8 common mistakes medical device startups and scale-ups must avoid

When you’re bring a medical device to market, you’re stepping into one of the most competitive and regulated industries in the world. In this blog post, Sam Shelley, a highly experienced medical device consultant shares the most common (and costly) mistakes that start-ups and scale-ups make on the long, hard road to launch.

1. Failing to validate a genuine market need

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.

How do you fix it?

• Conduct thorough market and user research early.
• Define and document User Requirements that reflect real clinical or patient needs.
• Get feedback from potential users and before you invest heavily in design

2. Ignoring regulatory requirements until it’s too late

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:

How do you fix it?

• Identify device classification (e.g., Class I, IIa, IIb, III in Europe, or Class I, II, III in the U.S.) from the outset.
• Map your process and documentation requirements to the right standards and regulations, from ISO 13485:2016 to the FDA QMSR.
• Discuss timelines and submission pathways (e.g., 510(k), PMA) with a qualified consultant to ensure your capturing the right details

3. Setting up your QMS too late (or not at all)

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

How do you fix it?

• Start your QMS as soon as you have a working concept or MVP.
• Create controlled processes for design and development, document control, risk management, and CAPA.
• Use an eQMS to manage documents, automate reviews, and maintain audit trails.

4. Thinking you can ‘buy in’ quality

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'

How do you fix it?

• Ensure you can customise SOPs to align with your company’s actual workflows, resources, and product risks.
• Engage your team in developing procedures so they are practical and usable.
• Regularly review and refine your QMS as your business evolves.

5. Paying lip service to procedures (instead of following them)

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!

• Write procedures that reflect actual workflows—and train staff thoroughly.
• Audit internally on a regular schedule to confirm you’re capturing real records for each process.
• Encourage a culture of quality with an EQMS at its centre, rather than treating procedures as a box-ticking exercise.

6. Mixing up verification and validation

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

How do you fix it?

• Maintain distinct Design Verification and Design Validation plans in your QMS.
• Test your device against engineering specs first, then confirm it fulfils clinical or end-user requirements.
• Document each step in your medical device technical file for easy reference and auditing.

7. Planning your audits badly (Stage 1 and Stage 2)

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

How do you fix it?

• Schedule Stage 1 once your QMS is fully documented and implemented.
• Plan 3–4 months between Stage 1 and Stage 2, allowing you to address any non-conformities that arise.
• Align clinical/validation timelines so you can show complete evidence of compliance during the final audit.

8. Failing to hire or consult a quality professional early

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

How do you fix it?

• Budget from day one for a consultant or part-time quality manager if you’re strapped for resources.
• Look for help in building an eQMS that supports the way you work, rather than imposing new quality procedures and ways of working from above
• Bring your quality consultant into look at major design decisions so that any changes align with relevant regulations and standards.

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.

Ready to see a LEAN EQMS in action?

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.