The Medical Device Matrix

Medical imaging systems have been talking to PACS systems for years, saving costs and improving care. I’m always impressed that my children’s doctors can access current and historical x-rays and MRI’s at the drop of a hat. Integration of devices with PACS enables medical images to be captured, backed up, transmitted, analyzed, and reviewed in other care sites and at other times. The age of the standalone medical imaging system is long gone.

Other medical devices are beginning to follow suit, interfacing with electronic medical records (EMRs) and hospital inventory management systems. Networked devices are on the way, and the age of the standalone medical device is heading to a close.

The era of networked medical brings challenges and opportunities. Are you ready?

As I write this, medical devices are talking to EMRs. Hospital-based medical electronics are leading the way. In 2008, Philips linked its patient monitors to hospital EMRs.  In 2009 Hospira boasted that it had achieved “the industry’s first-ever successful integration of infusion pumps with the electronic health record.” Bar code scanners and RFID systems are capturing the use of disposables and instruments during procedures, right in the hospital’s patient record, inventory management and billing systems.

It’s still early and most devices still stand alone. It’s difficult to get devices to talk to many different EMRs.  Industry groups are just beginning the hard work of getting device makers and EMR vendors to speak the same language.  Device companies are just beginning to learn the basics of connectivity.

Ultimately though, integration is inevitable, driven by significant environmental forces:

      1. The American Recovery and Reinvestment Act of 2009. As part of a US fiscal stimulus package, providers were given financial incentives to adopt EMRs.  Providers were also given a limited adoption timeline, as an added threat.
      2. Health care spending controls. Smart hospitals want to know exactly what devices are being used for which patients, and when and where. Believe it or not, costs have not been historically managed to this level of detail, with departmental spending being collected in one budget and departmental revenues in a separate bucket. Costs per patient can then be estimated by applying the infamous cost–to-charge ratio to individual patient billings.
      3. Health care quality improvement. Just as the availability of PACS reduced the errors of lost or misfiled images, device integration with EMRs will reduce the errors of lost or misplaced patient data. It’s easy to see when the patient had their last ECG, if the ECG data is in the EMR.
      4. Product competition. The ability of a device to integrate with EMRs is becoming a competitive product advantage, even if customer is not yet ready to perform the integration. Manufacturers like Welch-Allyn and GE need new features, especially in mature markets like patient monitoring.
      5. Moore’s law, Edholm’s Law and Metcalfe’s law. Cheap and ubiquitous computing power, bandwidth and connectivity have transformed our lives and will transform healthcare too.
      6. Emerging standards. There are tens of thousands of devices and hundreds of EMR systems. The only way to make this ecosystem work is through the development of standards such as the uniform device identifier and medical device interfaces to EHR from the US Dept of HHS, US NIST, and IHE.
      7. Apple’s iPad. Docs want iPads, just like everyone else. EMR looks to be the killer iPad app for physicians, simplifying the capture and display of medical data. Device portability is key to physician acceptance. By later this year, every major EMR vendor will have an iPad app, removing one of the critical roadblocks to EMR adoption.

Integrating your medical device with EMRs is a commitment to additional engineering, extra product cost and extra support cost. It’s hard work.

There may be some unexpected benefits too. Besides a one-way flow of data from your device to the EMR, suppose you could also extract patient data from the EMR. You could then find out if the patient is on blood thinners before your surgical instrument is used. In addition to displaying the patient’s current ECG, your patient monitoring device could display historical measurements, and analyze trends. Because your device no longer stands alone, your procedure no longer stands alone. Your procedure is part of a stream of activities for each patient. We can only begin to imagine all the new opportunities to provide value to the patient and healthcare provider.

What is a medical device company to do?

      • Assign someone on your team to watch the evolving standards and lead the planning effort for your company. Have them learn the basics. You might even have them attend HIMSS and the Medical Device Connectivity Conference.
      • Identify EHR interoperability requirements in your product’s design input specs. Talk to customer CIO’s. Keep an eye on your competitors and adjacent markets. Don’t get left behind.
      • Architect your software so that external data interfaces can be changed without ground-up software redesigns.
      • Consider third party vendors that sit between you and the EMR, such as Capsule, iSirona or others.
      • Begin thinking about new ways you might take advantage of EMR integration to provide additional value to your customers. These new business opportunities will make all the efforts worthwhile.
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