Article

Agile in FDA Regulated Medical Software – Partnering

Michael Walkden

Published on: June 25th, 2011

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more.

This may be generic advice, but it might not be a familiar concept for those in IT working within a large organization doing validated software:

Once you adopt the practices described in my previous blogs about regulated software, you will find that you aren’t working alone anymore. The tight feedback cycles allow you to regularly check-in with the business and involve them in building the software. Once this happens, priorities and features will change. Early on they will change often. Don’t discourage this as it’s a good sign things are moving in the right direction. The people talking to your customers are directly involved in building features your customers will use. This is exactly what you want because it increases the likelihood that you will produce a better product. Now that you have left your IT bubble you must partner with your stakeholders rather than simply delivering to them on a regular basis. How do you effectively partner with business and marketing? Here are the difficulties you will likely face:

Goals are different
The phases and corporate dialect are different
The time frames and processes for decision making are different
Required documentation will be different and address different goals
Stakeholders will feel comfortable giving verbal requirements, but you must document them, get them formally approved and finally build them into working software

How do you partner with the business and still meet your commitments? Follow the practices we presented earlier and stick to the following principles:

Consistent focus on activities that add business value
Build trusted partnerships
Constant customer engagement
Continual process and practice improvement
Be collaborative and transparent
Work together: No heroes, lone wolves, or cowboys
Pay attention to the team and adapt as needed