Applying DMAIC Six Sigma to Biotech Drug Approval

Introduction to DMAIC and Biotech Drug Approval

The DMAIC method from Six Sigma is a five-phase improvement cycle. The phases of the DMAIC process are Define, Measure, Analyze, Improve, and Control (Chieh, 2009). This problem-solving method can be used to improve any process.

In the context of a biotechnology company, one process that can be improved concerns bringing new drugs to market. The process is complicated, and in the time it takes to receive FDA approval and begin production, other biotech firms may be developing their own similar treatments or drugs and capturing first-mover advantages in the marketplace.

Define Phase: Framing the Problem and Stakeholders

The first step in DMAIC is to define the problem. For the process being improved — guiding new products through the approvals process to market — we begin with a problem statement: Our products are taking too long to receive regulatory approval. We must define the key resources available to address this issue. For example, staff whose job is to shepherd products through this process must be evaluated in terms of human resources capacity and effectiveness.

Also within the Define phase, we must determine a process owner or champion — the person who will take charge of improving the process. In this case, a relevant vice president, such as the VP of Marketing or VP of Research and Development, will champion this process improvement effort. Key internal sources of support include both Marketing and R&D departments, as well as the CEO and other senior executives. Executive support at the highest level is required because the firm must demonstrate full commitment both internally and to the regulators with whom it will be working. The primary source of external support will be the regulatory bodies themselves.

We must also determine the deliverables. The customers in this case are end users, and objectives must be set accordingly — for example, delivering new treatments and products in half the time currently required.

The second step is the Measure phase. We must define the defect we are measuring. This involves analyzing why some submissions to the FDA are rejected — errors are occurring at some point in the process. Data on current practices must then be collected. This data provides insight not only into the types of errors being made but also into how frequently they occur.

Measure Phase: Tracking Defects and Setting Baselines

With a data collection system established for past performance, that same system must be used going forward to track progress. As changes are implemented to address defects in the approval process, their impact on outputs must be monitored — for example, in terms of the rate of rejections and the time elapsed before regulatory approval is granted.

Finally, the Measure phase requires setting a baseline. There will always be some rejections and delays that fall outside the organization's control. The baseline should nonetheless be set at the point where the system is performing at its best — that is, at a point where all controllable errors have been eliminated. Establishing this benchmark is essential for meaningful comparison as Six Sigma improvements are introduced.

At this point, the problem has been defined in terms of deliverables to both customers and internal stakeholders. The process by which solutions will be measured has also been established, along with an understanding of current performance levels and the ideal performance level to be achieved. The next phase of the DMAIC process is to analyze the root cause of the defect (iSixSigma.com, 2009), which will inform the subsequent Improve and Control phases of the cycle.

Chieh, C. (2009). Six sigma basics: DMAIC like normal problem solving. iSixSigma.com. Retrieved October 25, 2009, from