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Digg It - Six Sigma is About More Than Just Number Crunching
Top executives who know only that Six Sigma is famous and popular have called for the implementation of Six Sigma programs, and, of course, want to see numbers. They may become very enamored with the copious numbers
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
that Six Sigma produces. Unfortunately, they may not want to see more than just a series of reports and may not understand that Six Sigma is about so much more than crunching numbers and generating reports.
Certai
Certai
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ly, Six Sigma is about number crunching. In Six Sigma, first you define your problem and your project, and then you measure your process from start to finish. Six Sigma produces a flood of data about your process. T
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ese measurements are critical to your success. If you don't measure it, you can't manage it. Through those measurements and all of that data, you begin to understand your process and develop methodologies to identif
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
and implement the right solutions to improve your process. Six Sigma’s clear strength is a data-driven analysis and decision-making process—not someone's opinion or gut feeling.
However, those who know Six Sigma h
However, those who know Six Sigma h
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ve learned enough to be wary of excessive “number crunching” that does not lead to performance improvement. It is not the measurements or the reports that create solutions; it is the Six Sigma team itself. Once a pr
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
blem’s root causes are determined in the analysis phase of a Six Sigma project, the team works together to find creative new improvement solutions. The data is used and relied upon—it is the measurements of the real
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
ties you face! Yet it is smart measurement and smart analysis of the data—and above all the smart creation of new improvement solutions and their implementation—that create real change.
Six Sigma is more than a dat
Six Sigma is more than a dat
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
-capturing, number-crunching process. It is a philosophy and a methodology; it is a way of looking at business and a way of doing business processes. Six Sigma provides a structured data-driven methodology with tool
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
and techniques by application of which companies can measure the baseline performance of their processes and determine the root causes of variations, as well as improve their processes to meet and exceed the desire
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
performance levels. Six Sigma is a technique to introduce controlled thinking into a continuous change management method. It is a desire to constantly improve a product or service offered.
The value of statistical
The value of statistical
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
analysis cannot be underestimated. How can an organization improve if it does not have an established baseline? How can an organization determine if it has made progress if there is no data to indicate improvement?
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
easurement of activity (lead times, cycle times, failure rates, downtimes, etc.) is very important. Using these measurements to understand the variability in your processes is substantially better than the ad hoc it
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
doesn't-feel-right approach. However, without thorough knowledge and skills of how to use statistics in a business environment, all of the number crunching in the world won’t create real change. Ultimately, business
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
process improvement is achieved through the acquisition of knowledge. Since knowledge is a commodity that people acquire, organizations must recognize their people as their most valued assets. Well-trained people ga
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
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
her the knowledge that leads to quality improvement. Through the effective deployment of Six Sigma, the utilization of people can improve process performance, affect product and service quality, positively influence
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
customer satisfaction, and ensure long-term business success.
Yes, you do have to know statistics well, but you also need to know the business needs of your organization to make Six Sigma a success. Six Sigma is a
Yes, you do have to know statistics well, but you also need to know the business needs of your organization to make Six Sigma a success. Six Sigma is a
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ig job that encompasses the entire organization; it isn’t just a set of mathematical tools or a separate function done by bean counters. Properly envisioned as a philosophy of quality improvement, Six Sigma helps ev
.
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
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
ryone in the organization become more efficient and productive.
Peter Peterka is President of Six Sigma us. For additional information on elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Peter Peterka is President of Six Sigma us. For additional information on elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
://www.6sigma.us/six-sigma-green-belt.php">Six
Sigma Green Belt or other Six Sigma Certification project programs contact Peter Peterka
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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