Medical device manufacturers have a thorough understanding of the science behind their products, every indication of use, and the cost savings or patient benefit when the device is used in practice. And they should, given the hundreds or thousands of hours in clinical verifications and trials required to receive regulatory clearance. As brochures are made for educating decision makers on the features and benefits of a device and instructions for use (IFUs) are produced for customers to reference before and during use, a manufacturer training program needs to be reproducible while still accommodating the preferences of each customer healthcare organization to best inform their practitioners. A device implementation training program should aim to establish adaptable processes while adhering to strategic best practice guidelines involving the training team, evaluation schedules, protocol modifications, and training materials.
Identify the Training Team
It is important to realize that any training team needs two separate sets of knowledge and skills: expertise and instruction. First, members of the team need to be the subject matter experts. In most medical settings, there are teams that specialize in the use of anything from feeding pumps to defibrillators. Subject matter experts are often department heads, unit educators, clinical nurse specialists, and frontline staff. Creating a training team isn’t one size fits all; other disciplines should be brought in as they relate to the device. As an example, for devices in the vascular access space, those with a recognized specialty are included in training teams. In many hospitals, they are referred to as vascular access teams, PICC teams, and intravenous (IV) teams, and are the facility’s recognized experts in the placement of PICCs, midlines, and peripheral IVs.
Second, the team must have the experience and skill set to transfer the knowledge to others. Good instructors are able to do the following:
- Demonstrate why the subject matter is meaningful.
- Adapt their teaching methods to match the learning style of each trainee.
- Communicate effectively and interpret feedback.
- Offer clear learning objectives and formulate questions to evaluate comprehension.
Department head and clinical educator involvement is encouraged to help build the training team and develop protocols and training content. In the end, the team an organization assembles to train others is at its discretion, but a training team works best when it has a full understanding of the issue and solution and is involved with clinical practice—including executing care and evaluating results, teaching clinicians, performing advanced evaluations, and providing guidance for implementing new procedures.
When developing a training schedule, book at least one educational meeting ahead of evaluations and implementations. For example, we begin with a review of the causes and signs of an IV infiltration/extravasation, which is the problem our device detects. The knowledge level of a specialist may not apply to clinicians across the hospital floors or different departments. Our training session will go on to discuss the multiple methods nursing units use to better assess IV sites to help with the early detection of an infiltration/extravasation event in addition to proper device set-up and best practices for use. This information helps the training staff assess what they are already doing and determine what protocols need to be revisited to deploy a new medical device into the equation.
Evaluations Set the Stage for the Relationship
Put the best foot forward when creating an evaluation plan by first determining the number of departments to be included based on the size of each unit and average daily census. Keep the size of an evaluation to where the onsite company representatives can maintain control and ensure correct implementation and use of the device. Having an onsite representative during the entire evaluation period should be part of any company’s protocol. To properly staff an evaluation and provide the customer with enough data to assess the device, an adequate timeframe for evaluations is one to two weeks but will vary by device classifications.
Evaluation expectations must be collaborative and agreed upon ahead of the first day. This includes education, data collection, evaluation summary reports, and personnel. Plan for best-case-scenario outcomes, but be prepared to request feedback about the device and report back to engineering and development teams, so they can interpret feedback or “feature requests” for future considerations and updates.
Resources Must Fit the Setting
Informational materials are a critical component of medical device packaging. In fact, many things like product manuals and instructions for use are a regulatory requirement. Depending on the needs of the customer, training takes on many different forms including classroom training, rolling education, change of shift and at the bedside. A good collection of resources should include job instruction sheets, videos, and handouts. As devices become more intuitive for users, we may see changes in what materials are necessary, but product and training materials should always consider the setting and workflow of the user.
High-quality medical device products must be accompanied by high-touch selling, implementation, and servicing models to keep customer satisfaction high.