Bridging Innovation and Compliance: Why Early Regulatory Integration Saves Startups

The Startup Reality Check 

Do you know this situation? You have a brilliant new idea to improve patients’ lives and have created an initial project plan, and it takes too long or needs too many resources to get it implemented. Now, where do you reduce resources? Risk management can be done later, same for IFU and all the requirements’ documents. Oh, and the Software we implement agile, and later we use a reverse engineering tool to create the Architecture and Design documentation for regulatory. In the end, the product is “ready to be sold”, but… 

• It fails standards tests as the distance between a conductor and the housing is 1mm too small, resulting in a redesign of another 6 or more months. 
• It fails to validate usability as the user interface is unclear for the intended user, and the detected issues need to be “prayed to be acceptable” in the risk management file. 
• The CE marking or FDA clearance lets you wait for another year until all deficiencies are fixed. 

And the usability problem (we’re still praying) will lead to an expensive recall in the next few years. 

Early Integration: What it Looks Like 

What if all these postponed tasks were done earlier? 

• The creepage distances would have been part of the requirements of engineering, and tests passed in the first round. 
• The formative usability evaluation would have unveiled the weaknesses of the user interface already months earlier, and the design would have been improved. 
• The CE marking or FDA clearance would be successful on the first try. 

And more than that, the recall we risk in the “do later” approach, will never occur: no costs, no damage to reputation, and free resources for the next idea. 

How to Implement Early Integration? 

Start with these small steps, which you should not skip: 

1. Define your medical device, so that you know where you want to go: What is the intended use? Who will be the user(s)? Who are the patients? Where will it be used? And do not overlook your target markets: Where will you sell the device? 

1. Map your requirements: identify the standards to be implemented and transform their requirements into requirements for your device. Watch out for national deviations and market-specific requirements.
   Do that in parallel to asking your target audience (medical staff, patients, etc.) about their requirements. 

1. Run a first risk assessment to identify hazardous situations from concept sketches and early architecture. Record potential risk controls as requirements and add them to the requirements list from above. 

1. Perform a first formative usability evaluation by using a rapid prototype or a cardboard model to uncover critical design issues before they become (too) expensive. 

1. Start with your QMS. You don’t need to directly have all processes implemented, but you should start with what you are already working on: design and development, risk management, software lifecycle (if applicable), usability, verification/validation, and maybe supplier control. Processes like post-market surveillance (PMS), vigilance, CAPA etc. can be implemented later in parallel to the product. 

After having set up your solid foundation for your project, go and develop it according to your processes and the identified standards. 

How to Get Smooth Through Medical Device Testing? 

Once you have implemented your medical device, you need to verify and validate it. Verification and validation are mostly done as part of your development process and done by your team. But some tests are usually done by test labs, such as biocompatibility, reprocessing, electrical safety, EMC and similar. The following steps help you, getting smooth to your standards reports: 

• Insulation concept for electrical medical devices, including your insulation diagram as well as the required creepage/clearance distances and rationale. This will not only help the lab understand your approach, but also your design team to ensure you’re not missing the 1mm. 
• Worst case configurations and failure cases should be defined in your risk management file so that internal tests and tests in a test lab can be built on them. 
• EMC starts with architecture. Cable routing, shielding, and filtering are design choices and should not be last-minute fixes in the test lab. 
• User and service manuals need to be in place for multiple reasons: not only will it help the test lab to understand your product, but it will also be checked for conformity in various standard test reports, and is often underestimated long-lead issue due to the translation into different languages ( it should be part of your market-specific requirements). 
• Traceability is key: trace requirements and risk controls to their implementation and verification/validation. Gaps in traceability are easy to find for an auditor. 

And finally: perform pre-compliance tests! Whether you ask for a timeslot in the accredited lab where you will later perform the compliance testing, or you go to a local university and ask to use their equipment, or you ask a development service provider to use their pre-compliance test lab: the lead time and costs are much lower than for the “official final testing”. Use this opportunity to ensure you’re ready. You can even use that opportunity as an iterative testing possibility in your agile development process. 

The ROI of Early Regulatory 

The ROI of early regulatory integration: 

1. You will need fewer test cycles. Each one can save six figures, and 3 to 6 months in project duration. 
2. Having less deficiencies in submissions for CE mark, or from the FDA will save you another couple of months in project duration. 
3. Early integration of risk management and usability, and a clear requirement engineering process will avoid recalls, saving your reputation as well as resources and costs for fixing. 
4. Having a credible regulatory plan brings confidence for investors and de-risks your path to market. 

End Note 

Early regulatory integration isn’t bureaucracy. It’s a design discipline. It turns standards into implementable requirements, aligns teams, and lets test labs confirm what you already know: your device is safe, effective, and ready. Start small, don’t skip steps, and keep risk management, requirements engineering, and tests connected from day one. That’s how startups bridge innovation and compliance – and avoid the 1 mm mistake that costs a year.

Disclaimer. The views and opinions expressed in this article are solely those of the author and do not necessarily reflect the official policy or position of Test Labs Limited. The content provided is for informational purposes only and is not intended to constitute legal or professional advice. Test Labs assumes no responsibility for any errors or omissions in the content of this article, nor for any actions taken in reliance thereon.