Healthcare Software Development Blog

How to build the right software, get customers and keep them coming back

Honeywell's Director of R&D Talks Tech Stacks in Healthcare Technology

Posted by Cameron Brackett on Mon, Apr 21, 2014 @ 08:30

Process Management and Agile in an FDA Environment

My background is primarily in healthcare software, so I’ve seen a lot of changes in the healthcare technology world. And as director of R&D at Life Care Solutions, a division of Honeywell, I’ve been able to be on the cutting edge of what’s happening.

Since I’ve been at Honeywell, we've done a lot with remote patient monitoring. About two years ago, we created a new direction in the field. Utilizing a mobile tablet equipped with the Android platform, we created the first telehealth solution available on the Android platform. We developed the software, which turned out to be a great solution, in 5 to 6 months.

Traditionally, in the healthcare space, people build custom hardware that either does not run an OS (operating system) or runs a very lightweight OS which creates challenges in the product’s flexibility. If a device doesn’t have an OS, you have to code everything. So we wanted to move toward a device that had an OS that provided more flexibility and was more off-the-shelf.

The mobile platform we started turned out to be something that met everyone's needs. While  discussing what we were trying to develop with the next telehealth generation, we realized we wanted it to be approximately seven inches, to have a touchscreen and and to run an OS. Those specifications obviously described a tablet. At that point, we realized that we didn’t want to reinvent the wheel; it didn’t make sense to build a Honeywell tablet since so many already existed in the marketplace.

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Topics: mHealth, HealthIT, healthcare 2.0, healthcare innovation, Healthcare Software, healthcare

Lessons from AirStrip on Agile Development in an FDA Environment

Posted by Dan Blake on Mon, Apr 14, 2014 @ 07:00

Experience has shown me the challenges of working with Agile development in an FDA environment. But it’s also helped me understand how to make the flexible development style of Agile work within the strict constraints of FDA regulations.

FDA regulations require processes and documentation for the development of healthcare-related products, from medicines to devices and other products - documentation that’s complete and traceable. But on the development side, the industry is moving toward new methodologies like Agile, that create a more flexible design space that may not be easily aligned with the individual, separate steps that FDA regulations require.

Although FDA regulations and Agile processes are somewhat mismatched (since FDA has a propensity towards Waterfall-like documentation), the key to overcoming this challenge is aligning [DB1] your Agile process from the onset. If you’re working in FDA space, you know your processes and products will be subjected to FDA regulations, so you should be proactive in making that approval process as easy as possible.

For example, at AirStrip, we spent a lot of time and effort making sure that we created our processes, tool sets and technologies so they very naturally lent themselves to creating the level of documentation needed in an FDA environment. This is somewhat at odds with the Agile principle of creating the minimal amount of documentation possible.

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Topics: FDA, Agile Development

The Growing Landscape of Medical Apps in Healthcare

Posted by Mitch Posada on Mon, Apr 07, 2014 @ 10:05

Handheld medical apps are changing the healthcare landscape. While medical devices with embedded software have been around for over two decades, the advent of smartphones with touch screens, smart Bluetooth technologies and internet connectivity has brought about a tsunami of apps designed for every purpose, from monitoring body temperature to measuring heart rate. Today's medical apps are becoming increasingly smarter, multifunctional and user-friendly.

In the past, healthcare and life science companies concentrated on manufacturing medical equipment and devices for hospitals and doctors. Now, they are switching to mobile apps more and more as their mainstream offering. The majority of these apps are intended for direct use by consumers and patients rather than doctors and caregivers. This has brought about a paradigm shift in people's perception of healthcare by making healthcare more accessible to patients.

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Topics: Mobile App, healthcare mobile apps, medical mobile apps

Lowering Risk Using Agile and Lean Methodologies

Posted by Jacque Harper on Wed, Mar 19, 2014 @ 11:27

Several common types of risks in software development can be mitigated by using Agile, Lean and a user-centered development process. In this post, we will look at three types of risk:

  • Risk of Poor Design, or the Wrong Features
  • Risk in the Marketplace
  • Risk of Unknown Factors

Risk of Poor Design, or the Wrong Features

This is the risk of building a feature or function that customers will not pay for, or will not use - or the risk of designing a feature (whether it’s in visual design, interactivity, or even the architectural design of the application) that frustrates users or complicates the operation of the system to the point where it will not be used. Building the wrong features or building the right features in a way that makes them unusable wastes money and time, and ultimately saps morale.

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Topics: medical device software

The Growing Significance of Bluetooth BTLE in Healthcare

Posted by Mitch Posada on Mon, Mar 17, 2014 @ 03:37

Bluetooth Low Energy (BTLE), also known as Bluetooth Smart, is a wireless computer network technology that allows Bluetooth-enabled devices to "talk" to each other over a short distance. Compared to a standard Bluetooth connection, BTLE runs on far less power and has only about about one-half of the range (15 meters or 50 feet), but offers most of the connectivity. This makes it ideal for medical devices that need to run on limited power supply, typically in the form of a button cell, for months, or even years.

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Topics: healthcare innovation, Healthcare Software, healthcare mobile apps, bluetooth

Fast Feedback Post Launch: Where the Rubber Hits the Road

Posted by Bernhard Kappe on Wed, Mar 12, 2014 @ 10:32

Feedback helps you make your product better.  The more good feedback you get, and the faster you get it, the faster you can incorporate that feedback to improve your product.  The best feedback you can get is not from ideal devices used under ideal conditions, but rather from real use in real conditions. In other words, postmarket feedback.

Getting actual usage data and feedback quickly and reliably is important in any industry.  But it’s becoming ever more important in medical devices and diagnostics:

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Topics: FDA Approval, Agile Development, FeedBack,

A Fully Functioning Agile Shop in an FDA Environment

Posted by Jim Kingsberg on Mon, Mar 10, 2014 @ 10:30

As an application and software development project manager at Pathfinder, I’ve been on the front lines of many product development processes, and I’ve witnessed both the successes and obstacles that cross the development path. Working with Agile Method lends itself to a fast-paced development cycle, but challenges can easily sneak up on you and throw a project off track. In order to stay ahead of possible snags, I suggest keeping an eye out for some common problems and tackling them as soon as they arise.

 

 

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Topics: 510(k), FDA, Agile Development

Planning for Feedback: Three User Thursdays

Posted by Bernhard Kappe on Wed, Mar 05, 2014 @ 11:10

There are many excuses for not getting feedback from users and customers:

  • They'll steal our intellectual property
  • They'll reject it if it's not perfect
  • It takes too much effort and is too expensive
  • (Secretly) We're afraid of being proved wrong
  • If we talk to them, we may have to change what we're building, and it's too late for that.
  • We don't have time

In our experience, the value of getting feedback from users far outweighs the risks and inconvenience.

As the graph from the Standish report highlighted in the eBook points out, 70% of software features that are built don't get used, either because they're not that important to the users, or because of inadequate design. At the same time, important features are often missed, or discovered late in testing.

To put it another way: You never get it right the first time. Frequent feedback from users lets you iteratively improve the product, starting with prototypes and moving through development, preventing wasted effort on unnecessary features and making the features you do build usable and effective (and reducing human factors risks in the bargain.)

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Topics: medical mobile software development, medical device software, Agile Development, Healthcare Software

The Increasing Importance of Software in Medical Devices

Posted by Mitch Posada on Mon, Mar 03, 2014 @ 01:00

Medical devices have become such a vital part of modern healthcare that practically no diagnosis or treatment is possible without them. According to the WHO, there are about 1.5 million medical devices available today, ranging from low cost devices like the thermometer and stethoscope to expensive, highly sophisticated devices like MRI and chemotherapy machines. With the increasing complexity and connectivity of medical devices, the role of medical device software development is becoming more crucial.

Medical software applications are designed to give devices a range of functionalities. For example, in addition to enabling a device to interact with the human body, a device could perform a host of other functions such as measuring blood sugar levels, monitoring heart rate and dispensing medication. Today's medical devices are also capable of communicating with each other wirelessly and over the internet to other devices and applications, magnifying the importance of software to process and display accurate information for various users.

The term "medical software" has been in use since the early 1980s, when advancements in software technology made it possible to build software-driven medical devices. The early software programs were little more than control programs that switched the device on and off and displayed readings like temperature and pressure. As devices became more complex, so did their software. In addition to the controlling and monitoring of the devices, advanced software functions began to emerge.

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Topics: mHealth, medical device development, medical device software, Healthcare Software, medical devices, healthcare

Getting your 510K Medical Software Ready

Posted by Mitch Posada on Wed, Feb 26, 2014 @ 10:31

Medical devices have become so indispensable to modern healthcare that practically no major diagnosis or  treatment can be done without them. According to the WHO, an estimated 1.5 million medical devices are currently available, ranging from the humble digital thermometer to the highly sophisticated MRI machine. An increasing number of these devices are being driven by software external to the device, for example, a companion mobile app.

The growing popularity of software-driven medical devices has made it necessary for manufacturers to be aware of the 510K medical software development process, especially in the case of regulated class II and III devices. Since even a small flaw in such devices can directly or indirectly result in the injury, or even death of a patient, every new device must be approved by the Food and Drug Administration (FDA) before it can be made available to the public.

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Topics: FDA

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