Post written by Male Contraceptive Initiative. This post originally appeared on MCI's website. View the original post here.
Introduction
The drug development process is often presented as a linear process: you achieve one milestone before moving on to the next, with progress taking the developer ever forward. The Food and Drug Administration defines this process as such:
Discovery & Development: research for a new drug begins in the laboratory
Preclinical Research: drugs undergo laboratory and animal testing to answer basic questions about safety
Clinical Research: drugs are tested on people to make sure they are safe and effective
Food and Drug Administration Review: FDA review teams thoroughly examine all of the submitted data related to the drug or device and make a decision to approve or not to approve it
FDA Post-Market Safety Monitoring: FDA monitors all drug and device safety once products are available for use by the public
Based on the way that this information is conveyed, you might expect the process to visually represent something like this:
But will the process of getting a new male contraceptive to market be such a clean, step-wise process? It’s a question that we wrestle with at Male Contraceptive Initiative. After all, the only male contraceptives on the market today are condoms and vasectomy; neither of which are “drugs”, so their regulatory journey to market was different than what many non-hormonal, reversible methods that we are supporting will likely face. With this in mind, we asked attendees to our inaugural ideation event to participate in a speculative design exercise seeking to help define and illustrate the anticipated journey to market for novel forms of male contraception. Given that participants represent a holistic sampling of subject matter experts from across the contraception research and development community, we feel that their collective knowledge and experience lends a certain level of gravitas to the exercise. That said, please keep in mind that this is speculative.
The Swirling Vortex
The immediate response from the group is that we need to consider the regulatory pathway as a “swirling vortex” full of feedback loops and interdependencies rather than a purely linear process. Granted, if, and this is a huge if, everything were to go perfectly as planned one could experience this journey in a linear fashion. However, it is highly unlikely that this can be achieved and should be viewed as an exception rather than the rule. The anticipated reality is that there will likely be multiple course-corrections along the way, utilizing an approach more akin to trial-and-error than one that is fully and clearly prescribed. Rather than visualizing this linearly, we synthesized the feedback from the group to create this illustration of the process:
Viewed in toto, the vortex can be a bit intimidating as there are numerous connections and loops (necessary and/or potential) to contend with. The legend seeks to aid in unpacking the journey. The solid orange line seeks to highlight the step-by-step process that, in a perfect world, could represent the linear progression of a product from inception to market availability. The dotted blue line identifies the possible retrograde motions required should progress stall or fall short of expectations along the way.
Steps
Focusing solely on the individual pieces, the stepwise process emerges a bit more clearly:
Each step is numbered, with the process beginning at #1 (Problem Identification) and continuing to the ideal “final” step #6 (Post-market/Marketing). (Step #6 is the last step when considering the process as a linear one. Ideally, this process is followed cyclically to ensure continued product viability and resonance.) The progression from step 5 to 6 is visually offset and indicated by a dotted line as it is part of the process beyond reaching market.
Step 1: Problem Identification
The first step in developing any new product or intervention is to identify the challenge or gap that it will address. For example, the automobile came about due to limitations with using animals for transportation purposes (e.g., speed, hauling capacity, etc.). It is critical to develop as holistic an understanding of the problem as possible, including factors that not only lead to its existence but also those that facilitate its persistence. Problem identification should be validated by engaging with those most closely affected by it to ensure that all pertinent information is considered and accounted for.
Step 2: Solution Identification
Once you have identified and adequately defined the problem you are seeking to address, the next step is to articulate the proposed solution to be developed. Functional questions should be paired with practical ones. In the case of male contraception, defining the mechanism(s) of action is just as important as the potential cost and aesthetics of the intervention. Building off of the process begun with problem identification, possible solutions should be validated by re-engaging with the affected stakeholders to ensure initial buy-in as well as long-term sustainability.
Step 3: Solution Optimization
After identifying the potential solution, the next step is to refine it to the highest fidelity possible. As such, this step can, and arguably should, actually be several steps. Each iteration of the intervention could/should be tested with potential users (to the greatest degree possible) in order to identify any gaps or shortcomings. This “rapid prototyping” approach can help ensure that the final version of the intervention is as viable as possible.
Step 4: User Validation
Those affected by the problem at hand are by nature potential users of any solution to that challenge. As such, they play important roles in the preceding steps. This step involves refining and honing this potential user set to identify the key target audience or audiences the product is being developed for. This is akin to, say, an app like Snapchat being developed for teens but still having functionality and appeal to other audiences as well.
Step 5: Go to Market
After completing the preceding steps of identification and validation, it is time to bring your product/intervention to market. In this step, product details and information are finalized including pricing, packaging, supply chain considerations, and more. While this step is later in the process looking at a linear chain, it is often being worked on in the background during earlier steps. This step features the product or intervention at its highest fidelity prior to being released to the general public. It is as “done” as possible.
Step 6: Post-Market (Marketing)
Getting the product or intervention to market is a considerable accomplishment, but should not be viewed as the final step in its progression. Marketing and promoting the intervention helps to ensure recall whilst building an understanding of its value and framing its value against any existing competitors. Analogous products can help to inform effective marketing approaches, though it is ideal to create a unique identity and related messaging for your product/intervention for authenticity and transparency.
Transitions
The transitions between each step represent distinct needs, opportunities, and challenges, that are important to keep in mind as you move through the process. Here we attempt to provide additional details to help elucidate these transitional realities.
Transitioning from Step 1 to 2
The first step of the development process is to translate a perceived challenge into a viable product or service opportunity. There is scope for innovation and exploration whilst exploring new opportunities, but the critical consideration that needs to remain at the forefront of activities is: “will this solution work?”
Transitioning from Step 2 to 3
This stage is all about testing and iterating. Efficacy is a key consideration, but it is not the only one. In this stage, user perceptions, interests, and needs should help evolve the solution to a fidelity so that it has the greatest impact with the greatest amount of users as possible.
Transitioning from Step 3 to 4
Once the proposed solution is refined to the highest fidelity possible, re-engage with the identified or emergent target user set/segment to ensure maximum resonance and interest. At this stage the proposed solution is designed to effectively be market-ready; this is the last opportunity to make any necessary refinements prior to market release.
Transitioning from Step 4 to 5
With all of the necessary testing and refinement complete, the proposed solution is made publicly available for consumers. Aesthetic considerations, costing, packaging, and supply chain necessities are resolved to the best degree possible at this stage.
Transitioning from Step 5 to 6
Now that the proposed solution has been translated to a tangible product, the next stage is to frame it through appropriate lenses such that the target user set can access it as well as understand its value and utility. Above and beyond promotion, this is the opportunity to educate prospective users such that they clearly see the benefits of using this new product.
Feedback Loops
The real crux of the “Swirling Vortex” lies in the potential feedback loops necessary to ensure efficacy and value of drugs being developed. They represent the course corrections that a developer may need to make in order to effectively succeed at not only bringing a new drug to market, but ensuring that that drug maintains its impact throughout the course of its shelf life. Here we detail what each of these potential feedback loops entails.
Solution Refinement
Challenges in optimizing a proposed solution may require revisiting the proverbial drawing board. For male contraception, this could mean “simply” adjusting aspects such as method of action or mode of delivery, or it could require an outright course-correction and development of an entirely new potential solution. Or…
Reevaluating the Solution
...perhaps the issue does not lie in the proposed solution at all. It could be that the problem itself was ill-defined. In instances such as this, one would need to reboot the process and truly start again from the beginning. Rapid iterations and tests of proposed solutions can reduce timelines and related costs whilst also allowing for the validation (or invalidation) of the solution.
Reacting to Market Realities
Once key users or beneficiaries have been identified, there is scope for revisiting Step 3 (Solution Optimization). The repetition of this phase has the potential for dual benefits as it can inform the need for additional refinement of the solution as well as identify any gaps or issues with the targeted user set.
Reevaluating Users
It may be the case that the market segment mobilized or excited by the product/solution is different from the target user(s) identified. The product’s resonance with a different user segment could require adjusting various elements of it. As such, it is critical to reevaluate your users and accurately identify the actual key segment.
Revisiting Target User(s)
The reevaluation of key user segments has a particular impact on the marketing of the product, and the messaging around it. For example, something designed for elderly users will be positioned quite differently from a product designed for teenagers. As such, accurately identifying your primary users is an integral part of sustained impact and success.
Reevaluating the Problem
It may be the case that a proposed solution makes it all the way to market, only to completely fall flat and fail to energize prospective users. In this extreme case, it is important to utilize the learnings from each stage and restart the entire process.
Conclusion: Evolve or Die
The Swirling Vortex is our attempt at articulating the potential process a male contraceptive solution may need to follow. As stated before, this is not prescriptive, nor is it a clean, linear journey with a clear beginning and end. Reaching the market is the ultimate goal, though it should not be indicative of work completing. The more a product can be re-tested, reevaluated, and refined the greater its long-term viability and resonance.