If you’re in the medical device manufacturing or hardware sales business your revenue growth (CAGR) is under pressure like never before. You’re being asked to do more with less but you’re probably going to find that hard to accomplish because of one or more of the following challenges:
* Longer product development timelines caused by more FDA and other government regulations
* Increased demand by customers to have your devices deliver user experiences that are more like “consumer” devices such as cell phones and tablets
* Lower margins as a reaction to commodity competition (your sensor hardware business will be commoditized faster and faster over time)
* More complex and longer sales cycles because devices are now being approved for sale not by facilities and clinical executives alone but increasingly by CIOs and IT teams
* Increased cost of risk management and compliance caused by connectivity requirements
Any one of these challenges is difficult to meet but these days you’re probably being asked to meet more than one simultaneously. The solutions are not simple but the good news is that medical device manufacturers have many revenue generation opportunities today that can fund the new strategic imperatives you’ll need to put into place to meet the challenges listed above.
This briefing, presented by Netspective CEO Shahid Shah, describes some of the opportunities and how device vendors can take advantage of them.
Device Vendor Opportunities in
Health IT Data Management
Data is becoming currency and device vendors shouldn’t
let health IT software firms own or control it
By Shahid N. Shah, CEO
Who is Shahid?
• 20+ years of software engineering and multi-
discipline complex IT implementations (Gov.,
defense, health, finance, insurance)
• 12+ years of healthcare IT and medical devices
experience (blog at http://healthcareguy.com)
• 15+ years of technology management experience
(government, non-profit, commercial)
• 10+ years as architect, engineer, and
implementation manager on various EMR and EHR
initiatives (commercial and non-profit)
Author of Chapter 13, “You’re
the CIO of your Own Office”
• A deluge of healthcare data is being
created as we digitize biology, chemistry,
• Data changes the questions we ask and it
can actually democratize and improve the
science of medicine, if we let it.
• While cures are the only real miracles of
medicine, big data can help solve
intractable problems and lead to more
• Healthcare-focused software engineering is
going to do more harm than good
(industry-neutral is better).
• Applications come and go, data lives
forever. He who owns, integrates, and
uses data wins in the end.
• Data from devices is too important to
be left to software vendors, managed
service providers, and system
• There’s nothing special about health IT
data that justifies complex, expensive,
or special technology.
• Spend freely on multiple systems and
What you’ll learn in this briefing
Data from devices is too important to be left to others
Manufacturer’s have a great deal to worry about
Customer is trapped by
their EHR vendors
Device vendors aren’t
benefiting from industry
Customer base has
shifted from clinical to
clinical + IT + system
Clinical customer goals
have shifted from basic
automation to advanced
access to regulated IT
and system integration
skills is limited
Struggling to find new
revenue sources as
Your customer, competitors, and industry are all shifting
Healthcare Industry / Market Trends
Major market and regulatory trends that are causing customers and competitors to shift
Device manufacturers must become experts on all of these terms
NEJM believes doctors are trapped by EHRs
It is a widely accepted myth that medicine requires
complex, highly specialized information-technology (IT)
This myth continues to justify soaring IT costs,
burdensome physician workloads, and stagnation in
innovation — while doctors become increasingly bound
to documentation and communication products that are
functionally decades behind those they use in their
Don’t buy the argument that the “enterprise EHR” should maintain / own / manage all data
New England Journal of Medicine “Escaping the EHR Trap - The Future of Health IT”, June 2012
Trend Goal: Patient Engagement
•Patients can easily make appointments and select the day and time.
•Waiting times are short.
•eMail and telephone consultations are offered.
•Off-hour service is available.
Superb Access to
•Patients have the option of being informed and engaged partners in their care.
•Practices provide information on treatment plans, preventative and follow-up care reminders,
access to medical records, assistance with self-care, and counseling.
•These systems support high-quality care, practice-based learning, and quality improvement.
•Practices maintain patient registries; monitor adherence to treatment; have easy access to lab
and test results; and receive reminders, decision support, and information on recommended
How does your device help customers engage with their patients?
Source: Health2 Resources 9.30.08
Trend Goal: Coordinated Care
•Specialist care is coordinated, and systems are in place to prevent errors that occur when
multiple physicians are involved.
•Follow-up and support is provided.
•Integrated and coordinated team care depends on a free flow of communication among
physicians, nurses, case managers and other health professionals (including BH specialists).
•Duplication of tests and procedures is avoided.
•Patients routinely provide feedback to doctors; practices take advantage of low-cost, internet-
based patient surveys to learn from patients and inform treatment plans.
•Patients have accurate, standardized information on physicians to help them choose a practice
that will meet their needs.
How does your device help customers coordinate care across their partners?
Why care about MU?
If you’re not talking about MU you’ll find it harder to get in the door
2011 2013 2015
“Enable significant and measurable improvements in population
health through a transformed delivery system.”
MU Stage 1 MU Stage 2 MU Stage 3
Start planning for
There’s money in MU
Devices can and should be “MU capable”
Fit into CIO’s strategic framework
In the future your devices won’t be sold into customers without CIO approval
Source: The Advisory Board
Implications of health IT trends
Evidence Based Medicine
Regulated IT and Systems
Don’t give up data to others without a fight
Software vendors, systems integrators, and others don’t have your best interest in mind
Data Transformation (ESB, HL7)
New revenue centers in software and services
Hardware Software Services
Build the right roadmap so that you don’t leave new revenue on the table
2 year ranking comparison of Top 30 HIT firms by offering type. Pure play firms are failing behind
Source - The 2012 Healthcare Informatics 100 ranks the leading 100 vendors by revenues derived from healthcare IT products and services earned in the U.S.
the way to go
% of all
Market your devices as data generators that
can help change medical science
Start small but think big
We’re digitizing biology
Last and past decades This and future decades
Gigabytes and petabytes Petabytes and exabytes
We’re just getting started
•Must be continuously collected
•Difficult today, easier tomorrow
started at $100k
per patient, <$1k
•Can be collected infrequently
•Family history is easy
•Must be continuously collected
•Useful for population health
•Part digital, mostly analog
•Family History is hard
•Business focused data
•Built on fee for service models
•Inward looking and not focused
on clinical benefits
Will you be ready for the coming data deluge and can you differentiate your device?
Data changes the questions we ask
Simple visual facts Complex visual facts Complex computable
Implications for scientific discovery
The old way
The new way
We’re in the integration age
Source: Geoffrey Raines, MITRE
We’re not in an
future but an
Educate your customers about the importance of
medical device data
Don’t become a commodity sensor company
Obvious sources of data
(DSS and CPOE)
Your device data needs to fit in and integrate across a wide variety of existing customer data
Architect for next generation sources of data
Clinical trials data
(failed or successful)
Secure Social Patient
SMS, IM, E-mail,
Voice, and Telehealth
Blue Button, HL7,
X.12, HIEs, EHR, and
Patient Family and
Your device data needs to fit in and integrate across a wide variety of new sources of data
Your device is a great source of data
Medical Devices Biomarkers /
Source Self reported by
Specimens Real-time from
Errors High Medium Low Low Low
Time Slow Slow Medium Fast Slow
Reliability Low Medium High High High
Discrete size Kilobytes Kilobytes Kilobytes Megabytes Gigabytes
Streaming size Gigabytes Gigabytes
Availability Uncommon Common Somewhat
Understand how your data compares to other data sources
Application focus is biggest mistake
The customer needs are changing from simple automation to complex process improvements
Application-focused IT instead of Data-focused IT is causing business problems.
Healthcare Provider Systems
Silos of information exist across
groups (duplication, little sharing)
Poor data integration across
Healthcare Provider Systems
Master Data Management, Entity Resolution, and Data Integration
Improved integration by services
that can communicate between applications
The Strategy: Modernize Integration
Be sure you fit into your customer’s data architecture and governance needs
Need to get existing applications to share data through modern integration
Data-centric device architecture
Extensibility and adaptability will be key in a data-centric world
Device Components 3rd Party Plugins
Security and Management Layer
(QNX, Linux, Windows)
Sensors Storage Display Plugins
Web Server, IM Client
Connectivity Layer (DDS, HTTP, XMPP)
• JDBC, Query
Ensure your devices fit in a modern IT architecture
Don’t give up your device data to others without a fight
Data Transformation (ESB, HL7)
E-mail [email protected]