When you build(or buy!) a house, you make sure the foundations are in place before starting anything else. The same goes for starting a new medical device project. And one of the major foundational pieces for starting a new medical device project is to know your regulatory requirements. Ignoring or misunderstanding these requirements can lead to significant setbacks, financial penalties, and even project failure.
Here’s why knowing your regulatory requirements at the beginning of a project is important
Knowing your regulatory requirements helps you avoid market entry barriers
Ignoring regulatory requirements is one of the most effective ways to ensure your product never reaches the market. While regulatory requirements may FEEL like bureaucratic hurdles, they are essential guidelines designed to ensure your medical device is safe and effective for patient use. By adhering to these regulations, you demonstrate a commitment to quality and responsibility, which are critical for long-term success in any market.
It helps you streamline your developmental process
Not knowing the regulatory requirements can lead to significant delays and potential rejections from regulatory bodies, which can be devastating for your timeline and budget. That is why, it’s important to fully understand the regulations early–possibly before you start developing new products. Doing so can help you streamline your development process and avoid costly setbacks.
Having regulatory compliance built into your system from the beginning ensures the safety and effectiveness of your medical device.
Compliance can be painful (you know where😉), but it forces you to focus on thoroughness, patient safety, and beginning with the end in mind (Stephen Covey would be proud). It supports product reliability. This ensures that the final product is both safe and effective, resulting in a medical device company that fosters trust and confidence among healthcare providers and patients.
The cost of non-compliance
Failing to comply with regulatory requirements can result in significant time, effort, and financial losses. You may face extensive design changes, additional testing, and prolonged timelines. More importantly, non-compliance can compromise patient safety, which is the ultimate priority in medical device development.
To ensure early compliance with all the regulatory requirements, you need to:
Secure the right regulatory counsel
Securing the best regulatory counsel within your price bracket is essential for navigating the convoluted landscape(there, I said it) of regulatory requirements. Your counsel should be a partner who can:
- follow your instructions
- provide critical pushback in areas where regulatory agencies are particularly sensitive.
- proactively challenge any attempts to cut corners, as compliance is not an area where shortcuts pay off.
The latter is invaluable, as it ensures that your product development aligns with all necessary regulations, reducing the risk of non-compliance early on.
Be committed to evidence and standards
Committing sufficient time and effort to provide evidence that regulatory requirements are being met is crucial. This typically involves adhering to and documenting, appropriate international or national standards for product testing and development. While thorough testing and documentation are vital in demonstrating compliance, they also serve as a safeguard against potential issues that could arise during regulatory review.
Budget for ongoing regulatory support
Make certain there’s sufficient budget allocated for your regulatory counsel to be available throughout the entire development process. Regulatory landscapes can shift, and having a knowledgeable partner can help you navigate these changes and keep your project on track. This continuous engagement also allows your counsel to weigh in on important decisions that may have regulatory implications. Having them involved from start to finish:
- ensures your product actually gets into the markets you’re targeting
- helps identify potential compliance issues before they become major problems.
While medical device compliance may seem an afterthought (especially if your product is still in testing or development), it is a cornerstone for a product’s success and sustainability. More important, it’s a smart strategic move. To be profitable, medical device companies need to introduce quality products to the market as soon as possible (and keep them working and marketable long term) while staying on top of the evolving medical device regulations and quality controls.
That’s where working with the right project management consultancy, such as Waddell Group, helps.
Waddell Group’s experienced consultants and project management experts have helped medical device companies worldwide address current quality and regulatory management issues, and future-proof their companies by identifying gaps in their current systems and implementing effective safeguards. Our proven 4 step framework will help your team stay on top of regulatory and quality requirements. You can know more about our framework here
Or you could just schedule a free consultation call by clicking on the button below.