Case Studies

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Cell & Gene Therapy: Understanding Customer Needs

The Product: S2insight has worked with several companies developing products for the burgeoning field of Cell and Gene Therapy (CGT). This case study describes two: a global life science company with several products used in CGT (Company A), and a smaller company with innovative instrument-based technologies with potential CGT applications (Company B). What these customers had in common was an awareness that they needed a much clearer understanding of the needs of CGT customers for their products to be adopted in that space.

The Project Team:

While the products ranged from early-stage feasibility to on-market the composition of the project teams were similar:

Product Management & Marketing
R&D
Operations
Quality & Regulatory

The Client Problem:

While the specific challenges varied by company, the common theme was that they each needed to have a “fresh look” at the needs of customers in their target markets.

Why?

Company A was in the synthetic biology space and had great products that had been used for years in CGT research. As the market evolved, larger players in CGT therapy development were looking for the same types of products but required much larger scale and “clinical quality” throughout the entire “order to receipt” process.

Significant infrastructure investments were required to satisfy these customer needs and our customer really needed to understand these needs before committing capital and signing contracts.

Company B had developed and successfully launched bench-scale instrumentation for creating nanoparticles (RNA/DNA encapsulated in a containing particle) for the research market. As the technologies and applications for genetic therapy evolved, existing and new customers were interested this type of instrumentation but at much larger scale, and also with a level of quality required for pharmaceutical production.

While experts in the technology, Company B had an incomplete understanding of the needs of these types of customers but understood that the new platform would need to meet these needs to be adopted.

Our Solution:

S2insight held 2-Day Customer Requirements Development Intensives™ for the product development teams at Company A and Company B. This Intensive™ session engagement included:

Using existing VOC information and other customer insights to create an initial Context Diagram that could be used to help define the actual User Needs of all “Actors” who would use or support the product.
Facilitation of a 2-day cross-functional workshop to create actionable and informative Customer Requirements based on the User Needs already defined. The workshop produced not only documented requirements but also a complete and shared understanding across all participating functions of customer needs and the problems that the envisioned product needed to solve.
The Intensive™ session output was formalized in the form of a Customer Requirements Document that would be the foundation of traceability through Product Requirements and ultimately to Design Validation.

Project Outcomes:

In both Company A and Company B the well-defined Customer Requirements, linked back to the true Customer/User Needs were of tremendous value.

Company A (our synthetic biology customer) has been incrementally investing in their infrastructure as they continue to work with individual customers guided by the unifying vision of the Customer Requirements Document.

Company B (our instrumentation customer) successfully developed and launched their new platform and were recently acquired by a global life sciences company.

Participant Feedback:

“Very productive and fun. Can't imagine a quicker way to do it.”
“The sessions were helpful, INSIGHTful, structured, organized, inclusive. Thank You!”
“The session was good. Like a lot of these things, I think we know a lot of what was gathered already but this provided the structure and gathering of the different groups to bring everyone onto the same page and document it.”
“Tough- hard work, really important conversations, but got us to a point we need to be. Progress is hard fought but visible”
“Overall, very useful session as we try to define how we would best serve our customer needs.”
“It was some investment, especially on the time schedule, it was totally worth it.”

The First of Its Kind

The Product: A late-stage startup developed a first of its kind neurological medical device to treat patients with debilitating chronic pain (new indication). While development of the device was nearly complete, the team wasn’t aligned on the scope and cross-functional dependencies of the launch activities, nor the resource needs to support the launch. The CEO had said, “We have one shot and have to get this right.”

The Project Team:

The project team consisted of 16 cross-functional team members in the following areas:

Internal & Physician Training
Regulatory
Clinical & Medical Affairs
R&D
Supply Chain & Operations
Service & Support
Marketing & Sales

The company had been operating for several years, and the focus was primarily on R&D developing the product as well as Regulatory preparing for a PMA. During this time most team members worked remotely, and some had never met in person.

While this siloed approach worked well in the early stages, the company now had to operate cross-functionally as they prepared for commercialization. Executive leadership knew that they needed to grow the organization but were unclear on the specific roles and responsibilities this would require.

The Client Problem:

As a lean startup targeting an undeveloped market, executive leadership felt they would have one shot at a successful launch. While they had a very energetic team, they had concerns:

Do we have the right people with the right skill sets in the right roles?
Do we have enough people?
Do we have a viable path to our target launch date?
Are team members working on the right things at the right times?
Are team members approaching the work in the most efficient manner?
Are team members creating high quality deliverables?

Prior to our involvement, team members were committing to unrealistic dates and then missing them with the hope that others would be late (a game sometimes called “schedule chicken”). Team members also had different opinions on the scope of various deliverables, and that contributed to missed deadlines.

“It feels like they often commit to dates they know they can’t hit, or they deliver the wrong scope for a deliverable because it wasn’t clarified ahead of time”, one senior executive confessed.

Despite having a passionate and hardworking team, management wasn’t confident that they could have a successful launch by the target date.

Our Solution:

We started by bringing the cross-functional team together and aligning them on the scope the launch deliverables. We then facilitated the creation of a fully integrated, detailed schedule that highlighted the interdependencies between functions & team members. This allowed the executive team to see how many resources of each type would need to be hired, and by when.

Project Outcomes:

With our help, the team established an aggressive, yet credible path to the target launch date. The plan provided visibility into resource needs, and allowed management to make strategic decisions regarding team member roles.

Management now had confidence that the team had an achievable plan to hit the target launch date, and team members felt that they knew what they needed to deliver and how to get there.

Participant Feedback:

“This was an incredibly valuable session to force us to gain alignment and ensure we can meet our commercial objectives. Thank you!”
“I really enjoyed the session as it gave me a true appreciation of how to bring all departments together and to allow us to acknowledge each other’s efforts in the company main goals.”
“Every company should go through this process.”
“Super informative and would do it again. Gained a lot of knowledge.”

3's a Crowd

The Product: A longtime client had acquired the rights to a novel, minimally invasive, endovascular medical device from a startup company. The startup company was in the early stages of development when the acquisition took place.

The Project Team:

The project team consisted of ~25 team members from 3 different organizations:

The startup company
A development partner originally contracted by the startup company
Our client that had purchased the technology from the startup company

Team members from these 3 organizations needed to work together for many months to finish development and ultimately bring the product to market.

The Client Problem:

Our client’s overarching goal was to finish development and bring this product to market within the aggressive timeframe and budget included in the deal model. To do this our client had 3 main needs:

Gain alignment on the overall Project Purpose and Objectives. Each of the 3 organizations were coming into this project with different perspectives, and had different goals. This caused significant confusion and was hampering execution.
Gain clarity on roles and responsibilities for all team members across the three organizations. Coming into the session no one really knew who was responsible and accountable for what.
Help facilitating the development of an aggressive but achievable plan and schedule. Our client needed a plan that the team could execute predictably, but also meet the aggressive needs of the deal model.

Our Solution:

S2insight held a 3-Day Project Planning Intensive™ that included participation from cross functional team members from all 3 organizations. A Planning Intensive is a facilitated workshop designed to deliver a detailed project plan and schedule with full team alignment. There were three key elements of the Planning Intensive that were instrumental to addressing the client’s needs:

Product Iteration Planning — The S2insight Facilitator guided the technical leads in the development of a prototype iteration plan designed to quickly reduce technical risk.
Cross Functional Detailed Planning — Based on the prototype iteration plan, the Facilitator led the entire team through a well-defined planning process to build out a detailed schedule for the entire cross-functional effort involved.
Collaboration & Trust — By working together in the same room, a collaborative atmosphere was fostered that helped the parties deal with their areas of disagreement in a positive manner, and resulted in alignment of all the parties to common objectives.

Project Outcomes:

After the Planning Intensive, the project team was fully aligned on the project purpose and objectives, they had a detailed plan and schedule that they were confident could be executed predictably, and everyone knew exactly who was responsible for all project tasks and activities.

Ultimately, the project team executed on the project plan and schedule and completed the project on-time. Scope changes and issues did arise during the project, but with an up-to-date detailed plan and schedule in place, the team was able to react and adjust appropriately to stay on schedule.

Participant Feedback:

"I imagine we’ll look back next March and fail to imagine how we would have succeeded without this process."
"The session was very collaborative and much needed to kick off the project and to begin the relationship building."
"Great 3 days to dive into what it will take to achieve our goal."
"A great concept, well executed.”

The Big Launch

The Product: A global life science company was preparing the world-wide launch the next generation of their immunoassay and clinical chemistry diagnostics platform in about 9 months concluding a multi-year development program. This would be their biggest product launch in the past decade.

The Project Team:

The launch project team consisted of ~80 team members from several different functions including:

Global Marketing & Branding
Medical & Regulatory Affairs
Customer Service & Support
Operations & Supply Chain
Sales & Commercial Operations
R&D (especially V&V)

Team members, spread across the globe, needed to coordinate their work to be ready to launch the product as soon as approved for various geographies.

The Client Problem:

The Chief Marketing Officer (CMO) realized that she had two major challenges:

The organization had not launched anything this big for over a decade and for many this would be their first big launch.
The organization operated in functional silos where each workstream assumed they had 9 months to get their part of the project done.

Our client’s PMO had spent several months trying to coordinate the launch by having each workstream independently plan their part. It became clear to the CMO that the “breakout” approach wasn’t working; that the team needed to be more cohesive; and that they needed to be working off a single fully integrated schedule. Given the importance and visibility of this launch, she knew her career depended on it being a success.

Our Solution:

S2insight held a 3-Day Project Planning Intensive™ that included ~60 participants from across the organization. It became immediately clear that a) the participants lacked a common definition of what a successful “Launch” needed to include, b) that there was too much scope in every work stream, and c) that the target Launch timeline was all but impossible. To address these concerns S2insight focused on the following:

Developing Common Objectives — Our Facilitator led the team through a step-by-step process to define both the Minimum Viable Project (MVP) criteria for Launch success, as well as the “must have” scope for each work stream.
Creating a Fully Integrated Detailed Schedule — With all the team members in the room together, our best-practice planning process was used to develop a detailed schedule that showed schedule impact of unnecessary scope in every work stream. As part of the planning process, key assumptions, issues, and risk were also identified.
Focusing Work Stream Integration on the Deadline — Work stream owners who thought they had 9 months to complete their work quickly realized that they had interdependencies that would force compromises. They also learned that some of their desired work could happen after the initial Launch without affecting Launch Readiness. Following the 3-Day Intensive session, S2insight consultants worked with the team in small groups to optimize the schedule to achieve the target date, with key decisions guided by the CMO and Project Manager.

Project Outcomes:

The schedule coming out of final optimization was within 2 weeks of the target date, and formed the basis for successful project execution. In addition, as a consequence of our work on the Launch project, the Product Development team asked S2insight to help them re-plan their remaining product development work to assure they could also hit their schedule for system completion.

Detailed schedules for both the Product Development project and the Launch Project allowed the client to successfully hit their target launch date, and deliver a product that truly excited their customers. Feedback from new customers was that the new system was a “game changer” that would solve many of the diagnostic testing throughput issues they were currently facing.

Participant Feedback:

“Great! Overwhelming and exhausting but definitely needed and useful, but should have happened last year.”
“Much needed for this group. Well done — wish we could have done this 6 - 12 months ago 😃”
“Excellent use of our time.”
“High value to this organization.”
“A great way to build an integrated schedule in a short period of time."

Agile Software Development in Systems Products

The Product: A client was in early development of a complex Apheresis System for blood collection & processing. The envisioned product required development of brand-new hardware, consumables, and software.

The Project Team:

The project team consisted of 45 cross-functional team members, and four additional software teams developing:

Embedded software
Application software
Graphical user interface (both instrument & application SW)
Data management system.

All software teams were in different geographies, and some were external contract organizations. The teams used Agile software development processes to organize their work and they had already developed hundreds of user stories in separate JIRA instances.

The Client Problem:

Prior to our involvement, the project team was consistently missing their commitment dates. We discovered that there was a very poor understanding of interdependencies between functions. This was especially true between the different software teams.

The software was being developed in isolation from the hardware and consumables development; each function was planning and executing in functional silos. One symptom of this was the absence of a well thought out technical risk reduction strategy and lack of testing of the product as a system. Teams were only focused on the development and testing of their piece of the product. They also lacked a data driven process to prioritize software user stories.

They were operating in a highly uncoordinated fashion, and in any given week none of the team members could say with confidence that they were working on what was actually most important for the project to meet its target launch date.

Our Solution:

We started by establishing a systems approach to planning where the entire product, as opposed to only the hardware or software, is considered the system. This was followed by aligning the team on the project success criteria as well as the detailed scope for each function, and then developing a cross functional integrated schedule.

All user stories were integrated into the schedule and all dependencies between functions were established. These interdependencies between software and other functions were then utilized to prioritize user stories and understand which ones were most critical from a schedule perspective.

Project Outcomes:

This approach allowed each function to understand when they would get what they needed from other functions and when their deliverables were needed by others. It allowed for the team to execute more efficiently and coordination between the different software teams improved.

The result was highly predictable execution, an improved ability to adjust to changes as they arise, and a product launch on the date predicted by the schedule.

A Clear Path to Success

The Product: A new client was developing a new and improved vascular device using a new cutting-edge manufacturing technology. The launch of this product would protect and grow the company’s market leadership.

The Project Team:

The project team was distributed across three different geographic locations, consisted of ~20 team members from multiple functional areas including:

R&D
Process Development
Design Quality
Marketing
Regulatory
Operations

The Client Problem:

Our client had already kicked off this project into the Concept Phase, but there were two main areas of difficulty that they were experiencing:

The project stakeholders were not aligned on the Project Objectives and therefore project scope was not well defined. Although it was still early in the project, the team was dealing with changes in scope coming from various stakeholders.
There was not a clear strategy in place to select a single design concept and develop the design to a point where the team was confident that it would meet requirements during verification and validation.

Our Solution:

S2insight held an onsite 3-Day Project Planning Intensive™ that included participation from all functions that were involved in the project. However, prior to the onsite Planning Intensive, S2insight held a Heavy Weight Prototype Iteration Planning Session that included two elements that were critical to the success of the onsite Planning Intensive:

Stakeholder Alignment Session — Project Purpose Statements and Project Objectives were developed with the Project Stakeholders and the Core Team together to ensure alignment prior to planning the project in detail. This ensured that Stakeholders were aligned, and the team had a clear understanding of the work to be completed.
Prototype Iteration Planning (PIP) Session — The PIP session was held with the technical team members to develop a technical risk reduction strategy through Design Freeze. The PIP session used Systems Engineering best practices to ensure that technical risks are reduced to a level where the team has confidence freezing the design and moving into verification and validation.

Once the Heavy Weight PIP Session was completed, the team was well prepared for the onsite Planning Intensive. A detailed project plan and schedule were developed by the cross-functional team through the Design Freeze milestone during the Intensive.

Engagement Results:

After the Heavy Weight PIP Session and the Planning Intensive, the schedule was optimized, and the team and stakeholders had confidence in a clear path to Design Freeze for this critical project.

Some comments from team members that were involved with this engagement included:

"Well run session. The process is well thought out and adds efficiency to our process."
“Effective process that produced more detailed output than traditional methods with higher confidence in the thoroughness of the content and accuracy of the required tasks and, post Opto, timing.”
“I thought the session was great. I’ve been pushing this method of project management for years. Hopefully it sticks.”
"Very well run, nice pacing. Insightful for the team to go through this approach.”

The project continues to successfully execute to the detailed plan, with updates weekly using S2insight’s proprietary Schedule Update Process.