Speed vs. Complexity in Life Sciences Projects: When Both Must Win

Speed vs. Complexity in Life Sciences Projects: When Both Must Win (June 4, 2020)

In today’s innovation-driven life sciences environment, speed-to-market can be critical for companies to serve target audiences with new medical devices, drugs and processes, as well as investors demanding a return on their investment.

Breakthrough science and technology is rife with complexity. Bringing new products to market often means there is no prevailing model, no process to duplicate or production venue available to replicate. Pioneering work typically requires an equally pioneering facility.

Creating spaces for innovation is no simple task and experience managing these developments is hard won. While details vary greatly from project to project, three foundational elements must be orchestrated simultaneously, and the intricacies of each thoroughly considered, if success is to be achieved.

1. Owner Expectations & Decision-Making

Leaders in the life sciences field – including owners, C-suites, board members, end users and other stakeholders – are focused on product development and testing, securing funding and getting products to market quickly.

They are not typically experts, however, in the delivery of new facilities, including construction, cost estimating, contracting or timelines which can lead to unrealistic expectations around project development, delivery, or schedules that, if not managed can cause confusion and significant cost overruns.

Efficiently managing a complex life sciences project means investing significantly in the earliest stages to clearly understand the details of the client’s needs and desires.

• Why is speed-to-market critical?
• What are the possible and probable risks with a speed-to-market project?
• Are there specific client-driven project milestones?
• How is success defined in project delivery?

Critical to the expediency of these highly-complex projects is a fundamental understanding by all parties that, with no status quo, fluidity and adaptability should be expected. Project Managers may need to challenge owners and advise them regarding realities of the construction process and, likewise, owners must remain open and willing to shift their expectations of how the project is to move forward. 

For example, owners are often driven by a speed-to-market goal and want to move the project ahead quickly even if it means approving budgets and schedules based on preliminary projections. Development of a Basis of Design (BOD) document is a necessity to developing realistic cost estimates, especially within the complicated environment of pharmaceuticals, biomedical technologies and other life sciences where many intricate elements must integrate flawlessly. Even with a mature design narrative that a BOD provides, changes to scope and plan are inevitable, requiring communication, contingencies and safeguards be put in place as part of the overall approach.

Identifying a clear decision-making process also ensures the greatest efficiency to advance speed-to-market. An explicit understanding of the owner’s needs and vision provide the footing for a hierarchical approval process that identifies who will provide comments and approvals for each aspect of the project.

2. Procurement Strategy

Like budget and schedule, the ideal procurement strategy is based on a mature design. With a fast-paced life sciences project, however, product development is often happening at the same time as project development, making this traditional procurement strategy unrealistic.

With so many unknowns, it can make sense to engage only a core team of architecture/engineering professionals to conduct a feasibility study and develop the BOD, shaping the project to provide initial scope, budget and schedule. Simultaneously, general contractors (GC’s) who are willing to join a project in advance of a complete design may be selected on the basis of their qualifications and agreed upon commercial terms, involved as an objective partner during pre-construction.

Similarly, early engagement of specialty contractors for input on design and cost assurance is a good strategy given the complex nature of these facilities but executing final contracts prematurely can actually result in late-realized schedule and cost over runs. As with the GC, procuring these key specialty contractors can be done on the basis of qualifications and determined commercial terms.  

Prior to project commencement, contract documents with the A&E team and GC can be executed at zero dollars in order to put in place owner protections in the form of terms and conditions, warranties and liabilities. As the project develops, contracts can be amended to specific dollar values. Other key procurement elements to mitigate risk include:

• Early release of long lead time material and equipment, including process-specific equipment
• Determining utility requirements with a potentially conservative approach as the development of an appropriate floor plate and underground work will need to be engineered quickly
• Constructability and structural design considerations for building speed and delivery, future-proofing and right-sizing

3. Validation

Validation is the process of establishing documented evidence that a procedure, process or activity carried out through rigorous testing will maintain and adhere to the required level of compliance at all stages from installation to production. Highly detailed, validation is critical in life sciences and yet is challenging to expedite for the sake of an accelerated speed-to-market schedule. With no corners to cut, establishing the validation Master Plan at the very beginning of a project and devoting sufficient internal resources to support the process are the best strategies against time.

The importance of documentation and quality are paramount in validation. Each level of review and approval lays the foundation for the next, so strict checks and balances are crucial in order to provide confidence for the subsequent round of documentation. Everything is documented in detail through every stage of the Installation Quality (IQ), Operational Quality (OQ) and Performance Quality (PQ) process.

• Standard Operating Procedures
• Environmental Health & Safety (EH&S) Protocols
• Project Manuals & Execution Plans
• Turn-over Packages
• Standards for design and construction quality, etc.

Most facilities requiring some degree of validation will need to adhere to a base set of industry standards such as Good Manufacturing Practices (GMP) and Good Engineering Practices (GEP). Additional criteria may be set by a governing body such as the Food and Drug Administration (FDA) or its International counterpart the European Medicines Agency (EMA).

The Commissioning, Validation, and Qualification (CQV) managers set the foundational guidelines for the creation of the project’s Validation Master Plan while outsourced conformance contractors and quality assurance consultants, may also need to be engaged. This often necessitates the development and release of early bid packages, data sheets and pipe & instrumentation diagrams. 

In order to meet speed-to-market goals, owners must be prepared to provide significant internal resources to ensure an efficient validation process. Operations, facilities management, quality control and even supply chain departments may experience huge workload demands as part of the process, the pace of activities increasing as these users prepare, review and execute the tasks mandated by validation.

Conclusion

A well-executed validation process coupled with a somewhat unconventional procurement strategy can help to expedite the development of complex life sciences projects while maintaining the exceptional quality controls demanded by these facilities. Owners and project teams must also be adaptable and willing to accept the inevitable changes that occur during these types of highly fluid projects if success is to be achieved within strict schedule demands.