Why Pharma Needs Digital Product Management

PART I - INTRODUCTION

PART II – PHARMA FACES SPECIFIC CHALLENGES TO GOING DIGITAL

PART III – PRODUCT MANAGEMENT CAN ACCELERATE DIGITAL DEVELOPMENT

PART IV –SERVICES PRODUCT MANAGER MUST PROVIDE TO PHARMA

PART V – CONCLUSION

PART I - INTRODUCTION

Software started with a Waterfall

In the time before software was updatable, developers had to ship a perfect version of their application on v1.0. Obviously in those days you would want to meticulously plan, document, and eventually code your application. It was known as “waterfall methodology” due to stacking all your planning at the top and pushing it over the development ‘waterfall’. It also meant a lot of software was terrible as it didn’t do a good job of ensuring that it satisfied the base needs of the users nor was it enjoyable to use. Additionally, without the internet there wasn’t a way to view how users were actually engaging with the software.[1]

Agile App Development is a Science Experiment in Real Time

Today is a very different environment. The technology industry has learned that to truly satisfy and delight users, applications must leverage data science and user research to figure out how an application in the real world can adapt to joyfully satisfy different segments of users. User research without an app in the market is only directional as real-world usage is vastly different with many unanticipated confounding variables. For those that have worked in technology companies, the experience is much more akin to running a live science experiment with a team of experts, analytical dashboards, and anomalies in the data which become questions that are answered with further user research. Hypotheses are formed, challenged, and tested as to what will drive more user adoption/satisfaction. Soon these hypotheses turn into theories as software is developed, released and the data analyzed. [2]

Molecule Development is Inherently Waterfall

After pharmaceutical companies develop a molecule, it is rigorously tested via clinical trials to ensure its both effective and safe. Upon release into the market, it does not get modified with new atoms to satisfy user demand. A molecule is not able to be updated much like software developed in the 1980s. While post market monitoring and longitudinal studies are meant to gather data on user behavior, it isn’t possible to monitor the usage of pharmaceutical in real time as analytics does for software. Pharma companies wishing to develop SaMDs (Software as a Medical Device) must be intentional in mitigating for the inherent gaps produced from waterfall methodology culture. [3]

Full Agile Transformation is not a Ubiquitous Fit

The solution to this issue for the last twenty years has largely been to march an army of consultants into waterfall companies and force agile transformations.[4] This approach has had some success but there have also been plenty of failures.[5] It’s more likely to be successful when you wish to transform your entire company; however, it’s not nearly as effective when the company needs to maintain a waterfall process for some of its products. Pharmaceutical companies certainly fall into this category as molecule development revenue far outpaces any digital product now. [6]

Outsourcing Development is not a Panacea

Other business options exist such as buying a digital company that is already agile or partnering with a SaMD development shop to be a contract manufacturer. However, these are no panaceas. The contract manufacturer/partner still needs to be cleared through the pharmaceutical company’s compliance regime (privacy, legal, regulatory, safety, etc.). Additionally, the commercial arm of the pharma company will also be marketing, releasing, gathering feedback, and making key decisions about the product and its features. Furthermore, commerical teams will also interact with doctors who are the gateway to the DTx (digital therapeutics). The issue of course is that when agile teams attempt to interact with waterfall culture, things rarely go smoothly. To make matters worse these are typically small tech companies interacting in vendor relationships with large pharma companies. That kind of pressure laden environment can lead to a killing of the so-called creative agile ‘golden goose’ as the vendor morphs to appease pharma, and ultimately this produces software which is sub optimally designed to satisfy user needs. Contrary to this are great product managers who view any obstacle to an engaging product as a battle they must fight and win. Without this strong voice, users are often relegated to nearly last place on the team’s day to day considerations. [7]

PART II –SPECIFIC CHALLENGES PHARMA FACES WHEN GOING DIGITAL

Pharma Needs New Skills to Build Innovative Digital Products

So how might we solve for this problem without spinning off an entirely new company which disallows leveraging an existing brand? First, let’s examine some of the specific issues within pharma that hinders agile product development from occurring:

Pharmaceutical Culture - Modern pharmaceutical companies were borne out of the intersection of chemistry and industrialization in the mid-19th century. Use of ‘medicine’ was largely unregulated which led to the scourge of patent medicine and so called ‘snake oil’ salesmen.[8] As corporate led chemical manufacturers such as Charles Pfizer, Eli Lily, and Edward Squibb, attempted to distinguish themselves from disreputable entities, they leaned heavily on scientific rigor and provable therapies. This necessitated a culture that was risk averse which still exists today and due to this approach millions of lives have been saved. The general idea is that products are meticulously researched, designed, and tested before release, and thereafter the molecule is not modified. This waterfall approach is largely the antithesis to how modern, engaging software is created and maintained. It leads to risk aversion, fear of experimentation, deemphasis on iterative design and ultimately a product that is maladapted to satisfy user expectations. [9]

Skills & Capabilities - Pharmaceutical companies are generally large, well-capitalized firms with formal, complex bureaucratic systems. Technology startups are small, sometimes well capitalized firms with often non-existent bureaucracies and an informal way of approaching work. In short, technology companies are in many ways the opposite of pharmaceutical companies’ culture. This means that technology talent likely isn’t attracted to employment opportunities at pharmaceutical companies leading to a dearth of skilled job seekers. Ultimately, this can negatively impact digital product success.

Org Structure and Collaboration - Ways of working is another difference between technology companies and pharmaceutical companies. In pharma the commercial team is ultimately seen as the ‘decider’ and driver of the project and tough decisions. In technology companies, Product Management is the ‘decider’ and driver of the project. When there’s ambiguity in terms of feature direction, product management holds the gavel and makes the big product decisions. They act as the center of the wheel, bringing together a diverse set of stakeholders to aggregate demand in order to drive product success.[10] This means that without pharmaceutical companies clearly giving product management responsibility for feature level decision making as they have in technology companies, it creates internal conflicts with the commercial team. Furthermore, in technology companies work is often presented to different departments while it’s still in the ideation phase while at pharmaceutical companies there is more of an emphasis on “completed” work over cross department collaboration.

Process and Technology - With large bureaucratic companies comes a lack of nimbleness and thus they are not likely to quickly try/adopt new technologies. While this also exists to some extent at mature technology companies, the issue is that pharma doesn’t use the standard tools that product managers need to develop agile software. For example, it may seem like a small issue to use Teams instead of Jira/Confluence/Slack, but this will make it much more difficult to retain talent and operate efficiently. [11]

PART III – ADVANTAGES OF PRODUCT MANAGEMENT IN PHARMA

Product Management Can Accelerate and Enable Digital Development

What is the correct path for a pharmaceutical company that doesn’t want a full organizational agile transformation but still wants to leverage their existing internal departments to drive many aspects of building a digital product? One approach is to use experienced product manager consultants as a thin wedge to begin to introduce agile product development culture within your organization. Working with a vendor/contract manufacturer to develop a product will still necessitate many granular product feature decisions to be made by the internal teams in addition to the compliance interactions. Having experienced product managers will smooth out the interactions with the contract manufacturer and will act as a thin wedge to seed agile product management practices in the organization. This approach offers many advantages:

Speed to Deploy - There’s no doubt that getting into market faster confers many benefits. By bringing in Product Management consultants pharma companies will gain the ability to circumvent internal hiring barriers to bring in the right talent when they need it. Additionally, internal practices may require a broad range of people to conduct the candidate interviews which lessens the chance of the product manager positively disrupting the current company culture.

Lower Financial Risk - It’s difficult to know how existing departments will work with product managers. Getting the budget and creating an entirely new department is onerous and risky. By bringing in contract Product Manager consultants the organization can determine the most optimal ways of working with other departments. These learnings can help prepare organizations for a more formal product management role.

Retain Internal Knowledge - Product management documentation is far more robust than just the Design History File. One negative of hiring a contract manufacturer is that much of the deep learnings and product feature documentation will reside with them. In order to mitigate for this, product management consultants can develop strategies and execute them to ensure that product knowledge is retained.

Develop a PM Team - Whether there is already a small product management team or not, building out a best practices-based product operations process (training, tools, meeting, and culture) will lead to higher retention and a more effective team.

Drive Product Features - By leveraging Product Manager consultants who have worked on many different pharmaceutical companies’ first in market digital products, pharma organizations can avoid the most common pitfalls which stymie launch dates and ultimately patient engagement. The experiences of product manager consultants allow them to better drive consensus from clinical, quality, regulatory, legal, commercial, privacy, etc. In short, Product Manager consultants have done it before in a very similar environment with relatively the same challenges.

PART IV – SERVICES PRODUCT MANAGERS MUST PROVIDE TO PHARMA

Product Managers Must Provide Essential Services to Pharma

Whether a pharmaceutical organization is just starting their digital journey, or have already launched a few digital products, they will benefit from experienced product manager consultants who have launched many products within this environment and therefore possess the scar tissue to avoid common strategic mistakes. There are a bevy of services which can be provided both at an organizational and also an individual product level.

Organizations:

Build Product Department - Early and mid-stage product management departments are often composed of individuals with very little product management experience but get ‘drafted’ into the role. Because of this there are often gaps in the initial structure of the department which would benefit from more precise definition around roles & responsibilities, title & level architecture, and other areas before attempting to scale up. Providing support around hiring practices such as interviewing, job descriptions and skill matching can also strengthen the talent pool within product management.

Product Operations - Having the proper tools, culture and meeting cadence is essential to a smooth-running product management team. Tools such as Slack, Jira, Confluence, Mural/Miro (whiteboarding) will allow the organizations to better disseminate information, encourage a cohesive team, create a source of truth, and foster a shared understanding of the product and its features.[12] These tools will need to be properly configured and introduced to the organization to ensure their success. Team members will be relieved that they are using the standard tools of the industry which will help attract and retain talent.[13]Creating a source of truth seems easy but it actually takes a lot of discipline and process to ensure its up to date and 100% accurate. Building and maintaining product templates for modifying existing/new product features, feature research, analytical questions, etc. will help to enable junior product managers to move faster and standardize the way knowledge to shared and retained. Lastly, understanding how to setup internal product management team meeting cadences and external meetings/communications with other departments is essential for a smoothly running product team.

Products:

Product Vision, Strategy and Roadmap - It’s all too easy for product teams to move forward with a product before following the best practices on how to unify an organization around a product vision/strategy. It’s fundamental to the success of a product to agree on a product vision throughout the organization before diving into the work in earnest. Typically, large white board sessions need to be conducted with a swathe of stakeholders to achieve this shared vision/strategy. In many cases this will not be an easy task as widely divergent ideas are held by different groups of people. It will take skilled Product Managers who have experience navigating complex organizations and facilitating a path forward. Product Management teams will also need to be able to regularly update their organization on their progress and create a ‘buzz’ around the product to activate people within the organization. Every great product must have champions who believe in its intrinsic value enough to dedicate themselves to its success.

Compliance Prowess - In some ways, to product and design teams it can feel like compliance actors are the ‘police’ of your product. They are solely interested in reducing risk for their organization, not in ensuring high engagement of a product. Negotiating with compliance on difficult issues will often involve outside opinions and scanning the market for current examples. In a regulated product, teams must understand that good manufacturing processes like ISO 13485 aren’t something that you layer onto a project, but rather it must be the connective tissue which underlays the product. Working with product teams who have ‘institutional’ knowledge and experience with these systems can increase the velocity of a project and reduce overall risk. Documents will need to be created such as Software/User Requirements Specifications, Design History Files, Risk/Hazards, etc., which will eventually inform the regulatory filing so it’s essential that they are produced with a high level of accuracy. Approaching products early with privacy in mind will help to reduce the complexity of issues as launch approaches. The teams can help by creating product features analyses to understand what is currently happening in the market. Having multiple expert opinions from multiple sources who can respond quickly will ultimately help guide the decision makers to not be too many standard deviations in either extreme direction.

Researching to Delight Users - Researching a product exists in many forms for health care apps. It can stretch on a spectrum from informal research with panels of patient/HCPs to get directional opinions of product features, all the way to Phase I, II, III clinical and double-blind clinical trials. In any of these scenarios, researchers will always need to be keenly aware if their research population mirrors the real world, if the app/materials will accurately convey the finished product, and if the quantitative/qualitative output can be reasonably interpreted into product feature decisions. Product management teams excel at understanding the elements that go into good research and driving it forward as this is an inherent part of their discipline. Experienced Product Management teams can help form relationships within your organization, bringing together disparate stakeholders to positively contribute to product feature discovery.

Feature Development and Prioritization - Deciding what product features to build is one of the most vexing challenges in product development. While it’s easy to think these ideas comes from external entities, the reality is that most organizations are not leveraging the wonderful internal ideas which have been floating around. When there is grass roots excitement about the potential of a product feature, ideas will corresponding be generated. Managing, aggregating, organizing, and supporting new product requests with interconnected systems is something experienced product managers are adept at creating and maintaining.

Ideation - Ideating in large groups can be challenging. Having experienced product managers who have strong opinions on how to build engaging products with a track record of successful launches will help to stymie the risk aversion winds from creating a product which users don’t want to use. Product managers will need to strongly advocate and prioritize the best user experience which in turn should lead to reasonable accommodations from compliance. If your process works opposite of that, then it’s likely registration / onboarding / engagement will be problem areas which seem unsolvable.

Product Manager Specialization - Developing product involves a wide variety of phases from discovery to product launch to product feature optimization. It’s important to ensure that your product expertise is composed of individuals that understand each phase as the skillsets are often very different. For example, in the earliest phase of a project, product managers typically work with creating story boards, evaluating designs for the app, and interviewing stakeholders to determine if the concept initially resonates with users. The skills needed for these activities can be very different than product managers who work directly with development teams to break down requirements into epics / user stories / tasks.

Go to Market Workstreams - As health care apps get ready for launch it will need to be connected to the overall technology infrastructure to be delivered to users. In addition to assisting with build/buy decisions, writing RFPs/RFIs to select vendors will be necessary. As these activities require precise requirements gathering/aggregation from stakeholders, Product Managers are well suited to accomplish this work to select a best-in-class company to meet the product’s needs. After selection, many vendors will need to be managed in such a way that seamlessly integrates with the product. For example, when selecting branding/marketing companies, there is often an opportunity to reskin the app to match the latest designs/colors of the marketing campaign which can help drive adoption.

Features to Fit Distribution Channels - Distributing the app is where product strategy meets product management. Whether it’s in clinic, employer wellness, or even over the counter, product managers with a deep feature level understanding of the app help bridge the feature gap from strategy to deployment.

Fighting for the Perfect User Experience - As the finish line approaches final decisions will need to be made about legal documents in the app such as the product label, consents, and other legal notices. Competent product managers know how to tactfully push back on compliance execs to fight for the best user experience. Driving consensus among these stakeholders while ensuring an excellent user experience is essential to deliver the user experience which will achieve high user engagement with the product. Lastly, data is essential for the proper operation of a product as well as understanding what future features will delight users. To be successful, data must be a forethought, and a workstream should be established as early as possible.

Product Analytics - One of the most important industry standard practices in successful technology companies is to deeply understand your users and continually modify the product to meet their needs. However, all these activities are reliant on having accurate, clean data generated from a variety of sources which can be connected to give it comprehensive meaning revealing insights about users and app features. Product managers with an analytics/data background can help to add velocity to projects as they aggregate information from specialist stakeholders to drive clear product related business objectives. They will ensure that data dictionaries are holistically defined so that APIs operate efficiently and KPI’s can be created and socialized for consensus. Analytics dashboards will allow keen product managers to understand user behavior and validate the personas imagined by early product development and marketing landscapes. To understand users more deeply, exploratory data analysis techniques such as k-means clustering, coefficient heatmap matrixes, regression and other analyses can be leveraged. Ultimately, analytical discoveries about user behavior will be socialized and coalesced into product feature decisions that drive the business. Lastly, having product managers with an analytical skillset to assist in interpreting clinical outcomes as they are related to the use of specific product features can help to increase reimbursement for the product.

PART V – CONCLUSION

Building Our Digital Health Product Future

The world is moving more and more into digital health. There is almost nothing that will stop this accelerating force from continuing as digital, scalable healthcare will eventually help millions, or even billions, of patients.

How can pharmaceutical companies begin creating digital products while leveraging pre-existing resources such as internal teams to retain design decisions? It’s quite clear by this time that digital is here to stay. It would therefore behoove pharmaceutical companies to view this as a strategic, long-term investment wherein it’s vital to build the internal skills necessary to be organically competitive for the future.

After a product launches, commercial teams gather product feature feedback which informs product development. Commercial would never talk to a R&D about adding a new atom to a molecule, but they will share information with product managers to influence digital product development. What new skills are needed to make this evolution as smooth as possible where existing departments in a pharmaceutical company can work on both pharmaceutical and digital projects without sacrificing the success of one or the other as many of the activities to go to market are similar? Using Product Management as a thin wedge to seed product management skills/principles, to drive product features, and to manage outside digital vendors is an essential part of the success of pharmaceutical companies pursuing digital for the long-term.