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In my previous article entitled: Measuring TQM Success published on [June 03, 2006 08:50:17 am], I wrote about Baldrige Values and Concepts as well as the Baldrige Assessment Approach. In this issue, I will pr

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

ovide an insight on common assessment findings in Baldrige Criteria Category 3 – Market and Customer Focus from several companies being assessed by a group of trained and experienced assessors. It is pr

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

Examples of combination products may in

vided in the form of case studies which include Criteria summary as described in year 2001 Baldrige Criteria (source: http://www.nist.gov/quality), assessment findings in terms of Strengths and Area for Improv

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

ements.

There are seven categories in the Baldrige Criteria. In this article, I will deal with the bold category listed below:-

Leadership | Strategic Planning | Customer and Market Focus | Inf

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

rmation and Analysis | Human Resource Focus | Process Management | Business Results

Criteria Summary, Category 3 - Customer and Market Focus

The Customer and Market Focus Category examin

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

Combination pro

e how your organization determines requirements, expectations, and preferences of customers and markets. Also examined is how your organization builds relationships with customers and determines the key factor

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

that lead to customer acquisition, satisfaction, and retention and to business expansion.

3.1 – Market and Customer Knowledge Describe how your organization determines requirements, expectations, and

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

preferences of customers and markets to ensure the continuing relevance of your products/services and to develop new opportunities.

3.2 – Customer Relationship and Satisfaction Describe how your organi

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

ation builds relationships to acquire, satisfy, and retain customers and to develop new opportunities. Describe also how your organization determines customer satisfaction.

Common Strengths

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

A formal customer survey is established to gather market and customer information periodically. Other form of information gathering are done during customer visits, customer enquiries and customer complaints

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

A systematic customer complaints procedure are well established and practiced. It is subjected to internal and external ISO Quality Management audit

Yearly distributor convention and recognit

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

Following aspects would a

on is held to maintain and improve customer relationship. It is also a forum for new product launch and dialog for feedback for continuous improvement Common Area for Improvement <

dd to the challenges in developing combination products:

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

ol>

Although customer feedback is obtained for market trend and end-user expectations, there is no process to manage these information to drive for customer satisfaction

Data collected form cust

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

mer complaints are not aggregated for analysis and systematic improvement

Response to customer expectations are ad hoc and non systematic. There is no process to gather these information for trend an

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

alysis for product feature enhancement.
In summary, the above are only sample of common assessment findings. Normally, a full assessment report is given to company being assessed. The report

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

would include details and scoring. It is a value-added feedback for senior leaders to use as an input to Strategic Planning. My next article will share assessment case study on Information and Analysis, Catego

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

Professional from academic institutions, pharmaceutical industries, health care indust

ry 4.

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Disclaimer:
All rights reserved. This article is written by the author based on his practical application experience. All de

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

initions 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 for the use of this article in any way

.

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 m

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

Companies that provide selfless information through particip

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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