In the medical device industry, regulation is a big deal.
Proper training for internal operations staff, and consumer and professional end users, needs to be done effectively in order to ensure patient safety and compliance.
E-learning has emerged as a cost-efficient and flexible way to disseminate training information to medical staff and patients and, although, there’s no one-size-fits-all solution, the relatively new practice can be tailored to fit specific needs.
What is E-Learning?
E-learning refers to training that’s done electronically, or on a digital platform. Instead of the old-fashioned paper trail left by traditional corporate training methods, e-learning uses webinars, interactive online classrooms and engaging web content to educate medical device employees.
To ensure compliance, a Learning Management System (LMS) is used to track and document e-learning progress. An LMS can create customized e-learning reports for companies and sometimes comes equipped with additional teaching and collaboration tools. LMSs administer, document and track e-learning projects.
Utilizing digital training techniques is advantageous for a few different reasons. Namely, having training material online allows for global companies to easily reach international employees and patients. At the same time, disseminating information online is cheaper and can be tailored to adapt to the specific needs of trainees.
With e-learning, professional trainers are no longer required to travel internationally to educate medical professionals. Additionally, audio, visual and interactive features help to delve into topics in a more effective way than traditional methods.
An e-learning campaign needs to be accessible to a global audience in order to be effective, and the prominence of English language e-learning programs leaves international learners at a disadvantage.
For this reason, it’s important to ensure e-learning materials are translated and localized properly. And a strong localization campaign requires more than just translation; learning styles differ by culture and taking into consideration stylistic changes such as color, images and tone are necessary.
Using a global writing style free of culturally biased references will keep costs down and increase the efficacy of training materials. Effectively localized e-learning material helps global offices scale operations, improve sales and meet regulatory requirements.
Electronic Instructions for Use, referred to as EIFUs, represent the newest form of e-learning for professional medical device end users. EIFUs replace traditional paper Instructions for Use (IFUs), physical copies of instructions provided to end users.
With audio and visual components, EIFUs make for more effective training materials than paper manuals, lowering printing and distribution costs.
EIFUs were approved by the U.S. Food and Drug Administration in 2003 and in 2007 the European Union created regulations for in vitro devices. In 2012 the E.U. implemented a set of regulations for medical devices.
EIFUs are extremely beneficial to medical professionals as virtual tutorials create visual images of how a certain medical product should be used. EIFUs are available on-demand and in a variety of languages, as well.
While the implementation of EIFUs can be a complex process in certain markets, the benefit to the end user is well worth it.
Choosing the Best Solution
Identifying the proper solution for a medical device manufacturer requires an understanding of the scope of a training campaign for successful implementation. Keeping in mind what languages and cultures training materials are aimed at, as well as what learning styles work best for employees and patients, is imperative.
E-learning applications must take into consideration users, languages and purpose. It is up to each medical device company to decide which model is right for them. Ultimately, accessibility and customizable solutions will provide the best results.