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Digg It - Six Sigma in IT Project Delivery
Research evidence and industry experience indicates that less than one third of all IT projects are delivered on time, on budget and with req
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
uired features. More than half are late, over budget or delivered with less than the required features. Most worryingly, nearly twenty percen
; 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
t are cancelled prior to completion or delivered and never used.
Most software project failures are the result of business needs not bei
Most software project failures are the result of business needs not bei
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
g correctly understood or by overly optimistic software development estimates. These errors lead to long delays and large cost overruns. In a
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ddition, poor software quality imposes high levels of support and ongoing rework.
Too often, IT projects start with an assumption that s
Too often, IT projects start with an assumption that s
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
mething “technical” needs to be done and discover too late that they were solving the wrong problem or that the approach taken to solving it
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
was based on outdated assumptions.
One of the key tools in the Six Sigma “toolkit” is its problem solving methodology. DMAIC stands for
One of the key tools in the Six Sigma “toolkit” is its problem solving methodology. DMAIC stands for
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
Define, Measure, Analyse, Improve and Control. The key to the success of this methodology is its focus on using data-driven tools to identify
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
what is to be changed and then to monitor the actual impact of changes in a feedback loop.
With DMAIC we start be reviewing these fundam
With DMAIC we start be reviewing these fundam
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
ental assumptions and focus on the goal of understanding the needs of the customer and how we can best improve delivery of them. This involve
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
developing a clear business case, understanding the problem and the expected results, determining limitations and customer expectations and
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
identifying key stakeholders and their roles. This results in a preliminary project plan. We then collect facts and numbers that offer clues
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
about the causes of the problem or the solution to an opportunity. Six Sigma goes beyond “test cases” by identifying both how a system might
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
e used, the expected behaviour AND the key indicators of customer satisfaction with the overall business process. DMAIC provides a robust fra
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
mework for ensuring that initiatives that reach implementation are most likely to add value to the business and can be measured to determine
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
heir actual impact. The final step looks at how the improvements that the project has made can be sustained and maintained over time. For IT
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
based projects this step will include full handover of documentation and support responsibilities, detailed post-implementation reviews and e
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
nsuring that management supports the ongoing success of the project.
Six Sigma provides an effective approach to achieving reliable IT p
Six Sigma provides an effective approach to achieving reliable IT p
.
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
oject delivery. Six Sigma insists on active management engagement and involvement, a financial business case, and in focussing on only the mo
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
st important business problems. Six Sigma also provides a clearly defined methodology, tools, role definitions, and metrics to ensure success
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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