When EU Regulation 2017/745 on medical devices came into force on May 25th 2017, it was like a giant bell ringing in a new era. Of course, manufacturers and related businesses in the medical technology sector were aware of the fact that the MDR would become a reality at some point. When it finally happened, it was high time to determine the impact.
Now, while regulatory affairs and quality assurance departments are focusing on the legal and compliance aspects of the regulation, it might be worthwhile to evaluate changes to specific workflows, areas or operating procedures – in order to successfully handle increased pressure on time and resources. Here are five keys to optimization from a communications perspective:
1. Small steps with huge impact
Now is the time to look into modern means and ways of communication. Before you head into any kind of MDR remediation process, take a moment to analyze current processes and question the status quo. Have you ever thought of introducing an editing system to eliminate endless correction loops during the creation process? What about the use of scripting to automate some steps and take shortcuts? Any improvement that helps you save time and costs is an important piece of the puzzle on the way to ensuring products comply with the MDR and that sales continue uninterruptedly.
2. Sure bet: The source is key
When it comes to translation, the emphasis is usually on the target languages. As a result of the MDR, translations into an increased number of target languages are now required. Before reshaping your translation process consider this:
- Invest in your source language: in technical documentation, much of the content within a publication, or even across different publications, is identical or very similar. For example in instructions for use (IFU). Note: consistency is key. Are you using an authoring software to support the writers of source language documents? Do you maintain a terminology database? Any measure to enhance consistency pays off in the translation process: the increased number of matches found within the translation memory results in valuable cost-savings and quicker turnaround times.
3. Translations: Choose a management model
Do you have a translation memory and are you keeping it up to date? If you work with a translation service provider, they probably do this for you. Fair enough. You want the savings that previously translated content can generate: the number of matches and repetitions normally defines the total cost of an individual quote – based on word rates you have agreed with your supplier.
Or are you working directly with freelance translators? Never heard of a translation memory? Then it is about time you looked into this. This does not mean you should start working with a translation service provider – keep doing your thing, if that is more like you. However, consider purchasing a translation management system (TMS). A TMS usually offers all the features you need to handle your translations in the most efficient way:
- Translation memory
- Terminology database
- CAT-tool (computer-aided translation)
- Workflow management
- Authoring support
- Project management tool
- Finances and reporting features
Once you have determined the volume of MDR-related translations, you might want to hire a dedicated translation manager – or book external support.
4. Unleash the power of your digital assets
Sometimes it is basic things that make the difference. How do you handle your digital assets in communications, say, your artwork files and images? Are they archived on a standard server or do you have a digital asset management system (DAM) in place? This system can help you to manage your data in a clean, reliable and more efficient way – with the help of these main features:
- Speed up your creation process: easy asset upload, integration of layout software, direct collaboration with colleagues, customers and agencies, automated versioning
- Comprehensive file management: asset enrichment with metadata, refined search function, general or project-based creation of folders and collections
- Easy output: share, distribute and publish your assets and publications quickly and on target
5. Use the full potential of your product data
Label texts is another important factor: how do you maintain product names and specifications? Product data provides the basis for successful product communications, as they need to be made available to customers quickly and in the highest quality. Whereas an enterprise resource planning (ERP) system is the more traditional solution, a product information management (PIM) system adds value by the following features:
- Media-neutral, central data management
- Efficient, slim processes
- Consistent and translation-oriented data maintenance
- Easy data exchange thanks to existing interfaces
- Agile product communciation on all channels: create product catalogs, data sheets or update your online shop and apps with just a few clicks
With the help of a PIM solution you ensure the quality of published data and save time and costs in the publication process. This type of solution also enables you to react promptly to changes in the markets and to update documentations at short notice.
6. Emphasize cross-functional teamwork
There are many ways to improve product communications, and the idea to challenge and change an established process may be easily put aside. However, if competences are spread over different departments in your company, this is an excellent opportunity to initiate cross-functional teamwork. The benefits can be manifold – for the project itself and, more broadly, for the company as a whole.
To summarize: If MDR roars at you, then roar back – plan smart and have more breath during implementation!
Need help taming the tiger? Stämpfli MedTech Services is here for you.