As executive director of both the Food and Drug Law Institute and AdvaMed’s Medical Technology Learning Institute, I developed hundreds of educational programs that relied on the shared expertise of FDA and industry speakers for firms wanting help with complying with FDA regulatory requirements. Today, as founder of Compliance-Alliance, LLC, I teach FDA and industry officials about effective documentation practices. Some of the insights I’ve gained on how to create effective educational programs are presented here.

The need for such programs continues to increase, due in large part to new medical-device requirements and advanced manufacturing technologies. In order to fulfill their regulatory obligations and provide safe and effective products, companies must commit the necessary resources for employee education programs.

Then the fun begins, or should.

Creating a desire to learn

New medical-device regulatory requirements and advanced technologies for improving manufacturing efficiencies create the need for companies to devote the necessary resources to their educational programs, so they can fulfill their regulatory obligations and provide the public with safe and effective products.

FDA’s Quality System Regulation requires that medical device firms identify the training needs of each staff member, so that the staff member will be able to perform the tasks assigned. Although most firms comply with this requirement by establishing formal training programs, these programs typically are not as effective as they could be.

Effective training must be able to change behavior. And forcing people to sit for hours in a crowded classroom, listening to an instructor with a monotone voice drone on about regulatory requirements won’t accomplish that goal.

However, when relevance to people’s lives enters the picture, an intellectual curiosity captures the audience’s attention. I have found that starting a presentation with a story about how the device company’s products improve the quality of patients’ lives stimulates interest. Then showing how each individual’s job contributes to the safety or effectiveness of the product, and explaining how failing to correctly perform the job detracts from product quality, usually drives home the message.

Another way to motivate people to pay attention is by reading excerpts from warning letters pertaining to employees at other device firms failing to comply with regulatory requirements. I then divide the class into small groups and challenge the groups to develop ways to improve procedures, so they will escape citation by FDA for similar deficiencies.

To increase interest in standard operating procedures (SOPs), I encourage people to imagine themselves as a prosecutor or FDA investigator. Then I ask these would-be prosecutors and investigators which activity would make them more indignant: a) if a firm did not have a procedure that was required by an FDA regulation; or b) if a firm had a procedure, but failed to follow it.

I have found that most people say it is worse not to follow a procedure. This shows a firm is not really committed to regulatory compliance, but rather is going through the motions to satisfy the government. After people reach that conclusion, I challenge them to examine their procedures, eliminate those that they are not following, and, perhaps, add new SOPs that accurately describe their operations.

Maintaining interest and measuring effectiveness

In this era of television and text messages, getting people to focus for more than seven or eight minutes at a time can be challenging. Speakers who read wordy bullet points from slides will quickly lose their audience, to what I call “PowerPoint hypnosis.” However, I have noticed that speakers who tell interesting stories and use pictures to illustrate concepts will likely keep their audiences.

The truth is many people would rather talk than listen. So I engage these students by using case studies and asking them to discuss proposed solutions to problems in small groups. Then representatives from the small groups are invited to compare their answers.

Other techniques I have found to be effective include group quizzes, role playing, voting, and prioritizing the importance of various tasks. Using people from different departments such as quality, marketing, sales, and training can also be an effective approach. Trainers can demonstrate the importance of the material by illustrating the effect of doing a task the right or wrong way from the point of view of those in his or her department.

Whether people actually change their behaviors determines if the training was effective. Predicting that is a big challenge. While tests can measure the short-term mastery of the subject matter, observation of product quality coupled with a thorough auditing of procedures will demonstrate whether the individual performed the function according to the information was presented during the training session.

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