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As opportunities within the digital therapeutics market continue to surge, more and more pharmaceutical companies are joining the technology launch party. In the process, many of these companies are joining forces with software developers to innovate products — from treating a disease to managing and monitoring the health of patients — to improve and streamline care.
However, in their well-meaning collaboration, many are learning the hard way that creating next-generation digital therapeutics isn’t as easy as signing a partnership agreement and deploying your tried-and-true, fit-for-purpose agile launch plan. That’s because the traditional pharmaceutical commercialization playbook isn’t enough, even if it historically enabled your commercial teams to seamlessly execute on launch, while communicating cross-functionally and proactively mitigating risk.
In addition to the cultural and operational differences between pharmaceutical and software companies, digital technology development and adaption brings challenges that must be accounted for and addressed. Bringing these two disciplines together requires creating a new script that accounts for many more implications and interdependencies. Here are some considerations for getting started.
Pharmaceutical companies focus on developing drugs. This requires a rigorous research and development process, followed by carefully orchestrated clinical trials and highly detailed premarket and postmarked regulatory submissions. While speed to market is extremely important, safety and efficacy come first. Pharmaceutical companies are used to this, but most software developers are not. The barrier to entry is generally much easier for software that does not classify as a medical device or digital therapeutic. Software companies are accustomed to sprinting to the finish line with a minimum viable product (MVP), comfortable knowing it can be refined later if and as needed. In this classic tortoise-and-hare scenario of digital therapeutics, however, both must adjust to a new pace without losing the disciplined approach.
For pharmaceutical companies less experienced in the ways of software, another major hurdle comes from not fully understanding best practices related to technology development and adaptation for bringing software to market. There are a variety of recommended steps that digital therapeutics companies should be considering as they build their launch playbooks beyond the traditional commercial activities. These include, but are not limited to the following:
User research and testing. Region-specific user research and testing is a vital component of building or migrating an application. This step helps companies understand how real users will use the software and inform adjustments to ensure users respond and engage well with it. Research and testing should be representative of the regions where the product will launch, since cultural differences may impact functionality, user experience, animation, content, etc. For example, colors can represent different values regionally. In Western nations, white typically aligns with peace and/or purity. However, in many Eastern regions, white tends to symbolize death and/or mourning. User research and testing can help identify cultural differences like these and highlight the need to adapt the look and feel of a product, for example.
As such, this research includes market scans, competitive analyses, prototyping, qualitative testing (e.g., focus groups, A/B testing, or eye tracking), cultural research, and interviews. For example, Netflix used these types of analyses when contemplating globalization. They primarily used geography and “psychic” distance, or perceived differences between markets to help prioritize their expansion. In doing so, they worked with each region in testing and localization efforts to identify internal process improvements, such as automatic translation alerts when in-app headers are changed from one language to another, and even how to best display selection titles across demographic dimensions, including culture, gender, and age. These same kinds of considerations are required for digital therapeutics.
Technology adaptation. Depending on the findings from user research and testing, technology adaptation means collaborating with other functional teams to understand what should be changed, so a product design can be modified to accommodate those changes. This can be a particular challenge due to the agile nature of software development versus the more traditional flow within the pharmaceutical space. For example, in a recent case scenario, friction around defect management for a digital therapeutic for depression treatment arose between a U.S.-based pharmaceutical and its software development partner. The pharmaceutical pushed for a fully finalized and bug-free product, while the developer pushed for an MVP. This negatively impacted the team’s product design and development process.
In addition, medical affairs and evidence-generation elements need to be considered, as well as region-specific regulatory and data security requirements. Take data privacy regulations for example. While many people regard the United States’ various state and federal policies complicated and cumbersome to understand and navigate, the European Union’s as a whole are even stricter, and have the added complexity of individual differences across member nations.
Infrastructure requirements. A component of technology adaptation, infrastructure will usually require significant adaptation when globalizing due to data compliance regulations. Data protection and infrastructure should not be taken lightly. A 2020 Security Report by Intertrust on 100 publicly available Global mHealth Apps, reveals that 71% of healthcare and medical apps have at least one serious vulnerability that could lead to a breach of personal health information. And 91% have mishandled and/or weak encryption that places them at direct risk for data exposure and intellectual property (IP) theft. Either of these vulnerabilities could place an unprepared company at risk of multimillion dollar fines in regions they are found.
To ensure compliance and reduce unnecessary rework later, pharmaceutical companies and their partnering software developers need to do the due diligence on regional requirements and recommendations. These can be very specific, ranging from requirements regarding local data storage to separating storage of user health data and general information to enhanced protection measures against reverse engineering, etc.
In limited cases, these strong regional infrastructure requirements may be considered excessive, but given the focus on data security and privacy across digital systems and technologies, along with the frequency of attempted and completed hacks, these are best practices. Pharmaceutical companies and their partners should consider long-term planning and research of these types of regional requirements before entering even their first market. By doing so, they may alleviate the need for most future infrastructure adaptations, while also providing best-in-class data protection to their users.
Agile product management. Agile is the predominant methodology used today in software development, as it enables products to be developed and released at pace with far more success than traditional (e.g., waterfall) management methods. Product management processes and governance plans should be implemented at the same time or before development. The core tenet of an agile mindset is to set strategy and roadmaps in an agile environment, allowing for a proactive and adaptive approach to product planning and implementation. This enables organizations to quickly respond to changes stemming from the marketplace, internal business stakeholders, and users.
Traditional pharmaceuticals normally follow a more linear, detailed process given the nature of the highly regulated atmosphere in which they operate. However, it will be prudent for pharmaceutical companies to adopt a more Agile approach for developing and managing digital therapeutics, or risk being outpaced – including in terms of speed to market, prioritizing future enhancements, engaging users, and deploying ever-evolving industry best practices — by nimbler competitors. Those pharmaceutical companies that can find the right balance between agility and regulatory due diligence will be best positioned for the digital therapeutics landscape. The critical gaps in style and approach can be bridged through the literal alignment of traditional pharmaceutical commercialization and software teams’ playbooks, as well as through a genuine commitment to collaboration and mutual success.
For pharmaceutical companies launching digital therapeutics, their commercial product launch playbook alone cannot be relied upon to yield the expected business outcomes. Companies need to think beyond commercial functions and overcome cultural and operational barriers to address digital technology development and adaption challenges. Rather than work in tension-ready silos amid industry-born cultural differences, pharmaceutical companies and their software development partners will need to come together to successfully launch innovative digital products in a timely fashion that solve treatment needs.
Maya K Desai, Ph.D., is a director in the Life Science Strategy Practice and heads commercial excellence, and Andrew Fraser is a director in Digital and Emerging Technology practice and leads the Digital Transformation team, both at Guidehouse.