Research Spotlight: Pioneering Medical Device Training in the Digital Age

Written By

Sharon Vipond

August 17, 2016

Our newest Guild Research case study focuses on innovative uses of interactive video for medical device training. However, its lessons learned extend far beyond the realm of health care and medical device training.

We have made the point in other case studies that the learning and development community is fully awakening to the power of interactive video. In a recent article, “Interactive Video and the Changing Face of Training,” Jack Leigh pointed out that in 2015, 86 percent of eLearning customers “expressed some level of desire to access interactive visual content on demand. … The amount of people who strongly agreed that they wanted interactive video increased from 34 [percent] in 2013 to 46 [percent] in 2014.” To many of us, it is becoming increasingly clear that understanding and using interactive video is an essential knowledge and skill area for today’s eLearning leaders and practitioners.

This case study describes how a pharmaceutical company successfully overcame substantial learning challenges and created an interactive video solution for users of its new medical device, as part of the approval process the device is still undergoing (as of the publication date of this case study).

Using interactive video to support transformative product training

Headquartered in Lexington, Massachusetts, USA, scPharmaceuticals (hereafter scPharma) is a biopharmaceutical company that develops transformative pharmaceutical products for subcutaneous delivery of widely used generic drugs. Subcutaneous (under the skin) delivery enables convenient “anytime, anywhere” use—for example, in an outpatient setting instead of the emergency room or other inpatient settings. In addition, subcutaneous delivery often eliminates the need for catheters, which can be associated with serious complications, frequent adverse events, and high medical costs.

The use of interactive video is an integral part of scPharmaceuticals’ user training program for a drug-device combination enabled by the sc2Wear pump, a proprietary patch pump for subcutaneous administration of drugs (Figure 1).

Figure 1: An sc2Wear pump delivers medication

When patients, caregivers, and health care providers (HCPs) really know what they are doing, subcutaneous administration is often easier, less painful for the patient, and can be performed by patients themselves, caregivers, and non-certified health care professionals such as medical assistants, as well as HCPs. However, the challenge was to design and deploy training that would enable all three of these constituencies to effectively use a device such as the sc2Wear pump.

Design challenges facing the training team

The scPharma team had two critical building blocks for designing its interactive training video:

  • Instructions for use (IFU). The initial set of device use instructions (80 pages in length) was too long, too complicated, and required too many steps.
  • Quick reference guide (QRG). On the other hand, the QRG (at two pages) was too short to provide a clear understanding of the entire process.

The information contained in both of these sources was critical, but the team needed to present these detailed, step-by-step instructions at each learner’s pace of comprehension and in a non-intimidating, “high-touch” manner. Further, it was important for the training to enable device users to successfully perform a number of cognitive functions, for example:

  • Perceive information from the device
  • Interpret the information sent by the device and make decisions about what to do next
  • Manipulate the device, its components, and its controls as required to respond to visual and audio cues, replace a component, or stop the device
  • Interact with the device by sending input and preparing the device for use (e.g., unpacking, setup, calibration), using the device, or performing maintenance (e.g., cleaning, replacing a battery, making repairs)
  • Perceive other types of instruction or feedback from the device about the effects of user actions

Equally important, learners needed to provide a positive affirmation at each step of the way in order to ensure that they understood all the steps. It was also important to provide a means for learners who had trouble understanding the initial detailed instructions to jump back to previous steps in the process and practice any steps they felt unsure of.

Other audience analysis challenges

In addition to these training design challenges, the scPharma team was confronted with a number of other challenges related to its target audience, which included three very different types of device users:

  • Patients. Patients can apply the device to themselves, but only after being trained by a health care provider such as a heart failure nurse. Video instruction for patients is provided for the standing-up position rather than the lying-down position.
  • Lay caregivers. These are typically family members or others who take care of the patient on a regular basis. Video instruction for lay caregivers is provided for the lying-down position so that the caregiver understands how to apply the device to a prone patient.
  • Health care providers (HCPs). This group includes health care professionals such as physicians, heart failure nurses, and pharmacists who may apply the device during a patient’s hospital stay or office visit, or who may otherwise train the patient (or lay caregiver) to apply the device.

Obviously, it was critically important to both carefully analyze the audience and understand how to speak to each of these constituencies. An essential component of this understanding was to establish and define a general level of medical knowledge that could broadly apply to each of these groups.

Testing any type of detailed training is always difficult. But in the case of training for new medical devices, successful testing is literally a life-or-death requirement. Testing was necessary in order to eliminate unconscious errors; make all aspects of the process easy and visible; simplify overall device operations; avoid reliance on memory; and make it easy for the device user to catch and reverse an error.

Kathy Taudvin, director of corporate development for scPharma, explained these challenges: “Operating the sc2Wear device is actually not complex. Rather, I would describe it as a novel device with many critical steps. Missing or incorrectly completing any of the steps leads to errors, very few of which are considered ‘high risk.’ Though there are very few high-risk errors, any error may result in the unit not functioning and the patient not receiving his or her dose. However, due to the type of pharmaceutical compound being administered (e.g., cardiac medications, antibiotics), the patient would know that the dose appropriate for that compound was not delivered if audio and visual cues [provided by the device] were missed.”

scPharma’s technology approach

Given the design requirements imposed by this learning challenge, the scPharma team, led by president and CEO Dr. Pieter Muntendam, evaluated several learning technologies and quickly came to the conclusion that interactive video was the only learning approach that adequately met all of the design criteria.

This was not the company’s first venture into video learning. scPharma had previously used video as a way to demonstrate the capabilities of the sc2Wear device. But this type of linear video, often used within static web courses, could not deliver the degree of interactivity that the new device training required.

At the beginning, company decision-makers intuitively concluded that video would be a better learning solution for this medical device than paper. Although (at first) they did not have a clear sense of how to use interactive video, they knew that the biggest challenge of using a novel medical device was user error and that effective communication was critical to success.

Video navigation and user interface

With interactivity and patient engagement in mind, Dr. Muntendam looked at a number of interactive video tools and providers and ultimately decided to partner with Boulder, Colorado-based Rapt Media. Founded in 2011, Rapt Media provides a cloud-based, interactive storytelling technology that combines personalized narrative with data integration. Its HTML5 mobile-native video platform can navigate a large number of individual videos. As the website CrunchBase notes, “The company also offers solutions in the areas of creative services, branching, link outs, site pairing, and strategy aspects. The videos are available on browsers, tablets, and handheld devices.”

The scPharma and Rapt Media team members used the following division of labor to accomplish their project objectives:

  • The scPharma team created paper-based curriculum designs for learning content and navigation paths. At the core of these designs were the IFU (instructions for use) and QRG (quick reference guide) for the sc2Wear device.
  • Another critical component of the curriculum design was a detailed audience analysis, which identified the variety of learning, comprehension, and word-use issues unique to each of the target audiences.
  • Although scPharma had a good structure for the learning content and curriculum navigation, it did not have the in-house technical resources to build the type of videos the team envisioned. Rapt Media provided these technical skills and also subcontracted with a Boulder-based video production company to provide the acting talent and shoot all the individual videos that would be placed within the platform library. Rapt Media also provided project leadership and coordination for all aspects of the initiative.
  • Using the Rapt Media Composer, a cloud-based creative tool and editing suite, Rapt Media then built the interactive video application that navigates throughout the scPharma video library, and the team created flexible and personalized learning paths for each of the three learner constituencies (i.e., patients, lay caregivers, and health care providers).

Figure 2: Interactive video library navigation

  • The scPharma video library and interactive navigation video engine was launched using the cloud-based Rapt Media Player. As shown in Figure 2, this tool satisfied scPharma’s need to easily and quickly navigate and branch within a large library of video content, and the tool could enable easy jumping to specific content segments or other device information.
  • The scPharma team then began work on US Food and Drug Administration (FDA) human factors testing of the interactive video training, including formative and summative testing as a component of product development (no deployment, yet). Briefly, “formative” testing is typically done during the course of a lesson or other type of process (e.g., a midterm exam). In contrast, “summative” testing is done at the end of an instructional unit or other type of process, by comparing test results against some grading standard or benchmark (e.g., a final exam).

Snapshot of the interactive video solution

The sc2Wear training is not linear, but it does begin with a main video page (Figure 3) from which viewers can select the audience-specific learning path they wish to take. Remember that three different learning constituencies start from this point but diverge soon after receiving an introduction and instructions (Figure 4).

The scPharma team originally began with a single video that asked viewers to identify themselves with the initial branch of training they wished to pursue. Due to the size of the training videos, a single video was too big for the video platform. As a result, the team changed the initial design so that viewers can now identify themselves before entering their selected training program.

Figure 3: sc2Wear pump training: main video page

Figure 4: sc2Wear pump training: video introduction

Figure 5: sc2Wear pump training: menu

Although video learners can navigate throughout various sections of the video using the main menu (Figure 5), one of the most important lessons they will encounter is a demonstration (Figure 6) of how the device is to be properly applied, either by a caregiver or by the patient (after sufficient training).

Figure 6: sc2Wear pump training: Lesson 6 (“Apply pump to body”)

The video concludes with a wrap-up, and then viewers can watch the troubleshooting segment if they have problems with using or maintaining their device.

The enduring importance of learner engagement

A high degree of learner engagement is always important, but it is absolutely critical for effective interactive video training. Jen Bergen, blogging for Rapt Media, writes:

“As Forrester’s ‘Move Beyond Awareness with Interactive Video’ report points out, ‘turning video from a lean-back to a lean-forward interactive experience redefines what is possible with the medium.’ And for video advertising, a medium with an industry standard click-through rate (how successful an ad is at generating interest) hovering at just 1 to 2 percent, it’s time for a change. Brands that use IV [interactive video], however, are seeing that change with click-through rates between 5 and 12 percent while also engaging and informing customers at the same time.

“Speaking of engaging, the downside of non-interactive video is that it suffers from high drop-off rates. IV, however, sees completion rates of 90 percent and above. And since viewers often like to explore all the branches in an IV, at Rapt Media, we’re seeing multiple views per unique visitor as well as repeat views for the same video.”

An important element of learner engagement with the sc2Wear interactive videos proved to be the actor featured in the videos (Figure 4). As one scPharma team member remarked, “[Many] men have commented on her attractiveness, with women commenting that she seems nice and approachable.”

Dr. Muntendam went on to say: “We were trying to engage an inherently uninterested audience; in other words, people who don’t like [reading detailed] instructions. At first, we didn’t think much about the actors when we started. But it quickly became clear that audience engagement was absolutely essential, and we were able to achieve that when viewers quickly ‘fell in love’ with the featured actor.”

Lessons learned

Dr. Muntendam and Kathy Taudvin summarized the following key lessons learned from their interactive video experience:

  • Audience analysis. Having a clear understanding of your audience’s communication style and preferences is absolutely essential.
  • Precise word usage. Beyond that, the selection of specific words is also critically important. The team was surprised at the significant impact that small word changes could have on audience interpretation, understanding, and learning.
  • Choice of interactive video partner. Choosing the right technology and implementation partner is equally important. Although at first the scPharma team was apprehensive about the distance between its partner in Boulder and its own headquarters near Boston, the team was ultimately very happy with its interactive video partnership because Rapt delivered “high-touch” service. As one scPharma leader stated, “[We worked with] good people, smart people, [who were] totally committed to the project.”
  • Continuing value of paper-based design materials. In spite of its move to interactive video, scPharma did not totally abandon its detailed, paper-based instructions for use (IFU) and quick reference guide (QRG). In addition to FDA documentation requirements, these were needed because detailed written materials are essential for curriculum design and also help ensure that the precise, correct content is embedded into the video. As one team member said, the “interactive video is the IFU brought to life. The paper and video mirror each other.”

Conclusion

If you are not sold on interactive video after reading about scPharma’s successful use case, you may want to review the resources provided in the following section and also take another look at Paul Clothier’s discussion of the specific learning benefits of interactive video. Although he talks about these benefits in the context of mobile learning, his insights apply more broadly to other types of learning as well. Following are Clothier’s descriptions of these learning benefits, with additional discussion of how each benefit applies to this case study:

  • Engagement. “Interactivity makes videos more engaging and immersive; hence, interactive videos make it possible to maintain attention for longer periods than typical videos,” or even other types of static training. As we also saw in this case study, the overall quality and warmth of the video presenter is essential to viewer engagement and satisfaction.
  • Discovery. It is widely recognized that “one of the very best ways to learn is by discovery. Interacting with videos that provide branching and options can help facilitate this. [Discovery] promotes learning and increases information retention.” As we saw with the navigational structure of the sc2Wear training solution, viewers can (and very often do) go back and discover additional aspects of the training that appeal to them or aspects that they need to review.
  • Immersion. With a navigation video interface such as scPharmaceuticals used for the sc2Wear training, learners are able to “move smoothly and seamlessly from one video to another … without interruptions or breaks in the narrative.” Having this type of navigational flexibility and ease of use “provides a higher degree of emotional engagement and immersion.”
  • Adaptation. As we saw with the scPharma interactive video, “decision points in the video timeline”—provided primarily at the beginning, but also throughout—enabled the team to adapt the training to specific audiences as well as individual viewers. Video users had “the opportunity to decide what they want to branch to or what they want to learn.”
  • Tracking. Most video engines also provide “the ability to track user interactions within the video.” Although scPharmaceuticals is not yet at this point in its evaluation strategy, it could track future metrics such as “what the viewer tapped, when they tapped it, what they completed, when they left the video, and so forth.” As scPharma leaders have already found, these metrics will be useful in building their future community of learners and will help determine learner’s “preferences, abilities, attention spans, or personality profiles.”

Although the scPharma team members were initially hesitant about being pioneers within their industry by using interactive video for sc2Wear training, they now firmly believe that interactive video is “impossible to beat for this type of training.” Dr. Muntendam said that he and the entire team are “more convinced now than ever” that they made the right selection of partner, technology, and learning approach.

References

Bergen, Jen. “Interactive Video 101: What is it and why should you care?” Rapt Media. 24 January 2014.
http://www.raptmedia.com/blog/what-is-interactive-video

Center for Devices and Radiological Health. Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff. U.S. Food and Drug Administration, Department of Health and Human Services. 3 February 2016.
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM259760.pdf

Clothier, Paul. “Interactive Video: The Next Big Thing in Mobile.” Learning Solutions Magazine. 28 October 2013.
http://www.learningsolutionsmag.com/articles/1292/interactive-video-the-next-big-thing-in-mobile/?utm_campaign=lsmag&utm_medium=link&utm_source=lsmag

CrunchBase. “Rapt Media.”
https://www.crunchbase.com/organization/rapt-media#/entity

Leigh, Jack. “Interactive Video and the Changing Face of Training.” Digital Training Solutions. 25 November 2015.
http://www.dtslimited.net/interactive-video-changing-face-training/

Rosenberg, Marc. “Marc My Words: From Interactivity to Engagement.” Learning Solutions Magazine. 12 August 2014.
http://www.learningsolutionsmag.com/articles/1483/marc-my-words-from-interactivity-to-engagement/?utm_campaign=lsmag&utm_medium=link&utm_source=lsmag

scPharmaceuticals. “Micropiston Pump Technology.”
http://www.scpharmaceuticals.com/technology/micropiston-pump/

scPharmaceuticals. sc2Wear Pump Fill and Delivery (video). Vimeo. 8 January 2016.
https://vimeo.com/151206139

U.S. Food and Drug Administration. “What does it mean for FDA to ‘classify’ a medical device?” 28 December 2015.
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194438.htm

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