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This TQM article is a continuation of the Part 4a article, the IMPROVE PHASE. In this issue, I will share with you some of the difficulties faced with the team in carry out this TQM project using these tools in the D.A.I.C. methodology as described in the article

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

.

Just to recap, tools used in the IMPROVE Phase are listed below. In this article, I will cover the tools in bold:

Brainstorming of action / solution | Selection Grid | Benchmarking | Cost-Benefit Analysis | Control lot and testing | Pilot the action /

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

Examples of combination products may in

olution | Force-Field Analysis | Prevention Planner

Problem with Benchmarking

a) Benchmark the result

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

normally taken from the budget which has been committed to the shareholders during the budget time. Subsequently, the target figures are used to compute operating costs.

After team is set up, team would follow the steps in the D.A.I.C. methodology. When team arrived 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

setting target, there were incidence teams still debate how realistic was the target given by the management. Team failed to realize that the target is a minimum benchmark figure as far as budget is concerned.

b) Benchmark the process
In many occasions, me

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

Combination pro

mbers from one plant visited another would agree the visited plant is better, their process are more efficient and so on. When asked to use the visited plant processes performance as a benchmark, member give many reasons why they are different from the visited plant hen

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

e cannot meet the benchmark processes. In many case, even the management are in agreement to their rationale. How to Overcome Benchmarking Problem

a) Benchmark the result
There are two schools of thoughts dealing with this issue.

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

irstly, to challenge the target set by the management with data to support your justification. You may should some trend of some historical data but keep in mind that data are historical. Strictly speaking, while historical data provides a trend in the past it does not

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

ully support prediction for the future. Since there is no absolute truth to its justification, the assigned target is good as anybody else guesses. Under such circumstance, management would not convince to change the target.

Secondly, instead of spending time to justi

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

fy how the target is too high, team might as well analysis what it takes to meet the assigned target. Most of the time, team complained that those assigned targets are unreasonable. Due to this fact, I always advocate the team that they must think of some unreasonable a

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

tions in order to get those unreasonable results. There is a saying “Only idiot would think of getting different result by doing similar things”

b) Benchmark the process
There is no better way to insist team to improve processes by using systematic improvem

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

Following aspects would a

nt tools such as process capability etc. Management should be persistent enough to follow through such expectations and provide assistance to help the team to succeed. Such assistance may include further training, enhancement of analytical knowledge and skill or even e

dd to the challenges in developing combination products:

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

gage external help. Problem with Cost-Benefit Analysis

While the tool is guided by a template, most problems faced by team in this tool is to justify the cost may have incurred and validity of the benefits stated. Team were not able to co

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

nvince the finance managers the tangible benefits are reasonable. I had many cases where team over estimate the saving, or over optimistic about the improvement results. Thus make the Cost-Benefit Analysis unrealistic.

How to Overcome Cost Benefit Analysis Prob

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

em

Key focus to this issue is to justify the cost and benefit with real data and analysis. Simulation test or even pilot run to confirm certain improvement will be a great help to ascertain your action. This is one tool that it must be done quantitatively not only

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

to justify the cost, but to provide assurance to the team for action to be taken.

In summary, there bound to have problem with the tools used. When it happened, it must be addressed promptly before team member loss confidence. Team must use these tools ef

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

Professional from academic institutions, pharmaceutical industries, health care indust

ectively so that it helps in the improvement planning. In my next article, I will continue to share how team uses other tools in the IMPROVE PHASE to improve their project. I welcome readers feedback how else I could present these articles.

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

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Disclaimer:
All rights reserved. This article is written by the author based on his practical application experience. All definitions and interpretation of terminology are his point of view and has it has no inte

.

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

tion to conflict with experts in similar topic. The author holds no responsibility for the use of this article in any way.

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

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reprint or re-publish this article as long as you include my resource box at the end of this article. Please ensure that the URL in the resource box remain intact and it is linked to the author's website.

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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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