Who are you?

Hi, I’m Aaron! I’ve worked in life sciences for more than 15 years.

I started as a software engineer for a medical device company here in Pittsburgh, PA. This is where I had my first exposure to agile development.

When I started, no one in the company was doing agile. (It wasn’t OK to even ask about “agile.”) But then, team by team, we began experimenting and saw positive results. Five years later, roughly half of all software development teams had adopted agile methodologies.

And product quality didn’t suffer one bit. In fact, we won our second Malcolm Baldridge National Quality Award.

Later I worked as a lead product developer for a vendor building FDA-compliant tools. This role allowed me to work as an agile team member and as a consultant to other companies. (Including 11 of the world’s largest life science companies .)

Throughout, I’ve learned a lot about becoming agile in a regulated environment. If that’s what you’re interested in, then you’ve come to the right place!

What is this place?

This is the place for agile change leaders. If you work in regulated software development and believe waterfalls should only be for nature hikes, then I have the resources you need to get started or bring your agile game to the next level.

Why should I care?

Because businesses–even life science businesses–need every competitive advantage they can create. And being more agile than the competition is an advantage. Shorter release cycles and tighter feedback loops result in faster times-to-market, higher product quality, and happier customers.

How are you different from the other consultants, coaches, or “coachsultants”?

I understand the bigger picture.

Many life science consultants hyperfocus on regulatory compliance. Don’t get me wrong, compliance is critical. But it’s not the only thing that’s critical. You have business and technical stakeholders, too.

Your boss needs to know when the next release is going out the door. Your developers and testers need the right information and tools to build an amazing product. And you need to be FDA-compliant and audit-ready. I can help with all of this.

How much can a software engineer (you) really know about audit readiness?

Quite a lot…from the perspective of an engineer. I have plenty of experience being audited and know what it takes to pass.

For example, I once did so well during an FDA audit that my manager and I received $50 gift cards from our department’s compliance manager. Do you know how hard it is to get a gift card from the compliance team? (Harder than getting an “atta boy” from Senior Drill Sergeant Martori in basic training. But that’s a different story.)

I’ve also consulted with dozens of life science companies of all sizes and have a proven track record of working with their internal compliance stakeholders.

That said, my expertise is in agile development processes. I won’t provide advice on an overarching Quality Management System (QMS), or guidance on obtaining regulatory clearances, etc. However, your QMS and your regulatory applications will be much more successful with my SDLC processes.

Why do you talk so much about Jira and Confluence?

Much of what I teach is based on Atlassian Jira and Confluence.  There a few reasons for this:

1. I have a lot of personal experience with Atlassian products.
2. Jira and Confluence are the two most-used management tools by professional developers.  (According to both the 2022 and 2023 Stack Overflow Developer Surveys.)
3. Through best-in-class configurability and extensibility (i.e. the Atlassian Marketplace), they provide everything we need to implement compliant workflows.

Do you only support companies that use Jira and Confluence?

No, I support other platforms, too. I have tons of experience with HP Micro Focus OpenText ALM, and I also have experience with qTest, Tosca, MKS, and several other platforms, too.

The agile principles, concepts, and processes I teach are tool-agnostic. You can apply them to any platform or technology stack, assuming it provides the minimum features and controls necessary for regulated development.

That said, if you aren’t married to a platform yet, I can give you a much bigger headstart on the Atlassian Cloud platform.

Do you ever work with teams in other industries (outside of life sciences)?

Yes. I occasionally support other industries, too. We may be a good fit if you’re interested in agile development and need (or desire) high-quality standards.

But if you embrace a hacker culture , you can find a better guide than me. Rather than “Move fast and break things,” I believe in “Move as fast as you can without breaking things.” Not nearly as catchy, but it will get you promoted instead of fired!

How can I follow you on social media?

You can follow me on “pseudo” social media, like YouTube .

You can also subscribe to my email list.

I’m not on LinkedIn, Facebook, Twitter (X), etc. And yes, I know it’s weird. But I tried them, didn’t like them, and haven’t looked back.

Ok, that was a lie. I liked them, but I didn’t like that I wasted 4 hours every day scrolling through feeds, counting my “likes,” and trying to win pointless arguments. (Mostly the last one.)

So it’s true that I don’t use them anymore.

I’m in. What should I do next?

Schedule a 15-minute call with me…entirely commitment-free.

We’ll chat on Zoom (or whichever software you prefer) and get a feel for each other. I’d like to learn more about your company or team–where you are in your agile journey, where you want to be, and the challenges you’re facing–and you can find out more about what I have to offer.

If we both agree it’s a good fit and that I can be helpful to you, then we’ll schedule a deeper dive where I can learn more and give some initial advice. If it still feels like a good fit, then we can setup routine coaching.

Too soon for a call? No problem.

Feel free to browse the website, checkout my YouTube channel, and download my free resources. Then come back to schedule a call when you’re ready.

BTW…were those really frequently asked questions?

No. Only the first one…and this one.