ARTICLES BY SHAHID SHAH

• 3 Steps To Design Medical Devices That Thrive In The Digital Health Ecosystem

  1/14/2016

  While discussions about why interoperability is important are pretty common, it’s still difficult for device designers to choose the best architecture and engineering approaches to implement that interoperability. In this article, I’ll make recommendations to help you create point-of-care devices that are good “digital health ecosystem citizens” and play nicely in modern IT environments.

• Inspector General’s 2016 Work Plan: A Cybersecurity Wake-Up Call To Medical Device Designers

  11/24/2015

  The U.S. Department of Health and Human Services (HHS) Office of Inspector General’s (OIG) Work Plan for 2016 summarizes OIG’s efforts to improve the overall effectiveness of more than 100 programs administered by HHS. In addition to scrutinizing Centers for Medicare & Medicaid Services (CMS) reimbursement for fraud and cost-cutting opportunities, OIG will put medtech cybersecurity under the microscope.

• Cybersecurity As A Competitive Differentiator For Medical Devices

  3/24/2015

  In 2013, the Food and Drug Administration (FDA) issued its first cybersecurity safety communication, followed in 2014 by final guidance. While it took the agency much longer to focus on cybersecurity than many of us would have liked, I think it struck a reasonable balance between new regulations (almost none) and guidance (in the form of nonbinding recommendations).

• Using Modern IoT-Style Protocols For Next-Generation Connected Medical Devices

  2/16/2015

  Why a “thin” design based on Internet of Things (IoT) and distributed message techniques might be the right approach for your next product.

• Top 9 Benefits Of Open Sourcing Your Proprietary Medtech Source Code

  11/20/2014

  Last month, I described techniques to help regulatory teams overcome their fear of using open source software (OSS) in medical devices and digital health applications.

• 10 Steps To Overcome Your Fear Of Using Open Source Software

  10/8/2014

  The entire Internet runs on open source software (OSS) and, if we used it more in medical devices, it would lead to reduced costs and increase the quality of devices. If you ask some regulatory affairs folks in medical device companies, they think OSS is too “dangerous” for use in safety critical systems.

• Why Data Connectivity To Traditional IT Systems And EHRs Should Be A Priority In Your Device Designs

  7/11/2014

  According to a recent PriceWaterhouseCoopers report, a major area that’s lacking in medical devices is electronic health records (EHRs), health IT, and patient data connectivity. Only about 18% of device companies integrate data into clinical workflows and EHRs, which means there’s a very nice opportunity for upstarts and savvy incumbents. Any manufacturer that focuses 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.

• How To Design Next-Generation Devices For Specific Patient Populations

  6/11/2014

  Digital health and Big Data are looking to transform the world of medicine through software and next-generation medical devices. In the past, we were able to segment device designs into easy to understand categories like consumer-centric, ambulatory (outpatient), and acute (inpatient). This was because we knew where our devices would be used and who would use them – either the patient directly or, more commonly, a healthcare provider (HCP) on behalf of a patient or an HCP using it for diagnostics on a patient. As we move from fee-for-service to value-based reimbursement and outcomes-driven care models like accountable care organizations (ACOs), it will be increasingly important to design devices not just based on where they will be used, but on what kind of patient population we will be targeting.

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

  4/28/2014

  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.