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 in health care. We’re going to consider three basic growth strategies: organic growth, product line extension, and the roll-up strategy.Read More
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 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 messaging middleware market are currently pursuing a variety of market segments or bowling alleys.Read More
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,Read More
We are encountering many hospital which are still based on wired LAN technology for medical device connectivity. Many have mentioned their gripes and major concerns about using Wi-Fi technology for patient monitoring and drug delivery monitoring in the OR as well as ICU departments.
Many hospitals are still using WMTS telemetry in their more critical patient monitoring areas. This is very expensive and maintenance for such a system is costly.
Can you tell us what are the major criteria to ensure a reliable safe and secure Wi-Fi network for medical devices?
If a hospital decides to use Wi-Fi technology, what are the proper guidelines to which they must adhere, to ensure that their current and future Wi-Fi network will be stable, reliable, safe and secure? What are the important features they should consider seriously before embarking on using this type of technology?
Great questions. Here we go with some answers:Read More
Some time ago Tim Gee pointed out that a major vendor for an in hospital communication system included the following statement in its documentation:
“This product is not intended for use with patient monitoring devices or other patient care devices. Do not use this product as the primary communications tool in health care environments, as it may use an unregulated frequency band that is susceptible to interference from other devices or equipment.”
Of course “primary communication” was exactly why the product was being purchased, and arguably what it was being sold for.
When discussing Clinical Decision Support (CDS) (here) I have pointed that it is common for CDS creators to in essence say that one should not rely on the output of the product, but instead always second guess the advice provided. This perhaps approaches a warning that I proposed for a product that I thought was seriously defective: DO NOT USE THIS PRODUCT. Maybe I was being facetious.
These examples may pale in comparison to the following disclaimer for medical image processing software:Read More
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 on the FDA. ONC and FCC received minor recommendations. This blog post focuses on the FDA issues and recommendations. You will have to read the workgroup’s recommendations yourself to pick up the specifics regarding ONC and FCC.Read More