Using Clinical Technology...but in a good way

Figuring out what system will improve your business and the why, when, and how it should be configured, implemented, and validated.

April 5, 2023

But before we get to that

A bit about me: I’ve been involved with life sciences technology for more than 20 years. I started writing about how to use the systems, then got into testing, determining how a system should look and feel, training users on how to use it…and so on. Along the way, I learned on the job and via coursework about software development, database administration, clinical trials, QC, QA, user interfaces, user experience, and software validation.

Before the life sciences, I worked in domains that were about as far away from clinical and pharma/biotech as possible (commercial diving/welding, textile manufacturing). However, by viewing everything as part of a system with data flows, process workflows, rules, and requirements, you can apply prior experience and learning to address challenges in seemingly disparate areas.

Why this, why now

A large part of my consulting practice has been focused on managing the implementation and validation of technology systems for clients. This work made me realize that simply enabling the software is only part of a solution, and that if the system is not properly configured and tested to meet the client’s needs, it’s worse than staying with their existing solution.

The primary goal of this column is to discuss the factors that go into implementing, configuring, validating, and preparing your users for a new system. Because we work in the life sciences, it is important that the technology we employ is set up and tuned correctly. These systems are part of the ecosystem dedicated to improving patient outcomes so it’s essential that we ensure they enhance the work of sponsors, clinicians, nurses, and everyone who is working with the system.

Ideal outcomes

As mentioned, I’ve done a fair bit of work in this area, but the domain is enormous. I’ve learned a certain amount, but there is so much more knowledge and experience out there. My hope is that the topics I cover here provide a starting point for discussions with others working in the space who undoubtedly know more than I do.

Although forward movement amongst the stakeholders in life sciences often seems slow, glacial even, certain changes are warranted based on prior experiences. Updates in regulatory guidances, new indications and treatments, and, especially relevant here, new technologies. In some cases these are incremental improvements but in others, the changes are significant, disruptive, and game-changing.

Plans

It’s important to have a plan. My intention is to publish something new twice a week, with the possibility of brief Notes (a new Substack fixture) in between, based on important and noteworthy updates. But, the best laid plans… Since this is my first go, an experiment at best, plans may change. I’ll do my best to update big changes to keep expectations aligned.

That’s about it. I’ll get some content out there and see where it leads.

Thanks.