Tag Archive for: Rethinking Agile

TIR45 AGILE software regulatory compliance

WEBINAR: TIR45 | An AGILE Approach to Software Regulatory Compliance

Are you ready to seamlessly move from CLIA, Research Use Only (RUO) or Emergency Use Authorization (EUA) to a clinical software product?

Join us as we discuss an AGILE approach to software regulatory compliance. We’ll be hosting this informative panel discussion with the owner of Agile Quality Systems and principal author of AAMI TIR45, Kelly Weyrauch, and our partner (and panel host) Beanstock Ventures as we to discuss bridging the gaps between modern software development and regulatory requirements.

This panel de-mystifies the belief that Agile development lacks the proper controls for producing safe and effective software and that the regulation is burdensome. We will share experiences, ideas, and tools you can use for your software regulatory compliance while still staying adaptive and effective.


Date:        Thursday, May 20th, 2020
Time:        10:00 – 11:00am PST

Our panelists include: 

Adam Darmstadt 

Adam DarmstadtVP of Product Development, BeanStock Ventures
Adam is a software engineer with over 19 years of medical device and life science industry experience.  Adam and his team are passionate about  using lean and AGILE methodologies to speed up reaching the end goal without compromising quality. 

  

Clay. Moore

 

Clay Moore –VP of Customer Success, Jama Software 

With over 20 years of experience architecting and delivering SaaS-based enterprise solutions, Clay and his team help medical device  development teams modernize their approach to requirements, risk, and test management to improvequality and delivery. 

 

Kelly Weyrauch

 

Kelly WeyrauchOwner, Agile Quality Systems& a Principal Author of AAMI TIR45 

As one of the principal authors of AAMI TIR45 “Guidance on the use of AGILE practices in the development of medical devices software”, Kelly  has worked with the FDA and industry leaders on the application of AGILE practices to the medical device world. 

 

Watch the recording now!

WATCH NOW

 

 

This is the final post in a series examining the changes that have occurred since the Agile Manifesto was published and the implications they have on how we might consider the Manifesto today. Read the first post here and download the full ebook, “A Modern Take on the Agile Manifesto.”

In my earlier posts in this series, I discussed the need to review the Agile Manifesto in light of how the world (and how we work) has changed. I’d like to suggest some recommendations to ensure that product development is optimized to give organizations the best chance of success and customer satisfaction:

Pause and Rethink

  • Decouple the manifesto from Agile – take a moment to consider the manifesto through the lens of your own surroundings and look your own processes.
  • Continue to shift the understanding of failure – Look at how you’re releasing information and reacting to the release of that information. If you’re providing some kind of working software, it’s important to understand how you’re reacting to that. What are you doing as an organization to react to that information?
  • Evaluate your current communication modes – Are you an organization that loves to have meetings? Do you love to talk on IM or email? It may be worth actually recording some data on this and do some research and looking at the results – number of emails and reply-alls. You may find that decisions are being made in those vacuums and people are being left out because they weren’t even aware of a conversation that was happening.
  • Track metrics – If you do not have metrics, then it’s an emotional game deciding which direction to go in. One risk you run with metrics is misinterpreting the data so be sure to debate then negotiate what the metrics mean.
  • Think of Agile from an organization perspective – The more we can spread the idea the more it will mature.

Communicate

  • Find ways to constantly provide visibility – Into what you’re working on – even if it’s in its early draft stages. Sharing early and often is a good thing.
  • Find ways to allow communication and opinions to flow freely – There can be a fear that the noise level will hinder progress but I have not found that to be the case. I think there are ways to allow information to flow, and if it is found to be overwhelming, you can always work backward and filter it down to the relevancy of it. Having the wealth of information is a wonderful starting point. Your customers could be interacting with you through hundreds of mediums. It’s not valid to say you wish they would not interact with you but more valid to distill the information down to its relevancy.
  • Identify where decisions are made and captured – Decisions are happening everywhere and they are what cause your product or project to drift – going away from the initial path to the objective for a number of reasons. This will continue to become increasingly important.
  • Constantly ask if people understand what they are doing and why – There is an opportunity from a company perspective to empower and motivate by enabling people at every level to understand what they are doing and why. It drives creativity, innovation and success.

Evolve

  • Open up the dialog about culture – If you think this is not your role than think again. If you’re involved in the development and delivery of products you have a perspective and a voice.
  • Embrace process – Focus on making the process more efficient and understandable. Process gives us guidelines to collaborate more creatively and effectively.
  • Continue to communicate – Content and data is incredibly valuable if it’s made available in the right place. Having a ton of information is a great starting point, the next thing is figuring out how to utilize it.
  • Start with too much information then work your way back – Find the balance. In early stages of a product this can be especially true. Having more information will help you eventually develop parameters.