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Building Connected Care Systems




CBI Mobile Medical Apps Summit 2015

Mobile apps provide an excellent opportunity for life sciences companies to improve patient support and health monitoring. Apps for disease management, patient information and engagement, as well as apps that enhance pharmaceutical product features and drug delivery are evolving quickly. Patients have more access to an immense amount of digital information and apps help make medical information more usable and user-friendly.

Pathfinder Software’s CEO, Bernhard Kappe will be sharing his expertise on Designing a Process Model for Using Patient Monitoring and Sensors for Adherence at CBI Mobile Medical Apps Summit, December

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10 Myths about Agile and the FDA

1. Myth: Verification and Validation should only start after all development is complete. 

Truth:  In traditional waterfall, verification and validation activities often commence at the tail end of a project, after all development is complete.  This diverges from the FDA’s recommendations:

“[The FDA] does recommend that software validation and verification activities be conducted throughout the entire software lifecycle.”[n]

In Agile, verification and validation start at the user story level, providing traceability from user story to code, code to unit test, and user story to

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Agile Without Fast Feedback is not Agile

Agile methodology has been adapted to the medical device industry to incorporate risk management, human factors and verification and validation so that it satisfies both the letter and the spirit of the FDA’s Quality System Regulation.

Agile methodology is designed to get feedback early and often during the course of product design and use this feedback to continuously improve the product. This fast feedback cycle, coupled with agile practices such as test driven development and continuous integration, allow product organizations to rapidly reduce requirements uncertainty, more closely

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Why We Need to Bend the Healthcare Cost Curve (in 3 Charts)

There’s a lot of discussion about ways to “bend the healthcare cost curve.”  What do people mean by that, and why do we need to bend it?

I like to answer that question by showing three simple charts.

1. The growth of Healthcare Expenses


2.  Where we spend our healthcare dollars

3.  What’s coming down the pike: the demographic timebomb

Source: U.S. Administration of Aging 2010a.


We’ve had a trippling of the share of healthcare costs as a percentage of GDP over the last 50 years, from 6% to

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Medical Software under UX Influenced Development

Clayton Miller is a user experience (UX) and visual designer at Pathfinder. His previous agency experience in the visual design world ranges from basic design work to UX design and development. Since joining Pathfinder, Miller has transitioned further into UX and visual design, incorporating UX into new product designs and development.

Creating a product with a positive UX is the key to success in any industry, but especially in the technology and healthcare spaces. The early stages of developing any product involve an intense research component, including

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Catalyze – HIPAA Compliant Cloud Computing for Healthcare

We asked Travis Good, Co-founder at Catalyze to write a guest post with his perspective on the space: 

We founded Catalyze a little over a year ago to solve compliance issues arising between healthcare, technology and data storage. It’s a very domain-specific problem, and many people outside of the healthcare industry don’t truly understand what it entails from the perspective of technology, development or healthcare innovation.

My co-founder and I had experienced challenges related to compliance, hosted technology, storage and data processing first hand at a

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Faster Feedback Before Development Starts: Feasibility

While change, new discovery and learning is inevitable during any healthcare app product development process, and agile processes reduce the cost and risk of change, there is significant cost associated with design controls for development, whether you are using agile methods or not.

In a typical product development cycle, a high level product concept or set of new features is given to an R&D organization, which defines detailed requirements and specifications before development begins.

There is still a lot of risk during this stage*:


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teamcity config



Automating Database Promotion With TeamCity, Azure, and SQL PowerShell

A current medical software project here at Pathfinder involves a lot of Microsoft SQL database development. There was already a good automation process in place for pushing our code out to different environments using TeamCity, our Continuous Integration (CI) server. But we were manually moving new database files into our Quality Assurance (QA) and User Acceptance Testing (UAT) environments when there was a database schema change. We quickly saw an opportunity for automation, and sought out the means to script database promotion from one environment to another. Our

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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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