

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How to Conduct Your Assessment of Products and Systems ......12/11/2012 1 Confidential Material 1 How to Conduct Your Assessment of Products and Systems Before Purchase Lab Quality