Medical Device Body of Knowledge Training Strategy


To provide more targeted training and validate understanding to employees, it is important to establish baseline knowledge. This case study explores how Chiltern developed its Medical Device Body of Knowledge training program.

Training is nothing without confirmation of knowledge transfer, retention and appropriate application.  

  In today’s ever-changing environment, where time is increasingly limited, resulting in less opportunity to formulate a targeted plan, the large-scale use of traditional monologue-based training as a solution to knowledge transfer is common. Attending a webinar or completing an online eLearning course is all too often deemed an appropriate stand-alone solution to a recognized training requirement.     At Chiltern, we accept that distributing core training material is a critical component in the training process. However, we also acknowledge that single, unintegrated events are simply not enough to quantify that knowledge has been transferred to the level required to ensure staff are immediately capable and competent on the associated tasks and activities. Therefore, we recognize that to provide more targeted training and validate understanding, it is first essential to establish baseline knowledge.   This core concept gained traction when our Learning & Development group and subject matter experts in Chiltern’s Medical Device & Diagnostics group decided to create a training and assessment program that validates device and diagnostics operational competency within the industry.   Clinical development within device and diagnostics carries unique requirements. Yet traditional training programs through the Association of Clinical Research Professionals or Project Management Institute lean toward medicinal product and industry-agnostic project management rather than medical device and diagnostics clinical development. Therefore, with leadership from our Medical Device & Diagnostics team and a benchmark review of the current CRA standards, we designed, built and implemented a CRA training program specific to medical devices that has become known as the Chiltern Medical Device Body of Knowledge.   The envisaged process was simple: Assess existing knowledge against a standard benchmark and then create a personalized training program for the CRAs based on the results. The data points supplied by the assessment process enable the L&D team to identify training requirements customized to each individual. For those CRAs who have previous medical device experience, the program serves to formally validate their knowledge in lieu of completing unnecessary training modules. By addressing each person’s exact training needs, this approach is not only more learner-centric but also more business-centric, giving a greater return on operational hours.    The first step to develop the program was to create the training material for the eLearning modules, encompassing all the information that should be known and understood for operational roles working on a medical device clinical trial, which was gleaned from our internal knowledge and materials. Our medical device faculty members then developed a strategic plan to align the material to the ACRP’s clinical research associate certification program. This was accomplished by developing a bank of questions designed to demonstrate a specific level of understanding relevant to the CRA role and mapped to associated areas of the ACRP’s content. This, therefore, means that, like the ACRP’s CRA certification, Chiltern’s medical device assessment certification contains clinical research content in the same areas, demonstrating the CRA’s proficiency in good clinical practices specific to medical device research.     Chiltern’s Learning & Development team ensures the delivery of the program is learner-centric. Working closely with colleagues in global resourcing, the team verifies that only the CRAs identified to work on medical device trials are assigned to the program. From there, the pre-assessment is administered through Chiltern’s Learning Management System.    The results from each CRA’s assessment generate training reference material to address the specific training deficiencies identified. Because the training modules and assessment were developed in tandem, the L&D team assigns just the relevant core topics to our colleagues, significantly saving operational hours and resulting in a user-centric approach to knowledge transfer.   In summary, the Medical Device Body of Knowledge program has achieved its objective. Through this program, we deliver targeted training to specifically identified staff according to their baseline knowledge and address any training deficiencies with customized, follow-up training material. To date, the program has been administered to over 150 employees globally, saving more than 100 hours in training time for this group.   So, to come back to the opening statement: To get a real return on a training investment, the training program ideally needs to be run as a complete end-to-end process of assessment, training and validation with the option for customized intervention for identified training needs. By applying a program as described in this article, companies more efficiently use resources while saving time, promoting engagement and knowledge retention and improving overall quality.   Michael Towse is the Associate Director of Learning & Development at Chiltern

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