plm transformation journey to improve patient safety transformation journey to improve patient...

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.


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


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


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


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


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













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


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


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


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


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


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


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

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