Building software for healthcare is tough. Between FDA regulations, safety requirements, and complex technical challenges, it’s no wonder so many teams feel overwhelmed. The reality is that developing medical software and Software as a Medical Device (SaMD) comes with high stakes. One wrong move can mean costly delays or failed approvals. But here’s the thing: it doesn’t have to be this complicated. After working with many teams in this space, we’ve noticed three common pitfalls that come up again and again. The good news? There are proven strategies to overcome them. Let’s dive into what’s tripping up many teams and, more importantly, how to avoid these pitfalls entirely.

Pitfall #1: Teams Working in Silos

Here’s what we see all the time: your development team is racing to build features and hit deadlines, while your quality and regulatory teams are focused on compliance and safety checks. These departmental silos result in major challenges. Sound familiar? This is one of the biggest problems we see in medical software development.

Why This Happens

It’s not that people don’t want to work together – it’s that they’re often speaking different languages:

• Developers are thinking about speed, innovation, and getting things working
• Quality teams are focused on compliance, safety, and thorough testing
• Everyone ends up frustrated because priorities seem to clash

Overall, it is a lack of mutual understanding and a communication breakdown. Developers may not fully grasp regulatory requirements, and Quality teams may not appreciate the technical constraints and timelines of development. Communication breakdowns occur often due to different technical languages and perspectives. The result? Miscommunication, inefficiencies, rework, delayed approvals, and increased risk of non-compliance.

The Fix: Guided Collaboration

Instead of leaving teams to figure it out on their own, the key is to implement Guided Collaboration. Guided Collaboration is a structured strategy where a dedicated individual or team acts as a neutral bridge between software and quality departments. This person’s job is to help both sides understand each other, translate terminology, and align goals across teams which results in:

• Accelerated time to market by reducing miscommunication and rework.
• Improved software quality and compliance through better alignment of goals and expectations.
• Reduced regulatory risk by ensuring documentation and processes meet FDA standards from the start.
• Enhanced team morale and efficiency by fostering a culture of shared ownership and mutual respect.

To implement Guided Collaboration effectively, the key is to:

• Appoint a highly skilled guided collaborator early in the project to facilitate communication and alignment.
• Schedule regular check-ins. Don’t wait for problems to surface. Get everyone in the same room (or video call) regularly to review progress, clarify expectations, and sort out any confusion or blockers.
• Design workflows that work for everyone. Create processes that let developers move fast while still meeting compliance requirements from day one.

The payoff is huge: faster development, better quality, and way less stress for everyone involved.

Pitfall #2: Failing to Define and Follow a Process from the Start

Here’s a hard truth: for medical device software, the FDA expects you to have a clear, repeatable process – not just a one-time packet. Yet so many teams treat documentation and quality management as an afterthought.

Why This Backfires

When you don’t define your process upfront, you end up with:

• Rushed or incomplete submissions
• Inconsistent documentation that raises red flags with regulators
• Last-minute scrambling that delays your timeline
• Documentation that clearly shows you created it after the fact

The Fix: Think Process-First

• Define your development and documentation process before coding begins. Doing this will provide a true roadmap along the way.
• Start with your Quality Management System (QMS). Even if it’s simple at first, having something in place early makes everything else easier. Be sure to right-size your approach by tailoring your QMS to your company’s size and the device’s risk classification. A low-risk Class I device doesn’t need the same level of rigor as a high-risk Class III device. The FDA gets this – your process should reflect your actual risk level.
• Document as you go. Follow the simple rule: say what you’re going to do, do it, then document what you actually did. This creates a natural paper trail that regulators love to see. Start with essential Standard Operating Procedures (SOPs) and expand as needed. Be sure to allow for adaptability as your product and team evolve.
• Keep it real. Your medical device software documentation should tell the true story of your development process and reflect the actual sequence of events.

Pitfall #3: Underestimating the Scope of Development

Medical device software development involves way more than just writing code and what is required varies based on risk classification. Teams often underestimate what they’re really signing up for, which can delay or derail FDA approval.

What Gets Overlooked

• Cybersecurity requirements that go beyond basic security
• Risk analyses that cover all the ways things could go wrong
• Process standards like ISO 13485 and IEC 62304
• The sheer volume of paperwork required for FDA approval

The Fix: Plan for Everything

Make a thorough project plan that identifies all the project deliverables. Before you start coding, list all user an design requirements. Yes, it’s a long list – but better to know upfront than be surprised later.

• Learn the standards. ISO 13485 and IEC 62304 aren’t just suggestions – they’re a framework for what the FDA expects to see. Get familiar with them early.
• Get the right expertise. Having qualified personnel isn’t just a good idea, it is an FDA requirement. If you don’t have someone on your team who really understands these standards, find someone who does. This might mean hiring a consultant or bringing in a partner, but it’s worth the investment.

The Bottom Line

Medical software development doesn’t have to feel overwhelming. When you break down silos, define clear processes, and plan comprehensively from the start, everything becomes more manageable. The benefits speak for themselves:

• Faster time to market because you’re not constantly backtracking
• Less risk and rework because you got it right the first time
• Smoother FDA interactions because your submission thoroughly meets expectations

At CieloWorks, we’ve helped companies navigate these exact challenges. Whether you’re building your first medical software product or trying to scale up your quality processes, we know how to streamline the path from idea to market. Ready to make your medical software development less stressful and more successful? Let’s talk about how we can help you avoid these common pitfalls and get your product to market faster.