Can healthcare SaaS really be agile?

Although healthcare regulations exist for good reasons they often pose signifcant challenges for anyone working in tech. Stringent rules often slow development cycles and stifle innovation in a sector already burdened by bureaucracy. Agile methodologies, with their focus on speed, flexibility, and iterative progress, don't always play nicely with with the exhaustive documentation and rigid approval processes required in healthcare.

When it comes to regulatory compliance, these are the main offenders for slowing down development

• Data Privacy: Ensuring compliance with HIPAA or GDPR involves meticulous encryption, user access controls, and audit trails.

• Clinical Validation: For solutions impacting patient outcomes, rigorous testing and validation processes are mandatory.

• Interoperability Standards: Compliance with standards like HL7 or FHIR requires additional development and testing time.

Even though compliance standards can slow things down, you can find impactful efficiencies with the right tech stack and process. The goal --> have the tools do the heavy lifting, solve problems quickly and focus on removing roadblocks.

The right tech stack will save you time

Invest some time upfront to research the right tools in order to align your tech stack with Agile principles while addressing regulatory demands. Here are some areas of focus that can increase your speed and save you time in the long run.

1. Automated Testing: Automated testing accelerates compliance validation by eliminating manual effort. Try tools like Selenium or TestCafe for efficient compliance checks.

2. AI-Powered Analytics: AI enables real-time monitoring and predictive analytics to proactively address compliance issues. A data platform platform such as Snowflake can provide robust and scalable insights.

3. DevSecOps: DevSecOps integrates security into the development pipeline, meeting compliance requirements continuously. Tools like Aqua Security can enhance your DevSecOps workflows.

4. Cloud-Based Platforms: Scalable cloud platforms support secure, compliant infrastructure. AWS HealthLake for healthcare-specific cloud solutions have many incorporated feature that can do a lot of the heavy lifting for you.

5. 21 CFR Compliance: Addressing regulatory requirements like 21 CFR involves maintaining detailed audit trails and validation processes. A tool like MasterControl streamline compliance for FDA-regulated industries.

Finding the right tools can streamline workflows, reduce manual errors and minimize operational overhead creating space for innovation.

Prevent stagnation and remove roadblocks

The best process is the one that works for your team and company culture. Adapting standard Agile practices to suit your team's needs will allow them to identify and resolve roadblocks and prevent them for getting stuck in the weeds.

Outcome-Driven Development (ODD)

ODD shifts the focus from features to measurable outcomes. Start with something easy to measure and interperet such as enhanced operational efficiency. For instance, for hospital incorporating new tools for operations, a measurable outcome would be to reduce hospital scheduling delays by 20% within six months of launch. This works well for ongoing iterations of existing tools. Teams can prioritize work that drives tangible value, avoiding distractions from non-essential tasks.

Dual-Track Agile

This methodology separates product discovery from delivery, enabling teams to explore and validate ideas in parallel with development. For healthcare SaaS, the discovery track can focus on compliance challenges and user needs, while the delivery track ensures that validated solutions are built and tested efficiently.

Basecamp Model

For healthcare SaaS projects that require multiple approvals or extended timelines, the Basecamp model—breaking work into discrete, manageable phases—can help maintain momentum. Each phase ends with a “basecamp” checkpoint for reviews, reducing the risk of large-scale rework. This can be beneficial for enterprises developing SaaS platforms that integrate with legacy systems or require extensive stakeholder alignment.

Balance compliance and innovation

If you're in healthcare, you can't ignore regulations, instead you can find ways to navigate them more effectively. By combining advanced technologies with methodologies like ODD and Dual-Track Agile, you can stay compliant without sacrificing speed or creativity. The key lies in aligning teams around shared outcomes, investing in automation and security, and maintaining a culture of continuous learning and adaptation.

Companies that respect the regulatory landscape will set the pace for the industry. Agility, after all, isn’t just about moving fast—it’s about moving smart.

What tools or methodologies have been effective for your development?