A Guide to Solving Complex Life Sciences Challenges

Life sciences organizations are consistently inundated with decisions and challenges of varying scale. These can occur anywhere during the life sciences value chain, under any treatment modality (e.g., drug, device, combination product), irrespective of company size, complexity, or their relative planning/preparedness. Organizations have to proactively manage a specific decision or action so that subsequent activities or processes within or outside their group can be executed.

In situations that require a simple action or decision, the challenge is easily surmountable. But, how do you thoroughly address a highly complex, multi-layered challenge that requires a structured approach for resolution?

What Makes a Challenge a Complex Challenge?

A complex challenge is one that has a clear key question, requires two or more of the below categories to be addressed for resolution, and requires significant coordination across project management, process optimization, and organizational change management to successfully achieve resolution. If a simple staff augmentation solution, a minor process change, or a limited enhancement of technology solves the challenge, then it is not considered a complex challenge. Complex challenges require core project management fundamentals and execution to satisfactorily achieve resolution.

When analyzing how to address the complex challenge, it is important to determine the impacted categories. Examples of these are:

• People: How to address roles, responsibilities, functions impacted by the complex challenge. What roles will need to be added, changed, or eliminated due to the complex challenge? How will training be designed and rolled out?
• Process: What processes need to be created, optimized, or eliminated due to the complex challenge? How will you ensure that aligned processes are addressed appropriately? How will impacted documentation and supporting tools be managed?
• Technology: What are the technology impacts to support resolution of the complex challenge and any changes in process? How expansive are the changes, cost implications, user concerns, and implementation difficulties that must be considered?
• Governance. What does oversight of the project addressing the complex challenge during and post-implementation look like? Does that structure currently exist and what needs to be enhanced to support the future state?
• Vendors/Partners. How are external vendors and partnerships impacted by the complex challenge? What must change with existing agreements, expectations, timelines, and deliverables? How will this impact the current relationship? How will you monitor the vendors/partners activities to ensure readiness for resolution of the complex challenge?
• Site/Facility. Are there any physical locations - sites, facilities, etc., that are impacted by the complex challenge? How? What must be implemented at each site to support the outcomes from resolving the complex challenge?
• Culture: How to manage the cultural impacts of the complex challenge; how will you bring them along in the journey to facilitate the organizational change? How will you address resistance to change?
• Product. Are any products (pre or post-launch) impacted by the complex challenge? How? If pre-launch, what are the R&D impacts and what can be done to minimize negative timeline or non-value add activities? If post-launch, what must be done to ensure that the product continues to be safely manufactured, shipped, and available for public use? How can internal groups effectively support messaging and implementation of project outcomes?

What are Examples of Complex Challenges for Life Sciences Organizations?

Some complex challenges appear very difficult when defining, are onerous when executing, generate reams of lessons learned, and produce the most excitement when completed. The most obvious and recent public example is the need to rapidly develop a safe and effective COVID vaccine that can be distributed globally in the shortest duration possible. All the aforementioned challenge categories were impacted, but some factors had a more outsized influence on the outcome due to the public’s critical need to stem the medical losses linked to the virus and the strong desire to return to life as usual. Evaluation of the success of the complex challenge also impacted all of the factors listed as development of the vaccine had to follow all regulatory agency requirements, it needed to be produced on a scale that was affordable, efficient, and reproducible, distribution and stability needed to be effectively managed (as part of the process), and as aforementioned, the vaccine needed to be safe and effective.

Conversely, there are complex challenges that initially seem simple, but after careful analysis, have hidden layers of complexity which can cause a seemingly unassuming challenge to become one of more significant complexity. An example is optimizing a global quality process. Typically, individuals consider the documentation updates which they assume can be quickly completed and implemented along with “Read and Understand” training as their definition of done. However, all legacy documentation has to be retired, impacted documentation has to be updated and made effective, new documentation may need to be created, translations need to be considered, intricate content reviewer panels have to be identified, technology may need to be updated, roles/responsibilities may need to be aligned, created, or eliminated, governance processes may need to be enhanced or created, and cultural impacts/journey of changing and rolling out a new process have to be considered and carefully managed. These examples are representative, not fully inclusive of all activities that could be implemented. If these additional items are not considered and addressed, resolving the seemingly simple, now complex challenge will not be achieved, negatively impacting the successful completion and roll-out of the optimized, global process.

Framework: How to Address Complex Challenges at Life Science Organizations?

Though complex challenges can vary significantly per life sciences function, region, type of challenges, different measurement of successful resolution, etc., all have a similar basic framework for resolution. Core project management fundamentals are critical in the resolution of the complex challenge.

The steps of the framework are as follows: 

• Govern/Communicate. Provide oversight of the ongoing project and execute a communications strategy to impacted stakeholders to provide ongoing communications and identify/escalate/resolve issues.
• Define. The key question(s) must be defined that will address the complex challenge. Clarity of the key question(s) should facilitate identification of definition of done and development of an approach to measure resolution of the complex challenge.
• Develop. Develop implementation approach that will address the complex challenge. Conduct review with impacted stakeholders to validate approach, identify dependencies and aligned project management deliverables.
• Implement. Complete project mobilization and execute implementation approach.
• Monitor. Upon completion of the project, monitor for successful resolution of the complex challenge.

While these steps are fairly basic, they are a useful foundation in building a more detailed, comprehensive approach to solving the complex challenge. By utilizing the complex challenge categories, more detail and focus can be integrated into the design of the solution, minimizing churn. This often brings out the hidden complexity of the challenge along with the understanding of the relationships and dependencies between the impacted elements that need to be addressed per the challenge. 

How to Evaluate Resolution of Complex Challenges?

When solving a complex challenge, some barometer of success is needed to ensure not only completion, but that the project effectively addressed the complex challenge. This measurement is preferably objective, quantifiable, and can be assessed per predefined timepoints.

Six areas can demonstrate whether a challenge has been successfully addressed:

• Compliance. Have you addressed or fulfilled the compliance gap(s) or requirement(s)? Have you minimized or eliminated the possibility for recurrence?
• Cycle Time. Have you observed a sustained decrease in cycle time for the impacted process(es)?
• Efficiency. Have you observed increased efficiencies for the impacted process(es)?
• Financial. Have you observed the proposed cost-savings, revenue increases, or profit increases as a result of addressing the complex challenge?
• Productivity. Have you observed sustained and increased productivity improvements for the impacted process(es)?
• Safety. Post completion of the project for the complex challenge, have you addressed any of the observed safety issues and either minimized or eliminated their recurrence?

Typically, complex challenges will impact at least one or more of the above areas and function as an objective indicator of the complex challenge’s successful resolution.

Closing Thoughts and Continuing the Conversation

This thought piece reviewed the definition of a complex life sciences challenge. We provided examples, reviewed how to solve the complex challenge, and discussed how to assess effectiveness of the solution. Pharmaceutical, Biotech, and Medical Devices leadership is inundated with the need to effectively address key decisions and challenges - big and small. While no two challenges are rarely the same, it is incumbent on leadership to have a structured rubric on how they can address the solution in manner that can lead to an effective approach and the desired outcomes.

In our “Solving Complex Challenges” series, we will provide several examples across the R&D lifecycle to illustrate how we utilized our deep expertise in project management, process optimization, quality and compliance, and organizational change management to address a myriad of interesting, not easily definable opportunities that our clients have found themselves needing to address. In all cases, we were incredibly successful and able to deliver on ProPharma’s value proposition to our clients.

If you have a complex challenge keeping you awake at night, we are here to help. Contact us today to speak with one of our experts and tell us how we can support the success of your initiative.