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PLM Transformation Journey to Improve Patient Safety
Stavros Stefanis, Principal, Product DevelopmentHitesh Tewari, Senior Manager, Product Development
November 12, 2014
2 PLM Transformation Journey to Improve Patient Safety Copyright © 2014 Deloitte Development LLC. All rights reserved.
Deloitte is a global leader in Life Sciences and Healthcare Consulting—unique in our scope and scale
The Life Sciences and Healthcare practice makes up 14% of Deloitte’s U.S. revenue.
Global organization
• 7,600 dedicated Life Sciences & Health Care industry leaders• Backed by more than 200,000 professionals• Deployed in 150 countries
With a 360-degree business perspective
Leader in Information Security Consulting
— Forrester
#1 Life Sciences onsulting practice
— Kennedy
Deloitte received the highest distinctions in reputation, international network, highly knowledgeable professionals, and complete tax services capabilities
— International Tax Review
Leader in IT Organization redesign Consultancies
— Forrester
Leaders’ quadrant for Oracle Applications Implementation Service Providers, Worldwide
— Gartner
Leading global consultancy provider— Kennedy
Serving leading companies across the Health Care value chain with an unparalleled “ecosystem” view
Life Sciences Health Plans Providers Government Health
Serving the largest companies in all three sectors; Pharmaceutical, Bio-Technology, Medical Technology
Serving the Top 25 Health Plans, Managed Care Organizations, and the Nation’s Blue Cross Blue Shield Plans
Serving Hospitals, Healthcare Systems, and For-profit and Not-for-profit Health Systems across all functions
Serving the key U.S. Federal Health agencies: HHS, CMS, CDC, FDA, IHS, NIH, VA, Defense Health
Consulting
FinancialAdvisoryServices
TaxAudit, Risk &
Controls
As used in this document, “Deloitte” means Deloitte LLP and its subsidiaries. Please see www.deloitte.com/us/about for a detailed description of the legal structure of Deloitte LLP and its subsidiaries. Certain services may not be available to attest clients under the rules and regulations of public accounting.
3 PLM Transformation Journey to Improve Patient Safety Copyright © 2014 Deloitte Development LLC. All rights reserved.
Our Experience
Ability to execute strategy and generate significant measurable value
Deloitte’s value proposition in Product Development
Deloitte brings a complement of deep advisory and implementation capabilities in the ‘Product Development’ service offering to drive unique and tangible value to the clients we serve.
• 25% in productivity improvement
• 50% reduction in time to market
• 30% reduction in product cost
• 50% reduction in supplier failures
• $10M per year in cost of poor quality
• Reduced $6 MM per year of warranty cost
Smith & Nephew
Emerson
General Electric
Novartis
Medtronic
BayerLife Technologies
Apple
Baxter
UnileverPhilips
SC Johnson
Stryker
ZimmerBoston Scientific
St. Jude
Cardinal Health
Johnson & Johnson
Key Capabilities & Services
• 400+ Product Development professionals worldwide with expertise in:
− PLM Strategy
− Process
− Quality and Compliance
− UDI Adoption
− Data and Lifecycle Management
− Organizational Effectiveness
− Change Management
− R&D Tax
• System agnostic
• Several thousand strategy and systems integration projects
• Strong partnership with Dassault Systemes
4 PLM Transformation Journey to Improve Patient Safety Copyright © 2014 Deloitte Development LLC. All rights reserved.
Healthscience businesses are facing a daunting task of adapting themselves to the fast changing marketplace, government legislations, generic competition and a shrinking product portfolio.
Well known challenges facing the Lifesciences Industry
Last year, a major consumer healthcare provider recalled 288 million items due to quality control problems
“...the drug industry will lose control over more than 10 mega medicines whose combined annual sales neared $50 billion”
Pharmaceutical giant agrees to pay $750 million as fine to settle charges against it for making and selling adulterated drugs
“... research and development spending has nearly doubled to $45 billion a year over the last decade, but the FDA has approved fewer and fewer new drugs”
External Challenges
• Compliance & Safety− Increased regulatory vigilance− Government investigations− Higher product recalls and claims
• Growth & Innovation− Higher cost of Research and Development− Slow integration of mergers and acquisitions− Complexity of product launch in multiple geographies
Internal Challenges
• Operational Efficiency− Siloed business functions and isolated solutions − Higher cost of Research and Development− Slow integration of mergers and acquisitions− Complexity of product launch in multiple geographies
• Data Management & Synchronization− Data privacy & security risks− Product data quality and inefficiency− Data mining & reuse for analytics− Manual data management
PATIENT
RISK
5 PLM Transformation Journey to Improve Patient Safety Copyright © 2014 Deloitte Development LLC. All rights reserved.
Product Lifecycle Management (PLM) is a core improvement area to address many of these industry challenges
Leveraging Product Lifecycle
Management (PLM)
Enabler
External challenges
Significant margin pressure
Increasing regulatory activity
Increasing competition
Changing public perception and reputations at risk
Growth & Time-to-Market
• Simultaneous multiple products development
• Reduced delays in launch schedule
• Competitive edge with product simulation and digital prototyping
• Visibility to enterprise data and efficient sourcing practices
Internal challenges
Siloed Business Functions
Data Inefficiencies
Diminishing innovation productivity
Research & Development Costs
Regulatory Compliance
• Integrated quality & risk management
• Coordinates external capacities – academia, research & regulatory authorities
• Business technology integration and scalability
Operational Efficiency
• Efficient Product data traceability through data digitization
• Increased focus on scientific activities than admin activities
• Improved enterprise collaboration
• Efficient change control on products and processes
Value Drivers
6 PLM Transformation Journey to Improve Patient Safety Copyright © 2014 Deloitte Development LLC. All rights reserved.
An integrated business driven framework is required to support process, organization and technology investments
IntegrationHow do you ensure seamless integration with the rest of the value chain?
Global processesHow can you drive process standardization and efficiency yet have flexibility across functions, entities?
GxP complianceHow do you ensure the process, system and role definition is GxP compliant?
Data transformation With years of legacy, how can you efficiently migrate data into PLM?
Cross-functional roles and responsibilitiesHow do you provoke cross-functional agreement on previously unclear roles and responsibilities?
One end-to-end global process
on One Platform
Global processes GxP compliance
Data transformation
• Reducing time to market with efficient transfers/launches
• Realizing acquisition and cross-division synergies
• Continuous monitoring & efficiency improvements
• Managing complexity without FTE increase
• Managing compliance risk in spite of increasing complexity
• End-to-end integrated process drives compliance with ICH-Q10 including data integrity
7 PLM Transformation Journey to Improve Patient Safety Copyright © 2014 Deloitte Development LLC. All rights reserved.
We’ve developed a comprehensive suite of tools to enhance and accelerate PLM initiatives from start to finish
PLM Cost Model DPLM Pre-Configured OCM For PLM
Training Assessments
Enterprise Value Map
Organizational Readiness PLM Training Curriculum
Pre-defined Requirements
Enterprise Data Management
Validation Approach
PLM Training Course Library Pre-defined CRP/UAT Scripts
Prebuilt Process Models
Data Migration Approach
Capability Transfer Library
Lean PD Methodology & OC SS O
Key
Des
ign
Dec
isio
ns /
Req
uire
men
ts &
Gap
sR
oles
& R
espo
nsib
ilitie
s /
Met
rics
& D
ashb
oard
s / T
empl
ates
Leve
l 4Le
vel 2
& 3
Leve
l 1
Library Document Process
Configuration Process
Product Change Process
Process Details
Manage Project and Stage-Gates
Key Design Decisions
Part/ BOM Obsolesce Process
Manage Manufacturing Bill of Material
Project Document Process
Process Details
Process Details
Part / BOM Creation Process
Manage Voice and Product
Requirements
Manage Engineering
Bill of Material
Process Details
Part Document Process
Manage Product
Configuration
MBOM Management
Process
Requirements and Gaps
Development Stage Process
Feature Change Process
Gate Review Process
Manage Documents
Process Details
Process Details
Process Details
Part/ BOM Update Process
Process Details
Manage Product &
Technology Portfolio and Roadmaps
Manage Suppliers
Manufacturing Change Process
AML Management ProcessDeviation Process
Manage Product
Quality and Compliance
Supplier Selection Process
NPI Portfolio Analysis Process
Product & Tech. Roadmapping
Process
Process Details
Process Details
Process Details
Process Details
Voice Collection Process
Metrics & Dashboards
Metrics & Dashboards
Metrics & Dashboards
Metrics & Dashboards
Metrics & Dashboards
Metrics & Dashboards
Metrics & Dashboards
Metrics & Dashboards
Metrics & Dashboards
Metrics & Dashboards
Metrics & Dashboards
Metrics & Dashboards
Metrics & Dashboards
Process Details
Manage CAD / Drawings /
Specifications
Specification / Drawing Creation
Process
CAD Model Creation Process
Manage Changes
Change Request Process
Change Order Process
Resource Allocation Process
Resource Scheduling
Process
Manage Resources
Resource Capacity Planning Process
Requirements Flow-Down
Process
Requirements Definition Process
Manage Sub-System and Component
Requirements
Change Impact Analysis Process
Change Notice Process
TemplatesTemplates TemplatesTemplates TemplatesTemplates Templates TemplatesTemplatesTemplates TemplatesTemplates Templates
Voice Analysis and Association
Process
Initial Requirements
Definition Process
In-Market Portfolio Analysis Process
Executive Portfolio Review Process
Portfolio/Roadmap Communication
Process
Roles & Resp.
Roles & Resp.
Roles & Resp.
Roles & Resp.
Roles & Resp.
Roles & Resp.
Roles & Resp.
Roles & Resp.
Roles & Resp.
Roles & Resp.
Roles & Resp.
Roles & Resp.
Roles & Resp.
Specification Development
Process
8 PLM Transformation Journey to Improve Patient Safety Copyright © 2014 Deloitte Development LLC. All rights reserved.
Our approach enables Life Sciences companies to identify the critical areas of improvement and deploy them during the Improvement phase
Months, Not Years
Assess Improve
WeeksFinalize Scope
Enable improvements
Organization and Talent Bolster the organizational structure, decision-making, competencies, skills, and talent
Operational Excellence Deploy lean business processes and associated roles, responsibilities and metrics
R&D Strategy Improve the growth and innovation strategy
Identify the critical areas for improving performance and develop roadmap
Define and deploy specific improvements across people, process and technology
PLM Technology
* Detailed approach for enterprise PLM program varies depending on industry, product portfolio and company vision
9 PLM Transformation Journey to Improve Patient Safety Copyright © 2014 Deloitte Development LLC. All rights reserved.
Our assessment phase helps you to achieve a business focused plan, starting with Process and not just proposing a technology refresh
Business Strategy drives Vision
Governance and Change Leadership
Translating Vision into Clear Objectives
Design with Technology in Mind
Compelling “Burning Platform” with leadership commitment to vision Translating commonality and uniqueness into clear and measurable objectives
Align leaders and stakeholders on case for change. Define clear governance and decision making rights across enterprise
We bring value when we are addressing the business situation and drive the business to that value, enabled by technology
Productivity Time To Market MarketGrowth
Supplier & CustomerCollaboration
Master DataRegulatoryCompliance
Topline and Bottom-line Growth
Better external collaboration and
innovation
Enterprise standards and productivity Single Quality Standard
10 PLM Transformation Journey to Improve Patient Safety Copyright © 2014 Deloitte Development LLC. All rights reserved.
Our pre-configured ENOVIA PLM solution helps reduce your implementation timeline during improvement phase
Pre-configured solution toolkit Faster Implementation
The value for clients
Higher quality Lower risk Enables best practice Facilitates adoption
1 2 3 4
11 PLM Transformation Journey to Improve Patient Safety Copyright © 2014 Deloitte Development LLC. All rights reserved.
Our risk based approach to validation specifically catered to Life Sciences industry enables total quality compliance Implementation phase
GxP Risk Rating Risk Definition
High (5) The functionality has a direct impact on the quality, safety, purity, efficacy, strength, identification, or traceability of drug products, packaged materials, or components
Medium (3) The functionality has an indirect impact on the quality, safety, purity, efficacy, strength, identification, or traceability of drug products
Low (1) The functionality supports compliance with the Quality System requirements, but does not impact the quality, safety, purity, efficacy, strength, identification, or traceability of drug products
None (0) The functionality is not GxP relevant
Three components of FRA
01 02 03Business risk Technical risk Regulatory (GxP) risk
* Detailed approach for enterprise PLM program varies depending on industry, product portfolio and company vision
12 PLM Transformation Journey to Improve Patient Safety Copyright © 2014 Deloitte Development LLC. All rights reserved.
A well-structured enterprise PLM program has positive impact on preventable recalls and helps clients realize significant R&D efficiency and time to market gainsPLM Transformation Impact Business Value
10–15% reduction in preventable recalls
15–20% R&D Efficiency Gain
5–10% Cost Reduction
Outstanding user experience
Single source of product data management
Better integration with enterprise systems
Shorter time to market
Higher accuracy of business case & roadmap evaluation
Enhanced external collaboration
Advanced visibility to analytics & business intelligence reports
13 PLM Transformation Journey to Improve Patient Safety Copyright © 2014 Deloitte Development LLC. All rights reserved.
How Can You Leverage PLM to Drive Growth?
Call for Action• Experience how to develop a strategy and implement a successful PLM
program in the plenary session on Nov 12th—Speaker Brian Meeker
• Visit the Deloitte booth today!
• Grab the Deloitte brochure
• Anticipating tomorrow's complex issues and new strategies is a challenge. Sign up for Dbrief webcasts at www.deloitte.com
• Sign up for healthcare reform memo at http://www.deloitte.com/us/healthmemos/subscribe
Emerging Market Strategy
Quality by Design
Compliance & Risk Management
Manufacturing Execution Systems
Growth StrategyLife SciencesHealth Care
Reform
PortfolioManagement
Mergers & Acquisitions
Supply Chain Operations:
Sourcing and Procurement
UDI Strategy
ManufacturingPD and PLM
Medical TechnologyService Offering
Q&A
Copyright © 2014 Deloitte Development LLC. All rights reserved.36 USC 220506Member of Deloitte Touche Tohmatsu Limited
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