Trusted Advisors to Healthcare and Life Science Executives
Improve Your Intelligence
by
Unlocking Your Data
Presented by
Daniel R. Matlis
Copyright
2009
Axendia,
Inc.Inc.
Copyright
2013
Axendia,
1
Copyright
2013115,
Axendia,
Presented at NetApp Pharma
RT, October
2009 Inc.
Improve Your Intelligence by Unlocking Your Data
Med-Tech companies have been implementing manufacturing information
systems for more than 30 years.
These systems were often part of automation initiatives
aimed at lowering manufacturing costs and improving product quality.
Med-Tech companies have desired the ability to unlock manufacturing data to
support initiatives such
Lean
Six Sigma,
Overall Equipment Effectiveness
Just in Time
Demand Flow Technology
Kaizen
Value Stream Mapping
Total Quality Management
Statistical Process Control
Design for Manufacturability...
This level of visibility is further hindered by Globalization and Outsourcing.
Unlocking Operational and MES data can empower decision makers—from
operators to corporate executives
across functional areas to make informed and timely decisions.
Copyright 2013 Axendia, Inc.
2
Transform or Perish – Macro Trends
Companies are poised to capitalize on global opportunities;
however, they must balance the risks and rewards of globalization.
Shift Happens
Regional
Vertically Integrated
Tribal knowledge
Corporate best practices
Supply Chains
One Size fits all
Copyright 2013 Axendia, Inc.
Global
Outsourced
Intelligence & Analytics
Network collaboration
Supply Networks
Taylored & personalized
3
“In this environment I sleep like a baby…
I wake up every 2 hours and cry.”
Dave Johnson, CEO ConvaTec Inc.
Source: ConvaTec CEO “Sleeps Like a Baby” in Challenging Environment, Life-Science Panorama, March 14th, 2011
Copyright 2013 Axendia, Inc.
4
Is your Knowledge Meager and Unsatisfactory
"I often say that when you can measure what you are
speaking about, and express it in numbers, you know
something about it;
but when you cannot measure it, when you cannot
express it in numbers, your knowledge is of a
meager and unsatisfactory kind;
it may be the beginning of knowledge, but you have
scarcely in your thoughts advanced to the state of
Science, whatever the matter may be."
Sir William Thomson, Baron Kelvin of Largs
PLA, vol. 1, "Electrical Units of Measurement", 1883-05-03
Copyright 2013 Axendia, Inc.
5
Data is not Truth
A collection of data is not information.
A collection of information is not knowledge.
A collection of knowledge is not wisdom.
A collection of wisdom is not truth.
Neil Fleming
Coping with a Revolution
Copyright 2013 Axendia, Inc.
6
What is DRIP?
A type of coffee maker
An environmentally friendly
form of irrigation
A form of torture banned by the
Geneva Conventions
A condition afflicting
Med-Tech Companies
Copyright 2013 Axendia, Inc.
7
What Does DRIP Stand For?
DATA
RICH
INTELIGENCE
POOR
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Top 10 Reasons for Data Rich
And the #1 reason for DRIP?
The FDA made me save it
2.
3.
4.
5.
6.
7.
8.
9.
10.
QA will not let us erase the data
The Lawyers need it for Discovery
To turn it off we’ll need to revalidate
We’ll need it for statistical analysis
It is not covered under our retention policy
Storage cost are going down
We might need it to justify deviations
It was preconfigured by the vendor
It was in the Requirements Document
Copyright 2013 Axendia, Inc.
9
Trusted Advisors to Healthcare and Life Science Executives
Top Reasons
for
Intelligence Poor
Copyright
2009
Axendia,
Inc.Inc.
Copyright
2013
Axendia,
10
Copyright
201310
Axendia,
Presented at NetApp Pharma
RT, October
15,
2009 Inc.
Organizational and Functional Silos
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11
I’m Done, Now it yours.
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12
“We Have Too Many Systems”
Most companies use a variety of stand-alone systems
It’s a natural evolution
Functional Areas addressing specific needs with point solutions.
Disparate systems may help individual departments/divisions/partners
However
This approach can be very inefficient
Creates Data Islands that hinder visibility across a global organization
Makes solving companywide problems across Data Islands extremely
difficult.
Coalescing data into meaningful information can tedious and costly
Copyright 2013 Axendia, Inc.
13
Global Visibility Systems
Plan to use
In use
Not planned
QMS (Quality Management System)
ERP (Enterprise Resource Planning)
Paper System
CRM (Customer Relationship Management)
Homegrown (Spreadsheet/DB/Custom)
Analytics/Business Intelligence
SCM (Supply Chain Management)
ECM (Electronic Content Management / Document…
PLM (Product Lifecycle Management)
MES (Manufacturing Execution Systems)
LIMS (Laboratory Information Management System)
Cloud Based Data Exchange
0%
10%
20%
30%
40%
50%
60%
70%
Source: Walking the Global Tightrope: Balancing the Risks and Rewards of Med-Tech Globalization, Axendia Inc. 2012
Copyright 2013 Axendia, Inc.
14
Drowning in Un-Actionable Data
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15
System Effectiveness for a Global View
Ineffective
12%
Effective
32%
Marginally
effective
(manually
aggregate the
data)
56%
Source: Walking the Global Tightrope: Balancing the Risks and Rewards of Med-Tech Globalization, Axendia Inc. 2012
Copyright 2013 Axendia, Inc.
16
Silver Spring, We’ve Had a Problem
Emergency scrubbers built by Swigert and Haise.
Consisted of a taped-over double canister holding one end of a suit nozzle.
The canister was built of arched cardboard, which was covered by a plastic bag
Source: NASA
Copyright 2013 Axendia, Inc.
17
Desired Visibility into Supplier Data
100%
Real time data
On-Demand data (data when we need it)
90%
80%
70%
35%
42%
49%
60%
40%
40%
61%
50%
46%
40%
30%
49%
48%
20%
43%
39%
36%
28%
23%
10%
0%
Outsourced
Contract
product R&D / manufacturers
Design
Critical
suppliers
Logistics /
Shippers
Distributors
Other Tier 1
suppliers
Tier 2
suppliers
Source: Walking the Global Tightrope: Balancing the Risks and Rewards of Med-Tech Globalization, Axendia Inc. 2012
Copyright 2013 Axendia, Inc.
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Copyright 2013 Axendia, Inc.
19
Don’t Take our Word for it:
“We also continued to see strong returns on our investments in the
emerging markets with combined revenue in Brazil, Russia, India and
China growing 35% in the quarter. As we further build our capabilities in
these countries, we expect this growth trend to continue into 2013,”
Michael F. Mahoney, CEO & President at Boston Scientific
“Our international revenue grew 7% in Q4, including 20% growth in
emerging markets, with strong finishes to the year, with growth well in
excess of 20% in Central and Eastern Europe, Greater China and India.
Looking ahead, I believe sustained emerging market growth greater than
20% continues to be a realistic goal,”
Omar S. Ishrak - Chairman & CEO at Medtronic
“…the emerging markets present significant growth opportunities by
growing at CAGR rates double of that of the developed world,”
Alex Gorsky, Chairman & CEO at Johnson & Johnson
Copyright 2013 Axendia, Inc.
20
Company’s Priority for Medical Device Platform
High priority
Medium priority
Low priority
No interest in pursuing
49%
31%
Emerging markets
16%
4%
67%
24%
Developed markets
4%
5%
0%
10%
20%
30%
40%
50%
60%
70%
Source: Walking the Global Tightrope: Balancing the Risks and Rewards of Med-Tech Globalization, Axendia Inc. 2012
Copyright 2013 Axendia, Inc.
21
80%
Executives Agree
“As we build our platform approaches with brands that endure and
products that can grow and ultimately lead in the marketplace,”
Alex Gorsky, Chairman & CEO at Johnson & Johnson
“I think if we go aggressively after emerging markets in creating that value
segment that automatically positions us to create products at a lower tier.
-- as we look at the U.S. and the developed markets, as we see opportunities, especially
where there's heavy pricing pressure and the feature sets are not being used and people
aren't paying the price for those, we will go into our resources and product lines and the
value segment and introduce them in the U.S. and developed markets.
At the same time, we will differentiate them adequately so that the price of our highertier products and the value that they generate remain, and -- but we think that as the
pressures on cost savings in the developed world and the healthcare systems increase,
there will be room for different tiered service lines.
If we can execute well in our global strategy for value segments, this will
give us a significant advantage in developed markets.”
Omar S. Ishrak - Chairman & CEO at Medtronic
Copyright 2013 Axendia, Inc.
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Business Threats Next 3 Years
Regulatory environment (cost and ability to comply with
regulations)
65%
Exposure due to single sourcing (geopolitical unrest, natural
disasters, etc)
43%
Nonconforming raw materials / components
33%
Lack of supplier visibility and control
31%
Appropriate skill sets to deliver quality products or services
26%
Products being counterfeited, stolen or diverted
26%
Product recall (non-conforming finished product)
25%
Raising labor costs (becoming roughly equivalent to internal
costs)
24%
Lack of ability to trace product genealogy
22%
0%
10%
20%
30%
40%
50%
60%
70%
Source: Walking the Global Tightrope: Balancing the Risks and Rewards of Med-Tech Globalization, Axendia Inc. 2012
Copyright 2013 Axendia, Inc.
23
What Globalization & Outsourcing Issues Keep Your Up at Night
60%
Quality of the product, raw material or service that is provided
59%
Maintaining consistent quality standards across internal & external sites
49%
Protecting your intellectual property
Ability to deliver product, raw material or service as promised (on-time and
on budget)
45%
43%
Changes without our approval
32%
Outsourcing partners becoming competitors
28%
Product theft, diversion or counterfeiting
Lack of visibility into their business & ethical practices (child labor laws,
FCPA, environmental, etc.)
28%
26%
Inadequate visibility into in-process parametric quality information
23%
Increasing cost of doing business with them
0%
Copyright 2013 Axendia, Inc.
20%
40%
60%
24
Perceived Risk with Suppliers
Low Risk
Moderate to High Risk
26%
Tier 2 suppliers to critical suppliers
73%
32%
Critical suppliers
68%
42%
Other Tier 2 suppliers
58%
42%
Other Tier 1 suppliers
58%
0%
10%
20%
30%
40%
50%
60%
70%
80%
Source: Walking the Global Tightrope: Balancing the Risks and Rewards of Med-Tech Globalization, Axendia Inc. 2012
Copyright 2012 Axendia, Inc.
Confidential
25
Changes without Prior Knowledge
Occasionally
Frequently
70%
5%
4%
60%
6%
50%
2%
40%
30%
59%
55%
3%
50%
20%
37%
33%
10%
0%
Process Changes
Testing/Inspection
Practices
Raw Materials
Critical Components
Design Changes
Source: Walking the Global Tightrope: Balancing the Risks and Rewards of Med-Tech Globalization, Axendia Inc. 2012
Copyright 2013 Axendia, Inc.
26
Benchmarking other Industries
“The Medical Device industry should look at some best practices followed by
automotive, telecommunications, and aerospace sectors for risk
management and supplier controls and adapt these for consistent, better
quality results”
Kim Trautman, FDA's Medical Device International Quality Systems Expert
Source: Walking the Global Tightrope: Balancing the Risks and Rewards of Med-Tech Globalization, Axendia Inc. 2012
Copyright 2013 Axendia, Inc.
27
Trusted Advisors to Healthcare and Life Science Executives
Recommendations
Copyright
2009
Axendia,
Inc.Inc.
Copyright
2013
Axendia,
28
Copyright
201328
Axendia,
Presented at NetApp Pharma
RT, October
15,
2009 Inc.
Recommendations
Copyright 2013 Axendia, Inc.
29
Control Over GRC Practices
Enable partners to become an extension of the Brand Owner’s
own quality and information systems
Consider a “Smart-Sourcing” strategy; evaluating the total
cost and potential risks, not just initial cost.
Implement commercial, legal, and technological frameworks
that promote the exchange of information
Define a clear change control and notification framework to
avoid surprises
Move beyond audits to On-Demand-Visibility
Copyright 2013 Axendia, Inc.
30
Enhanced Visibility across the Partner Network
Integrate data islands and point solutions to aggregate data needed
to glean business information
Implement global, standards based, and interoperable systems to
support visibility outside the corporate four walls
Collect, analyze, and act on critical-to-quality indicators &
parameters.
Implement IT solutions to achieve business results, not simply meet
regulatory requirements.
Require partners to document their complete supply network
Employ risk-based supplier management strategies
Copyright 2013 Axendia, Inc.
31
Improve Collaboration with all Constituents
Define cross functional teams to support each initiative
Identify partners who share your approach and philosophy to quality and
compliance
Educate your colleagues, employees, and partners on your standards,
policies, and methodologies toward compliance.
Provide a clear understanding of the letter, spirit, and interpretation of
regulation (compliance or beyond compliance)
Create transparency and accountability to support product safety,
effectiveness, and quality
Create clear lines of communication to support transparency and
continuous improvement.
Establish honest dialogue with partners to enhance the value and impact of
the relationship.
Collaborate on continuous improvement to drive lower costs through
improved yields, fewer returns, and less rework.
Copyright 2013 Axendia, Inc.
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From Data to Truth
Understood data becomes information
Understood information becomes knowledge
Understood knowledge becomes wisdom
Understood wisdom becomes truth
Copyright 2013 Axendia, Inc.
33
Can You Handle the Truth?
Source: A Few Good Men – Columbia pictures
Copyright 2013 Axendia, Inc.
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Thank You
Thank You for attending this session
Improve Your Intelligence
by
Unlocking Your Data
Daniel R. Matlis
President & Founder
[email protected]
(267) 352-4801
www.axendia.com
URL:
www.axendia.com
Blog: http://lsp.axendia.com
Twitter: www.twitter.com/axendia
Trusted Advisors to Healthcare and Life Science Executives
Copyright 2013 Axendia, Inc.
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