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1. © PTC 2018, All rights reserved.
The Next Wave in Healthcare: Improving
Patient Outcomes with the Internet of Things
Integral R&D, Manufacturing, Quality, Compliance, And Risk
Management For Connected Devices
2. © PTC 2018, All rights reserved.
“We envision IoT enabling a hospital of the future based
almost exclusively in the cloud. Digital healthcare market
could see as much as $32.4 billion in near-term
revenues.”
- Goldman Sachs, The Digital Revolution comes to the US Healthcare, 2015
Industry Compelling Events
Connected Healthcare
Changing Regulatory
Requirements & Impact of
Healthcare reform
• Digital disruption in
healthcare industry driven
by connected devices (IoT)
• Improving Patient Outcomes
with the Internet of Things
(Value-based care)
• Recent revisions to the global
medical device regulation
ISO13485
• “Case for Quality” initiative by
the FDA and the medical
device industry
• Hospital Value-Base
Purchasing -Affordable Care
Act (ACA) program aimed at
advancing value over
volume
Changing Industry Trends are Impacting
Medical Device Manufacturers' Total Cost of
Quality (TCoQ)
Cost Of Poor Quality Costs Medical Device Companies
Between 12%-18% Of Their Revenue
1
2
3. © PTC 2018, All rights reserved.
Serious adverse event reports related to
medical device use have outpaced industry
growth by 8% per annum since 2001.
7,839 7,829
9,262
11,735
13,868
16,567
17,513
19,832
28,049
0
5,000
10,000
15,000
20,000
25,000
30,000
2001 2002 2003 2004 2005 2006 2007 2008 2009
Patient injured in
serious adverse event
# of patients injured
Trends In Medical Device Adverse Event Report
Source: FDA 2011 https://open.fda.gov/device/pma/
“The medical device industry is approaching a tipping point
where the increasing likelihood of a quality event, the rising
costs of such events, and the public nature of quality
performance will force companies to focus on quality and
reliability throughout product design, manufacturing, and
marketing.”
- McKinsey, The Business Case for Medical Device Quality , 2013
1
4. © PTC 2018, All rights reserved.
McKinsey estimates the financial benefit to
improve quality costs in Medical Device
companies is around $4.75-$6.0B USD.
Design Suppliers Manufacturing
Post Production &
Change Control
Hardware 15% 12% 2%
Software 8% 7%
Labeling 4% 3% 1%
Packaging 1% 3%
Process 3% 2% 18% 1%
Total By value
Stream
31% 14% 24% 12%
An analysis of root cause data reveals that failures
in product design and manufacturing process
control caused more than half of all product
recalls.
Source: Data from RECS database
“Data
indicates an
over
emphasis on
pure
compliance
versus quality
outcomes.”
Source: FDA 2011 -
Understanding Barriers to
Medical Device Quality
“Reducing the Cost of Poor quality can convert 12%-
18% of revenue into profit.” - Mckinsey
Recall Failure Codes
1
5. © PTC 2018, All rights reserved.
“We envision
IoT enabling a
hospital of the
future based
almost
exclusively in
the cloud.
Digital
healthcare
market could
see as much
as $32.4 billion
in near-term
revenues.” –
Goldman Sachs
Medical Device Companies can spur
Innovation, Transformation, and Growth by
Embracing the Potential of Connected Devices
Hospital
Doctor’s
office
Anywhere
Cost Efficient
Precision/performance
Portable/Afforda
ble
Patient
Comfort
Early
Diagnostics /
RT Monitoring
Electronic health
records
Personalized
Chronic Disease
Emergency care /
Remote
Patient Profile
Analytics
Telehealth
Source: TI Medical
2
Connected
healthcare can
increase patient
safety and cost
reduction by
monitoring devices
used by hospitals,
patients and doctors
office
-35%
-53%
-59%
Hospital admissions
A&E use
Hospital bed days
0
Source: Deloitte Center for Health Solutions, Connected Health, 2015
6. © PTC 2018, All rights reserved.
Manage
customer
requirements
Manage
compliance
Visualize
automatic
dashboards
Manage
projects and
changes
Track
full audit trail
Create
trend metrics
Reduce
manual
reporting
Manage
UDI
Compliance
Reduce
time for
submission
Integrate
compliance,
quality &
product
Speed
change
requests
Visualize
new
products
PTC’s Medical Device Value-Ready
Deployment™ (VRD) supports the FDA’s “Case
for Quality” and offers a set of pre-configured
validation ready regulatory templates
PTC Windchill VRD
enables customers
to improve patient
safety and product
efficacy while
following the ISO
13485 standard,
harmonized with the
FDA Total Product
Life Cycle (TPLC)
and 21 CFR Part
820 regulations.
7. © PTC 2018, All rights reserved.
Innovation Compliance
CostComplexity
Quality
Standards
Product
Development
Closed-Loop
QualityRegulatory
Compliance
• Speed-to-market first-mover
advantage and repeatability
• Decisions via access to
connected product data
• Quality of new products and
processes
• Global regulations to expand
into more markets
• Complete supply chain needs to
comply
• Traceable throughout the
product lifecycle
• Efficiency in operations and
product introductions
• Insight into sources of issues
and costs
• Preventive Action to reduce
costs and risk
• Systems designed for
software and hardware, and
iOT
• Lifecycle collaboration across
the organization
• Strategic new technologies
PTC’s smart connected PLM™ solution enables
companies to design, manufacture and
service connected medical device products
in a closed loop fashion
“Smart, connected products require a rethinking
of design.” – Harvard Business Review
Source: How Smart, Connected Products Are Transforming Companies, HBR
Windchill PLM
helps
customer
maximize
profitability at
each
Lifecycle
Phase
8. © PTC 2018, All rights reserved.
Next steps: Request a collaborative
session to see how smart, connected PLM
can help you lower Total Cost of Quality
(CoQ) and improve patient outcomes
Integral Document Control, Design Control
and Quality Management
Document Backbone
Manage & Control all key documents / Document Control
Product Backbone
Manage and control product information / CAD, BoM, BOO, Change
Control, Processes / Workflows…
Quality Backbone
Quality, reliability, and risk management is harmonized with
engineering & suppliers, across products & processes
9. © PTC 2018, All rights reserved.
Author: Swapan Jha
Vice President, IoT Solutions group
Contact PTC: http://www.ptc.com/contact-us
Customer Care 877-ASK-4-PTC (877-275-4782)
www.ptc.com
“According t o a st u dy from GE ,
a 1 pe rce nt I oT -ge ne rat e d
re du ct ion in he al t hcare syst e m
ine fficie ncie s cou l d bring abou t
sav ings of $ 6 3 bil l ion ov e r a 1 5 -
ye ar pe riod .”
Industrial Internet: Pushing the Boundaries of Minds and Machines, GE, November 2012
