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Author: Tim Gee

FDA Takes Step Backwards with New MDDS Guidance

This summer, FDA proposed lifting regulations from certain currently regulated medical devices. This unprecedented policy shift targets devices known as Medical Device Data Systems (MDDS) and is intended to benefit the mobile app industry and companies like Google, Apple and others. The current regulatory burden for MDDS devices is Class I, 510(k) exempt. This means manufacturers have to follow a basic quality system (i.e., design controls) on par with ISO9001, and report instances of patient injury or death in addition to any product recalls to FDA. The following is a guest blog post embodied in an abridged version of...

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Inaugural Clinical Alarm Safety Symposium

Clinical alarm safety can be hard to achieve, and once attained, a struggle to maintain. There are so many challenges: False/positive and non-actionable alarms; Optimizing default alarm limits across patient populations and for individual patients; Spread out nursing units with high patient-to-nurse ratios; Numerous alarm notification methods – audible signal amplification, monitor techs and alarm notification systems; And the constant threat of complacency and alarm fatigue. The inaugural Clinical Alarm Safety Symposium, November 20-21, 2014, will delve into these issues and more to provide attendees with actionable information that can be later applied in your institution to ensure continued...

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Interview with Jim Welch, EVP, Sotera Wireless

This interview is with a long established thought leader in patient monitoring and alarm notification, Jim Welch. Jim has demonstrated a knack for bringing a fresh approach to long-term persistent problems in monitoring, nursing vigilance and patient care. At Sotera Wireless, Jim’s had a chance to re-imagine patient monitoring in low acuity settings with predictably innovative results. At the AAMI 2014 conference, I had the opportunity to attend the breakfast symposium where Jim presented, Transforming Care in Non-ICU Settings through Disruptive Continuous Monitoring Technology. The following discussion centers on patient monitoring data analytics, pioneered by Sotera Wireless. What is...

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Messaging Middleware Growth Strategies

Developing and launching a competitive product, and getting initial traction in the market are not inconsiderable milestones. And yet for the entrepreneur and their investors, this is just the beginning. What was record setting last quarter is barely acceptable this quarter, and next quarter had better be back on track. Developing a solid plan for growth depends on two things: a good understanding of the basic means to drive growth, and a deep understanding of the market. This post seeks to combine both of these in a brief survey of the key factors to drive messaging middleware revenue growth...

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Interview with Todd Dunsirn, CEO, True Process

A while back I had the opportunity to chat with Todd Dunsirn, the CEO of True Process. True Process provides products and services to both hospitals and various manufacturers. The company is focused on the point of care market offering a medication administration solution and a medical device data system. What was the genesis for starting True Process? I started the company in 2004. I have an engineering background, and had several other companies doing IT consulting and then web development, and application development. Then I had a friend contact me to develop a bar-code point-of-care simulation so that...

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Messaging Middleware Market Segmentation & Adoption

The previous post in this series suggested a set of characteristics to define the messaging middleware market and described the typical product architecture for these systems. In this post, we’ll look at ways the market may be segmented and how the market is adopting these systems. Market Segmentation Market segmentation is the dividing of a broader market into subsets of potential buyers who have common market requirements who then become the target for your product, sales and marketing. Using my favorite market adoption model, Geoffrey Moore’s Crossing the Chasm, this is the bowling alley strategy. Software developers in the...

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Secure Messaging Middleware Market Defined

What do secure communications, care team coordination, patient engagement various workflow automation solutions and alarm notification have in common? They’re all examples of messaging middleware solutions found in health care. Which begs the question, what the heck is messaging middleware? This label is a term of art that was first coined by Emergin in the early to mid 2000s. As the name of a product category, it’s descriptive of the underlying technical functions of the product, but has nothing to with how the products are actually used – which can vary considerably. All of this said, the term messaging middleware...

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HIMSS 2014 in Review

The HIMSS conference is so big, with so many different kinds of attendees and exhibitors that it’s almost impossible to have one big theme for any given year. Yet the question of theme for any given HIMSS is something we all talk about. The themes one perceives are at least partially defined by our own interests and area of focus. Consequently, the #HIMSS14 themes for me were: The shifting product and value proposition focus of many of the vendors I track, The tension between spot solutions and enterprise solutions, and The big buzz word of the show, population health....

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Defining the Point of Care Market

It’s useful to segment and analyze markets for developing company and product strategy or analyzing competitor’s actions. Such an exercise helps illuminate why companies and markets do what they do – and what they might do in the future. In getting ready for this year’s HIMSS in Orlando, I’ve been thinking about the point of care (PoC) market. At the first Medical Device Connectivity conference in 2009, I defined the PoC market as the workflow and data associated with direct patient care in nursing units, the ED, surgery and related areas. This contrasts with EMRs managing orders, diagnostics, capturing...

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Role of Montoring Techs in Alarm Notification

Challenges with alarm notification and fatigue have plagued the health care industry for decades. Long before alarm notification systems like Emergin (now Philips IntelliSpace Event Management) and GlobeStar Systems (ConnexAll) appeared, some hospitals addressed alarm issues with the original alarm notification system, monitoring techs. Monitoring techs remain an accepted and effective tool in the constant battle to reduce alarm fatigue and avoid failure-to-rescue events. With the growing adoption of electronic alarm notification systems, is there still a role for monitoring techs? Are electronic alarm notification systems superior to flesh and bone monitoring techs? This blog post will explore monitoring techs...

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