Author Archive for Bob

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Personal Healthcare Products: This is what the future looks like.

Published on January 4, 2011 by Bob in FDA and Medical Devices. 2 Comments Tags: .

I’m jealous of companies that get to produce diagnostic medical devices without having to go through the FDA 510(k) process. For example, the iHealth BP3 blood pressure monitor is a high-tech looking device with a  free Apple application:

Hopefully they’re using an approved non-invasive blood pressure (NIBP) device like the SunTech module.

The built-in ability to e-mail results to family or a physician seems useful, but posting your blood pressure on Facebook or Twitter?  I don’t know…

Hat Tip: medGadget

Medical Devices and the Cloud

Published on January 3, 2011 by Bob in Cloud Computing, EMR, Interoperability and Medical Devices. 2 Comments

The article Is Cloud the tomorrow of Medical Devices Industry? includes some of the challenges — regulatory, privacy, security etc. — faced by manufacturers trying to manage medical device data in the cloud. You can’t disagree with this statement:

The success of the vision of Smart Connected Health Grid is dependent on wide scale adoption of cloud computing in all areas of healthcare.

There’s no doubt that adoption of cloud-based technologies are starting to provide concrete market opportunities in the Healthcare space.

There are also two major market barriers that will have to addressed in order for the cloud’s full potential to be realized:

1. Who’s going to pay for it?

  • The Apple/Google/Facebook “created a marketplace around the end consumer” model will not work in the medical industry.  Consumers do not manage their own healthcare, and certainly not their medical data.
  • Glucose monitoring is also not a good model. Strips and meters are reimbursed by Medicare and most private insurers.
  • The “Service Delivery Platform” may be a great idea, but unless you can prove its effectiveness at saving money in the overall healthcare delivery system it has only limited value.
  • Proving this effectiveness is difficult to do, and the bar is very high on the expected returns for preventative care.  Maybe this is where the vertically integrated Accountable Care Organizations (ACO) could have an impact?
  • The end consumer (re: their willingness to spend money anyway) is not likely to be part of the revenue generation equation.

2. Interoperability.

  • You can’t overstate connected in “Connected Health Grid.”  This is where the real value is.
  • Data collected from a medical device must be put into context with all of the available health data in order to properly access a patient’s current state.
  • This means you have to make the device data that resides in your cloud available to be consumed by others, e.g. payers, PHRs, hospital EMR systems, etc.  Each of these interfaces is unique and costly. HIPAA is also key barrier here.
  • There are many technical issues surrounding medical device connectivity. I’ve written frequently about these interoperability topics in the past.

The potential is there, but IMO creating a value proposition that will result in a sustainable market based on a technology alone will probably not work. It’s the old “hammer looking for a nail” problem.

Medical device data combined with cloud-based technology will be part of many effective healthcare solutions. Some of these may actually make money, someday.

The Cardiocam: Physiological Monitoring via Webcam

Published on December 19, 2010 by Bob in Medical Devices and Technology. 0 Comments Tags: .

Today’s New York Times Magazine The Year in Ideas: 10th Anniversary Special features the MIT Cardiocam:

Cardiocam is a low-cost, non-contact technology for measurement of physiological signals using a basic digital imaging device such as a Webcam. The ability to perform remote measurements of vital signs is promising for enhancing the delivery of primary health care.

Medgadget covered this in October: MIT Student Uses Webcam to Measure Heart Rate From a Distance includes a video that shows how the Cardiocam is used to create a “medical mirror” for home health monitoring.

A link to a PDF (here) has a full description of the research, including their Cardiac pulse recovery methodology:

The method uses Blind Source (Signal) Separation (BSS) by Independent Component Analysis (ICA) of the changes in the video signal:

Volumetric changes in the facial blood vessels during the cardiac cycle modify the path length of the incident ambient light such that the subsequent changes in amount of reflected light indicate the timing of cardiovascular events.

Very cool.

Hacking Your Own Health Data

Published on December 15, 2010 by Bob in EMR and PHR. 1 Comment Tags: .

The MassDevice article Doctors to patients: Track your own health data has an interesting take on the  personally controlled healthcare record (PCHR).

Keely Wray advocates that PCHR data should be “Hackable” (my highlight):

I mean “hackable” in the sense of the word that is quickly growing in popularity: allow owners of a product to manipulate, re-purpose or add to the functionality of a product to serve their own personal needs.

Ms. Wray asks:

Doesn’t it make sense to allow patients to put the technologies together in a way that meets their needs?

Their own needs? Maybe yes, but probably not.

The biggest incentive for innovation will be where someone sees an opportunity to meet a lot of other people’s needs. This may well be for group that shares a common problem or aliment with the technologist(s).  The initial intent may be altruistic, but real growth will only take place when a market emerges.  This is the reality that could lead to significant new health data management solutions.

For example, PatientsLikeMe started off this way (from the About Us page):

Our personal experiences with ALS (Lou Gehrig’s disease) inspired us to create a community of patients, doctors, and organizations that inspires, informs, and empowers individuals.

There’s nothing wrong with that.

Your Brain on Ads

Published on November 14, 2010 by Bob in EEG. 1 Comment Tags: .

Today’s New York Times article Making Ads That Whisper to the Brain gives a pretty balanced view of using EEG monitoring for doing market research — “Neuromarketing.”

This is not a mind reader,… We can only measure whether you are paying attention.

I write frequently on EEG related technologies, and often sceptically about some of its applications. The term “pop neurology” seems to apply here, especially when it comes to the ability for this technology to correlate to purchasing behavior. The establishment of NeuroStandards will only ensure that everyone is fooling themselves the same way.

Also, “brain-whispering” makes no sense. Most ads I see are loud and intellectually insulting (TV) or are visually annoying (Web) — it’s more like brain-shouting.

Here’s a Today show segment on this: Inside the brain of a shopper.

Agile Software Development in Regulated Environments

Published on October 16, 2010 by Bob in Agile, FDA and Software Quality. 3 Comments Tags: .

As part of a series on High Assurance Agile Development in Regulated Environments is the article
Agile Software Development in Regulated Environments Example: Medical Devices. The purpose of this article and future posts is to introduce the FDA regulatory landscape and then

… see what we can do to “agilify” our practices under these standards as we move forward.

It’s been three years since I wrote Agile development in a FDA regulated setting.  I’ll be interested to see if the application of “agile, high assurance activities” in this environment — and the associated issues — have changed since then.

UPDATE (10/23/10): Can and should agile be used for medical device development? Absolutely!

UPDATE (11/27/10): More discussion here: Can Agile Software Methods be used in medical device software development?

UPDATE (11/28/10): Agile Medical Device Software Development?

UPDATE (12/17/10): GE Healthcare Goes Agile

UPDATE (1/5/11): Missed this one: Four Reasons Medical Device Companies Need Agile Development

Brain Monitoring News

Published on September 8, 2010 by Bob in EEG and HCI. 0 Comments Tags: , , , .

There have been some interesting EEG related stories lately:

I’ve followed BCI: Brain Computer Interface and EEG work for a long time. There is still a long way to go on the “mind reading” front, but these types of developments are all encouraging.

Second Annual Medical Device Connectivity Conference

Published on September 2, 2010 by Bob in Interoperability and Medical Devices. 0 Comments Tags: , .

This year’s Medical Device Connectivity Conference is being held Sept. 28-29, 2010 in San Diego.

From the press release Tim Gee says:

The only conference devoted to the topic of medical device connectivity, the program will offer a unique opportunity to get immersed into every aspect of connectivity, workflow automation and enabling technologies. The keynotes and panel discussions on the first day frame the conference’s focus on connectivity and tackle two of the biggest issues facing health care: industry standards and regulatory issues. Program tracks on the second day provide a survey of connectivity applications, clinical capabilities and outcomes, and explore the gap between regulated vendor-managed systems and the customer-managed and controlled environments in which these systems are used.

Here are just a few of the topics I’m particularly interested in:

  • EMERGING PROBLEMS AND RISING AWARENESS OF MEDICAL DEVICE SYSTEMS ON ENTERPRISE NETWORKS
  • LOOKING BEYOND CONNECTIVITY IN HOSPITALS TO HOME HEALTH AND MOBILITY
  • OPEN EHR MANIFESTSO: OPPORTUNITIES FOR MEDICAL DEVICE COMPANIES
  • INTEROPERABLE MEDICAL DEVICE SYSTEM ARCHITECTURES

Looks like another great conference!

Closer to Launch: Healthcare IT Q&A

Published on September 2, 2010 by Bob in General. 3 Comments Tags: , , .

The reverse psychology I used in Failure to Launch: Healthcare IT Q&A is finally starting to work. The question definitions are complete and the commitment phase has begun:

Go over and sign up today.

A Threat Analysis of Networked Medical Devices

Published on August 14, 2010 by Bob in HIPAA, Medical Devices and Microsoft. 2 Comments Tags: , .

Here’s an interesting analysis of security threats within a Windows-based hospital network for embedded medical devices: A threat analysis of critical patient monitoring medical devices.

The threat models are fairly complex and clearly a product of wider enterprise network IT security needs. I’ve discussed some of the other issues of putting medical devices on an institutional network in Networked Medical Devices. Security threats were not covered and this is an important topic for every hospital network.

There are a couple of items in this article worth commenting on.

The top five unmitigated threats were found to be:

The corrective action for the top threat (T002) was (my highlight):

After it was decided to remove all ePHI from the medical device data storage, the risk assessment changed and the threat of the medical device infecting the hospital enterprise network (T017) then became our primary concern.

This may be the “most effective countermeasure possible for HIPAA compliance and protecting patient privacy”, but it is a not practical solution in the real world. Many medical devices store patient demographics. Because the benefits of patient identification outweigh the security risks, this practice is not likely to change in the future.

On these questions:

  1. Can the medical devices be infected from the enterprise network?
  2. Can the medical devices be infected via removable media?
  3. Can infected medical devices propagate malicious software back into the enterprise network?

I generally agree with the conclusions for the device under analysis. The challenge for a hospital is how do you ensure that every networked medical device follows these best practices (communications integrity, hardened OS, clean distribution media, etc.)?

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