Medical Device Interoperability: Are You Up to the Challenge?

November 20, 2015, Woburn, MA – Auriga Inc. conducts market research to uncover significant trends, issues, and concerns of healthcare professionals related to the interoperability of medical devices and information systems. 

The growing diversity of patient devices, wearables, and healthcare apps generates an overwhelming amount of patient data. This should be a good thing. Cutting-edge patient-oriented technologies provide for better medical care—or at least, that’s how it’s supposed to be. Unfortunately, that’s not the reality.

Interoperability is the top medical device challenge (1,900 U.S. hospitals surveyed)

Having a common set of interoperability standards would lead to saving $430M in device development and testing costs

Over 90% of the hospitals use 6+ types of devices that could be integrated (HIMSS Analytics, 2010)

Healthcare organizations face some serious challenges here, because even if they are fully equipped with various devices and systems in place that constantly generate the most comprehensive and accurate patient information, they can’t make full use of all this great equipment. The data that the medical staff members get is usually segmental and organ specific and comes in different formats. It’s difficult for the personnel to get the whole picture and start a patient’s treatment, especially in emergencies. And all this stems from the fact that the devices won’t “talk” to each other, as they were never designed to do that.

Even though more institutions and providers are addressing the issue of interoperability nowadays, it remains a problem that significantly impacts the quality and efficiency of medical care (not to mention that the lack of interoperability between devices costs device manufacturers over $430 million industry-wide (according to a West Health Institute report)). According to the same report, addressing interoperability issues will help reduce healthcare spending by more than $30 billion per annum.

This indicates that there is a substantial market for interoperability and significant interest in the subject in the medical industry.

Auriga has recently conducted our own study with the assistance of LTM Research, an independent research company that collected and analyzed unbiased data from medical device/software professionals to examine the primary trends, issues, and concerns related to the interoperability of medical devices and information systems.

The research uncovered some significant information on the challenges faced in medical device interoperability. The key findings of the study can be found below.

Medical Device Interoperability

About 60% of respondents believe achieving interoperability and defining common interoperability standards are important for the industry.

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Over three quarters of respondents (77%) develop and manufacture products that need to exchange information with other medical devices or information systems. Almost a quarter of them (27%) need to provide data sharing for seven or more devices/systems.

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Moreover, in the next two years, 67% of companies expect a significant increase in the number of medical devices and systems to exchange information with their products.

Outsourcing in Medical Device/Software Projects

We asked companies if they outsource the software development and testing of their medical products. Though the industry professionals remain traditionally prudent in their forecasts, the number of companies already outsourcing R&D tasks might grow by 1.5 times during the next year, from 32% to 46%. Plus, a good share of companies is planning to start or expand their outsourcing activities.

Don’t outsource & don’t plan to 51.5%
Don’t outsource but plan to start in the next 12 months 9.7%
Don’t outsource but will likely start in more than 12 months 6.8%
Outsource and plan to increase the amount or scope of outsourced tasks 13.6%
Outsource and plan to continue at the current level 15.5%
Outsource but plan to reduce or close the outsourcing initiative 2.9%

An important aspect in choosing the right provider and building successful and prosperous outsourcing relationships is selecting and prioritizing the most important project criteria. Andrey Pronin, Auriga’s SVP of Strategy, Technology, and Marketing, has discussed this topic in the Outsourcing Tips & Tricks article series on our blog. It’s a pleasure to see that the survey results proved Auriga’s hands-on experience. Communications and management style is the #1 criterion for selecting an outsourcing provider, and it is noticeably more important than proven medical domain expertise.

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Technologies & Standards Used in Medical Device/Software Projects

An important part of the survey was focused on identifying technologies and standards incorporated in the medical device industry today. This information helps us to recognize the most common systems and protocols used in the area and estimate the efforts required to standardize and implement seamless data sharing across all healthcare infrastructure systems and provide device connectivity in the hospital ecosystem.

Some of the most interesting findings of the survey were the following:

  • Embedded medical devices are most often based on ARM and x86 technologies
  • Microsoft Windows (Desktop, Embedded/CE, and Phone) is still the primary operating system platform used in all types of medical software development
  • LynxOS plays a considerable role in embedded systems
  • The top three interoperability standards used in today’s medical devices and systems are HL7, DICOM, and CCR (Continuity of Care Record)

Are You Prepared for Interoperability?

Interoperability has become a determining factor of the success of healthcare providers and medical device manufacturers. It is probably safe to say that those who fail to join the medical interop race now and misplace their priorities might end up losing both the battle and the war.

That’s why it’s important to have your own interoperability strategy in place. That’s the only way to prepare for the future and contribute to the value and quality of healthcare. You can start with investing in technology, focusing on relevant partnerships, identifying risks, and evaluating current processes.

How do you know if you are prepared for interoperability? There are certain areas that you should focus on if you want to implement an interoperability and connectivity concept.

Ask yourself the following questions:

  1. Do you track and document the versions of interoperability standards and vendor specifics that you need to support when communicating with devices/systems from other vendors?
  2. Do you use an abstraction layer or the 3rd party abstraction framework to hide communication details for different devices/systems from other vendors?
  3. Do you have interoperability use cases defined? Do they include testing timeout, retransmission, rejection and other “negative” scenarios?
  4. Do you use automated tests (including load and stress testing) for verifying interoperability?
  5. Do you have a heterogeneous test setup that supports the verification of multi (3+) party communications between devices/systems from different vendors?

If you answered “no” to all or most of them then it is about time you focus on interoperability. This is a challenge everyone is facing right now. To deal with it you need a reliable and skilled provider with extensive interoperability research and development experience.

Auriga’s Expertise in Medical Device Interoperability

Auriga has gained significant expertise in performing interoperability research and development projects for embedded and system-level software—not only for the medical device industry, which remains mostly fragmented, but also for the telecom, automotive, and avionics industries and other high-tech hardware and software vendors.

In addition to our interconnectivity and interoperability experience, Auriga’s deep understanding of the underlying system internals allows us to design embedded software capable of running on a diverse set of hardware equipment and operating systems with an extensive common code base and a relatively thin abstraction layer.

To learn more, please refer to our web page.