Project Management
Drug Development / Medical Device


The drug development and medical device development involves perplex process and often becomes a long path from concept generation to commercial launch. A large number of documents need to be filed in order to meet FDA CTD (Common Technical Document) requirements for module submissions for IND (Investigational New Drug) and NDA (New Drug Application) for drug development.

The medical device development is driven by the FDA Design Controls requirements.  Under this circumstance, the PMO becomes a lighthouse of organization and navigates the high-level organizational operation to daily tasks.  Our PMP­® certified professionals provide thorough assessment of your Medical Device Project Management process and design the optimal PMO function to achieve your organizational goal.

Portfolio Management

A Portfolio Management governs the investment committed to make for the business based on the goals and objectives determined by the strategy.  It is a framework to examine rationales why the work, specifically defined by programs, projects, and tasks, are performed.

The portfolio management consists of identifying, prioritizing, authorizing, managing, and controlling projects, programs, and other tasks to support it.  The portfolio management is a consolidated management system based on one or multiple portfolios.  If the organization is failed to fully establish the centralized portfolio management, an investment will not be capitalized as much as it should.  Subsequently, a number of programs and projects will lose their purposes.

Our experienced eyes carefully scrutinize your current organization’s PMO structure and provide a framework that capitalizes the investment.

Drug Development & Medical Device
Project Management
PMO Structure

Medical Device Project Management

Let Our Experience Be Your Guide

Transform Your Drug Development & Medical Device Project Management Today

Program Management Framework

I. Strategic Program Management
II. Program Life Cycle
  – Initiating
  – Planning
  – Executing
  – Controlling
  – Closing

III. Benefits Management
IV. Stakeholder Management
V. Governance

Program Management

A program management is a group of associated projects in the coordinated manner in order to obtain the benefits and control not available by managing them individually.

The program may consist of a group of projects and tasks.   For instance, a new product development can be a program.  It requires multiple stream of projects with an involvement of many stakeholders, R&D, Quality, Manufacturing, Regulatory, Marketing, Technical Services etc…  Their work falls under one DHF (Design History File).  The PMO function performs a significant role in today’s medical device development since the program management framework must reflect FDA Design Controls.

Is your business not performing as efficient as you expect?  Do you feel competitors in your market are doing better than your company?  We are highly experienced in bringing definitive metrics to measure your current program status, find the loophole of current operation, and develop a high-performing program structure and team that will substantiate your organization from your competitors.

Project Management

The drug development & medical device project management becomes a core element of organization’s day-to-day activities.  The corporate vision is determined by the senior management.  The portfolio of business unit is established by the PMO body portfolio manager.  The program manager oversee the multiple projects to achieve milestones.

The project management framework is designed to maximize the productivity of daily tasks as efficient as it can be.  The employees work, however, the management often overlooks to measure and monitor the true productivity of work being performed.  As a result, the organization is not capitalizing its own potential.

It is a management’s responsibility to establish these project management phases and develop a clear plan for execution.  The organizations, which did not fully establish or do not constantly examine the effectiveness of current project management process, often perform less than its own potential, creating the environment that the employees are struggled to thrive and fully utilize their talent.

Project Management Framework

The Project Management Framework is designed to govern following topics
1. Project Management Process
2. Integration Management
3. Scope Management Process
4. Time Management
5. Cost Management
6. Quality Management
7. Human Resource Management
8. Communication Management
9. Risk Management
10. Procurement Management
11. Stakeholder Management

The project management follows these phases.
I. Initiating
II. Planning
III. Executing
IV. Monitoring & Controlling
V. Closing

Agile Cycle

Medical Device Agile Method

Agile To Do List

Agile To do List PMO Medical Device Management


Have your organization already adopted Agile methodology?  If not, your organization is not ahead in the market.  The demand for faster project turn around is becoming increasingly popular.  The Agile process is essential to catch up fast changing market.  We have been transforming drug development & medical device companies by implementing Agile methods and how the medical device project management should take the advantage of the benefits.  It’s not too uncommon to see our clients drastically improve their performance through education and training.  It is often “This is exactly what we needed but didn’t realize actually what that was.”  A conjunction with our Business Intelligence service really synergize the advantages of Agile framework.

Why Agile method should be adopted for drug development & medical device development?

1. Suited to manage multi-discipline team
2. Active team member involvement
3. Less mis-execution
4. Less idle time
5. Faster task and project turnaround
6. Prevent tasks being left out
7. Transparency in the team

Let Our Experience Be Your Guide

Transform Your Drug Development & Medical Device PMO Today

Crisis Management

Are you prepared to work on something urgent that requires the majority of resources?  Does your organization have protocols to tackle something catastrophic harm to your business?   The crisis often takes place under unexpected circumstance.  In the drug development & medical device industry, it’s possible that the federal government asks your business to double the production quantity.  Your production plant might be capable of doing that in reasonable time frame.  But what if your major production plant went into major problem during same time? perhaps, a natural disaster, malfunction of major fixture / machines or large portion of work forces are unable to perform or come to work.  Also the medical device project management still has to meet all the regulatory requirements even under exigent circumstance.

The numerous scenario can be considered for the crisis management.  The management must have a series of protocols to counteract the impact of crisis.  The scenario based training exercise should be prepared and implemented under normal operation.  Once this very unlikely scenario takes place, your employees are able to shift their focus with less disturbance.  We provide planning and training to minimize the impact of crisis and stabilize the situation to get through the crisis.

Crisis Management Strategy

These are some of examples that we provide our clients for the crisis management
– Simulate the situation
– Formulate the task force
– Identify and assign the role of stakeholder
– Establish the communication protocol
– Facts gathering and analyzing
– Qualify and quantify the facts
– Set multiple small goals
– Assess the feasibility of options
– Identify tasks and execute
– Have a transparency and keep employees informed