The harshest lesson a startup can learn is building a product nobody wants - or a device solving a problem that doesn’t exist. And it’s not just wild-eyed entrepreneurs who make these errors. Big corporations can fall prey to the problem, too.
Watch: Sam Shelley from SQMS explains the biggest mistake any device start up can make
Remember, Pfizer’s Exubera, the world’s first insulin inhaler? You wouldn’t. The product flopped spectacularly as the bulky design failed to consider the primary customer need for a solution that was highly portable and discrete. It lead to a $2.8 billion loss and one of the biggest pharmaceutical failures in history.
Medical device development demands time and money, so skipping market due diligence can be disastrous if you can’t prove there’s a real, unmet need for your innovation.
Many teams focus on building prototypes first, leaving regulatory questions for ‘later.”’ But with medical devices, failing to classify your product properly or neglecting key regulations (MDR, IVDR, FDA QMSR) at an early stage can bring your entire project to a standstill later on.
That’s because the regulations dictate how you organise your end-to-end development process. They determine the document controls you’ll need in place to record your decision making, manage project risk, and validate outputs. They show you the extent of the technical documentation you need to index and retain for future auditing - and everything you will need in place to launch your product legally.
Watch: Sam Shelley from SQMS explains why you need to know the regulation:
A Quality Management System (QMS) needs to shape every phase of your development process.
You need to have the procedures in place to define your SOPs - and impose the document and design controls that will build your products to the required standard in a consistent way. The right electronic quality management system (EQMS) helps you automate required processes from CAPAs to calibration and NCRs - helping you minimise costly errors and future recalls.
It helps you structure the documentation and maintain complete traceability, so you can always prove to auditors that your product is safe and effective.
If you only start thinking about quality requirements mid-way through your project you’ll struggle to piece together your documentation retroactively.
Watch: Sam Shelley from SQMS explains why quality cannot be back-solved
Many companies assume they can shortcut compliance by purchasing bundled SOPs to meet ISO 13485 requirements. While these templates can provide a starting point, simply ‘stocking up’ on generic procedures misses the point - your QMS must reflect how your company actually operates.
Off-the-shelf SOPs are too generic to address the specific risk profile, product classification, and operational structure of your business.
Watch: Sam Shelley from SQMS explains why you can't 'buy in quality'
It’s one thing to have SOPs on paper - it’s another to practice them consistently. Regulators and Notified Bodies check whether your actual processes match what your QMS says. If they see inconsistencies, you risk audit failure, product launch delays, or even product recalls.
Watch: Sam Shelley from SQMS explains why you must do what you say!
Verification checks whether you built your device correctly (meeting technical requirements). Validation checks whether you built the right device (meeting user needs). Ineffective planning and execution of your V&V steps can lead to a product that is clinically irrelevant - or one that’s never proven safe.
Watch: Sam Shelley from SQMS explains the difference between validation and verification
The requirement for Stage 1 and Stage 2 audits comes from ISO 13485:2016. Stage 1 assesses whether your QMS is correctly documented and ready, while Stage 2 evaluates whether you are effectively following those processes.
Misjudging readiness is a major cause of audit failure. Some startups schedule them too close together, leaving no time to collect records or fix issues uncovered in Stage 1. Others space them out incorrectly and risk breaching regulatory windows.
Watch: Sam Shelley from SQMS explains why your Stage 2 audit timing is so critical
A founder alone can’t juggle device development, risk mitigation, and regulatory affairs without specialised knowledge. Not bringing in a quality/regulatory expert - or at least a consultant - can lead to fundamental missteps that stall your product’s progress.
Watch: Sam Shelley from SQMS explains when you'll need professional quality support
By avoiding these pitfalls early - and focusing on your quality management process - you can slash time-to-market, reduce compliance headaches, and give your investors the confidence they need to back your product.
Contact us to learn how the Cognidox eQMS can be the foundation of a scaling med dev business. We’ll demo our platform and show you how to keep your project on track from concept to market launch.