Advice You - Business

In this issue, I will share my experience acquired from the conglomerate and its operating companies. For the purpose of this article, I will articulate the Managing by Fact which is one of the Eleven Values and Concepts in Malcolm Baldrige

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

Criteria. As before, I will use case studies to show how some of the companies implement them.

To recap, below are the Eleven Core Values and Concepts of Baldrige Criteria:-

Visionary Leadership
Customer-Driven Excellence
Orga

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

Examples of combination products may in

izational and Personal Learning

Valuing Employees and Partners

Agility

Focus on the Future

Managing for Innovation

Management by Fact

Public Responsibility and Citizenship

Focus on Results and Creating Value

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

ystems Perspective I will deal with the one of the Value in bold letters in this article as below:-

Articulated Managing by Fact

Organizations rely on measurement and analysis data to view their performance for decision making. Appropria

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

e measure and analysis should derived from business strategies. It should provide an insight about data and information about business processes, operation processes, customer and market data, competitor or other form of comparative data, Financial perfor

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

Combination pro

ance, benchmark data etc.

For the purpose of improvement or trouble shooting, data should be broken down into various level meaningful for decision making. Such data should include market segmentation, market share by region, loss of accounts, new marke

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

t entry, product profiles, Cost of production, reject rate, time to market etc. Appropriate tools for analysis should be used to provide different set of scenarios for comparison.

Performance indicator for comparison should be taken from best practices,

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

etter competitors, Customer preference, Voice of customer etc. And these should be evaluated and used for target setting for improvement initiatives.

Case Study on Management by Fact

The companies I worked with have comprehensive sets performance

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

indicators such as Investment and Financial indicators, key market indicators. To some, key operation indicators are included. Many still lack appropriate indicators for overall business process, operation issues, Human Resource, and other support proces

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

es.

Since indicators or data are not available for many areas, decision making are based on past experience and judgment. Due to lack of accuracy, some decisions are not favorable hence resulted in changes to the decisions. If data are available, time sp

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

nd to collect them became a burden due to lack of infrastructure to support it etc. lack of the use in computerized data capturing system. In many cases, manual data collection into log sheet is widely practices in many companies. As data collation is don

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

Following aspects would a

e manually, its accuracy is way done the drain.

Opportunity for Improvement

There is saying: “You cannot measure, you cannot manage”. I fully subscribed to this statement. Organization should serious look into selecting a comprehensive set of ind

dd to the challenges in developing combination products:

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

cators and data that is needed to use for decision making or day to day operation. Data collection should be made easy and accurate that calls for a different way of data collection. As much as possible, it should be human dependant to reduce error.

On

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

e data is made available, data analysis should be performed to ensure data accuracy, relevance. Analysis of these data should be performed to provide difference scenarios. Where possible, data should be tested for its accuracy and value-add. Analyzed da

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

a should be reviewed at various level of the management hierarchy. Use if Information Technology for data sharing and updating should be explored. Meanwhile, employee should be trained in data base software such as Ms. Excel to ease the compilation and

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

analysis of data

In summary, having understood the Management by Fact in Values and Concepts of Malcolm Baldrige, it should be taken as a strategic issue rather than operational. Leaders might benchmark their CEO of Baldrige Winners on their TQM s

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

Professional from academic institutions, pharmaceutical industries, health care indust

uccesses in this value. My next article will articulate the next Core Values and Concepts in Public Responsibility and Citizenship

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Disclaimer

All rights reserved. This art

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

cle 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 intention to conflict with experts in similar topic. The author holds no responsibility f

.

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

r the use of this article in any way. Full Baldrige Criteria are available at http://www.nist.gov/quality

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All rights reserved. You are free to reprin

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

Companies that provide selfless information through particip

or re-publish this article as long as you include my resource box at the end 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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When you first start out on your business venture, money is usually tight but you still need to advertise. One of the most affordable, yet very effective, ways to begin your advertising campaign is with flyers...

When it comes to data entry training, the purpose is to help develop the necessary skills in an individual so that individual can effectively do their job with little or no problem.

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