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Digital Transformation Overview Joel Schipper – Board Member Webinar www.PCBAPPS.com

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Page 1: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

Digital Transformation Overview

Joel Schipper – Board Member Webinar

www.PCBAPPS.com

Page 2: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

Agenda

! Company Overview

! What is Digital Transformation?

! What is Oracle’s View of Digital Business?

! Trends and Digital Transformation in Agribusiness

! Trends and Digital Transformation in Life Sciences

! Is Digital Transformation Right for Me?

! Tips for Success

! Q&A

Page 3: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

PCB Apps! 2003 - 2016 - 275 - 14

! Oracle Platinum Partner for Digital Transformation

! Business Consulting Services, Managed Services, and Hosting/Cloud services

! Finance, Agribusiness, Oil & Gas, Life Sciences, Engineering/Construction, Manufacturing, Logistics, Wine & Spirits, Real Estate

! Mobility applications

! JD Edwards to Cloud Integrations

www.PCBAPPS.com

Page 4: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

www.PCBAPPS.com

Great Partnerships and Global Customers

Quest International Users Group – Silver Partner

Oracle Platinum Partner for license resale and full life-cycle implementation of Oracle applications & products

IBM business partner for IBM IM product

Page 5: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

What is Digital Transformation?

Page 6: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

What is Digital Transformation?

• Disruptive Technology

• Quantum Leaps of Change

• Strategy to Transform

• MORE THAN Automating Status Quo

• MORE THAN Incremental Improvements

• NOT a simple Tech Initiative

Page 7: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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NYPD - Shades of Batman

! Drones patrol above Times Square using facial recognition software

! Fails to find the target

! Upload revised Algorithm with analysis of his stride pattern

! Suspect found and apprehended

Page 8: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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Minnesota Predictive Farm Management

! Text message

! analysis of temperature, humidity, and soil moisture

! Rain forecast for tomorrow

! Predictive Analysis performed

! Advisory text notice

! Irrigation and fertilizer systems will run one hour less than planned tomorrow

Page 9: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

www.PCBAPPS.com

Robotic Mining

! Robotic drills mine iron ore

! Autonomous loaders fill driverless dump trucks the size of a house

! Driverless trucks haul the ore to automatic trains

! Automatic trains shuttle 24x7 between mine and processing plant

! Technician monitors from 750 miles away

Page 11: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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Why is this Important Now?

A faster, more connected world -3B connected people; soon 20B connected machines -More computing power in your pocket

New networks are evolving -1/4 of humanity is on Facebook -Facebook is melding news, politics, videos, marketplaces

A Digital Industrial Complex of data and physics

-Complex, continuous flow of data -Offers new insights and behaviors -WAZE is optimizing traffic lights

Page 12: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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Why is this Important Now?

! A faster, more connected world

! -3B connected people; soon 20B connected machines

! -More computing power in your pocket

! New networks are evolving

! -1/4 of humanity is on Facebook

! -Facebook is melding news, politics, videos, marketplaces

! A Digital Industrial Complex of data and physics

! -Complex, continuous flow of data

! -Offers new insights and behaviors

! -WAZE is optimizing traffic lights

Page 13: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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If You Don’t Keep Up …

! Products quickly becoming obsolete

! Tech (Internet & Mobile) cannibalize legacy products

! Can’t keep up with competitors

! Must leverage innovative digital strategy

! Products

! Customer Experience

! Supply Chain

Page 14: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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Digital Transformation - Recap so far …

! Pervasive application of digital tools and technology to achieve hyper performance

! Pairs digital technology with transformational changes in business processes and optimization of the value chain

! Connects workers to each other, and to ERP, via real-time information and collaboration

! Leading to

! Breakthroughs in speed and agility to change

! Massive operations cost controls.

! Grabbing breakout opportunities and outperforming the competition.

Page 15: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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Digital Combines with Physics

! Digital thread will tie physical machines to their digital twins

! Continuous data flow

! Digital twins of machines will learn ('machine learning')

! then predict future, physical behavior

! We will teach machines what we do today

! Or can't do

Page 16: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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Example: Schindler Elevators

! Cabins that respond to your lobby floor request, and whisk you to your requested floor with few, if any stops ! - Continual monitoring of patterns and results

! The Digital twin monitors passenger experience and convenience - changing urban mobility ! - Tracks busy floors and groups people to a single stop ! - Rationally distributes the remainder ! - Fewer people per car, fewer stops per trip

! From elevator/escalator to digital industrial ! - Less wasted energy - more “Green” ! 20,000 service tech’s are now also digitized

Page 17: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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Physics + Transformation = Investment

! Physics and analytics lead to additive innovation ! Creates an industrial internet of design and material ! Combines with Analytics to lead into the future ! Productivity is the outcome

! Transformation plus massive strategic execution changes people and culture ! New skills, new processes ! Moving faster

! Investing massively in technology ! More outcome driven for the customer - a service model ! A change in total context

Page 18: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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Return on Equity of Digital Transformation

! Return on Equity (ROE) drives stock prices and company value

! Productivity can be a key driver to ROE in three ways

#1 - Improve Profit Margins — substitute (cheaper) technology for labor

Even if revenues remain flat

#2 - Improve Asset Utilization — substitute tech for brick and mortar

#3 - Improve Leverage

Leverage = total assets / shareholder equity

With fewer assets, you can return excess equity to shareholders

buy back shares, raise cash dividends, pay down debt

! The payout ratio rises, so more Tech = less need for Capital

Page 19: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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What Digital Transformation is NOT …

! Not merely automating what we already know and do

! Example: Airline check-in kiosk

! Nothing revolutionary

! Merely automation of existing practices

! Replaces humans - saves money for airlines

! Improves productivity for travelers

! But does not radically alter the way we travel

! WAS “big” initially - but now it’s all “me too”

Page 20: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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The New Emergent Era will come before it’s fully formed

! Emergence explains how birds fly in formation, how ants work together, how neurons communicate ! Many individual pieces will exchange information in real-

time to drive large scale patterns of organization

! Thomas Stilling - "Macro behaviors come from Micro motives“ ! Soon" - 5B connected people, 50B connected machines

! Emergent change seems impossible -- and then it's upon us, as if inevitable ! McKinsey - 82% of the US economy is not realizing its digital

potential ! Get ready to live in disruptive change - an "in-between"

place

Page 21: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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Radically Changes What We Do … Before We Know It

! Facebook rolls out Facebook Live video globally 2014

! Zuckerberg makes it his priority for 2016

! Gives team 2 months to get ready

! “Ship it out and work out the kinks along the way”

! Wall Street Journal quote

! How Silicon Valley sees life

! 2017: A live murder is recorded

! Human “content teams” cannot police 2 Billion users

! Video content is still challenging to software automation

Page 22: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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We’re More Ready for this: Paying for Gasoline with Loyalty Points

! Use credit/debit card “loyalty” points at point-of-sale terminals

! Free, cloud app from Verifone for merchants

! Just swipe your regular card, and get prompted to pay with “points”

! Taps unused $16B / year source of purchasing power

! Amazon already accepts Discover Card “cash back” balances

! Competitive advantage that “digitally empowered consumers” expect

Page 23: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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A.I. based Data Mining is Transformative

! MSFT acquires LinkedIn - integrates it to Dynamics 365 Sales

! AI mines these professional relationships

! The more data presented to AI, the more it learns

! LinkedIn data can

! Measure warmth of a potential customer relationship

! Recommend steps such as calling a co-worker with a close relationship

Page 24: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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“Making Informed Decisions at the Speed of Life”

! Smarter cities and connected cars reduce commute time, congestion, and air pollution

! Predictive maintenance improves manufacturing efficiency, and speeds time to market

! Smart grids tell utility companies exactly when and where to meet power demand

! Personalized customer experiences across any channel (i.e., ‘omni-channel’) give an edge to retailers

! Hospital patient experiences improve while rates of admission decline, and overall IT costs decrease.

Page 25: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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3 Foundations for Digital Transformation

! A strong, modern ERP backbone

! Infrastructure ready for accommodate

! mobile technologies

! massive amounts of data

! High speed Internet access

! Management ready to enable change

! led by empowered, operational workers

Page 26: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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Rural Broadband - the “fly in the ointment”! “RURAL AMERICA IS STRANDED IN THE DIAL-UP AGE”

! “High costs and lack of access to broadband service prevent residents of far-flung communities from joining the modern economy”

! 39% of the U.S. rural population — 23 million people

! Lack access to broadband internet service

! “fast” by FCC definition

! Compared with 4% of the urban residents.

! Farmer raises sheep and sells mohair wool online

! Drives 4 miles to local gas station to get decent internet access

! Pays $170 a month for a satellite internet service too slow to upload photos, much less conduct business.

Wall Street Journal Page One, June 15, 2017

Page 27: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

What is Oracle’s View of Digital Business?

Page 28: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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Oracle’s View of Digital Business

! Pervasive application of digital tools, technologies, and automation

! Process and business model change

! Significant performance potential

! Strategic opportunities and challenges for the market

Page 29: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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How Oracle and Deloitte see End Users Driving Digital Transformation

Page 30: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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JDE/Oracle Components of Digital Business

Page 31: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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JDE/Oracle Technology Options for Transformation

! Mobile connects employees anywhere, anytime to each other and to ERP

! Wearables allow heads-up, hands-free, connected work on operational tasks

! Augmented (Virtual) Reality is real-time, location-aware to know more, do more, do it better … extending ERP to hands-on operations and service staff

! Internet of Things (IoT) extends digital connections beyond people, to places and devices

! Cloud increases over abilities with rapid system provisioning and faster deployment of new applications

! Big Data visualizes and analyses large amounts of data in real-time to help make decisions, e.g., from IoT devices

! Cognitive uses “natural language” to inquiry and communicate based on large amounts of structured — and unstructured — data, such as with IBM’s Watson, so see hidden patterns

Page 32: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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JD Edwards’ View of the Characteristics of a Digital Enterprise

Page 33: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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Using JD Edwards Today, You Can …

Page 34: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

Industry Trends and Examples

Page 35: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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Trends in Agribusiness

! Truly Global Marketplace

! Instantaneous Transfer of Information

! Population Explosion and Growth of Middle Class

! Competition for Limited Natural Resources

! Unprecedented Volatility and Instability

! Food safety / Environment / Global Warming / Green

Page 36: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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Resource Constraints

! Petroleum energy based resources will become increasingly restrictive

! Water will become a huge issue….for everyone

! Agricultural land will become more scarce

! Many other natural resources will be in short supply

! Renewable resources used to produce energy

! Is the future of agribusiness to be a producer of renewable energy?

Page 37: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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And, as Always …

! Changing Marketplace calls for business to be flexible and dynamic

! Requires dynamic leadership from the executive suite

! Information Technology plays a key role

! Technologies must be flexible

! Consumer trust drives demand for brands

! Traceability technology is the key

! Productivity is still the key to profitability

! Supply chain offers many opportunities

! This is the entry point for Digital Transformation

Page 38: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

Digital Transformation Examples in AgribusinessSpatial

Page 39: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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Land Boundaries and Ownership

Page 40: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

Increasing Precision to Reduce on-the-ground efforts

! Increasing resolution of spatial images can identify abnormalities

! Direct on-the-ground resources

! Save time, effort, gasoline, cost

Page 41: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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Precision Farming Improves with Spatial

! Airborne and terrestrial imaging

! Crop growth and quality monitoring

! Environmental and regulatory tracking

! Climate, ground water, and waste monitoring

! Fertilizer and pest inputs

! Soil types and conditions

Page 42: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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Monitoring Damage Through Spatial

Page 43: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

Digital Transformation Examples in AgribusinessFood Safety

Page 44: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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Food Safety Problems

Page 45: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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The Data You’ll Need

What’s needed are more productive, more accurate, more automatic ways to tie these together and to use them.

Page 46: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

Digital Transformation Examples in AgribusinessMobility in Field and Vineyard

Page 47: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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Precision Farming in Vineyards

Page 48: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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Critical Pictures – e.g., Pests

Page 49: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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Mobile Tracking of Weather & Soil

Page 50: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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Mobile Record Keeping

Page 51: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

Digital Transformation Examples in AgribusinessCapital Asset Management, and IoT Security Concerns

Page 52: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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CAM Improvement Goals

! 60% of all maintenance activity is “proactive” work ! Maintain before it breaks ! Achieved through 90% compliance to known PM’s ! IoT Sensors alert that PM may be needed ahead of

schedule

! Achieve 70% overall utilization of maintenance labor ! Remaining 40% of all maintenance will be “on demand” ! Break-and-Fix activity

! Establish a goal of at least 21 hours for MTBF ! MTBF - Mean Time Between Failures ! More up-time and longer runs = more productivity ! = more revenue at lower cost = more profit

Page 53: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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CAM System + ERP with Financials —>

! Cloud Mobility Services to process and interpret IoT sensor data

! Dashboards to alert staff to review exceptions and take action

! Addresses reliability & planning

Page 54: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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Security Concerns will not stop IoT

! “Despite risks, potential revenue and efficiency gains are likely too enticing to stop Internet of Things deployment”

! Wall Street Journal, CIO Journal, 09Mar2017

! “IoT devices have not been developed generally with security in mind. They need to be constantly evaluated to see if they create vulnerabilities that hadn’t been considered when they were first deployed.”

! Michael Zweiback, a partner at the law firm Alston & Bird LLP (WSJ, 09Mar2017)

! Zweiback adds, “IoT is too efficient to stop.”

! http://blogs.wsj.com/cio/2017/03/08/wikileaks-spotlights-iot-vulnerability/?mod=djemCIO_h

Page 55: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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One Solution to the IoT Security Issue

! Utilize a protocol to secure a private channel of communications around the device network.

! PCB Apps has been working on this potential solution in conjunction with PivotCloud Solutions

Page 56: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

Trends in Life Sciences

Page 57: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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Cloud Innovation and Adoption will Modernize Commercial Models

! Today resembles:

! Taxi cabs before Uber, hotels before Airbnb, retail before Amazon, or airlines before Sabre

! Ripe for disruption!

! Everyone is re-inventing the wheel

! Gartner — “a renewed interest in how life science companies can use technology to support improved business practices and improve consistency. That's not something that we would have said two years ago."

! Look for movement towards a single platform

! Manage content and digital engagement

! Deliver a more coordinated, valuable customer experience

! Handle many touch points

! LifeTech was working on a single Digital Presence in 2013

Page 58: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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Collaboration is a Top Theme

! Collaboration within the health care ecosystem, with patients, or internally

! More timely and tailored information

! Too much friction

! Pharmacy deals with 10-15 digital channels

! each one separately recognizing a single HCP!

! Commercial side will define and adopt industry standard processes for shared customers

! Avoid frustration

! Get right information faster —> better outcomes

! De-risk by creating a platform for information and idea exchange (Deloitte)

Page 59: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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Intense Debate over “Value” by Stakeholders

! Four key stakeholders (PWC)

! Funders/payors who evaluate if a drug is effective for a give population

! 3rd party Assessors who evaluate how much a drug should cost

! Executors or medical providers who take on part of the risk through reimbursement tied to outcome metrics

! Patients who have a larger co-pay

! Use social media to make their voices heard

! Interact with FDA on patient-focused drug development

! Outcome and quality now = efficacy and safety

! New perspective on drug trials

! Informs decisions made long before commercial launch

Page 60: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

Digital Transformation in Life SciencesPharma and Biotech and Clinical Trials

Page 61: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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Transformation through Data Driven Actions

! Sales teams need contextual insights —> take right actions

! Get real time recommendations on next steps

! Send email, make a call, drop off sample

! Know better what to do, and what to say

! Remove silos between medical (R&D) teams and commercial teams

! Same stakeholders —> high confusion

! better coordinated, more holistic customer experience

! Compounded by faster (even quarterly) product releases

! Gartner sees “enterprise-wide deployments of EDC [electronic data capture] and electronic patient-reported outcome systems”

! Common theme of CIO’s to “enable a mobile workforce”

! Be more effective with smaller sales teams

Page 62: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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Transformation of Regulatory Information Management

! Regulatory information captured in multiple, disconnected systems

! registrations, submission content, health authority correspondence, etc.

! duplicate data, documents, efforts

! challenging to respond to regulators in a global setting

! Gain visibility and alignment across regulatory activities and teams

! Better compliance and efficiency from HQ throughout regions and into the field

! Utilization of electronic batch (and device history) records - EBR/eDHR

! Development of electronic design control for regulatory submission records management

! WL Gore utilizing Agile PLM’s Project Portfolio Management for Part 820.30 Design History and Device Master records

Page 63: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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Quality and Regulatory Outsourcing

! Rising costs, faster time to market demands

! —> more outsourcing

! CRO’s (contract research organizations) always did this on the clinical side

! M&A drives need to manage costs for global submissions and production

! Look for more CMO (contract manufacturing organizations)

! Growing 7.5% per year, towards $80B in 2019

Page 64: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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Explosive Clinical Use of Cloud Computing

! Genomics and precision medicine —> data explosion

! Personalized medicine = 42% of clinical pipeline (Tufts)

! Real world data from wearables adds to a gigantic data processing need

! Genomics analytics has huge content and complexity

! Data standards will be needed

! “Big Data Talent” demand might > supply by 50% (PWC)

! Content management in the Cloud will reduces IT footprint

! Drive greater efficiencies, lower costs.

! CIO’s must deal with limited budget increases

Page 65: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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Clinical Trial Data Standards (CDISC)

! Clinical Data Interchange Standards Consortium

! Enables clinical research to work smarter by allowing data to speak the same language.

! FDA is encouraging, not mandating

! Supports data mining

! Important after a drug has been released (Vioxx - Merck example)

! e-Detailing helps make sure physicians really understand the drug

! Goes beyond the clinical trial results — seeking “end to end evidence”

Page 66: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

Digital Transformation in Life SciencesMedical Devices and Manufacturing

Page 67: Digital Transformation Overview · Mobile connects employees anywhere, anytime to each other and to ERP ! Wearables allow heads-up, hands-free, connected work on operational tasks

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8 Trends for Transformation in Medical Devices (PwC)! 1. Merger mania

! Regulators concerned with consumer impact

! Leading companies use scale and resources to redefine competition

! 2. Care in the palm of your hand

! Consumers will have care anywhere, anytime

! Biggest impact is on diagnostics industry for health and clinical needs

! 3. Cybersecurity becomes a medical device industry issue

! By 2020, Internet-connected healthcare products will be worth an estimated $285 billion

! 85% of large health organizations experienced a data breach in 2014

! 18% of those cost more than $1 million to remediate

! Requires preemptive action to maintain consumer and investor trust, and prevent potentially crippling breaches

! 4. Consumers more in charge of their own spend

! Higher deductibles

! Device makers must define the value to attain and maintain health

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8 Trends for Transformation in Medical Devices (PwC)

! 5. Behavioral health is a new frontier, and more important

! Common goals are to keep costs down, productivity up, and consumers healthy.

! 6. Care moves to the community

! Value-based models —> lower-cost settings and creative approaches to delivering care

! Balance consumer demands against clinical requirements

! Deliver products beyond the hospital or doctor’s office

! 7. New databases improve patient care and consumer health

! New tools to unlock insights from massive consumer information

! Learn how this defines and captures value

! Partner with those that have extensive consumer knowledge

! 8. Mystery of Cost

! Be able to calculate true cost of services —> more efficient and improve outcomes

! HCP’s look to device makers to lower cost, improve efficiency, improve outcomes, and mitigate risk. 

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4 Digital Themes —> Initiatives

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Smart Care

! Mapping the human genome leads to precision medicine

! less frequent inappropriate intervention

! More capable robots provide surgeons with 3D magnified views inside the human body

! example: Intuitive Surgical’s da Vinci system

! Less invasive surgery

! Remote surgeons provide world-wide coverage

! 3D printing to manufacture customized medical implants.

! Reduces need to buy One-size-fits-all implants

! Growing from $3B to $12B between 2013 and 2018

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Care Anywhere

! 25B of IoT devices will double in next 5 years

! Opens alternative care channels - self care and virtual care

! Primary H/C will start in the home with monitoring

! Reduces strain on overloaded hospitals

! Virtual care through TeleHealth units for high risk patients

! HealthTap has unlimited video consultations

! Access to rural areas and the emerging world

! Better than high cost ER and office visits

! Connected Home

! moving to $71B in 2018, beyond entertainment

! Simple TV-interface “(Independa”) sends notifications, captures monitors, provides emergency contact

! Spanish Basque TEKI platform allows for gesture response questionnaires, communicate rehab exercises, check vital signs

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Empowered Care

! Intelligent digital services respond contextually

! Customized to individual needs

! Empowers citizens to manage their well-being

! Smart sensors and devices, cloud applications and maturing analytics provide “living services”

! 5 percent of US patients with chronic conditions and or unhealthy lifestyles = 50% of healthcare costs

! 200MM people world-wide will have diabetes by 2035

! 24MM use a diabetes “app” to help

! two-way smart glucose meter connected to the Cloud gives personalized insights

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Intelligent Healthcare Enterprise

! Big Data let Google track spread of H1N1 flu outbreak in real time

! Used to take 1-2 weeks

! National Singapore digital healthcare records system

! Exchange medication history and diagnoses among HC providers

! Samsung Medical Center is 100% paper free

! Combine EMR with IoT connected devices and lower cost genomic information

! Leads to predictive analytics

! Cultural and legal barriers to adoption

! 50% of nurses have seen a hospital medical error resulting from lack of connected devices

! Paramedics are being equipped with Google Glass

! New devices - Novartis and Google working on a connected contact lens that senses glucose levels in tear fluid every second

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Rural Broadband - the “fly in the ointment”! “RURAL AMERICA IS STRANDED IN THE DIAL-UP AGE”

! “High costs and lack of access to broadband service prevent residents of far-flung communities from joining the modern economy”

! 39% of the U.S. rural population — 23 million people

! Lack access to broadband internet service

! “fast” by FCC definition

! Compared with 4% of the urban residents.

! Farmer raises sheep and sells mohair wool online

! Drives 4 miles to local gas station to get decent internet access

! Pays $170 a month for a satellite internet service too slow to upload photos, much less conduct business.

Wall Street Journal Page One, June 15, 2017

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Is Digital Transformation … Right for Me?3 Questions

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Is Digital Transformation Right for Me?

1. Do I have an aggressive growth strategy?

2. Are there tectonic shifts going on in my industry?

3. Am I facing a big competitive overload?

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Am I Ready to Begin?

1. A strong, modern ERP backbone

2. Computing infrastructure ready to accommodate mobile technologies and massive amounts of data

3. Management ready to enable change led by empowered, operational worker

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Will I Succeed at Digital Transformation?

1. Strong business process management practices

2. Comprehensive and broad organizational change management

3. Firm executive sponsorship

4. Technological creativity and objectivity

5. An attitude of "Why not us?" And "Why not today?"

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Beware of a Silo Approach

! CMO's fine tune omni-channel customer engagement

! COO's use IoT for supply chain and business efficiency

! CFO's automate processes to cut costs and use BlockChain to raise revenues

! However … CIO’s can see the iceberg

! Above ... departmental solutions

! Below ... supporting infrastructure

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Beware of a Silo Approach

! 75% of CIO's will spend more on digital technology, cloud computing, analytics

! 82% will modernize core legacy systems

! Jeff Immelt on CIO’s

! “I would say you have to be an active leader, demanding your seat at the table because your company needs you.”

! If not, then expect to find “new”

! Chief Data Officers

! Chief Digital Officers

! Chief Technology Officers

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Keys to Success5 Clear Steps

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Key to Success #1

! Organize around information flows

! Permission to act quickly

! Allow emergent structures

! An adaptive business culture

! Radically open communication systems

! Real time data

You Need To … Which Requires …

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Key to Success #2

! Empower Individuals ! Evolve from manager/employee to collaborators.

! More local, less formal.

You Need To … Which Requires …

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Key to Success #3

! A good Mission Objective

! “MO” bosses become coaches.

! MO is a habit of mind.

! MO connects larger vision to tactical objectives of individual and team

! Visionaries

You Need To … Which Requires …

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Key to Success #4

! Live in the in-between

! The defining mindset of Digital Transformation

! Not having total knowledge

! But having faster data

! Leading to more options

! Not creating more certainty.

You Need To … Which Requires …

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Key to Success #5

! Continuous feedback flow

! Transparent reliable information

! Meaningful intelligence

! Seek it, Use it, Give it

! Seeing solutions and finding answers that occur spontaneously

You Need To … Which Requires …

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Above All …

! This is not just about attaching sensors and collecting data

! It’s about solving a business problem

! And, it’s about leaping ahead

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In the End … We need Leaders to …

! Attract the right people

! Set out goals

! Live values and beliefs

! Provide imagination, inspiration, and renewal

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.

THANK YOU FOR YOUR TIME TODAY!

Q&AJoel Schipper

[email protected] Google phone 530-763-3630

http://YourSystemNotGuiltyAsCharged.wordpress.com

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Other References! Police Drones http://www.nydailynews.com/new-york/nyc-crime/nypd-drones-fight-crime-article-1.1799980 and following

Barron’s article.

! Soy Bean Farming Predictions http://www.barrons.com/article_email/stocks-that-can-profit-from-new-tech-boom-1496162764-lMyQjA1MTA3NzM2MTIzMzEwWj

! Robots are coming to farming https://qz.com/726667/cheap-robots-are-coming-for-our-farm-jobs-by-taking-the-most-brutal-tasks-first/

! Robotic Mining https://www.technologyreview.com/s/603170/mining-24-hours-a-day-with-robots/

! Retailer JD.com Wall Street Journal article, June 14, 2017

! Deloitte https://www2.deloitte.com/us/en/pages/life-sciences-and-health-care/articles/life-sciences-outlook.html

! Veeva on top trends https://www.veeva.com/blog/top-life-sciences-trends-to-watch-for-in-2017/

! Gartner on pharma IT trends http://www.bio-itworld.com/BioIT_Article.aspx?id=27172

! PWC https://www.strategyand.pwc.com/trend/2017-life-sciences-trends

! CDISC https://www.cdisc.org/about/what-we-do

! MedDeviceOnline https://www.meddeviceonline.com/doc/healthcare-trends-that-will-transform-medtech-in-0001

! GE presentations on Minds + Machines https://www.youtube.com/user/GE

! Oracle presentations on Digital