Tom Schady is the Director of Engineering and Quality at Pathfinder Software, a Chicago-based software consulting firm specializing in the development of medical software. In addition to running the day-to-day operations of his department, Schady is also responsible for ensuring FDA compliance in the company’s product development process. His expertise in FDA compliance in the medical technology industry made him a perfect panelist on the Regulatory Panel at the recent MMA Roadshow in Chicago, sponsored by MRCH and the mHealth Regulatory Commission. The main purpose of this “roadshow,”
According to a recent poll of doctors by Epocrates, one-third of physicians planned to purchase the iPad Mini prior to its public announcement. It makes sense, given the size of lab coat pockets and the fact that almost 2/3 of physicians use tablets.
So, what does this mean for developers?
First, it means that doctors want to use medical apps. We developers will see an increasing demand for apps that medical professionals can use in their daily practice, including apps that make use of the device’s camera and audio recording capabilities. Animation
One of the reasons VGBio is one of Pathfinder’s favorite clients is because they show how four of the most powerful technology trends affecting healthcare (body area sensor networks, smartphones, cloud computing and big data/predictive analytics) can be used together to reduce costs and improve outcomes. VGBio technology enables the daily monitoring of patients with chronic diseases and provides early notification to clinicians of a negative change.
VGBio has been going strong, including presenting at TEDMED last month as part of The Hive, and having the The US Department of Veterans Affairs Center for
RockHealth recently published a great guide on how to navigate the FDA for the emerging wave of digital healthcare innovations including mHealth apps. It is especially useful for any team member of an early stage startup that may not be familiar with the FDA regulatory environment. I liked the simple and succinct examples provided from classification to 510(k) pre market submission to post market recommendations.
FDA 101: A guide to the FDA for digital health entrepreneurs by @Rock_Health from Rock Health
If you are in a healthcare startup keep on
If you are new to agile development, you’re probably swimming in a sea of unfamiliar terms: user story, spike, sprint, stand up, points. In this series, we’re going to tackle one of agile’s trickiest concepts: What exactly is an agile “point,” and how does it relate to time and budget?
Points measure the complexity and effort required to complete a unit of work. Pathfinder uses points because we find they are both more efficient and accurate than estimates of hours.
That’s the technical definition, but let’s relate this to something you’re probably
So, you’ve developed a great product and now you want to take it to market. Let’s just say it’s a widget. You’re so excited about it that you want to announce it over loud speakers, “Hey everyone, try my new widget, it will change your life!”. This may be what you want to do, but it’s not the right move. Where do you go from here?
Five tips to market your product are:
Know your product
Know your customers
Know your competitors
Build your following
Keep your customers coming back
Tip 1 – Know your product
The explosion of the mobile health (mHealth) arena seems to have many players in the
healthcare industry running a race they haven’t trained for. There are roughly 40,000 mobile health and wellness apps in the marketplace today, up from about 6,000 in 2010. That type of growth shows the demand for mHealth apps, but as user engagement remains relatively stagnant one must wonder how developers are deciding what to build. In order to increase user engagement while limiting the clutter on app store shelves, mHealth needs to be introduced to another fairly
When you combine cheap sensors with the computing power and interface capabilities of modern iPhones and Android smartphones, you can get powerful mobile diagnostics. When you add in smartphones’ data transmission capabilities to feed data analytics in the cloud, you have the potential to dramatically improve the state of medicine.
Last week I wrote about a project we worked on this area, VG Bio’s Vitalink, which combines wearable bio sensors, an android smartphone and cloud based predictive analytics to identify significant medical abnormalities earlier than current systems are able to
One of the trends from the 2012 MHealth Summit I briefly touched on last week was the growing number of bluetooth and wifi enabled wearable medical devices. I think this trend will become extremely important over the next few years.
Body Area Sensor Networks combine pervasive wireless networks, small non-invasive sensors and ultra-low power consumption chips to enable the continuous collection of physiology data from ambulatory patients.
VitaLink, a project we recently worked on with Insight Product Development and our client VGBio, illustrates the potential power of combining
What I will talk about at DRC is the ‘research-product’ gap. I just gave a talk at the Stanford D School about some of these issues. I discussed the research-product gap. This didn’t concern them. I said that if they were not interested in how their work got into a product, they were wasting their time.
“And they said, ‘We’re just doing the research, we’re not responsible for the product.’ And that’s the problem (even with you folks at the Institute of Design). You guys do the research – who does
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