Assessing Product Feasibility - Case Study

Product Realization Group

Webinar SeriesWebinar Series

Product Feasibility

…. Annuvia case study, understanding product readiness

Michael KeerMichael KeerFounder and CEOProduct Realization [email protected]

©Product Realization Group, Inc., 2012 Pg 1

[email protected]

Where does Feasibility Fit?y

Product LifecycleFollows a product from concept to end-of-life

Feasibility is a subset of the product lifecycle, and focuses on understanding the readiness to move a product into development


Impact of Feasibility in the

Product LifecycleProduct Lifecycle


Importance of Feasibility in the Product Lifecycle

Escalator EffectEscalator Effect

2000

2500$$$$$$$$

1500

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# of Units

500

1000

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#

0NPI Proto I NPI Proto II Pilot Vol. Prod.

Do it right from the start -

Feasibility


Do it right from the start The leverage is HUGE!

Speakers

Micah BongbergMicah BongbergIs the President and CEO of Annuvia. Annuvia is one of the leading health, safety, emergency preparedness, and emergency response organizations in the United States.

Michael KeerIs the Founder and CEO of Product Realization Group. The PRG enables rapid and cost effective introduction of products to the market, regulatory compliance, manufacturing, service, and lifecycle


compliance, manufacturing, service, and lifecycle support.

Speakers

Mark Brinkerhoff, PEMark Brinkerhoff, PEIs the President of Fusion Design. Fusion provides mechanical development services for medical, industrial, recreational and many other product applications

Walt Maclay Is the President of Voler Systems. Volerprovides electronic design and software services for medical, industrial, aerospace and instrumentation applications


and instrumentation applications.

Feasibility Tips y p

Identify risks early (regulatory, technology, manufacturing, etc.)

Evaluate multiple solutions

Use known & easily available ytechnology


Feasibility Tips y p

Consider emerging technologies & markets

Weigh evolutionary vs. revolutionary

Choose scalable solutionsTechnologygyManufacturing


BEACON PRODUCT FEASIBILITY:CASE STUDY

©Product Realization Group, Inc., 20112

AED Industry Backgroundy g

Sudden Cardiac Arrest (SCA) is the leading cause of death in the United StatesAutomated External Defibrillator (AED) units Automated External Defibrillator (AED) units provide a therapy that can save the majority of victims (+70%)Time is of the essence: Victim loses a 10% chance of survival for every minute that passes


Arch Software: What Does it Do?

Maintains records for AED owners, distributors, Maintains records for AED owners, distributors, and manufacturersRegisters units with local EMS or 911 dispatchOversee records by a licensed MDSend AED owners reminders to update equipment


The Beacon Product Conceptp

Integrates with ArchIntegrates with ArchTurns our “static” database “dynamic”

Live FeedbackAutomatically “reads” an AED’s statusAccurate AED location/placement dataNotification Instant AED is openedNotification Instant AED is opened

Additional features (remote updates) updates)

Voice to connect rescuer with 911 operatorTemperature monitoring


Now What?

T th k t t it hil t ti Toe the market opportunity while testing feasibility

Understand all risks and expenses (to build produce and operate)build, produce, and operate)

Does the market opportunity exceed the Does the market opportunity exceed the costs? How soon will we break even?


Is it Feasible?

lRegulatory Environment

TechnologyTechnology

Time-to-Market

Manufacturability

C tCosts


Regulatory Environmentg y

What class medical device would it be?What class medical device would it be?AED is class III, most highly regulated

Extra cost of developing a medical device can easily double the costcan easily double the cost

Quality systemRegulatory paperworkRegulatory paperworkFDA filingWaiting for FDA response


Determining Regulatory Statusg g y

Getting FDA to give definitive advice Getting FDA to give definitive advice before a product is developed is very difficultdifficultPRG regulatory partner has experience working with FDA staffgWas able to get an email stating the proposed product would not be a medical deviceHuge savings in time and money


Technology: Feasibility Approachgy y pp

Define key methods of detectionDefine key methods of detectionDesign a test set upBuild Build Test and submit resultsUpdate test set up per feedbackUpdate test set up per feedbackTestR t f ibilit fi diReport feasibility findingsUpdate Product Requirements

( )©Product Realization Group, Inc., 2013 Pg 17

Document (PRD)

Technology Feasibility

Product RequirementsProduct RequirementsSense a message on LCD displayg p yPhotosensor with LED illumination is simple, low cost detectorWide range in ambient light – dark to full sunCan’t obstruct view of Can t obstruct view of LCD display

Wireless data transmissionLow power consumptionQuickly open and replacedelectronics

Mechanical alignment


Technology Feasibility - V1gy y

Built simple circuit & mechanical mock-up to test detection of warning

Tested in direct sunlightTested in full darknessTested in full darkness

2-3 weeks to design, build, and testTest results

Could sense error symbol in all light levelsDifficulty with reflected lightObstructed view of displayObstructed view of display



Pivot and design changePivot and design changeCamera chip sends image of LCD display

Easier to handle reflected lightTransmit entire image

Heavily compressed imageLarge amount of data still makes detection easierLarge amount of data still makes detection easier

Technical challengesReflected light / proper illuminationTransmit entire image with low power consumptionWhat type of wireless transmission?


Mechanical Feasibility: V1 vs. V2y

LED Method Camera Method

VSVS



Built and tested mock-up (2 – 3 weeks)Built and tested mock up (2 3 weeks)Built circuit from development boards (off the shelf)Mechanical fixturing (board and light mount/shroud)

T t ltTest resultsDetection worked in all light conditionsDisplay obstruction satisfactoryp y yDetermined housing could support solution

Cellular service met requirements bestA il bl h AED l t dAvailable where AEDs are locatedSimple installation, no repeaters requiredLow monthly cost


Technology Feasibility V2

Integrated Camera System

gy y

Integrated Camera System


Product Feasibility

ConclusionsConclusionsRegulatory impactRegulatory impact

Knew what regulatory path was requiredLower cost and lower risk

I t f f ibilit t h i l kImpact of feasibility technical workAvoided designing a product that didn’t workSaved two months and 10% of Dev. CostLowered project risk – remainder of project had little uncertainty

Product Requirements Document completeProduct Requirements Document completeDesign schedule and cost accurately estimatedReady to begin the design


y g g

Feasibility Tips (summary): Q&Ay p ( y) Q

Identify risks early (regulatory Identify risks early (regulatory, technology, manufacturing, etc.)Evaluate multiple solutionsEvaluate multiple solutionsUse known & easily available technologyConsider emerging technologies & marketsConsider emerging technologies & marketsWeigh evolutionary vs. revolutionaryChoose scalable solutionsChoose scalable solutions

TechnologyManufacturing


Manufacturing

Product Realization Group

Webinar SeriesWebinar Series

Product Feasibility

…. Annuvia case study, understanding product readiness

Michael KeerMichael KeerFounder and CEOProduct Realization [email protected]


[email protected]