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In my previous article entitled: Implementing TQM, Who drives TQM initiatives piblished on [May 19, 2006 04:07:21 pm]. I mentioned on the role of the CEO of the company who implement

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

TQM and CEO of Baldirge winners who are successful implementing TQM in their companies.

What is Malcom Baldrige and is there any similarity with TQM? Well, there are many comm

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

Examples of combination products may in

n management principles between the two. To appreciate that, readers is encouraged to understand the core values and concepts, its Assessment Criteria and its assessment approach. I h

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

ave worked with several companies who have adopted the Baldrige Criteria and assessment as a benchmark. For the purpose of this article, I will outline the Eleven Values and Concepts 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

d the Seven Categories of Baldrige Criteria

Criteria for Performance Excellence Goals

Baldrige Criteria are designed to provide organizations an integrated approach in persuit

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

Combination pro

of performance excellence that results in:-

Delivery of ever-improving value to customers, contributing to marketplace success
Improvement of overall organizati

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

nal effectiveness and capabilities

Organizational and personal learning

The Eleven Core Values and Concepts

The Malcolm Baldrige Criteria are built upon

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

eleven sets of interrelated Values and Concepts. They are those embedded beliefs and behaviors found in high-performing organizations. They form the foundation for integrating key busi

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

ess requirements within a results-oriented framework that formed the basis for action and feedback. The Eleven Values and Concepts are listed below:-

Visionary Leadership
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
i>
Customer-Driven Excellence
Organizational and Personal Learning
Valuing Employees and Partners
Agility
Focus on the Future
Man

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

ging for Innovation

Management by Fact

Public Responsibility and Citizenship

Focus on Results and Creating Value

Systems Perspective

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

Following aspects would a

These Core Values and Concepts are embodied in Detail Baldrige Criteria which are grouped into Seven

dd to the challenges in developing combination products:

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

Categories as follows:

Leadership
Strategic Planning
Customer and Market Focus
Information and Analysis
Human Resource Focus

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

i>Process Management

Business Results

In summary, having understood the Value and Concepts and Baldrige Criteria, leaders of company would have a better idea TQM

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

success may be represented by Malcolm Baldrige Assessment. The assessment would report both Strengths and Area for Improvement. It is a value-added feedback for organization to move fo

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

rward. My next article will share some case studies on Baldrige Assessment for several companies

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Disclaimer:

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

Professional from academic institutions, pharmaceutical industries, health care indust

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

s 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

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. And ensure that the URL in the resource box remained 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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It has always been a mystery to me why certain chief executive officers do such a poor job hiring key executives for their management teams. I submit that one reason is because chief executive officers spend company money and the stockholders' equity in the hiring process. What if the chief executive officers had to hire their key people with money out of their own pocket? You better believe their judgment and discretion would improve in a hurry.

We've all seen it, we've all been subjected to it... The sales person that for some unknown reason wants to lose their customer. So if you have too many customers and don't want to win any new ones, take a look at these easy steps to be sure they are driven away.

As more and more people start or consider starting their own business, it is important that they understand the core steps that are required to launch successful ventures. These steps include spotting, assessing, selecting and executing upon opportunities.

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