Navigating Regulatory Uncertainty for Smartphones
Uncertainty abounds regarding the potential regulation of smartphone apps by FDA and other international regulatory bodies. For this discussion we’ll divide uncertainty into two categories, uncertainty due to a lack of knowledge about the potential regulations on the part of manufacturers and uncertainty about just what various regulatory agencies are doing – or going to do – about new and innovative products that meet the definition of a medical device.
What is a Medical Device?
Let’s start with the first category; there is an astounding amount of misinformation and just plain wrong-headedness on the part of many vendors (and providers) who are outside the ranks of traditional medical device manufacturers. The first issue we need to address is the question, “What is a medical device?” Here’s the legal definition of a medical device, courtesy of FDA:
EMR Integration for Medical Devices: The Basics
Medical device manufacturers in markets that have managed to resist creating connectivity solutions are facing increased pressure from providers adopting EMRs. I mean, what’s the use of automating the EMR if users have to write down numbers read from medical device displays and then manually type them into the EMR? That’s certainly not “automation.” This feature is already a required and necessary feature in some device markets, and rapidly becoming a necessity in many other device markets.
Manufacturers in this situation (needing an interface to EMRs for clinical documentation) often come to me with a plethora of questions. Before we get started, let’s frame the discussion. In this post you will be introduced to a framework for clinical documentation connectivity. I do not get into details on product design or features. Rather we look at a basic framework and external factors that come to bare on any manufacturer contemplating a connectivity feature for their products. What follows is a sketched in foundation or starting point for manufacturers to use to plan for and implement what is probably the most basic connectivity application.
Let’s run through the basics.
What are the basic components of a clinical documentation solution for a medical device?
Charting Your Regulatory Course
Do you think your product could be a medical device, and regulated by FDA?
There are all kinds of regulatory strategies. Any new product development project for a regulated product should have a regulatory strategy that optimizes requirements, specifications, risk and verification testing, especially as it relates to the off the shelf components of a medical device. I would call this a product-specific regulatory strategy.
At the other end of the spectrum, a company should have a regulatory strategy that charts the regulatory course of the company in addition to its relevant products. Companies already regulated by FDA should have one of these as part of their management responsibilities – and it should be kept up to date as products, the company, and the regulatory environment change over time. Let’s call this a corporate regulatory strategy.
You especially need a corporate regulatory strategy if your company’s products, or the products of companies you see as direct competition, are in that gray zone that could maybe be interpreted as a regulated medical device.
Why Medical Device Makers Love/Hate Wi-Fi
In this post we’re going to lift the window shade a bit on why many manufactuers love Wi-Fi, and why they also hate it with equal passion.
You see, I’m often asked by manufacturers about alternatives to Wi-Fi for wireless medical devices. And I’ve done a number of wireless technology surveys for manufacturers, looking for attractive alternatives. There are no attractive alternatives, at least for most medical device applications at this point in time.
Before we dive into this sordid tale of passion and betrayal, let’s frame the discussion. The wireless application I’m referring to is the connection between a portable or mobile medical device and the enterprise wired network. While the examples in this post come from hospitals, there is much here that is applicable to ambulatory settings. Applications that are not considered are cable replacement applications (Bluetooth or wireless USB) or wireless sensors in body area networks (BANs) that are, by their nature, low power and short range, are a different animal.
Which Tablet Will Win in Healthcare?
Neil Versel has a good story this week on Mobihealthnews about competition among tablet manufacturers for the health care market. He notes the considerable potential market demand for tablet computers with the right features and capabilities.
It is true the iPad is magical. Don’t deny that. On the other hand, there seems to be a lot of Apple fan-boy hyperbole surrounding the iPad in health care. Most stories on the iPad in health care focus on what a sexy product it is and how clinicians would love to use it in their practice. But there’s more to gaining market share in health care than a sexy product with usability and customer hopes, wishes and desires.
There are 4 key hurdles any tablet manufacturer must overcome to succeed in health care. First, software developers must redesign the user interface of their applications to run on the smaller screens of tablets (compared to desk top computers). This is no easy task, but at HIMSS last month, it seemed everyone had (or promised have soon) demo software running on the iPad. A great tablet that no one’s ever heard of, from Emano Tec, faded away at least partially due to a lack of applications designed for it’s form factor. And it is not clear that HIT vendors will jump at the chance to re-implement their software on multiple tablets, let alone the iPad.
