Guest Column | April 28, 2014

Modernizing Your Medical Device Design For An Outcomes-Driven Reimbursement World

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

HTO Futuristic Doctor

These days we take the Internet for granted — we visit websites, send emails, shop online, run mobile apps, and even get up-to-the-second and down-to-the-inch travel directions from GPS satellites orbiting the earth. Although they’re less visible, we’re starting to see medical devices, especially those with digital components, moving faster towards the same kinds of consumerization. Next-generation medical devices are evolving to be much smarter as their sensors switch from analog to digital native, as their hardware becomes not just portable but more mobile, and perhaps most importantly, as they become part of the Internet of Things (IoT) by generating enormous amounts of coveted clinical data.

What’s going to be even more spectacular is that you’ll soon be wearing smart watches that know your vital signs, electronic bandages that can sense whether wounds are healing, and many other personal medical devices that continuously monitor things going on within and around your body. These kinds of devices will make up what will soon become the Medical Internet of Things (MIoT). MIoT devices will generate significant amounts of digital data, and managing this data becomes what’s known as a Big Data problem. The reason is obvious — data flowing continuously from your body comes in rapid velocity, large volumes, and many different varieties.

IoT, Big Data, MIoT, and analytics will certainly transform the digital medical device landscape and grow it dramatically; however, those companies that don’t adapt their devices designs won’t be around to enjoy the spoils. The way next-generation devices are designed must adapt so that new devices generate the right kinds of data that is easier to analyze and utilize by consumers and healthcare providers — the specific traits that buyers of clinically useful equipment use when making purchasing decisions will be very different tomorrow than they were yesterday.

New health system medical device purchase decisions will be made in an era of value-driven decision-making. The current fee for service (FFS) payment models are being augmented by outcomes-based payments in so-called Accountable Care Organizations (ACOs) as part of Medicare’s Share Savings experiments. As health systems and other buyers of medical devices get paid less for the services they perform and more for the patient outcomes they improve, their expectations of data generated from the medical devices they buy also get more sophisticated.

As we create and upgrade future devices, our designers must realize that they’re no longer just making standalone devices — they’re likely crafting a system component that fits into a larger system-of-systems ecosystem that is creating and moving around enormous amounts of coveted data. Coveted because that data can be used to improve diagnostics, tailor clinical workflows, improve patient safety, and advance care coordination. All of these kinds of tasks and the data that will make them possible become even more important as payment models move from FFS to outcomes-driven.

If you’re a company making an analog device living in a digital world, your days are numbered and you need to be worried. If you’re making digital devices and you’re not sharing data with IT systems, your competitors will be selling more products than you will because ACOs and outcomes-driven organizations have an insatiable appetite for data. Because next-generation health systems will be paid for outcomes, they will not settle for aging, expensive, stand-alone equipment when connected digital alternatives are available. If you’re selling digital devices that are sharing some data but not capturing enough data to make it useful for analytical purposes, you’ll see limited revenue growth and margin pressure along with loss of sales, as your customers phase out your products in favor of those that generate clinically valuable data for improving their workflows.

Most medical devices, like other IOT devices, will be disrupted by the business-value focused Big Data movement at some level. How much your company’s products are disrupted will depend on whether your devices are built around the idea of enabling agile clinical workflows and whether your devices generate patient outcomes improvements in a measurable way. Think about the mobile phone and digital devices world in 2007 vs. 2014 — almost none of the same players that were big back in 2007 are still big today. Now, think about the world in 2021. Will your company be around or will it be disrupted out of existence by Big Data, analytics, and new payment models?

Shahid Shah is an outcomes-driven care specialist and an award-winning medical device hardware / software design coach with 25 years of technology strategy and engineering experience. You can reach him via Twitter or email.