Alex Butler, Medical Device Solutions Manager, MasterControl 12.11.17
Hollywood influencers like to say, “You’re only as good as your last film.” In the medtech industry, it’s more like “Your device is only as good as its product dossier.”
No matter how cutting-edge your device, you must demonstrate its safety and efficacy to regulators through its dossier, or it will never reach patients and consumers. Whether you’re applying for a clearance or premarket approval (PMA) in the United States, a Shonin in Japan, or a CE mark in Europe, you’re going to need an effective dossier.
Getting a device cleared or approved is not easy. In the United States, a total of 2,957 devices received 510(k) clearances in 2016, the lowest number since 2010, according to a report from Emergo [PDF]. Further, the report stated that medical device firms waited an average of 177 days before receiving a 510(k) clearance from the U.S. Food and Drug Administration.
Device manufacturers can’t afford delays in the product registration process, and effective dossier management is key to a timely and successful regulatory submission. It’s no wonder dossier management is a source of constant anxiety for many regulatory, submissions, and quality professionals. Their pressures grow exponentially if they are registering more than one device in several markets across the globe.
4 Dossier Management Tips
Whether your device is innovative or iterative, you are going to need the following essential elements in your product dossier to avoid delays and ensure success in regulatory submissions.
1. Establish a Single Source of Truth
Creating a single source of truth is critical, but also more difficult, for companies with teams spread across the globe. It’s common for big companies to use multiple systems (e.g., PLM, MES, ERP, and QMS) based on the needs of their business units or divisions. If those systems can’t “talk” to each other, it means the teams and business units can’t work together efficiently either. If this is the case with your organization, you need a platform that will integrate the different systems and serve as the repository for all submission artifacts.
2. Create Project Registration Transparency
Project transparency is necessary to facilitate collaboration across departments. If your organization is registering multiple devices in different markets, team members should be able to see all geographic locations where the product is being registered and the corresponding requirements. Inversely, they should readily see all products (and corresponding artifacts) that are up for approval or re-registration in every geographic location. This kind of transparency is possible only with automation. Choose a system that provides project visibility by region and product through dashboards, analytics, and reporting functionalities.
3. Nail Down the Moving Targets
When you have more than one product in multiple countries or regions, you will be managing various product expirations, registration deadlines, and compliance requirements. All of these elements are moving targets that could change at any given point.
A simple spreadsheet is not enough to track down and monitor so many variables. A spreadsheet doesn’t scale to the granularity of regulatory requirements or to the growth of your organization. Equip your team with the right tools so you can track down changes in projects in real time and identify any bottlenecks. The more devices you manufacture and the wider your company’s market reach becomes, the more you need a scalable system.
4. Keep Abreast of Changing Global Regulations
The global market is indeed huge, especially when it comes to the array of regulations and standards that apply to medical devices. Countries and regions (e.g., the European Union) enforce different regulations and standards. The more markets targeted, the more regulations a company needs to monitor and comply with.
It’s hard to keep up with an evolving international regulatory landscape with manual processes. Let’s say your catheter is about to expire in five countries. Each country has different rules for re-registration. On top of it, you must find out if those rules have changed since your last registration. A manual system will require extra vigilance in checking every country’s requirements. If you are considering automating your system, choose a solution that will automatically schedule review of regulations and expiration deadlines. An electronic product registration solution can make all the difference between a timely and a late submission.
Market Growth
The global market offers many opportunities for manufacturers. Worldwide sales for medical devices are expected to increase by 5 percent annually until 2022. This year, sales are expected to reach $413.6 billion, a big improvement from a negative growth between 2014 and 2015.
To compete in the global market, you must ensure a timely and successful product launch. If your organization continues to rely on a manual or hybrid system that combines paper-based and automated processes, it’s high time to consider a fully automated system. It’s the first step toward increased efficiency and effective submissions. Choose a system that offers best-practice templates, checklists for expirations and deadlines, and robust project management tools.
Alex Butler is MasterControl’s manager of medical device solutions. He leads the development efforts for MasterControl Registrations. He’s also responsible for developing and/or improving other software solutions, namely MasterControl Customer Complaints, Bill of Materials (BOM), Projects, Risk Management, and PDM Connector. Butler’s medical device experience includes working as a product development manager for Opal Orthodontics, a division of Ultradent Products Inc., where he helped launch several Class II medical devices.
No matter how cutting-edge your device, you must demonstrate its safety and efficacy to regulators through its dossier, or it will never reach patients and consumers. Whether you’re applying for a clearance or premarket approval (PMA) in the United States, a Shonin in Japan, or a CE mark in Europe, you’re going to need an effective dossier.
Getting a device cleared or approved is not easy. In the United States, a total of 2,957 devices received 510(k) clearances in 2016, the lowest number since 2010, according to a report from Emergo [PDF]. Further, the report stated that medical device firms waited an average of 177 days before receiving a 510(k) clearance from the U.S. Food and Drug Administration.
Device manufacturers can’t afford delays in the product registration process, and effective dossier management is key to a timely and successful regulatory submission. It’s no wonder dossier management is a source of constant anxiety for many regulatory, submissions, and quality professionals. Their pressures grow exponentially if they are registering more than one device in several markets across the globe.
4 Dossier Management Tips
Whether your device is innovative or iterative, you are going to need the following essential elements in your product dossier to avoid delays and ensure success in regulatory submissions.
1. Establish a Single Source of Truth
Creating a single source of truth is critical, but also more difficult, for companies with teams spread across the globe. It’s common for big companies to use multiple systems (e.g., PLM, MES, ERP, and QMS) based on the needs of their business units or divisions. If those systems can’t “talk” to each other, it means the teams and business units can’t work together efficiently either. If this is the case with your organization, you need a platform that will integrate the different systems and serve as the repository for all submission artifacts.
2. Create Project Registration Transparency
Project transparency is necessary to facilitate collaboration across departments. If your organization is registering multiple devices in different markets, team members should be able to see all geographic locations where the product is being registered and the corresponding requirements. Inversely, they should readily see all products (and corresponding artifacts) that are up for approval or re-registration in every geographic location. This kind of transparency is possible only with automation. Choose a system that provides project visibility by region and product through dashboards, analytics, and reporting functionalities.
3. Nail Down the Moving Targets
When you have more than one product in multiple countries or regions, you will be managing various product expirations, registration deadlines, and compliance requirements. All of these elements are moving targets that could change at any given point.
A simple spreadsheet is not enough to track down and monitor so many variables. A spreadsheet doesn’t scale to the granularity of regulatory requirements or to the growth of your organization. Equip your team with the right tools so you can track down changes in projects in real time and identify any bottlenecks. The more devices you manufacture and the wider your company’s market reach becomes, the more you need a scalable system.
4. Keep Abreast of Changing Global Regulations
The global market is indeed huge, especially when it comes to the array of regulations and standards that apply to medical devices. Countries and regions (e.g., the European Union) enforce different regulations and standards. The more markets targeted, the more regulations a company needs to monitor and comply with.
It’s hard to keep up with an evolving international regulatory landscape with manual processes. Let’s say your catheter is about to expire in five countries. Each country has different rules for re-registration. On top of it, you must find out if those rules have changed since your last registration. A manual system will require extra vigilance in checking every country’s requirements. If you are considering automating your system, choose a solution that will automatically schedule review of regulations and expiration deadlines. An electronic product registration solution can make all the difference between a timely and a late submission.
Market Growth
The global market offers many opportunities for manufacturers. Worldwide sales for medical devices are expected to increase by 5 percent annually until 2022. This year, sales are expected to reach $413.6 billion, a big improvement from a negative growth between 2014 and 2015.
To compete in the global market, you must ensure a timely and successful product launch. If your organization continues to rely on a manual or hybrid system that combines paper-based and automated processes, it’s high time to consider a fully automated system. It’s the first step toward increased efficiency and effective submissions. Choose a system that offers best-practice templates, checklists for expirations and deadlines, and robust project management tools.
Alex Butler is MasterControl’s manager of medical device solutions. He leads the development efforts for MasterControl Registrations. He’s also responsible for developing and/or improving other software solutions, namely MasterControl Customer Complaints, Bill of Materials (BOM), Projects, Risk Management, and PDM Connector. Butler’s medical device experience includes working as a product development manager for Opal Orthodontics, a division of Ultradent Products Inc., where he helped launch several Class II medical devices.
