The medical device industry is in dire need of robust, practical and easy-to-use software to make regulatory professionals’ lives easier. Without a unified, collaborative, and regulatory digital system, serious consequences to a business can occur, including an increased risk of noncompliance, increased costs, and a significant reduction in a product’s revenue potential.

Here are the five biggest indicators that it’s time to take your medical device regulatory team digital.

1. You miss simple regulatory compliance requirements

Has your company missed an update to a standard?  When a standard is updated that compliance is claimed for your products, a thorough review and associated gap analysis need to be conducted to determine if there is any impact to your products.  You also need to go through every single essential requirements checklist to determine where that standard is referenced and update it throughout. If you miss those activities, you will most likely receive a finding when being audited that will require corrective action and significant resources to fix and ensure it doesn’t happen again.

Additionally, as the new Medical Device Single Audit Program (MDSAP) is rolled out, regulators from different markets are now working together to identify instances of noncompliance as well as misalignment of information in submissions and other communications.

MDSAP requires medical device manufacturers to produce evidence of marketing authorization for each country that they sell into.  Your regulatory team needs automation to work for them in a way that creates safeguards to prevent unintentional release of products into markets.

There is a high need for more effective control of the submission process, enabled by a unified platform, which can lead to a leaner, higher quality submission and a reduced regulatory burden.

2. Your revenue is impacted

Are you missing registration dates, experiencing slow-to-market losses or long-term, cascading impacts such as loss of customer loyalty?  All of these have an immediate and lasting impact on market capitalization.

If your marketing authorization lapses, your company legally cannot continue to sell within that country or market, guaranteeing your sales team becomes frustrated because they won’t hit their sales numbers and your company’s financial projections will be impacted.

Moreover, improper release of a product due to lack of visibility to regulatory statuses can cause fines and loss of credibility with authorities, which can result in increased scrutiny.

Based on a recent survey of 100 companies, 65% of regulatory professionals require at least a week to gather the information needed to determine where their products are sold and whether they are properly registered within a country or market.

If you can’t easily find the information, how effective and compliant can you really be? It may be time to take your regulatory team digital.

3. You miss your time-to-market targets

How do you organize and manage your regulatory information?

If you immediately thought of SharePoint, Excel, Word, Email, Outlook, or Dropbox, you probably aren’t working in the most efficient manner.

In fact, based on a Deloitte study, up to 50% of a regulatory team member’s time is wasted looking for information.  Not only is your process inefficient but the way that you manage data and documents from a regulatory perspective is broken.

Based FDA’s published data, 35% of all 510(k)s submitted to the FDA get stamped with Refuse to Accept (RTA) designation due to simple and avoidable mistakes.

Avoiding these needless delays in getting your products to market should be a top priority to ensure months or years are not added to getting your product the proper clearances.

4. You are burdened by administrative activities

Are you having trouble with efficiency, collaboration, and talent retention on your regulatory team?

Employee turnover on regulatory teams is linked to stress and increases greatly if team members consider processes to be inefficient or wasteful.  Being able to perform one’s job efficiently and the perception of being part of a high-performing organization contributes to employee satisfaction and retention.

Regulatory processes touch multiple functional areas of a business in the highly regulated medical device industry. Regulatory teams have been piecing together disparate systems to achieve marginal improvement for years and are notoriously understaffed.

By giving them the right tools, so that they can do their jobs effectively and efficiently, should be priority number one.

5. You rely on institutionalized knowledge

Has a top member of your regulatory team left the organization, leaving you with no idea about what projects they had their hands in, the status of current submissions, broken down communications with external stakeholders, or lost critical tribal knowledge that wasn’t passed down?

Have you ever called that employee at their new company just to “pick-their-brain” because that critical information wasn’t transferred before they left?

Having a fail-safe in place now for when (not if) your top talent leaves prevents the loss of company and product specific tribal knowledge.

Bringing your regulatory processes into the digital age so your team and company can perform work within a central location ensures everything is properly documented and builds that critical archive of information.  A unified system and collaboration hub keeps everyone on the same page within a single regulatory platform. Think of it as your company’s regulatory insurance policy.
Employees change roles, leave departments, and move on to other companies, leaving you to pick up the pieces. Retraining a new employee without the subject matter expert can cause delays and wasted time.  So stop relying on disparate systems, disjointed processes, color-coded excel files, and emails that get lost in the shuffle and inhibit progress.

The Good News

There is good news.  Software solutions already exist that create a collaboration hub to help medical device companies actively navigate the changing regulatory landscape.

Software solutions such as RIMSYS Regulatory Management Software and Right Submission can empower your current team.  They provide better planning and tracking in a unified system that can monitor process metrics, milestones, and automatically inform submissions plan timelines with actual performance. A solution that connects planning to execution, allowing improved, real-time process monitoring provides teams visibility to quickly spot constraints and take action, allowing products to get through your regulatory process faster and with improved compliance.

It is time to set the new standard for the industry.  It is time to go digital and start automating your broken systems.


This article, in collaboration with Right Submission, is part of a regulatory insight content series catered specifically to the medical device industry. RIMSYS and Right Submission, leading medical device regulatory software solution providers, have teamed up to provide decades of regulatory expertise and behind-the-scenes knowledge to its current and future customer base which includes thousands of regulatory affairs professionals.

About Right Submission:

Right Submission enables medical device regulatory professionals to create higher quality content by bringing automation, project management, and collaboration to regulatory submission creation and publishing.

www.rightsubmission.com 

About RIMSYS:

RIMSYS is a Regulatory Information Management (RIM) platform designed specifically for the medical device industry.  RIMSYS offers a suite of cloud-based regulatory affairs software solutions to simplify and manage global product registrations, standards, essential principles requirements, regulatory documents, changing regulations and more.

www.rimsys.io

Often, the first thing we hear from a consultant or a medical device company regarding an FDA 510(k) premarket notification is that it was delayed because the FDA reviewer did not understand something simple within the application, or completely missed it.

What is wrong with the reviewer?  How could they have missed something so simple?  I couldn’t have been any clearer!

Sound familiar?

FDA is overworked, under-resourced, and will most likely miss something simple in your file upon reviewing.

As the specification developer, you know the design and history of the product better than anyone.  You are providing that entire history in a formal application for review, and hopefully, clearance.  A basic understanding of the technology is a must; however, think about the situation from the FDA reviewers’ point of view.  510(k) applications are inherently technical and sometimes need a brief discussion with the FDA reviewer for clarification or a general overview of your device.

Starting this dialog earlier is important for a smooth path to clearance.  Part of this process involves requesting a Pre-Submission (“Pre-Sub”).  Pre-Subs are a type of feedback that is part of FDA’s Q-Submission program.

Pre-Subs

Pre-Subs are a formal written request from an applicant for feedback from FDA to be provided in the form of a formal written response or a meeting (in-person or teleconference) in which the feedback is documented in meeting minutes.  A Pre-Sub provides the opportunity for a submitter to obtain FDA feedback prior to intended submission of a premarket submission (i.e., IDE, PMA, HDE, De Novo request, 510(k), Dual, BLA, IND) or Accessory Classification Request, among others.

Pre-Subs are entirely voluntary on the part of the applicant. However, early interaction with FDA and careful consideration of FDA’s feedback may improve the quality of subsequent submissions, shorten total review times, and facilitate the development process for new devices.

Pre-Subs provide FDA reviewers with an introduction to you and your device rather than just having a 510(k) application dumped on their desk.  FDA reviewers appreciate Pre-subs because they can get a sense of when they should anticipate filings and can plan their workloads accordingly.

FDA reviewers, like all of us, only have a certain amount of time during the day.  If they are unable to find information easily or do not properly understand something, then they may state that the relevant information is missing from the application or needs further clarification.  This kicks the 510(k) application back to you and stops the review clock. That is directly on the industry submitter, not the FDA reviewer.

The Bottom Line

FDA reviewers are people too.  This is an obvious but often overlooked point to make.  Sometimes they miss simple (and sometimes seemingly apparent) information.  They make mistakes.  The last thing you want to do is start yelling or pointing fingers.  After all, you don’t want to burn any bridges as you will most likely deal with the same FDA reviewer upon subsequent submissions for similar products.  Always be timely, concise, straightforward and respectful.

At the end of the day, keep in mind that your FDA reviewer isn’t as familiar with your medical device as you are.  You need to help them understand items that are unclear, and the only way to do that is through building the communication channel early and having constructive conversations.

Did you know RIMSYS Regulatory Management Software will keep track of all communications, notes, decisions, and tasks associated with your 510(k) application and other international regulatory submissions?  Find out more now with a free demo and we will show you the power of the only regulatory information management (RIM) system platform designed specifically for the medical device industry.

This article, in collaboration with Right Submission, is part of a regulatory insight content series catered specifically to the medical device industry. RIMSYS and Right Submission, leading medical device regulatory software solution providers, have teamed up to provide decades of regulatory expertise and behind-the-scenes knowledge to its current and future customer base which includes thousands of regulatory affairs professionals.

About Right Submission:

Right Submission enables medical device regulatory professionals to create higher quality content by bringing automation, project management, and collaboration to regulatory submission creation and publishing.

www.rightsubmission.com 

About RIMSYS:

RIMSYS is a Regulatory Information Management (RIM) platform designed specifically for the medical device industry.  RIMSYS offers a suite of cloud-based regulatory affairs software solutions to simplify and manage global product registrations, standards, essential principles requirements, regulatory documents, changing regulations and more.

www.rimsys.io