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Does this sound familiar? You were hired for the new management position. You were tasked to turn the numbers around. You take some time reviewing the current situation. Now it’s time to take a

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

look at the current processes and get your staff together to analyze the data. You tell them that you want to brainstorm; work on a few mind maps, whip out a couple Ishikawa’s to get started a

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

Examples of combination products may in

nd then have them bring Pareto charts relative to their respective functions.

One of your department heads looks at you and asks “Ishiwhat?” “You know,” you reply, “a fishbone diagram.” Still

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

blank stares. “Cause and effect?” you say as you scribble out a trout carcass on your white board. Still nothing. You’re starting to think the elevator doesn’t go all the way to the top. You’ve

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

got your work cut out for you. So you decide to punt. “Ok, let’s just start with the Pareto charts,” you concede. “Sir, what is a potato chart?” asks another supervisor. “Let’s take a five min

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

Combination pro

te stretch break and then meet back in here so that I can welcome you to the world of Pareto charts.

A Pareto chart looks similar to a bar chart. It has columns and it also has a line graph. G

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

enerally number of occurrences (frequency) is listed on the left side and percentage on the right. This type of chart is used to graphically summarize and display the relative importance of the

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

differences between groups of data. For example, perhaps you have determined, or at least speculate that your widgets are being rejected due to – improper fittings, defective sorting machine,

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

too large or too small, or other. If you look at the reports or studies and gather data on each of these reasons for failure, you can then plug the numbers into a chart. You may have assumed th

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

e reason for rejection was because the widgets were too large to fit through the tunnel. However your numbers may actually show (the data will validate) that indeed there was nothing wrong with

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

the size of the widget, but rather the sorter was bent, thereby causing the good pieces to bounce into the reject bin.

Typically you isolate five categories to measure. A Pareto chart can be c

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

Following aspects would a

onstructed by separating the data into categories. Let’s look at another example. If your business was investigating the delay associated with processing mortgage applications, you could group

dd to the challenges in developing combination products:

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

the data into the following categories: No signature, address not valid, illegible handwriting, existing customer and other.

The left-side vertical axis of the Pareto chart is labeled Frequenc

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

y (the number of counts for each category), the right-side vertical axis of the Pareto chart is the cumulative percentage, and the horizontal axis of the Pareto chart is labeled with the group

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

names (categories) of your response variables. Are you getting the idea? Your bottom row will be labeled: No signature, address not valid, illegible handwriting, existing customer and other. Ea

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

h title will have a corresponding column associated with it.

Next determine the number of data points that reside within each group and construct the Pareto chart in a spreadsheet program; Exc

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

Professional from academic institutions, pharmaceutical industries, health care indust

el works very well for these types of charts. The difference between a Pareto and a typical bar chart is that the Pareto chart is ordered in descending occurrence importance.

Once you have you

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

r Pareto constructed and you can visually see what the data is telling you, and you will be able to answer a few questions. You will be able to determine the largest issues facing your team, 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

partment or business; you will be able to see what 20% of sources are causing 80% of the problems; and lastly you will know where you should focus your efforts to achieve the greatest improveme

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

Companies that provide selfless information through particip

nts.

No more guess work. You won’t be needlessly wasting more time and money trying to fix problems that weren’t broken. Call a staff meeting and get to work on your potato, er a Pareto Charts

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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