Guest Column | July 11, 2014

Why Data Connectivity To Traditional IT Systems And EHRs Should Be A Priority In Your Next-Generation Medical Device Designs

By Shahid Shah, president & CEO, Netspective Communications
Follow me on Twitter @ShahidNShah


In my last two articles of this series I reviewed how to modernize medical device design for value-based care and how to design for specific patient populations. Neither of these topics is commonly considered, even by savvy marketing and R&D teams, when designing next generation devices. Pricing transparency to demonstrate device value for reimbursement is something that most healthcare customers are looking for — but that very few device vendors are providing out of the box.

Another major area that’s lacking in medical devices, according to PricewaterhouseCoopers’ (PwC) Top Health Industry Issues of 2014 report, is that of electronic health records (EHRs), health IT, and patient data connectivity. According to PwC, only about 18% of device companies integrate data into clinical workflows and EHRs — this means there’s a very nice opportunity for upstarts and savvy incumbents. Any vendors that focus on device integration and data connectivity from devices into traditional health IT systems like EHRs and billing systems will have a unique offering that customers will elevate during their product selection process.

Medical devices generate an enormous amount of data on a routine basis, but most of that data is discarded needlessly — simply because data connectivity and device integration is an afterthought. When valuable data is discarded, it not only means that patient data isn’t available for future use, but it’s also very likely that device vendors are leaving millions of dollars in revenue on the table.

Why would customers want your device data to go into their EHRs and other IT systems? Here are some important reasons:

  • The Medicare Shared Savings program, the Patient Protection and Affordable Care Act (PPACA, or “Obamacare”), and the rise of medical homes have given more weight to value-based reimbursements. In the new world order your device’s customers have to understand their costs much better. That means they need to know not just what your devices costs, but how much they are utilized and what their contributions are to the outcomes of a patient’s care.
  • The CMS Meaningful Use (MU) reimbursements program requires a lot of new data entry to be done by clinicians. Customers are looking for ways that devices can automate some of the new data collection requirements by taking sensor or input data and emitting it in a way so that it can be imported into EHRs.
  • mHealth and new remote care technologies are creating more and more data, but the data is getting difficult to synthesize across dozens of apps and systems. By taking device data and coupling it with mHealth and remote workflows, customers believe they can improve patient outcomes by tailoring and personalizing care experiences using “big data” analytics.

While the reasons above are applicable to both small and large providers and health systems, one reason that larger customers want more data to come from their devices into their traditional IT systems is that it helps answer important questions like:

  • What is the cost per patient per procedure/treatment, and why is it going up when other costs are coming down?
  • Why does the same procedure/treatment plan vary so much across localities?
  • Why are certain drugs more effective than others in certain patient cohorts?
  • Why are some treatment and procedures more effect in similar patients?

Government regulations and significant market trends would be good enough reasons to add device connectivity, and helping customers answer the bigger questions around effectiveness is an even better one. However, the easiest reason to understand is that it provides terrific opportunities for new or incremental revenue streams. Here are some examples:

  • Customers are willing to pay significantly more if devices can help fill clinical documentation into EHRs. This is because the new MU program is asking some clinical providers to become data entry clerks, and frustration over having to enter data multiple times — once in devices and then again in EHRs — is growing. Not only is multiple data entry it a waste of time, but it also causes more errors and potentially harms patients.
  • Alarm fatigue is both annoying and potentially detrimental to patient care. Customers are willing to pay more for devices that integrate their alarm data into central alarm notification systems.
  • Many care plans and protocols need to be automated because they are complex and difficult to train and prove adherence. Customers are willing to buy devices that support complex event processing by automatically checking whether protocols are followed and by providing evidence from data captured in devices. Automating clinical workflows is a big business, and hooking into those workflows makes your devices more valuable and creates more barriers to entry for your competitors.
  • More and more devices are becoming “virtual,” so customers are looking to add signal/data processing for new parameters without purchasing new equipment. Vendors that can remotely upgrade through new but safe software updates can charge more for their devices.
  • Health system operations are already complex, but having biotech staff run around and manually manage security patches, software upgrades, etc. is getting both annoying and costly for health systems. Customers want to buy devices that have remote servicing and automated reporting for calibrations and related maintenance operations built-in. Not only can this have positive revenue implications, but remote servicing also reduces hard dollar costs on the vendor side, netting better margins.
  • Customers need devices that can provide remote device surveillance and data integration capabilities in telehealth, telemedicine, ambulatory, and home care environments. Next-generation devices need to be provisioned, managed, and remotely connected to health system IT environments. Any devices that can help with remote surveillance will be worth a premium.

If you’re designing next generation devices and want to stay in business for the long term, IT and EHR connectivity is a must. In an upcoming article, I’ll describe some of the techniques you can use to implement data integration capabilities into your device design.

Shahid Shah is an EHR and health data integration coach and an award-winning medical device hardware / software design mentor with 25 years of technology strategy and engineering experience. You can reach him via Twitter or email.