Advice You - Business

This TQM article is about Implementing Total Quality Management (TQM) in an organization. It is quite known to the business world that this is not an easy task. However, there is a systemati

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

c approach to assess its likelihood of success in implementing TQM provides an early sign for actions. Below are a set of questionnaires to assess 5 critical success factors for a Implementi

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

Examples of combination products may in

ng Total Quality Management in an organization. It is a simple and direct questions asked to draw the readiness of an organization in its sate of preparedness. The questions should be answer

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

in a skill of 0 to 10, being 0 is the lowest score and 10 is the highest score. when allocating score, the instantaneous answer in mind should be taken instead of think through too thorough

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

ly. There are 2-3 questions to each of the Critical Success Factors.

Strategic Focus

To what extent are team improvement objective focused on stra

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

Combination pro

egic organization goals?

To what extent are team success related to the organization financial success?

Management Commitment
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
rong>

To what extent do senior managers review the progress of improvement teams?
How often senior management involve in the team activities?
How often are team impr
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
ovement recommendations approved by senior management

Links to the Line Organization

How well are team improvement recommendations execu
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ted by the rest of the organization (other department with similar processes
To what extent improvement recommendations are derived from a systematic tools?
To what extent ar
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 team improvement recommendations piloted before a solution is launched?

Organizational Versus Functional Focus

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
>To what extent are employee in your organization rewarded for meeting organization goals?
How well do employee work across functions and departments in your organization?<

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

Following aspects would a

/li>

To what extent are team emphasize on organization improvement project as opposed to functional projects?

Methods and Support
dd to the challenges in developing combination products:

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

To what extent do your teams get training and support from trained facilitators on a regular basis?
To what extent do your teams follow a consistent Improvement Methodo
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
logy?
To what extent do your sponsor understand the Improvement Methodology?

In summary: Upon completion of all the questions, you can d
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
raw the score into a radar chart with the high score at the outer sphere of the radar chart. The shape of the radar chart would provide a clear indication which is the area of focus for impr
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

vement. These questionnaires should be taken as an indicators for success in Implementing Total Quality Management.

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

Professional from academic institutions, pharmaceutical industries, health care indust

rong>Disclaimer: 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

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

it has no intention 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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.

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

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Free to reprint or re-publish: All rights reserved. You are free to reprint or re-publish this article as long as you include my resource box at the end

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

Companies that provide selfless information through particip

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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