Design Thinking: A Shared Methodology Between Sponsor And CMO To Benefit Patients

Over the last three decades, there has been a vast number of medications, innovations, and technologies aimed at helping patients. And over the same period, more and more companies have leveraged the skillsets of CMOs/packaging organizations to help with these advancements. Collaborative efforts made by the sponsor and the CMO, coupled with a well-defined process grounded in design thinking, can lead to improved patient compliance.

Design thinking is not a new way to approach a solution, and it is not just about making something new; design thinking is rooted in how a solution is approached and why something new is developed. If used appropriately between a sponsor and CMO, it can be invaluable in tackling complex problems to ensure patients receive the treatments they need. Design thinking works well where the issues are ill-defined and complex, the issues and solutions take into consideration the human need and empathy with the end user, and the problems can be reframed in human-centric ways. There are five main steps to the design thinking process. These include:

1. empathy
2. defining the state of the user’s needs and problems
3. ideating or creating ideas
4. prototyping to start solutions
5. testing.

START WITH THE END USERS’ NEEDS, CONCERNS

Empathy is a concept shared by the pharmaceutical industry and design thinking; that is, consideration centered on the end users’ needs for medical treatment and the basis of the approach is paired. For this article, assume an orally administered dosage form (i.e., tablet) has been developed and needs to be packaged in a manner that is compliant, safe, and acceptable to the patient. And we have awareness the medication is not being taken because of some stigma within the patient population due to something about the way the product is packaged. Using the steps associated with design thinking, a unified effort by the sponsor and the CMO can be applied to develop a packaging configuration to address treatment managed by the patient.

Packaging and labeling are a blend of science, regulation, and art. And while most of the research and development of a pharmaceutical product is placed on the formulation, so much of the product’s success rests in the packaging and labeling for the intended population of people taking the medicine. It is not just about how novel or interesting the commercial packaging looks — though that certainly is a factor — but it is also about understanding the needs of the intended patient population to ensure they maintain compliance during the treatment regimen.

How the medicine is packaged and used and what types of issues the patient is facing in managing the illness are interlinked considerations. All too often, a sponsor can lose sight of a patient’s struggles and barriers. For example, some patients living with certain diseases face incredible stigma, and this stigma can undermine treatment access, uptake, and adherence. Further, what may be acceptable in one part of the world may pose challenges for another.

In sub-Saharan Africa, a great number of people are living with HIV or AIDS and face various degrees of social stigma as a result. As part of a treatment regimen, patients are given antiretroviral therapy (ART) in the form of a tablet. Typically, tablets are packaged in plastic bottles. As subtle as it sounds, the rattling noise from the drug container could pose (and has posed) a nuisance to patients, resulting in their feeling exposed to more stigma as they go along their daily activities. Consequently, some patients either cease treatment to avoid the added stigma or remove the tablets from the bottle and in so doing subject the tablets to damage or contamination.

Since AIDS is a chronic, potentially life-threatening condition, it requires continuous and regular treatment. How the tablets are packaged (1) to protect from environmental degradation and handling, while (2) remaining compliant to local, state, and federal regulations, and (3) mitigating a patient stigma becomes a complex project between the sponsor and a CMO.

LEVERAGE CMO’S EXPERIENCE TO GENERATE SOLUTIONS

Tablet packaging can be accomplished in a variety of ways using bottles or blister packaging. In either presentation, protecting the tablets from moisture and temperature is key. And in addition to these factors, the packaging for an AIDS patient facing social judgment from the rattling of tablets in a bottle needs to be evaluated. Ideation or generating ideas between the sponsor and the CMO is the next step in the process. How should the packaging look and feel? What materials should we use? How big or small should the final presentation be? These are some of the questions to consider in addressing the problem.

Ideation is the act of forming an idea or conception. In the problem of tablets rattling inside a bottle, an idea could be developing a novel packaging configuration aimed at minimizing the noise attributed to tablet-on-tablet and/or tablet-on-bottle contact. As experienced as a sponsor may be, there is strength in the added experiences of a CMO — given it likely works with many clients addressing myriad issues.

Some CMOs have experience with and technical capabilities for rapid prototyping. Current technology exists where prototype container-closure systems can be made in a handful of days using several tools, including fused deposition modeling (FDM) or stereolithography (SLA) in combination with computer-aided drafting (CAD). For example, rather than placing tablets into a bottle or even making a large blister card booklet, tablets might be able to be blister-stripped onto a tight roll that could be contained in a clamshell mold or something pleasing and functional that looks like a mobile phone case. These are just some of the discussions that take place toward prototyping between the sponsor and CMO.

Once a few ideas are prototyped, the next step in design thinking is to test the idea. Testing may include child-resistant and senior-friendly testing, patient-use testing, and stability testing — assessing how the quality of a drug substance or drug product, and the packaging, vary with use and time under the influence of environmental factors, including temperature, humidity, and light. Individually and collectively, findings from these tests may require the sponsor and CMO to re-loop through the design thinking process and regenerate more prototypes. Early failures can often lead to improved designs that meet the end goals better in the shortest period.

Using design thinking tools and techniques in collaboration with a CMO can lead to some amazing outcomes benefiting patients’ needs for medical treatment. Patients who live with AIDS OR HIV, particularly where stigma can occur from the rattling of medication in a bottle, deal with more than just managing their viral loads. Naturally, not everyone’s journey is the same, but regardless of where a patient is in the journey, there’s always room for improvement. Aligned efforts by the innovator and CMO using design thinking principles can have a profound impact. This example demonstrates only one way in which design thinking could be used in the pharmaceutical industry. Clearly, there are more areas, in this industry and others, in which design thinking could make a major difference in solving significant issues.

CHRISTOPHER OHMS is a San Francisco Bay Area native who serves as director of supply chain at Rigel Pharmaceuticals. Prior to joining Rigel, Ohms held positions at Gilead Sciences, Patheon, Stanford School of Medicine, Pain Therapeutics, and ALZA.