With the European Medical Device Regulation (MDR) looming, medical device companies are focusing on ensuring compliance with the new regulations.  One of those key aspects of compliance is to ensure your devices conform to the General Safety and Performance Requirements (GSPR).  This guide provides you with some practical guidance on how to meet those requirements.

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

First and foremost, we hope everyone has a safe and healthy New Year!

2018 was a great year at RIMSYS and 2019 is starting off just as strong.

We are excited to announce that we have teamed up with Right Submission, LLC to release a regulatory insight content series catered specifically to the medical device industry.  Combining decades of regulatory expertise and behind-the-scenes knowledge, this new partnership will provide unparalleled value to its current and future customer base which includes thousands of regulatory affairs professionals.  You can check out our full press release here and our first content piece here: 2018: A Year of FDA Regulatory Changes to the 510(k) Process and Why it Matters to You.

If you haven’t heard of Right Submission, you are in for a treat.  Right Submission is a software solution provider specifically catered to the medical device industry (just like RIMSYS) and has developed a SaaS-based tool that creates high quality 510(k) applications ready for submission while meeting FDA’s technical and style requirements.  It utilizes a guided process reducing resource requirements, cost, and time, strengthening the content of your submission and streamlining workflows.  They also have other tools to help with your Clinical Evaluation Reports (CERs), Clinical Study Reports (CSRs), and researching the correct regulatory pathway.  You can check out all of their products here.

I had the opportunity to sit down with Jon Speer, Founder & VP of QA/RA at Greenlight Guru to record a podcast to discuss streamlining the MDSAP Marketing Authorization & Facility Registration Process.
If you are not familiar with this topic, you need to hear this.
We discuss:
  • Why your regulatory team may be perceived as a bottleneck and why it is important everyone needs to be on the same page about when the product can be released.
  • The connection between marketing authorization and facility registration required for various countries – United States, European Union, or elsewhere.
  • The need to get organized, get better systems in place, and stay compliant when an auditor comes through your door or when you plan to sell into markets.
  • Why small and large companies need to get organized now (i.e. small companies have too much information to maintain, organize, and track while large companies may have resources but suffer from miscommunication and disjointed processes.)
  • The need to not be complacent and not be afraid to change systems. RIMSYS was created to help regulatory professionals successfully and efficiently handle documentation.
You can hear the podcast below or at the Greenlight Guru blog.

The medical device and in-vitro diagnostic medical device industry are in dire need of a robust, practical and easy to use regulatory information management (RIM) system.  Without a unified and collaborative system, serious consequences to your business can occur, including an increased risk of non-compliance, increased costs as well as a possible significant reduction in a product’s revenue potential.

1. REVENUE IMPACT

Missing registration dates, slow-to-market losses, and long-term, cascading impacts such as loss of customer loyalty have an immediate impact to market capitalization. Moreover, improper release of product due to lack of visibility to regulatory statuses can cause fines and loss of credibility with authorities, which can result in increased scrutiny.

2. REGULATORY COMPLIANCE

Compliant product releases are required in the medical device industry. Automation that creates safeguards to prevent unintentional release of products into markets is a must. Regulators from different markets are working together to identify instances of non-compliance as well as misalignment of information in submissions and other communications. More effective control of the submission, enabled by a unified platform, can lead to a leaner, higher quality submission and a reduced regulatory burden.

3. FASTER TIME TO MARKET

Better planning and tracking in a unified system can monitor process metrics, milestones, and automatically informing submissions plan timelines with actual performance. A unified solution connects planning to execution, allowing improved, real-time process monitoring. Teams can quickly spot constraints and take action, allowing the product to get through your process faster.

4. EFFICIENCY AND COLLABORATION

Regulatory processes touch multiple functional areas. Regulatory functions have been piecing together disparate systems to achieve marginal improvement. This landscape inhibits the accurate and timely transfer of data and disruption in cross-functional workflow.

5. TALENT RETENTION

Employee turnover on regulatory teams is linked to the 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.

6. INSURANCE POLICY

Having a fail-safe in place now for when (not if) your top talent leaves prevent the loss of company and product specific tribal knowledge. Retraining a new employee without the subject matter expert can cause delays and wasted time. A unified system keeps all information within the company.