Healthcare Compliance Essay

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The-Key-Challenges-Facing-Medical-device-Manufacturers_WhitePaper.pdf

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The Key Challenges FaCing MediCal deviCe ManuFaCTurers (and how to meet them with strategic interoperability)

The Key Challenges FaCing MediCal deviCe ManuFaCTurers (and how to meet them with strategic interoperability) Executive Overviewaccountable care and value-based reimbursement models are causing a seismicshift in the medical device industry. in the new medical device market, the valueof the device and data alone will not drive sales. instead, it will be solutions thatbundle device, data, and real-time analytics that clinicians, health systems, andpayers will want to buy. For improved decision-making and outcomes, they needthese solutions to deliver actionable information into existing electronic medicalrecord systems and health information exchanges. and they need them to providethe efficacy and results data required in value-based reimbursement models. in this environment, nearly every manufacturer of medical devices faces two key,interrelated challenges: n how to adapt to the shift to value-based payment models n how to protect margins with products that elude commoditization you can meet these challenges by using a strategic interoperability platform tocreate solutions with leading-edge integration, data aggregation, and analytics capabilities. Adapting to value-based payment models: A focus on analyticsToday’s shift to value-based reimbursement is also causing shifts in to whom devices are marketed and sold, and how the new buyers value what you’re offer-ing. From 2005 to 2009, the yearly average number of announced us hospitalmergers and acquisitions was 56. in 2012 that number was 94. From 2005 to 2009the average percentage of physicians in private practice was 33. in 2012 the aver-age was 24 percent. These rates of change show no signs of slowing.as more physicians become employees of large medical groups, hospitals, andidns, and payer and provider organizations merge, the influence of individualphysicians on medical device sales is waning. The new influencers, the hospitalgroups, idns, and payers, have the clout to secure large purchases of a device foruse across entire healthcare systems and in homes. But their decisions will bebased on more than just ease-of-use, or how compatible the device is with otherequipment.

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“Value in medtech will increas-

ingly be defined by a company’s

ability to use analytics to prove

the effectiveness and efficiency

of its products and actions.”

Ernst & Young, Pulse of the Industry Medical Technology Report, 2013.

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as the excellent ernst & young 2013 “Pulse of the industry, Medical Technologyreport” notes, “Companies need to invest significantly in expanding beyond prod-ucts and in developing new business models for a world of value-driven health-care.” Preferred products will be a combination of devices and services builtaround delivering solutions for payers, providers, and patients. “These businessmodels will frequently be created in collaboration with a diverse set of playersfrom across the spectrum of health care. Many of them will be built around data and analytics — capabilities that medtech companies need to expand to demon-strate value to payers and influence the behavior of patients.”Opportunity waits during this time of change for those with the vision to see itand the agility and technology to act on it. Re-inventing the wheel not requiredWhere does this ability come from? The long answer is that your organization canbuild data aggregation, management, and analytics software to complement yourdevices – if you have the expertise, time, money, and will. The short answer is thatyou don’t have to build it. you can rapidly incorporate proven, powerful, strategicinteroperability and analytics capabilities, such as provided by intersystems, intoa solution offering. With this approach you can provide solutions that: n interface devices quickly with nearly any electronic health record n Monitor device performance for proactive maintenance and product improvement n aggregate and analyze data for trending that helps customers manage population health n Turn aggregated data into revenue by providing it for other companies’ research efforts n deliver actionable information directly into clinician workflows n reduce alert fatigue by applying analytics and rules to the data before clinicians are notified n support multiple industry standards as they evolve and new ones are developedinnovation in the use of data is a natural path to becoming a solution provider, andnot just a device vendor. using the services of a strategic interoperability platformenables you to focus on your core competency in device innovation, while gaininga ready-made solution for device connectivity, data aggregation and normalization,workflow, and active analytics.

“Companies need to invest

significantly in expanding

beyond products and in

developing new business

models for a world of value-

driven healthcare.”

Ernst & Young, Pulse of the Industry Medical Technology Report, 2013.

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Protect margins, elude commoditizationsuccess in meeting customer demand for integration of devices and data with theirelectronic health records (ehrs) – either by writing code or using an open sourceinterface engine to handle connectivity and data formatting – doesn’t change howcustomers value your product. it is still a piece of hardware. it may be the best,but eventually it becomes a commodity that can be replaced by another piece ofhardware from another company, perhaps at a lower price. Computer manufac-turers have fought this dynamic for years. Those still thriving do so by offeringservices, support, and hardware wrapped into solutions that address businessproblems.innovation at the device level stays the tide of commoditization only for a shortwhile.

Fine-tuning pacemaker data models, improving population health

A strategic interoperability platform can give makers of implantable devices

a new way to gather and analyze data to improve products and processes,

and demonstrate efficacy. A maker of pacemakers might use such a platform

to aggregate data from all patients using the device over a given time period,

including relevant information from the electronic health record. The analy-

sis could look at outcomes from use of the device and help the manufacturer

fine-tune its data models. With access to the health record and information

such as demographics and medications, the manufacturer could determine

who responds best to its device, or if one segment of the population

responds better than another to a particular model. The end result for

providers, patients, and payers would be better population health, increased

patient safety as each person would get the best device for their profile, and

lower overall costs.

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Use data to establish clinical expertiseinnovation at the data and solutions level provides additional long-term value toyour organization and customers. across locations, therapeutic areas, and popu-lations of patients your devices generate and share critical data. With the growingemphasis on population health management and accountable care, having theability to aggregate, analyze, and understand this data means that you can be positioned as the clinical experts in improving outcomes using your devices. Thisis a key to avoiding the commoditization trap and thriving during this time ofhealthcare transformation. “Clinically interoperable” camera increases accuracy, speeds workflow, improves communication

A major manufacturer of cameras sold to healthcare organizations for use

during surgery needed a breakthrough to differentiate its product, increase

its value to buyers, and become more strategic to its customers’ business. The

company understood that in the increasingly interconnected world of health-

care, the value of stand-alone devices was declining. A rapid and successful

proof of concept project with InterSystems gave this company’s business

executives the technology, product, and value proposition they needed to

ignite sales. They now have a clinically interoperable device that uses

InterSystems HealthShare to transform camera image and meta-data into

a format that HealthShare can insert automatically into electronic medical

record systems. Combined with HealthShare’s workflow and analytics

capabilities, the company is gaining an edge not only in its camera business,

but also in consulting opportunities for information integration and work-

flow improvements using its other products throughout the hospital.

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Long-term success: The advantages of strategic interoperability and partnership with InterSystemsstrategic interoperability is the new paradigm for creating solutions to serve cus-tomers who are transforming the way they buy medical technology, improve care,and control costs. a strategic interoperability platform like intersystemshealthshare brings together all the technology needed for medical device solu-tions in a single, integrated platform that: n reduces complexity and risk n reduces design, testing, and implementation costs n increases maintainability n accommodates innovation n includes strong security and privacy capabilities n is highly scalable in both directions n supports a wide array of industry standards covering the gamut of healthcare clinical and business needs n helps you bring products to market faster

Home care device gains advantage for reducing readmissions

A leading manufacturer of home health devices, including blood pressure

and heart monitors, uses the strategic interoperability capabilities of

InterSystems HealthShare to make its products more compelling to providers

and payers, and less likely to be dislodged. When measures taken by a device

or devices cross a pre-defined threshold, an “exception report” and message is

generated and sent automatically to alert relevant providers, based on rules

created and stored in HealthShare. The report includes information on the

threshold that was crossed and related health data for that patient. For a

patient with congestive heart failure, such a threshold might be too much

weight gained over too short a period. The device manufacturer is able to

deliver what clinicians want – trustworthy alerting and important informa-

tion from home care inserted directly into their workflow. Patients appreciate

knowing that their care is being monitored and coordinated. Hospitals and

payers appreciate improved care, fewer readmissions, and lower costs.

InterSystemsintersystems healthshare comes with the full support, reliability, and experienceof intersystems, a leader in healthcare information technology and interoperabil-ity since 1978, with offices in 25 countries. healthshare is widely used as a strate-gic interoperability platform in the us and internationally. in sweden it is used toprovide a national health information exchange with real-time access for the coun-try’s clinicians. in the us, it powers statewide exchanges serving more than 60million americans, and is widely used by integrated delivery networks for inter-operability, data aggregation and normalization, and analytics.intersystems data management technology is behind many of the leading health-care applications worldwide, including those from epic, ge, 3M, the us depart-ment of veterans affairs, Baxter healthcare, Beckman Coulter, Bio-rad, sunquest,verizon Mobile health, and many others. Learn moreTo learn more about using healthshare in medical device solutions, contact usnow at 800-753-2571, or visit intersystems.com/devices

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Supercharged infusion pumps give nurses more time with patients

A global supplier of infusion pumps is supercharging its products with

advanced capabilities, independent of core FDA regulated components,

using InterSystems technology. The goal is to free nursing staff to spend more

time directly with patients. These capabilities include: EHR connectivity;

automatic recording of input/output in the medical record when drip rates

change frequently; automated monitoring to determine if a device is OK to

use, and to alert staff when maintenance is needed; “score cards” to compare

device maintenance performance between hospitals as a baseline for

improved training; making it easier to positively associate device data with

specific patients; and tracking of patient data against outcomes to determine

best practices.

intersystems CorporationWorld headquartersOne Memorial driveCambridge, Ma 02142-1356Tel: +1.617.621.0600Fax: +1.617.494.1631intersystems.com

intersystems Caché, intersystems ensemble, intersystems healthshare, intersystems deepsee and intersystems TrakCare are registered trademarks of intersystems Corporation. iKnow is a trademark of intersystems. Other product names are trademarks of their respective vendors. Copyright © 2014 intersystems Corporation. all rights reserved. 2-14