Input of Patients for New Diabetes Technology Products

Introduction

When companies are developing new products for people with diabetes (PwD), numerous factors drive decisions about what the specifications shall be, which features should be included, and how the product should appear. Traditionally, the necessary information to determine how these decisions are made has come from a limited number of in-person interactions between industry representatives and either patients and/or healthcare professionals (HCPs). This user information is valuable to manufacturers because product features and design features are critically important, because they determine what is needed to make the product successful. Features of diabetes products that receive favorable reviews by PwD and HCPs that are representative of the widespread population of patients and professionals are likely to result in success in the marketplace. It is important to incorporate the views of many stakeholders before a product is launched, but the views of the users—which might be quite diverse—must play a key role in such development processes. Four types of input that are necessary before a final iteration of a product is launched include:

• (1) Patient advisory boards,

• (2) Social media input,

• (3) Human factor studies, and

• (4) Consultation with HCPs such as educators and physicians.

We believe that the use of new communication technologies for receiving input from these four sources can make the process of product design more efficient and more effective.

Patient Advisory Boards

Some companies assemble patient advisory boards in order to have access to patients’ opinions. Topics that can be covered in these groups are listed in Table 1. ¹ However, it is difficult to assess whether the patients in a group are representative of the overall population. Virtual patient advisory boards can bring in diverse populations, although in some cases the patients might not divulge as many personal opinions input as with in-person boards. Although keeping patients engaged on a virtual platform can be difficult, and it is necessary to invest in a robust survey platform for virtual advisory boards, an advantage of a virtual advisory board is that it is much less costly than an in-person meeting because no travel or meals need be provided. Thus, budget goes further, and many patients can be interviewed virtually for the same cost as a limited number of patients in a live environment. One approach to virtual advisory boards to avoid video fatigue from many hours of answering questions is to use a hybrid approach between live and asynchronous interactions. Instead of a multi-hour virtual advisory board, an alternative is a series of brief live advisory board meetings complemented by small assignments carried out asynchronously.

Table 1.

Topics That Can be Discussed in Patient Advisory Boards. ¹

Protocol/study design

Study synopses

Schedules of assessments

Clinical trial execution simulations

Informed-consent form design

Clinical trial medicine kits/packaging

Clinical trial technologies and procedures

Patient recruitment and study or research program communication materials

Social Media/Patient Interaction

Communication between patients via social media/the internet has changed the role of patients in the last decades drastically, that is, when patients agree that a certain development/product is problematic, then this input can impact their buying decisions. Therefore, manufacturers look to follow the discussions in such media quite carefully. The use of popular social media platforms, like Twitter, Facebook, and Instagram, as well as diabetes-focused networks provide opportunities for patients to exchange information about existing products and comments about what they are seeking in future products. Social media is therefore rich in real-world data, but analyzing the data and organizing it into meaningful categories for comparisons is difficult. Natural language processing (NLP) is a branch of artificial intelligence that extracts organized data from unstructured free-text or speech. This method of text analysis can be applied to unstructured free-text patient comments on social media. NLP often uses machine learning to make sense out of social media comments. ² One problem with using reviews on social media for making decisions is that sometimes reviews are fake, and reviews on social media websites, while widely accepted by consumers, are not automatically legitimate. ³

Human Factor Studies

The FDA, that is, a regulatory agency, is asking manufacturers to perform human factor studies as an essential part of the clinical development process of a new medical product or a new technology. Such studies are more focused on if and how patients can handle/use such a new product. Ideally, these assessments should be carried out early in the development process. Human factors testing involves three formal phases to ensure that a product can be used properly by a patient and that it does not contain features that could result in human error and lead to an adverse outcome. Human factors testing involves observation of the patient using the device. The first phase of the testing is conducted early in the development of a device. This phase is known as formative testing. This phase involves determining whether the product meets the patient’s needs by collecting user feedback to refine device design and instructions for use. The second stage is conducted in the middle to end of device development. This phase is known as pre-summative testing. This phase involves observing the user’s interaction with a product prototype. The third phase involves testing later iterations of the device to see whether the initial observations led to a useful product. This phase is known as summative testing. This phase is intended to demonstrate that users can use the device safely and effectively in the intended environment. ⁴ Application of a human factors approach to product design results in more effective product training, improved adherence to use, and greater product safety. ⁵ From the manufacturer’s standpoint, all these outcomes result in greater sales and profitability.

Role of Diabetes Education and Care Specialists

Input from diabetes education and care specialists (DCESs) can be useful in product design. It might very well be that patients communicate with these HCPs, compared to physicians, in more detail about their thoughts and concerns. This is because the time that physicians have to talk with their patients about “non-medical” topics is generally quite limited. Most DCESs routinely educate, train, and supervise patients and physicians in using hardware and software technologies for managing diabetes. DCESs are therefore well equipped to advise industry about what types of tools are needed to improve diabetes management. ⁶

Underserved Population

It is understandable that the range of patient’s expectations is difficult to totally cover and might require additional development efforts. However, underserved groups should have an opportunity to express their wishes and needs openly. These groups include but are not limited to children, pregnant women, elderly patients, patients with limited eyesight, blind patients, and patients with limited dexterity or numeracy. Digital health and telehealth connectivity have become important parts of care for PwD. Digital connectivity has been proposed as the sixth vital sign. ⁷ More support and services are needed to match diabetes technology with underserved populations. ⁸ Surveying only some types of PwD and not others might result in the development of products that do not serve the entire population.

The Effect of Sustainability on Product Development

To our understanding, the number of patients complaining about the amount of waste generated when using diabetes technology products has increased drastically in the last years, probably to a different level depending on the sensitivity about this topic in a given country/region.^9,10 There is currently no forum at which patients can raise/express such concerns. However, we expect that increasing numbers of patients will be switching to more sustainable products (eg, continuous glucose monitoring systems, blood glucose monitoring system, insulin pumps, automated insulin delivery systems, or insulin pens) if the performance of competing products is perceived to be somewhat comparable but the amount of waste generated differs. This preference for products that use fewer resources in the manufacturing, packaging, and shipping and are more readily managed or more ecologically disposed of at the end of their product lifecycle will have an impact on sales. We believe that as concern for the environment becomes more widespread, then manufacturers will increasingly have to account for the sustainability of their diabetes devices.

Summary/Call for Action

The aim of this editorial is to raise the question of how and where individual PwDs and groups of PwDs can express their voice with modern technology in a manner that

• (1) Receives public acknowledgment,

• (2) Initiates a discussion and

• (3) Will have an impact.

If an organization like the Diabetes Technology Society would support a platform that would allow patients to express their thoughts/concerns in a meaningful manner, this might allow patients with diabetes to provide greater input into the development of new products. ¹¹ The results will benefit patients who will see better products and better technologies becoming available that meet their needs, and industry will see increased sales.