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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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A Medical Device Recall of an EHR-like Product

The recent recall (links below) for McKesson’s Anesthesia Care system raises interesting questions about potential information system failure modes as well as what system/software functions cross the imaginary line between unregulated EHRs and regulated medical devices. First the facts. The FDA announced McKesson’s voluntary recall of its Anesthesia Care system in several on-line (here, here and here)  postings. This trio of postings is interesting because the first links only to the second, the second does not link to either of the other two. The third also does not link to the other two, and was not part of any of the announcements, but it is the most complete. The statement of the reason for the recall is that, “There was an occurrence where the patient case data did not match the patient data when the case was recalled in the anesthesia care record (ACR) in that it included data from another case.” It was further noted that, “Use of this affected product may cause serious adverse health consequences, including death.”  In the third link the FDA identifies the product as, “…a computer based system which collects, processes, and records data both through manual entry and from monitors which themselves are attached to patients, such as in the operating room environment. The system provides clinical decision support by communicating potential Adverse Drug Event alerts proactively during the pre-anesthesia evaluation and at...

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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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Patient Context Workflow

Connectivity enabled medical devices send patient data right out of the medical device to a network, be it a body area network, cellular broadband network, home or enterprise network. The network then conveys this medical device data to databases and applications that store, display and manipulate the data. When a medical device is directly attached to a patient, there is no question as to which patient the device data belongs. As soon as the data leaves the actual medical device via the serial port or a network connection, the association of that data with a particular patient is no longer obvious. Much of the data used in establishing and maintaining patient association or patient context comes from, or is stored in, the patient management database. Patient management workflow is an important enabling component in the overall connectivity solution and key to patient context management. It is critical to reliably know that the data from a medical device belongs to a particular patient. If the data is not associated with any patient it’s worthless; should the data be associated with the wrong patient it could be deadly. When patient data from patient A is misidentified as belonging to patient B, patient A can miss out on a life saving clinical intervention that is mistakenly applied to patient B. In this example, patient A may die due to a lack of...

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FDASIA Report on Regulating HIT

On September 4, 2013, the FDASIA mandated workgroup presented their recommendations to the Health IT Policy Committee in Washington, D.C. Some reporting on the meeting cast the draft report as downplaying potential FDA regulation of healthcare IT applications (HIT), while others emphasized the uncertainty (subscription required) of the process and ultimate outcome. Such news stories are, by necessity, short and can’t cover all the issues but this one from iHealthBeat provides a good summary. The final report (links to all draft documents) was submitted September 4, 2013 and was basically unchanged from the preliminary report. The question to be answered by the workgroup was how to regulate HIT. I think we’re past the question of whether or not HIT should be regulated:  there have been reports of patient deaths starting in 2005 (here and here), and that’s with almost zero reporting requirements on the part of providers or vendors, and the proliferation of HIT vendor non-disclosure and hold harmless agreements to supress reporting (see reports here and here). The report, also called the “Section 618 report” for the section of FDASIA that mandates the workgroup and their report, is extremely concise and to the point – perhaps too concise for those outside the world of regulated medical devices. Of the three entities, FDA, ONC and FCC that are the focus of the report, by far the most focus was...

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Medical Mobile App Draft Guidance Reaches 2nd Birthday

On July 21, 2011 the FDA released its “Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Application.” We have discussed this draft and mobile apps generally here, here, and here. As with all draft guidance documents, following the release of the draft the FDA is supposed to receive and review comments (reported to be about 130), and then issue a revised draft, a final guidance document, withdraw the draft, or do none of these for an extended period, just letting the draft sit. The latter appears to be the  fate of many drafts. The two years that this draft has been out probably qualifies as an extended period. However the FDA did tell Congress, and the public, that the guidance would be released by the end of this fiscal year. Outsiders cannot tell if the appropriate FDA people are hard at work on this item, or if they are distracted in part by other issues. The FDA’s claimed devotion to transparency does not include being able to see how such things are progressing. Once finalized, the guidance document will provide the FDA’s “current thinking” on the subject, but it does not (or should not) officially create any new regulations since new regulations require actual rulemaking. Thus a guidance document is the FDA’s interpretation of the current law and regulations, but is not itself a...

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How Big a Loophole is “Wellness”?

The medical app and regulatory pot is being stirred as products continue to appear, including those with questionable FDA credentials, or lack of credentials. As discussed in our earlier posts on apps regulation (here and here), an app is a medical device if its meets the congressionally mandated and FDA enforced definition of a medical device as something whose intended use “is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man”.  As stated in the FDA’s Draft Guidance, omitted from this definition, and therefore not medical devices, are apps “that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness.” Some manufacturers have identified this health and wellness exception as fertile ground for asserting that their product falls within this exception, and therefore is free of FDA before-market scrutiny. In some cases this ground is plowed in the form of an express disclaimer, even though such a disclaimer may not be particularly credible. For example Brad Thompson, in a post for MD&DI cites the example of a urinalysis phone app and hardware system that includes the disclaimer that the device “is intended to be used for health and wellness information purposes and as a demonstration of technology. It is...

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The FTC Weighs in With Mobile App Advice

Those of us engaged in medical devices and their connectivity often (or perhaps not often enough) look to the FDA for regulation and guidance. In these pages there has been discussion of FDA regulation generally (here), as applied to Medical Device Data Systems (MDDS) (here), medical device mobile apps (here and here), and clinical decision support systems (here) We sometimes remember that there are also other government agencies that may have impact on what we do. For examples the role of  the FCC has been discussed here with respect to medical device wireless applications, and more recently the prospect of the FCC taking away part of the Wireless Medical Telemetry Spectrum (WMTS) has received attention in clinical engineering circles (while no one else seems to care). CMS is always of interest with respect to medical device reimbursement, and more recently with respect to meaningful use of electronic health records (EHR), which may or may not be medical devices. Advertising of medical devices is regulated by both the FDA and the FTC, and some over-the-counter devices bridge the FDA and Consumer Products Safety Commission divide. The FTC (but curiously not the FDA) has previously gone after smart phone  acne treatment apps because of their “baseless claims.”  When there is dual authority and a need for regulatory action I have wondered if having two responsible agencies is worse than having just one (leading to some...

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