When you are in the early stages of developing a medical device, over half of your activities are regulatory-related. Therefore, having an optimized and efficient regulatory affairs operations is critical. It will be the difference between getting your device to market on time or suffering a crippling setback.
Automation is one of several key factors that allow you to optimize your entire regulatory affairs process. Without it, you leave yourself wide open to an array of potential mistakes. For example, manually compiling over 1,100 pages of content can lead to an accident such as omissions an discrepancies.
These critical errors can cause delays that cost your company thousands, if not millions of dollars. Depending on your current financial situation, that might be a type of loss your company cannot recover from. This type of financial setback can turn those avoidable missteps into fatal ones.
However, the right automation tool can transform your regulatory operations and make sure this never happens. The key is to invest in a platform that provides you with crucial submission insight. This includes a complete go-to-market strategy, understanding the required testing your device needs to complete, and more. Leveraging the power of automation is a choice you cannot afford not to make.
The Rapid Evolution of Regulatory Policies
Regulatory rules and policies change and shift at a rapid rate. Medical device companies are constantly facing the challenge of balancing these regulatory requirements with the commercial viability of the device they are bringing to market. Failing to strike the right balance in this area can be the difference between your device getting to market and watching it die before it even has a chance to succeed. It is up to a companies regulatory affairs team to balance these competing priorities.
However, a team is only as effective as the operational process they implement and follow. It’s important to understand the importance of an optimized regulatory process. To do this we must better understand the complexity and magnitude of the rapidly evolving library of regulatory requirements. Only then can we truly grasp the workflow required to manage the widening range of medical technologies.
The Role of Regulatory Affairs
The sheer number of relevant guidance documents, testing protocols, and submission checklists a regulatory affairs team must include in their submission presents a massive challenge. This high volume of data and information presents several potential areas for mistakes. If you are not careful, your chances for a successful pre-market application in jeopardy.
Not to mention, submitting regulatory submissions is only part of the job description for regulatory affairs specialists.. They also contribute to the regulatory strategy by gathering competitive intel using the FDA 510k database and coordinating with cross-functional teams.
They also must consistently monitor changes to product codes, guidance documents, and standards. This issue can be seen on full display when looking at the FDA’s refuse-to-accept rate when it comes to reviewing regulatory clearance applications.
A surprising 31.3% of applications get rejected before even initiating the review process and are forced to withdraw due to errors. This requires your team to go back into the 1,100+ page document, find and correct the mistakes, and start the process again. This delay in getting your device to market can cost your company millions of dollars.
Managing Your Cross-Functional Teams
It takes a village to manage the regulatory process for a medical device. While one person may run point on the entire project, they rely on significant help from their cross-functional teams. This includes design, labeling, sterilization, clinical and quality departments. For this type of collaboration to work, all relationships must be built on the following four pillars:
Ensuring everyone has access to the latest regulations, guidances, forms, and templates required by the regulatory authorities you are submitting into.
Following project management procedures that create a seamless workflow amongst all cross-functional teams.
Identify and eliminate/reduce repetitive manual tasks that only serve to delay progress and cause errors.
Establishing a relationship with a regulatory affairs expert who can provide specific guidance based on your device based and the regulatory testing required by the region you are launching in.
Setting up these pillars at the start of your regulatory pathway is vital. Once your initial regulatory strategy is set up, the cross-functional teams listed above will be responsible for supplying various types of documentation for your submission. The data and content will be based on several factors, including the type of device, applicable regulations, changes to the device, manufacturing site, materials, and more.
Having Access To The Latest Regulations Guidance Documents That Impact Your Device
The average length of a 510(k) submission has reached 1,185 pages. This is a staggering 150% increase since 2009 and a direct result CDRH’s actions to clarify and strengthen 510(k) submission expectations. The FDA and European Commission (EC) have issued hundreds combined new guidance documents with 50% of them being released in just the last two years alone.
These new guidance documents can have a significant impact in the trajectory of your device. Furthermore, these consistent updates force your regulatory team to spend 4-6 hours a week keeping up with the latest developments. This is a time that can be much better spent working with cross-functional teams to collect and review all content before it is added to the submission.
Guidance documents are crucial to the regulatory lifecycle of your device because they identify several key changes. This includes, but is not limited to: UDI Management, device registration, and listing management. Failure to stay up to date on these changes can result in the aforementioned fatal mistakes we mention earlier.
Eliminating Costly Mistakes and Expediting Time To Market
One of the most time-consuming parts of compiling a regulatory submission is collecting, organizing, and revising key content such as tables and graphs. In addition, once all of your tables and graphs are uploaded, you must make sure they are correctly numbered.
However, what happens when a team member sends you a new table or graph that needs to be placed amongst the assets you already have in place? This often results in having to go through and re-number the majority of the list. These types of manual tasks only serve to waste time and increase your chances of making a costly mistake.
Asset numbering is just one of several types of administrative tasks your team is responsible for executing. This type of extended manual labor increases the odds of making a crucial mistake. Furthermore, once everything has been double-checked, it is then time to publish your 1,100+ page submission into a format that the regulatory body will accept.
This administrative burden will add weeks to your regulatory submission timeline. Optimizing your process by using automation tools makes sure that does not happen. The right tool will re-number your remaining assets after an addition has been completed. Automation tools go through a complete checklist to ensure you have included every step you need to complete.
No matter how long you have been working on regulatory submissions, it’s unreasonable to think you can learn everything. This is because of how rapidly things change in the medical device regulatory industry. With everything else going on, you do not have time to keep on top of everything. Leveraging an automation tools makes sure every box is checked, every document is formatted correctly, and you end up with rejection-proof and regulatory body-abiding submission.
Having Access To An Expert That Understand The Regulatory Requirements For Your Device
While your team may be excellent at creating and organizing content and data, they will undoubtedly run into an issue they cannot solve independently. The regulatory requirements for each device vary based on several factors, and it can be challenging to understand which applies to your device. Optimizing your regulatory process becomes meaningless if you don’t understand which steps you need to take.
Regulatory consultants are external experts who have the knowledge and experience to help you understand the regulatory landscape for your specific device. They can also be beneficial depending on the location you are seeking clearance in. For example, if you seek clearance outside your primary country, you must work with an authorized representative in-country. The right regulatory expert can walk you through this entire complex process.
Optimizing your regulatory operations saves serious time and money. The regulatory lifecycle of your medical device is long and complex. Without automation, you are forced to perform tedious administrative tasks that open you to all types of errors and delays. The right automation tool takes all of this off your plate and provides the peace of mind you need to move forward to compile an accurate regulatory submission on time and under budget.
Essenvia is a regulatory lifecycle management tool designed to help you automate the entire regulatory operation process. Our solutions include an innovative approach to building both your 510(k) and MDR submissions. Our software is designed to reduce errors, streamline processes, and guarantee faster regulatory clearance for your medical device.
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