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Identify and fix the right root causes.

Complicated problems have multiple root causes, probably more than y

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

ou can handle all at once. The trick is to address the important causes first. Don’t waste time or money on causes t

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

Examples of combination products may in

at are either insignificant in impact or only peripheral causes of the problem you’re trying to fix.

Root cause

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

identification. Use an appropriate root cause analysis tool to identify the possible causes of your problem. Whi

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

h tool is best depends on the problem, but Ishikawa analysis (also called cause-and-effect or fishbone analysis) is

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

Combination pro

good general-purpose tool. Keep checking that the causes you identify are possible causes of the problem you are an

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

alyzing, and not some other problem. It’s really easy for the problem definition to expand at this point.

Root c

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

use verification. The result of the identification step is a list of possible causes. Check again that they are

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

all possible causes of the problem you’re working on, and that nothing extraneous has crept in. Then verify that the

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

causes are real by answering:

Did the suspected cause really occur? E.g., if the possible cause is that

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

a procedure wasn’t followed, verify that the procedure really wasn’t followed. No assumptions allowed.

Could the su

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

Following aspects would a

spected cause actually cause your problem? E.g., if a procedure wasn't followed, but the symptoms you see would occu

dd to the challenges in developing combination products:

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

whether or not you followed the procedure, following the procedure won't solve this problem. Seems obvious, but you

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

won't know if you don't answer this question.

Set priorities. Establish priorities to help you

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

fix the right root causes, i.e., those that are the biggest culprits in causing your problem. There two factors two

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

onsider:

Will eliminating the cause have a big impact on your ability to achieve your success criteria

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

Professional from academic institutions, pharmaceutical industries, health care indust

(your measurable definition of how you’ll know the problem is solved)? If yes, make it a high priority.

Will it be

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

asy to eliminate the cause? If yes, make it a high priority even if the impact is only moderate. It it’s hard to eli

.

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

minate and won’t have much impact, don’t waste your time.

It’s not necessary to fix every cause, even

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

Companies that provide selfless information through particip

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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