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Projects, both planned and unplanned, can get out of hand, producing undesired or no results after waste of huge resources and time unless they are monitored accurately with

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

the appropriate tools. The pitfalls of not using Six Sigma tools are extremely complex in nature. It becomes impossible to manage the quantum of data in a systematic way that

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

Examples of combination products may in

facilitates pragmatic analysis as desired by the project goals.

If you look at it from another angle, which is from the administrative side, pressures like time, lets-see-n

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

ext-time from management and project cost overruns can help things grow out of hand.

Six Sigma Tools: Three Distinct Groups

Six Sigma tools can be broadly categorized into

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

three groups as per their utility and nature.

1. Statistical tools
2. Software tools and
3. Judgmental tools

Even though software tools are based on statistics, t

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

Combination pro

here is not much difference between them and statistical tools in Six Sigma as they just differ in they way they are made use of. The third one, the judgmental tools, are ent

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

irely distinct from the other two, and draw significance by way of aiding decision-making throughout the project phases.

Statistical Tools

The first one under this head, CP

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

M (Critical Path Method), is not exactly a dedicated Six Sigma statistical tool but it still finds its way owing to its ability to contribute to project management. Working u

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

nder pressure and concurrently running several projects requires a timetable to be put in place. Enumerating the defined critical events on the path you can predict the key d

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

ates you cross each hurdles and completion date. Key events are typically break down structures of projects. CPM is basically a planning tool.

The next set of tools can be s

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

ub-grouped as analytical tools which aid decision making. For example, the FMEA, Failure Modes and Effects Analysis, helps anticipate problems through analytical interpretati

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

Following aspects would a

ons.

Translate vague remarks by customer into measurable functional requirements toning up the ability of the team to design and deliver results that satisfy customers. VOC

dd to the challenges in developing combination products:

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

Requirements Translation and Kano Analysis suffice here. There are tools in this segment to deal with customer data like Customer Segmentation and VOC Data Collection etc.

J

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

udgmental Tools

The Ishikawa Root Cause Analysis Diagram (Fishbone diagram,) is handy to look at reasons for initial problems at a Six Sigma initiative, identify data collec

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

tion areas and more importantly, to answer why projects are off track and not producing results.

There are several other tools falling into this category, such as the Though

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

t Map Regulation Diagram, Brain Storming & Affinity Group Tool etc. For more complex and non-linear problems, it is not advisable to depend on the Cause and Effect Fishbone D

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

Professional from academic institutions, pharmaceutical industries, health care indust

iagram, which is more suited for linear complications. Then there is the Thought Map Relations Diagram for handling complex non-linear issues.

But by far, Brainstorming is s

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

till the more dependable final tool for analyzing the data.

Software Tools

Software tools do not just speed up things, but also eliminate errors from the analytical stage.

.

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

Most popular ones in the category are available as Spreadsheet applications. However, notable ones are

1. The RapAnalyst which simplifies DOE and many predictive modeling ac

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

Companies that provide selfless information through particip

tivities in data mining.

2. There are total packages like MiniTab, SixNet Intelligence for enterprise-wide deployment.

3. The simplest hand tool is the Six Sigma calculator

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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If your company has successfully implemented Six Sigma, there are certain things that need to be checked and rechecked to verify that results are accurate. This article makes clear how and when you should conduct a Six Sigma Audit!

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