For medical device companies, the ultimate goal is to commercialize their products, usually in more than one market. The road to a successful product launch in multiple markets is full of obstacles and one of the biggest hurdles is dossier management.
“Whether the device is new and innovative or an iterative product, its manufacturer must demonstrate the device’s safety and efficacy through its dossier, or it will never reach patients and consumers,” said Alex Butler, MasterControl’s manager of medical device solutions. “When I worked as a product development manager in a medical device company, dossier management and product registration were a source of constant anxiety and tremendous pressures for regulatory, submissions, and quality professionals.” (1)
In a new white paper, Butler shares the 10 most common problems encountered by medtech companies when it comes to dossier management and product registration. Butler, who has helped launch several Class II medical devices, also offers some practical tips.
Here are three tips for improving your dossier management. These are just a few of the many insights Butler shares in his white paper.
Create a Single Source of Truth: For medtech companies with facilities scattered in different cities and countries, it’s hard to ensure that the entire organization is using current, approved documentation if individual departments and offices have their own systems and servers.
“You need a single source of truth—preferably a fully automated, web-based system as the repository for all artifacts,” said Butler. For example, when a company’s headquarters in San Francisco approves a design change, there should be full confidence companywide that the teams outside of California will be using the same document because they will be pulling it from the same centralized source.
Make Your Registration Projects Visible: The lack of transparency usually results in poor collaboration across departments. Worse, it can lead to submission delays. Butler said you can hardly expect team members to be proactive if they can’t readily see the status of a project or monitor milestones. Project visibility is particularly crucial for regulatory and quality professionals managing the submissions for multiple products in multiple markets. If your organization still uses manual tools (e.g., spreadsheet) for tracking down regulatory submissions, consider switching to an automated system that will give you all the tools (e.g., analytics and dashboards) that will make your registration projects visible to all stakeholders.
Nail Down Moving Targets: Butler said product expirations, registration deadlines, and compliance requirements across multiple markets all represent moving targets. How to nail them down? Equip yourself with the right tools for tracking down changes in your projects and flagging down any delays and bottlenecks. A robust automated solution will also be able to alert you upon the approach of registration expirations.
Medical device sales worldwide are expected to grow by 5 percent annually, reaching $413 billion this year, according to Evaluate, a research firm for the life science sector. This is a significant improvement from the flat device sales between 2014 and 2015. (2)
There’s a vast global market for medical devices out there. You have every reason to make sure your product is launched in a timely manner. An effective dossier that will prove the safety and efficacy of your device is key to getting a 510(k) clearance or premarket approval or CE mark, which in turn will be instrumental in helping you get a piece of the pie.
Cindy Fazzi writes about the life science industry and other regulated environments for MasterControl. She has worked as a journalist in three countries. Her two decades of experience as a news reporter, writer, and editor includes working for the Associated Press in Ohio and New York City. She has a master’s degree in journalism from Ohio State University.
(1) Alex Butler, MasterControl’s manager of medical device solutions, 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. His 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.
(2) Quoted in “Medical Technology Sales to Hit $500 B within 5 Years” by Bruce Japsen, Forbes, Oct. 17, 2016.