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Building Connected Care Systems




Faster Feedback Through Integrated Cross-Functional Teams

In FDA regulated software development one of the most important keys to getting the most out of agile methodology is to ensure fast feedback from outside of the development team.

One way to do this is to build cross-functional teams – bringing some functions that are outside the development team into the team, so that it has all of the necessary skills to move a user story to completion.

In an FDA regulated environment, that includes not only developers, project managers and business analysts,

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Getting your 510K Medical Software Ready

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

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User Experience in an FDA Environment

Navigating UX through an FDA Environment

Amy Willis brings years of field experience to her current role as Director of User Experience and Visual Design at Pathfinder. As part of her responsibilities in this position, she’s learned how to navigate user experience testing within FDA regulations, how UX and FDA interact and how mutually beneficial their relationship can be.

Working in an FDA environment can add its own set of challenges to any project or development process, particularly when it comes to incorporating user

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The Increasing Importance of Software in Medical Devices

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

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Planning for Feedback: Three User Thursdays

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

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A Fully Functioning Agile Shop in an FDA Environment

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.

Mitchell Posada No Comments Agile developmentFDA

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Lowering Risk Using Agile and Lean Methodologies

We asked Jacque Harper, User Experience Architect of Pathfinder to write a post with his perspective on the space:

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

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The Growing Significance of Bluetooth BTLE in Healthcare

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

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The Growing Landscape of Medical Apps in Healthcare

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

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Dan Blake discussing how to launch products fast with Agile in an FDA environment

We asked Dan Blake,  Chief Technology Officer of Valence Health and former Senior VP of AirStrip Technologies to write a guest post with his perspective on the space:

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

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