Main Subject - Business

The Six Sigma DMAIC process methodology is a system that brings measurable and significant improvement to existing processes that are falling below specifications. The DMAIC methodology can be used when a product or process is in existence at your company but is not meeting customer sp

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

ecification or is otherwise not performing adequately.

DMAIC is an acronym for five interconnected phases:

* Define the project goals and deliverables for both internal and external customers

* Measure the process to determine current performance

* Analyze and determine the root ca

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

se(s) of the defects

* Improve the process by eliminating defects

* Control future process performance

Step One: Define

In the Define phase, the Six Sigma project team identifies a project for improvement based on business objectives and the needs and requirements of the customers.

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

Six Sigma is about “solving a problem with an unknown solution.” To unearth the solution, the problem needs to first be defined in concrete measurable terms. The team identifies critical-to-quality (CTQ) characteristics that have the most impact on quality–separating the “vital few” f

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

om the “trivial many.” With the CTQs identified the team can create a map of the process to be improved with defined and measurable, deliverables, and goals.

Step Two: Measure

In the Measure phase, the team begins with the proper metrics. Critical measures that are necessary to evalu

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ate the success of the project are identified and determined. The initial capability and stability of the project is determined in order to establish a measurement baseline. Valid and reliable metrics to monitor the progress of the project are established during the Measure phase; inpu

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

, process, and output indicators are identified. Once the project has a clear definition with a clear measurable set of indicators, the process is studied to determine the Key Process Steps and an operational plan defined to measure the indicators. Potential impacts on CTQs from each i

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

nput are considered with respect to the defects currently generated in the process. Key Inputs are prioritized to establish a short list to study in more detail and to determine the potential ways the process could go wrong. Once the reasons for input failure are determined, preventati

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

e action plans are put into place.

Step Three: Analyze

Through the Analyze phase, the team can determine the causes of the problem that needs improvement and how to eliminate the gap between existing performance and the desired level of performance. This involves discovering why defe

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

cts are generated by identifying the key variables that are most likely to create process variation. As the Six Sigma team moves through the Analyze stage and subsequent Improve stage of the process they will discover various process improvement scenarios and determine which has the be

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

t net benefit impact to the company. A common error people make when they discuss Six Sigma is thinking that the DMAIC process takes too long to achieve improvements. This is far from the truth. Quick improvements are often achieved early in the project and frequently already implement

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

d by the time the team reaches the Analyze phase. If the team has not already identified major improvements, then the breakthrough often results from careful process analysis with data. Six Sigma analysis techniques are valuable tools to uncover more difficult solutions.

Step Four Imp

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

rove

The Improve phase is where the process transitions into solutions. Critical inputs have been verified and optimized toward nailing down the problem causes. Once problem causes are determined in the Analyze phase, the team finds, evaluates through testing, and selects creative new

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

improvement solutions. The team identifies and quantifies what will happen if needed improvements are not made and what will happen if the improvements take too long. This develops a cost/benefit analysis. More often than not simple process experimentation and simulation bring the team

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

big gains in this step. Also at the Improve stage, the team develops an implementation plan with a change management approach that will assist the organization in implementing and adapting to the solutions and the changes that will result from them.

Step Five: Control

Success in the

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

Control phase depends upon how well the team did in the previous four phases. The keys are a solid monitoring plan with proper change management methods that identify key stakeholders. Lessons learned are now implemented and tools are put in place to ensure that the key variables remai

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

n within the acceptable ranges over time so that process improvement gains are maintained. The team develops a project hand off process, reaction plans, and training materials to guarantee performance and long-term project savings. Documenting the project is very important so that the

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ew procedures and lessons learned are maintained and provide concrete examples for the organization. At the close of the Control phase, ownership and knowledge is transferred to the process owner and process team tasked with the responsibilities. Finally, the team identifies what the n

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

ext steps are for future Six Sigma process improvement opportunities by identifying replication and standardizations opportunities and plans.

Step Six: Synergize

This extra step is to ensure the gains a Six Sigma Team has made are shared with the organization as a whole. This sharing

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

is needed to help create a learning organization. Integrating and institutionalizing the lessons learned and the improvements made multiply the real gains generated by the Six Sigma project. A Six Sigma project should not be an isolated process. It is not the end but just the beginning

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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