New product launches are exciting times for manufactures bringing new products to market and patients awaiting new treatments. In recent years, innovation has resulted in new regulatory structures and processes for evaluating products prior to entering the market. An example of this is the formation of the Office of Combination Products (FDA – 2002) and new guidance documents related to human factors and technical considerations of combination products. Combination products are those combining a drug, device and/or biologic product. These products can be classified as single entity, co-packaged or cross-labeled, depending on the product’s primary mode of action. Examples of currently marketed delivery devices include auto-injectors, injection pens, prefilled syringes and respiratory inhalers. Companies within these markets focus on delivering value to patients through devices and programs that support them throughout the patient journey. Training and education has emerged as a cornerstone of such programs and can successfully be applied to pre- and post-approved products. Device training products now include multisensory and smart technologies that improve the strength and recall of educational messaging. This approach can compliment devices and improve the training aspect of products in development. As a result, providing patients the appropriate education during clinical trials can mitigate launch delays and device revisions from human factors studies. Below are common indication-specific attributes incorporated into the development of such devices:

1. Psychological and emotional impact of diagnosis
2. Physical impairments associated to age or therapies
3. Fear and anxiety associated with self-administration, often leading to avoidance behaviors
4. Social needs of the patient, including family and medical support systems
5. Experience and education with drug delivery devices leading to onboarding challenges

As combination products enter clinical trials, their ultimate goal is to promote better patient outcomes with new product offerings. Through the stages of clinical trials, randomized and controlled studies are conducted to evaluate the safety and therapeutic effectiveness of new products. In addition, combination products undergo human factors and usability testing to ensure drug delivery devices are appropriate for use by specific patient populations. This includes considering how the user, usage environment and device interface affect patient outcomes. These studies ensure products are safe, effective and within the natural abilities of patient populations. 

Human Factors Studies
The human factors stage of product development begins early in the design process when firms use the historical references of predicate devices as a foundation for improvements. From that point, development teams enter an analytical planning stage to identify and mitigate foreseeable errors. Many tools can be used to accomplish this, including heuristic evaluations, expert interviews and cognitive walk-through assessments. After completing analytical studies, devices progress to a more robust stage known as formative evaluations. During this stage, human factors continue to modify drug delivery devices to improve usability and reduce errors. This process uses simulated user studies to identify and prioritize risks based on their severity and probability of occurring. A number of risk management methodologies can be used at this stage, including Failure Modes & Effects Analysis (FMEA), Fault Tree Analysis and other statistical methods. Training, education and design modifications are effective routes to mitigating risks discovered through formative evaluations. In recent years, training devices such as device simulators and education marketing products have proven to be effective at improving product safety and the patient experience through device development and new product launches.

When risks have been mitigated to acceptable levels, development teams complete validation studies to validate the safety and efficacy of the product. Actual usage situations are required to test the drug delivery program proposed by a sponsor. These reports are then condensed and submitted to the FDA for evaluation. If new risks are identified, the agency will require sponsors to conduct additional formative evaluations to mitigate them. Launch delays due to these decisions can result in costly changes to launch strategies, affecting market share and production schedules.

Post-marketing Surveillance: Phase IV
After the FDA has approved a product for market, manufacturers enter a period of post-market surveillance where products are monitored to identify any long-term effects or trends in adverse events. A number of challenges can arise during post-marketing surveillance that can adversely affect a brand’s position in the market. These include delayed approval of new indications, mandated label changes/safety warnings and in severe cases, product withdrawals. This information is often collected through feedback mechanisms established by manufacturers and the FDA related to adverse events and adverse reactions. Examples of these programs include MedWatch, MDRs, CAPA and others. According to the FDA, a use error is defined as an act or admission of an act that results in a medical response other than intended by the manufacturer and expected by the user. Unintended outcomes can result from abnormal use, mistakes, lapses and slips, all of which are related to a user’s interaction with a device interface.

During a new product launch, brands scale up production and marketing efforts to meet the demands of patients and build market share within their approved indications. This often includes strategies to increase brand awareness and patient satisfaction, and promote healthy outcomes, all of which are adversely affected by errors and misuses. Many brands have realized the benefits of patient empowerment and have developed device training programs to support and transition patients in various stages of treatment. For newly launched brands, such programs mitigate risks related to adverse events caused by preventable errors. As a result, many brands include device training within their launch strategies to accomplish the following goals:

1. Familiarize the patient with the injection devices
2. Teach patients proper self-administering techniques and procedures
3. Reduce patient errors when self-administering
4. Establish a competitive advantage by offering a superior training experience
5. Reduce in-office training time, thus establishing HCP brand preference
6. Improve the patient onboarding experience by building confidence and reducing anxiety for new and existing patients

Additional outputs of this phase include comparisons to alternative therapeutic options and cost-effectiveness analyses. In this framework, training devices serve as a product differentiators that can result in therapies that are more effective, based on clinical observations and patient satisfaction ratings. This is done through building patient confidence and teaching patients the proper usage requirements needed to safely and effectively use a delivery device.  Recent research has shown sensory feedback to be an effective way of achieving this. As a result, proactively developing training devices with smart technologies, which detect, notify and correct errors in real time, provides patients an improved learning experience while onboarding to a new device. During Phase IV trials, such technologies proactively prevent errors and adverse events from occurring and thus support brands in the successful commercialization of their new products. 

Improving the Patient Experience
A recurring theme in the clinical trials process and product lifecycle is the need to prevent errors and improve the patient experience. In recent years, device training has emerged as an effective mitigation strategy for currently marketed products and those in development. Such errors are often the result of slips or lapses in memory. This concept is known as message erosion, which adversely affects the strength and recall of information provided to patients by HCPs. Within this model, HCP serve as learned intermediaries between the drug manufacturers and patients. This introduces an additional layer of training that affects the consistency of educational experiences within patient populations.

According to a number of research publications, patients pass through several stages of learning from their first self-administered dose to a level of autonomous disease management. During this process, errors vary in frequency and severity, with the most critical being observed as patients onboard to new therapies. During clinical trials, these errors can affect the results of formative and validation studies of new products. For new product launches, post-market surveillance data can lead to product modifications and delayed approval of additional indications. An attractive alternative to these setbacks includes providing patients with the right education throughout their treatment to prevent errors and promote healthy outcomes.

In recent years, device-training solutions have evolved to now include multi-sensory technologies within the traditional interface. These technologies facilitate consistent learning experiences that empower patients and support HCPs. Feedback mechanisms include auditory, visual and tactical technologies that compliment instructions for use (IFUs) and drug delivery devices.

Neurological research suggests that multisensory educational experiences result in cross-modal processing, which strengthens the recall of strength of device education. Due to the growing demand by patients and the world’s leading brands, device training devices now include smart technologies to detect and correct user errors in real-time. To brands undergoing human factor studies, these features can reduce user errors and patient dissatisfaction, leading to improved experiences for patients, HCPs and sponsors. For established brands, these tools keep patients on therapy and support them in living healthier lives.

At its core, the ultimate goal of device training is to improve the patient experience and create value for HCPs and industry stakeholders. As new brands continue to launch and augment markets, brands will continue looking for strategies to differentiate themselves from competitors. In the modern era of patient-centric care, those able to provide a superior product and educational experience to patients will be competitively positioned and benefit from the loyalty established by patients and HCPs. 

References
All illustrations shown in this presentation are the property of Noble.  Any reproductions or display without expressed written consent of Noble^® is in violation of Federal Copyright laws and will be prosecuted to the full extent of the law.

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Craig Baker is executive vice president at Noble. For more information about this article, please contact the company at info@noblecorporate.com.