Life, they say, comes full circle. This summer I have seen and felt this to be true.

Earlier this year (the first day of summer to be exact) my good friend had a baby girl. The joy of this event was interrupted, however, because the umbilical cord became wrapped around the baby’s neck and stomach, causing her to aspirate meconium and fight for her life. Fortunately, the neonatologists and nurses worked to save her life, and she was brought home a few weeks later. Just last week my friend and her baby girl stopped by for a visit; I was elated to see them both so happy and healthy. Even though her baby will require some follow up care, she is by all accounts a healthy baby girl and is just starting out in her brand new life.

For a close family friend, the opposite was to be true. Last month her life was tragically cut short due to cancer.  She had been diagnosed too late with the disease and the cancer had spread to most of her organs. She suffered with extreme pain through the end of her life, a life her husband helped her through until the end. I never in my life experienced a disease like this, or had a life experience impact me as much as this did. As I think of her husband and the pain he is enduring, it takes me back to an earlier email I sent in June. 

The email was about Suleika Jaoud New York Times columnist, Emmy award winning writer, health advocate, and cancer survivor. Her message was about changing perspective based upon an experience. I heard her speak at a conference that I attended and felt empathy for her and her story about fighting her way through cancer to her remission. Her message also caused me to reflect upon my career, and the pride I feel of the industry I work in. Initially, we see what we do in the life sciences as work, but we cannot forget that all our work goes to the diagnosis and cure of the patient, (who can be our own friends and family). Her overall message was, “Don’t give up on pushing for new and more effective cures. Don’t stop traveling where the silence is. Your work has the potential to affect real lives and real people.”

When I think about Suleika’s message (and how true it is) and reflect on these two life experiences that my friends have gone through, I realize that the circle of life is reflected in the work that we do. It reminds me of things like (the continuous feedback loop, the plan-do-check-act circle and the corrective and preventative action cycle), but mostly I am reminded of the product development life cycle. The commonality of all of these loops is that they are all continuous by nature, come full circle, and are defined by a beginning and an end before restarting again. Just like the circle of life.

Here at QSN, our part in this cycle is project management. In the medical device, combination product, drug and biologics manufacturing industries, the product development lifecycle must be managed very carefully. This specifically includes customer information and communication, product design and development, supply chain operations, and enterprise resource planning.

• Customer information and communication translates to focus groups, customer requirements, customer relationship management, and marketing requirements, to name a few.
• Product design and development looks at discovery, chemistry, manufacturing, and controls, product planning, product design, and product development, as is applicable to the industry.
• Supply chain operations consider suppliers, customer orders, fulfillment, storage, and distribution.
• Enterprise resource planning includes product planning, purchasing, production planning, manufacturing or service delivery.

As your products, company, and supply chain become more complicated, so do the processes needed to bring your products to the market before your competitors. What better way is there to manage the product development life cycle in light of this? Most in our industry understand that project management is the best way to manage the product development lifecycle.

The Project Management Process

The principal operatives behind effective project management:

• Scope, milestones, cost and risks of project shall be defined.
• Project plan with timelines will be created.
• Procedures, processes, tools, techniques, people and relationships will be managed appropriately for successful project outcome.
• Reports and status updates throughout the lifecycle of project will be communicated.
• Project deliverables will be provided on time and within scope.
• Risks, issues, and dependencies will be managed.
• Impact on normal business operations shall be minimized as much as possible.

Scope, milestones, cost and risks of project defined:

• What is and is not in scope of the project shall be defined.
• Resource costs and budgets need to be agreed upon initially and throughout the project.
• Milestones must have deadlines clearly communicated and delivered upon.
• Cost, scope, and budget must be approved by all stakeholders prior to the start of the project.

Project plan with timelines will be created:

• Milestones must be defined that are realistic and measurable (usually comes from a project charter).
• Project plan with tasks, durations, responsibilities, and dependencies shall be established to define the project.
• Progress against project plan must be tracked.

Procedures, processes, tools, techniques, people and relationships will be managed appropriately for successful project outcome:

• Procedures and processes shall be verified to be established prior to the start of the project.
• Tools and techniques will be identified and utilized to deliver on time, on budget and on scope.
• Stakeholders will be managed to obtain support for project and its delivery.

Reports and status updates throughout the lifecycle of project will be communicated:

• Stakeholders based upon priority, communication plans, and communication strategies shall be established to keep project communication fresh.
• Reports and status updates must be developed and distributed based upon on project performance to all stakeholders.
• Project shall be tracked and managed against scope, cost, and durations initially agreed upon and elevate accordingly if any of areas are at risk for slippage or other issues.

Project deliverables will be provided on time and within scope:

• Deliverables must be tracked from beginning to end of project.
• Risks or issues with scope, cost, or durations will be mitigated to reduce impact of any problems.
• Stakeholders must be managed appropriately, so all know what they are accountable for according to the project plan.

Risks, issues, and dependencies will be managed:

• Risks, issues, and dependencies log shall be created to track likelihood, impact, and mitigations of risks, issues, and dependencies.
• Plans and mitigations will be established to minimize or prevent any adverse impact on the project.
• Risks, issues or dependencies will be escalated to key stakeholders if they threaten project.

Impact on normal business operations shall be minimized as much as possible:

• Training and support must be provided for successful execution of project and its delivery.
• Project must not impact standard business operations.

In today’s global times, managing the product development lifecycle can be complex due to large cross-functional teams, competing priorities with limited resources, and virtual organizations. Because of the complexities, project management is essential in driving a team to be collaborative, accountable, and self-driven to reach goals by mitigating risk. Project Management is also necessary for harnessing all of the necessary checks and balances to ensure that the customer is heard, the developed product is safe and efficacious, the supply chain is lean, but robust, and the enterprise resource planning is fully effective.

Our industry, like life, is ever-changing and many times comes full circle. At QSN, we’re part of that circle by offering project management expertise. Hearing stories like Suleika’s and those of my dear friends reminds me of this and keeps me focused on moving forward and being a part of work that can affect real people and make a difference in their lives.

Do you feel apart of this circle with the work you do? I’d love to hear your thoughts!