NexInfo and Propel Webinar

1
New Ways to Accelerate Product Innovation
Improve Quality Processes
Wilma Flanagan PLM Expert VP of PLM
Miguel Tam VP Alliances

• August 22, 2019

_at_NexInfoSolution
2
Agenda

• Introduction
• Life Sciences Industry Challenges
• PLM QMS Trends/Technology Landscape
• Overcoming Challenges Improving Quality
• Solution Benefits
• Building a Business Case for a Better QMS

1
2
3
4
5
6
3
Reminder Submitting Questions
Questions?
Please submit questions using the Questions
option on the GoToWebinar panel
4
Meet the Presenter Wilma Flanagan

• Vice President, PLM Practice at NexInfo
• Experience
• Former Startup CEO/COO, Innovation/PLM
  Consultant, IT Management Consultant, CIO
• Over 25 years helping clients around the world
  with their PLM journeys, including
• Process Streamlining Alignment with PLM
• Organization/PLM Evolve Assessments
  Optimizations
• PLM Benchmarks Selections
• Business Plans Strategies
• Data Model/Quality/Integration Data Governance
• Leading PLM Implementations
• Organizational Change Management

Working with clients to identify compelling
business problems. Delivering on the promise of
innovative results.
5
Who is NexInfo?

• Started as a supply chain consultancy in 1999
  with more than 50 PLM implementations across
  several industries and PLM Solutions, many across
  the globe We are the enablement leaders behind
  the leaders
• Proven PLM Framework, implementation approach
  and learned Best Practices
• Life Sciences Business/IT Process and
  Applications Solution Architect experience
• Large, proven Talent Pool with PLM, ERP, Supply
  Chain, integration skills and GxP
• trained consultants
• Current State, Future State Process Design and
  alignment with PLM solution
• Realized PLM benefits for many Pharma and Med
  Device clients
• Ability to provide hosted solution and support
  managed services
• Our partner relationships

6
Meet the Presenter Miguel Tam

• Vice President Alliances at Propel
• Experience
• Early product manager and product marketing at
  Agile Software
• Over 20 years of SaaS, manufacturing, and
  enterprise software experience, including Oracle,
  Apttus, CA Technologies, and Ernst Young
  Consulting
• Retired mechanical design engineer - worked on
  new product designs for almost 10 years

7
Who Is Propel?

• Founded in 2015 by former Agile Software, SaaS,
  product and manufacturing veterans
• First and only integrated PLM, QMS and CRM
  solution on modern cloud
• Over 70 customers around the world, 1 industry
  is Life Sciences
• Venture-capital backed including Norwest and
  Salesforce
• Partner with NexInfo for implementation and
  support

8
NexInfo/Propel Partnership

• NexInfo/Propel Team is committed to our clients
  success
• We have delivered on the promise of innovation
  and as a result have helped many clients realize
  PLM business benefits
• Our delivery results are based on
• Teams comprehensive capability both with
  Technology and Business Process
• Our flexibility
• Informed opinions and years of client consulting
  experience
• Proven PLM process alignment/migration approach
  with best-in-class QMS solution, Propel
• We pride ourselves in doing projects with our
  clients

9
Polling QuestionWhat QMS System do you use
today?

• Homegrown/spreadsheets
• Master Control
• Sparta Systems
• Other
• None

10
Polling QuestionWhat PLM System do you use
today?

• Oracle (Agile Software)
• Teamcenter
• Windchill
• Other
• None

11
Life Sciences Industry Challenges
12
Key Trends Impacting Life Sciences
13
Industry Challenges for Life Sciences
TO MAINTAIN COMPETITIVE ADVANTAGE
Business Drivers

• Innovation
• Growth

14
How PLM QMS Help Life Sciences
15
Key Trends Impacting Life Sciences
16
Technical Landscape with PLM Data Connectivity
Typical Enterprise Systems for Life Sciences
Manufacturing Planning Companies

• Product Lifecycle Management
• Products Product Portfolios
• Bill of Material
• Manufacturers Suppliers
• Quality
• Documentation

Quality
PLM(Product Lifecycle Mgmt.)

• Supplier Management Quality Assurance
• Maintain Audit Data

Supplier Deviation Mgmt.
Doc Mgmt.
Suppliers / Contract Mfr
Key Documents
Supplier Data Flow
Metadata
Supplier Rating

• Document Approvals
• Document History
• Document Collaboration

BOM
Manufacturer
Item Data
BOM
Suppliers
Regulatory Mgmt.

• Forecasts
• Supply Chain Plans
• MPS MRP

• Log Regulatory info

Forecasting Planning
ERP
Project Mgmt.
Other systems CRM, HUBs, RD,, etc.

• Enterprise Resource Planning
• Manage Manufacturing, Procurement, Costing, etc.
• Manage Finance, Projects, etc.

Abbreviations BOM Bill of Material
17
Key Systems Sources of Truth

• Enterprise Resource Planning (ERP) has always
  been a key system and source of truth for
  manufacturing
• Product Inventory
• Procurement Supplier
• Manufacturing
• Sales Shipping
• Finance Management Reporting
• Today Product Lifecycle Management (PLM) has
  emerged as a critical system and source of truth
  across the enterprise
• Product Lifecycle Management
• Products Product Portfolios
• Bill of Material
• Manufacturers Suppliers
• Quality
• Documentation

PLM has emerged as a strategic enterprise system
connecting all the partners in the value chain by
providing a single, collaborative software
platform for development and management of
products from product inception to product
retirement Wilma Flanagan, NexInfo PLM VP
18
What Drives the Need for PLM

• An enterprise is in control of its products
  regardless of lifecycle phase and current
  ownership of product
• Addresses and improves engineering and
  manufacturing activities
• Innovation acceleration
• Product Portfolio Management
• Development, realization and support
• Product-related cost reductions
• Engineering changes
• Product recalls
• Warranty and recycling costs

PLM has become essential for enterprises to be
competitive in a rapidly globalizing world of
more customized products (Kroes et al.)
19
Sample Life Sciences Realized Benefits

• For a number of Med Device and Pharma companies
  Greatly reduced risk of non-compliance Release
  process timeline efficiencies of 40 in first 3
  mos. increasing to 50 60 in 9-12 months
• Ability to multi-thread business process and
  approve electronically
• Automation of manual processes
• Efficiencies in supplier collaboration by
  automating request forms/workflows
• Easier access and more visible information
  improving audits and traceability

20
Overcoming Challenges Improving Quality with
Propel
21
Impact of Key Trends on QMS and PLM

• Product Complexity
• Flexible support for new types of products and
  business models
• More configurations and regional SKUs
• Easy and secure access for new technology partners

• Regulatory Changes
• Compliance to increasing number of regulations
  around the world
• Flexibility to support regulatory changes, new
  markets, acquisitions

• Rise of the Customer
• Increased responsiveness to customer complaints,
  ideas, enhancements and feedback
• Single view of customer and product for multiple
  stakeholders
• Greater visibility for customers into product
  development and delivery process

22
Propels Approach to Industry Changes
Integrated Product, Quality and Customer Processes
23
Evolution of PLM and QMS Uses
NEW PRODUCT DEVELOPMENT
CONTRACT MANUFACTURING
PRODUCT QUALITY
OMNI-CHANNEL SALES
INCREASING COLLABORATION AND COMPLEXITY
Move from internal engineering to collaboration
within partner ecosystem
Engineering and manufacturing handoff shifting to
custom products and closer customer engagement
Move from internal quality processes to broader
external signals and real time post-market
surveillance
Customers having greater say in what products
they want and buying directly from medtech firms
24
Solution Demonstration
25
Propel Benefits
26
Top 5 Signs Its Time for a Change

1. Increase in reported incidents or customer
   complaints indicate that current systems are
   inadequate
2. Longer times to resolve customer complaints show
   lack of common view/process into critical data
3. Presence of multiple systems, especially
   homegrown, usually introduce unneeded risk to the
   business
4. Decreasing customer satisfaction show lack of
   responsiveness and communication
5. Increasing field customer service costs show
   lack of communication across QA, service and
   design teams

1
2
3
4
5
27
Polling QuestionIs anyone experiencing one of
more of these signs indicating a need for a
change?

1. Increase in reported incidents or customer
   complaints indicate that current systems are
   inadequate
2. Longer times to resolve customer complaints show
   lack of common view/process into critical data
3. Presence of multiple systems, especially
   homegrown, usually introduce unneeded risk to the
   business
4. Decreasing customer satisfaction show lack of
   responsiveness and communication
5. Increasing field customer service costs show
   lack of communication across QA, service and
   design teams

28
Top 5 Ways Propel Helps

1. Lower risk and errors by having an integrated
   flow and place to manage all processes and data
2. Faster customer responsiveness by quickly sharing
   customer issues with right people
3. Higher employee productivity by eliminating
   manual data entry and double-checking of data
4. Increased IT agility by leveraging a flexible,
   highly configurable and integrated cloud platform
5. Lower TCO with a single modern cloud platform

1
2
3
4
5
29
Propel offered more customizability than our old
system.
Brian Beach, Project Engineer
Scalable platform grows with Yukon's
business Flexibility to manage and communicate
any product updates Greater collaboration on
product and manufacturing information Easier to
train and onboard team members
30
Building a Business Case for a Better QMS
31
Call to Action

• To thank you for your time today, we are offering
  to help you define compelling business challenges
  that can be addressed with a PLM/QMS solution and
  develop a roadmap based on your current system
  deployments.
• Deliverables (at no cost to you)
• Roadmap based on your enterprise systems
  priorities
• Assistance building a business case
• If you are interested, please contact me, Wilma
  Flanagan at wilma.flanagan_at_nexinfo.com
• In addition, as promised you will be receiving
  two free bonuses by email
• A QMS Buyers Guide
• How to Build an Effective Business Case

32
QA
33
Contact Us
HEADQUARTERS615 W Civic Center Drive, Suite
350 Santa Ana, CA 92701 EMAILLetsTalk_at_nexinfo.co
m TELEPHONE[phone]