Integrating End-User Research in MPT Product Development and Commercialization Strategies: Post-Webinar Discussion

Published: July 5, 2022

The seventh webinar in the “Let’s Talk MPTs” Discussion Series featured end-user researchers, product developers, and marketing experts with extensive experience in MPT R&D. The presentations centered discussion around challenges and strategies for conducting end-user research in the early stages of product development, as well as utilizing the findings to effectively inform product development and commercialization strategies. Featured speakers included Moushira El-Sahn, the co-founder of Routes2Results, Dr. Andrea Thurman, a principal investigator and certified OB GYN with CONRAD, Liz Pinto, the Associate Vice President of Brand Marketing for Evofem Biosciences, Inc., and Karina Fedasz, Head of Business Development for Evofem Biosciences, Inc.

Following the webinar – which can be accessed here – our esteemed panelists were given the opportunity to elaborate on the thoughtful questions posed by audience members. You can access their unabridged responses here.

Here’s what they had to say:

“How can commercialization strategies be built into the earliest stages of product development, including preclinical testing?”

The following response was provided by Moushira El-Sahn and Jeff Lucas, co-founders of Routes2Results (R2R):

Socio-behavioral research (SBR) can be utilized throughout all stages of the product life cycle: understanding end-user perceptions and experience is critical to understand potential for impact and market success. The High Impact Practices (HIP) Strategic Planning Guides reveal how important it is to conduct and integrate SBR from the outset of a product life cycle.

Asking yourself what commercial success looks like is a strong starting point to ensure these milestones feed into what developers incorporate into their design parameters. Furthermore, bringing commercialization research experts into the fold as early as possible can optimize strategic processes to uncover critical information that can support product development and planning.

There are some critical points to remember with innovation and processes. These are three blind spots which are important not to miss:

The most successful processes do not skip the critical stage of idea development. Holding an internal brainstorming session as a means of idea development, however, is not sufficient. Idea development must emanate from a thorough understanding of the consumer and the market which is then translated into an innovation strategy. Develop ideas with your consumer/end-user: co-creation can reveal critical user insights that may not be obvious to product developers.

Processes are not inherently nurturing, and can kill ideas rather than help to make them better. The process, by its very nature, is about progressing through key milestones by demonstrating that certain hurdles have been met. If these hurdles are not met, projects can often be killed prematurely. Nurturing ideas can take shape through research: What is it that is causing a barrier? Can this be reframed?
Some processes stop at the launch stage, without formal follow-up to monitor and evaluate the product’s in-market performance. Being able to breathe with the product/service as it lives in the market setting is critical to establishing iteratively if any aspect of the product/service needs refining. If there is no research supporting the real-life experience of the product/service post-release, market impact can be muted.

Many of the research types depicted in the above table can be used multiple times at various stages. It can be very helpful to repeat research and monitor changes, adapting accordingly.

There are some important caveats to the above recommendation:

We do not want to give the impression that every single idea is generated through understanding the end-user. So much of what Pharma spends on R&D is based on scientific parameters, too. This is a complex balance – what is feasible and what is desirable. In many ways, feasibility comes first and acceptability is tested later. Having multiple ideas to test is an ideal situation for any organization.
The definition of ‘end-user’ can be broadened to include Health Care Providers (HCP) in the Pharma world. Gathering input from this group can seem like a very different approach than social impact work, but can reveal valuable information.
Much of the spend can be for already established brands – pharma companies have brands and will develop brand plans – everything done should be supported by evidence for that brand.

“How useful are Discrete Choice Experiments in defining end-user preferences?”

Discrete Choice Experiments (DCEs) are an alternative to conventional qualitative research, designed to elicit end-user feedback using hypothetical or placebo-based frameworks.

The following response was provided by Dr. Annie Thurman from CONRAD:

CONRAD has been involved in several DCEs. In my opinion, I think we initially expected one product to “win” out over others, but what we found through DCEs is that there was no clear winner or loser. All of the placebo products tested (e.g. in the QUATRO study: placebo vaginal gel, placebo IVR, placebo vaginal insert, placebo vaginal film) had pros and cons that each individual woman considered in making her choice. It is also well known that women often choose different contraceptive products at different phases in their life, and may even add contraceptives for different partners (e.g. adding condoms to an existing method with a casual partner).

The thing that I really liked about the QUATRO and MTN 035 studies was that they exclusively tested placebo dosage forms – the participants did not have to deal with side effects of an active pharmaceutical ingredient (API) and other issues that come up in clinical trials or implementation studies, they could focus solely on the dosage form itself. Since some of the dosage forms tested may have been less familiar to participants in both studies, this really gives product developers and funders valuable data on acceptability.

Finally, at the CONRAD Clinical Research Center, we do a lot of Phase I studies of MPTs, and as is the norm for doing first-in-women studies, we test these products on women who are not at risk of pregnancy, are at extremely low risk of HIV or other STIs, and who are often not on contraceptive hormones. This tends to be an older population of women (age range of 30-45). Although these women are not in the target end-user population, these seasoned research participants give us excellent feedback on the products, particularly if there are unacceptable side effects, as we saw in the CONRAD 117 study. We can also use this population to test the invivo dissolution of vaginal inserts (CONRAD 134).

“Is it advisable to inform finalized target product profiles with SBR along with technical and regulatory requirements?”

Target product profiles (TPPs) outline the desired characteristics of a product under development to address a particular disease(s). A TPP states intended use, target populations, and other intended attributes of the product, including safety and efficacy-related characteristics.

The following response was provided by Moushira El-Sahn and Jeff Lucas, co-founders of Routes2Results (R2R):

SBR can be very helpful when formulating and finalizing Target Product Profiles (TTPs), alongside technical and regulation requirements. This information can highlight which aspects of the product are most influential, and which may cause tension, as well as valuable communication strategies for product introduction. Here, being able to conduct SBR early in the design phase, where some product parameters/attributes can still be adapted, is very supportive.

How the TPP is expressed is critical. In all our co-creation partnerships with product developers, scientists, and product experts, the TPP is rarely left unrevised. Often, TPPs are not necessarily consumer/end-user friendly, and therefore require refinement. This process also involves gathering insight into how the TPP impacts all research participants (e.g. adolescent girls and young women, romantic partners, influencers, HCPs, Community Health Workers (CHWs), and Key Opinion Leaders (KOLs)). Importantly, for such data to be meaningful, spaces between research phases which allow for reflection and refinement are critical for the project to breathe and respond effectively. We have, in all our work, created pause-points between research phases to consider our findings and make changes to the tools and TPPs.

The following response was provided by Dr. Annie Thurman from CONRAD:

During the webinar, several presenters spoke about having to be honest early-on, and if a product either had difficulties with formulatation or expense issues, it needed to be off-boarded. To this end, very early end-user input is so important. At CONRAD, we collected clear end-user input that a on-demand, portable, dual compartment, discreet, vaginal/rectal insert has many appealing qualities. However, we identified a major acceptability issue in our first-in-women study of the vaginal insert in CONRAD 117 (chalky vaginal discharge).

Even though the CONRAD 117 phase I study was conducted among women (n = 51) who were not the ultimate end-users of this product, we were able to recognize this highly negative product attribute would not be acceptable to end-users. Fortunately, through USAID funding, CONRAD was able to pivot and do early end-user studies to test the in vivo dissolution of reformulated inserts (CONRAD 134).

“Technical risks are necessary to address early in product development to inform early development ‘kill’ of development efforts: This is done by established processes and procedures. Are there similar approaches to risk assessment on the SBR side so as to guide early stage SBR studies to not only define impact risk, but also cost effectiveness risk, procurer interest risk, and other launch and commercialization risks? It would seem important to define the magnitude of such risks early, as well as develop strategies to address these non-technical risks to go in parallel with technical development.”

The following response was provided by Moushira El-Sahn and Jeff Lucas, co-founders of Routes2Results (R2R):

We agree! In research, you can talk to anyone, from Key Opinion Leaders (KOLs) and end-users to payers, pharmacy boards, and procurement, and, in those conversations, you can find space to investigate perceived and experienced risk-factors. Through this process, you may discover risks that product developers or funders have not considered, and the risks product developers may have been concerned with may be of little concern to end-users, or off-set by other product attributes/value propositions.

While consumer appeal is vital to understand, there are two additional important aspects when thinking about new product impact:

Choice frameworks: Context (i.e. perception) is everything. Understanding the environment within which people are making decisions can be a major factor in understanding the reasons behind perceptions / choices regarding your product. Note that the end-user is not just the consumer.

Demand dynamics: Understanding the potential demand and impact of the market environment and systemic context is vital. This can be conducted through building a market-reflective forecast, utilizing consumer and market data and building in market assumptions and marketing plans.

“As researchers, how do you handle the issue of ‘trialability’, which, according to innovation adoption frameworks, may be important for new products/technologies? How can you improve trialability for new health products when you target a new market/ end-users?”

The notion of trialability refers to “the ability to trial an idea, process or system before making the eventual decision to implement or not to implement the idea, process or system. In relation to innovation, trialability can be described as the degree to which an innovation may be experimented with on a limited basis (IGI Global, 2022)”.

The following response was provided by Moushira El-Sahn and Jeff Lucas, co-founders of Routes2Results (R2R):

There are many ways to segment a population in terms of how they may react to a product. Market segmentations can draw on various aspects, from demographic segmentations through to behavioral segmentations which take into account the motivational backdrops of potential consumers.

Rogers’ Innovation Adoption Curve presents a social system for adopters of recent innovation. According to this framework, the adoption of innovation varies throughout the course of the product-life cycle, from Innovators to Early Adopters, Early Majority, Late Majority and Laggards. Understanding where these groups fit into the product life-cycle can enable tailored marketing and design activities which are focused on tapping into these adopters’ specific needs and perspectives. While Innovators may be the first ‘uptakers’ of a product, the Early Adopters are considered the most influential, although more risk-averse than innovators. These groups would have higher ‘trialability’ scores, so to speak.

The Rogers framework of innovation adoption would argue that incorporating Innovators as well as Early Adopters early in product design and clinical trials process is critical in developing prototypes prior to a broader market final design. SBR research in the MPT, HIV prevention, and contraception arena can help illuminate what qualities characterize these segmented groups and what their relative size may be.

With consideration for HIV prevention, Consideration Three of Rogers’ framework is vital: Understanding the Context. How I think I may behave in interacting with a new product may, in reality, be very different from what I am able to do. Here, we learn about the pushes and pulls of behavior change – and in many ways adopting a new innovation, can be thought of as a change in behavior.

The Push: The expression of the unmet sexual and reproductive health needs pushing women to desire change, or an increase in the availability of prevention method options. Benefits and concept delivery can work as a push, as well as dissatisfaction with current family planning methods.
The Pull: The realities of women’s experiences, present in-market barriers, or anxieties towards the new product. Women’s access to the healthcare system can act as a pull, so can a lack of anatomical education and product-based concerns.

We learned in our work with Microbicide Trials Network (MTN) that 18-21 year-old women could be considered Innovators and Early Adopters (not in the financial sense but in how they see change). These young women are informed, aspirational, and open to new products. They have a strong awareness of what they should do, however, they are not fully able to activate, realize or act upon this knowledge due to their environmental restrictions. They are faced with interpersonal and structural challenges that can make change and adoption difficult. This could impact the relative size of Rogers’ segments. As Evofem presented during the webinar, this work is about establishing whether there is a need, how to generate demand, and if there is an enabling environment.

The following response was provided by Dr. Annie Thurman from CONRAD:

We face “trialability” issues when we are offering long-acting reversible contraceptive (LARC) methods, where patients are interested in a product, but hold certain hesitations due to the fact that it is less immediately reversible. I tell patients, “Let’s put this in, and why don’t you make an appointment to see me back in 1-3 months, and if you hate it, you can come back and I’ll take it out, no big deal. If you like the method, just cancel the appointment”. I think having the autonomy to easily reverse the method helps with getting patients to try something. The situation is obviously different with an injectable or a biodegradable implant.

Interestingly, use of Intrauterine Devices (IUDs) has significantly increased over the last 25 years in the US. I can’t tell you how many times we have had a young woman in the office discussing IUDs as a form of birth control, and the nurse or medical assistant is an IUD user. I think these types of interactions really help with trialability of long-acting products.

Interested in learning more? Be sure to check out the IMPT’s Socio-Behavioral Research Hub. This dynamic resource center offers the latest publications and tools to assist researchers working in contraception and prevention of HIV and other STIs in keeping the end-user in mind throughout the product development life cycle.

Prepared by Hannah Rubens, IMPT with support from Moushira El-Sahn, Routes2Results and Andrea Thurman, CONRAD. Please contact the IMPT on our website or Moushira El-Sahn at Moushira@routes2results.org if you would like to follow up further.