Are You a SaaS Company Looking for a Piece of the Life Sciences Action?

Terri Hanson Mead
Terri Hanson Mead
Published in
3 min readOct 27, 2022


I’ve received a few inquiries lately from SaaS vendors interested in selling into life sciences. They see the big dollars in the sector and want a piece of it. I don’t blame them.

The calls I received were for validation services. They wanted me to come in and ‘validate’ their applications to make it easier to sell to biotech, pharma, med device, and/or peripheral types of companies.

I could have just said, sure, let’s ‘validate’ your application.

I could have taken their money, provided them with some documentation and gone on my merry way, but as a business person and as someone who has worked with biotech, med device, diagnostic, and digital health companies for over two decades, I couldn’t.

There’s a gap between what SaaS solution providers see as the opportunity and what the real needs are.

There’s also a gap between what life sciences companies want to believe they need in a SaaS solution, and actually selecting and implementing a compliant SaaS solution.

Market Opportunity Realities

Before I even talk to SaaS vendors about providing a validatable SaaS solution to life sciences, I ask the following questions:

— What’s your budget? Are you realistic about the required investment for creating and sustaining a validatable and compliant SaaS solution for life sciences?

— What’s the market opportunity? Who are you selling to? Who is the decision maker within the life sciences company? Is it big enough to offset the investment you are about to make?

— What are your expectations about creating a SaaS product for the life sciences space? Are you expecting it to be a one time activity or an ongoing series of business functions?

—Who are the competitors in the space?

— Are you aware of how conservative the life sciences space is in trying new technology solutions? How are you going to get the first customer?

— How frequently are you updating your SaaS solution?

— Do all customers have to update to the latest release?

— Are you aware of what the life sciences customers need to do on their end as part of the change management process for a validated system? What are you planning to do to make it easier on them?

— What documentation will be provided to the life sciences customers in advance of the release? How far in advance?

— Will a test environment be available to the customers to perform testing prior to production release? How much time will customers have to test? What if they find issues?

— Are new functions/features automatically turned on with each new release?

I’m pretty sure that with these questions I’ve made it more difficult for me to actually get the consulting gigs.

Often these companies retreat to meet internally and reconsider whether it’s the right move for their companies, especially if they currently serve a non-life sciences industry with very different requirements.

The infrastructure and processes that need to be put into place to be a true life sciences SaaS solution result in a serious investment and often a change in company culture.

New people have to be hired.

New tools need to be put in place.

New processes need to be developed and implemented.

It takes a lot of money and resources to go after the big dollars seemingly available in life sciences with no guarantees of success.

So do you do it? Do you take the risk? Is the investment worth it?

Need help? Not sure if you do?

Please reach out to me if you have any questions or want to learn more. I can be reached at Or check out my company website at

Other Resources from Terri Hanson Mead: Blog Posts

SaaS Vendors’ CSA/CSV Responsibilities for Life Sciences

SaaS Systems: Validating for Intended Use

SaaS Vendor Audit: Sample Audit Agenda

SaaS Adoption Will Lead to Compliance Issues for Life Sciences Companies

Failed IT Implementations Are Expensive: Here’s How to Avoid Them



Terri Hanson Mead
Terri Hanson Mead

Tiara wearing, champagne drinking troublemaker, making the world a better place for women. Award winning author of Piloting Your Life.