I was listening today to the CE-IT Webinar on CE and HIT from the 2014 AAMI conference in Philadelphia. Much of the session reviewed what has happened over the last five years and it got me thinking about my experiences and what I’ve seen over the last ten years in medical device connectivity and remote monitoring. It’s been an interesting ride and yet I realize there are a few basic ideas that have resonated over the years. These basic ideas are:
- Specifying those requirements that are unique to my situation are where I have the most control in acquisition;
- There are other players in the market who may change the landscape of what is available to me; and,
- The government may require something which can constrain my options.
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
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 is terrible because it’s too generic and the term middleware usually doesn’t mean anything to people outside of IT. A survey of the market shows that many companies are avoiding messaging middleware and using words that describe their product in terms of their target market segment – secure messaging and alarm notification as two examples. In this series of blog posts, the terms messaging middleware, secure messaging, and messaging applications are used pretty much interchangeably.
What Is Messaging Middleware?
Messaging middleware provides integration with and transport for data or communications between users, applications and medical devices. The data streams between these entities are mediated by software to orchestrate secure message flow, message payload and can even generate new messages based on the content of data streams. These systems also provide closed-loop communications where the transmission, reception, reading and response of a message is tracked, with messages resent or redirected (i.e., escalated) in response to a variety of possible delivery failures. All of this communications is recorded and logged in a database to provide management information and big data analytics opportunities. Messages sent to or from users typically entail some sort of mobile device, a wireless voice over IP handset or smartphone running a client app. Such systems also have web based clients that can be accessed on PCs for users to both send and receive messages. These systems can include a number of common features:Read More
The above title is the topic for my presentation at this year’s Medical Device Connectivity Conference. The event this year will be held at the Hyatt Dulles in Herndon, VA November 21-22. The agenda is just about finalized; you can check it out here.
This post is both a preview and a bit of thinking out loud as I continue to develop the the presentation. Suggestions or criticisms are welcome via comments below.
Whenever connectivity is added to a product or solution, things change. If this is a new product direction for the company (or a new variation of an established product category purchased by a provider organization) the resulting changes are often unexpected – by both buyer and seller. And whether expected or not, not meeting the market requirements that result from these transformations means bad things can happen like:
- Unsatisfied customers and/or user resistance due to unmet requirements,
- Lower than expected adoption rates, and
- Lost sales to competitors who better meet requirements resulting from transformations.
The goal of the presentation is to provide a concise framework to be able to identify and anticipate those changes, even when it’s the first time dealing with connectivity.Read More
As noted before, from time to time I answer questions and exchange ideas with folks from hospitals, companies and with students. It’s a karma thing with me – if I can help out with reasonable effort in situations where there’s no immediate consulting opportunity (although there may in the future), and it’s interesting, then I do what I can.
The following is the most recent exchange from a conversation I’ve been having with a product manager at a HIT software vendor about MDDS. They develop and sell an information system, part of which consumes medical device data. Not every customer already has an MDDS, and those that don’t look to their company to provide one as part of a “complete solution.”
From my research, it seems that having FDA clearance for MDDS seems to assure that the product will work out of the box and it’s tested for safety and effectiveness and seems to be a better choice to have than an MDDS (reliability, safety for patients).Read More
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.”Read More