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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

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

will provide an insight on common assessment findings in Baldrige Criteria Category 2 - Strategic Planning from several companies being assessed by a group of trained and experienced assessors. It is

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

Examples of combination products may in

rovided 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

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

or Improvements.

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 Mar

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

et Focus | Information and Analysis | Human Resource Focus | Process Management | Business Results

Criteria Summary Category 2 – Strategic Planning

The Strategic Planning Catego

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

Combination pro

ry examines how your organization develops strategic objectives and action plans. Also examined are how your chosen strategic objectives and action plans are deployed and how progress is measured.

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

.1 Strategy Development

Describe how your organization establishes its strategic objectives, including enhancing its competitive position and overall performance.

2.2 Strategy Deployment

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

Describe how your organization converts its strategic objectives into action plans. Summarize your organization’s action plans and related key performance measures/indicators. Project your organizatio

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

’s future performance on these key performance measures/indicators.

Common Strengths

A systematic Strategic Planning Process is in placed. It is used since 1998 and has gone through

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

several rounds of improvement based on feedback from the management teams

A planning horizon is tabled for the entire Strategic Planning Process. Each activity before the Strategic Planning worksh

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

p date is completed promptly. Data collection and analysis is systematic and quantitative

Strategic Deployment are planned using a systematic Tree Diagram to articulate key actions, target and dat

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

Following aspects would a

lines. Periodical reviews of these key actions are in the companies key meeting schedule

Common Area for Improvement

Although there is regular review on status of key act

dd to the challenges in developing combination products:

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

ons, there is no recovery plan to further improve those key actions not able to meet the set target

Although there are improvement teams within the companies, none of the improvement projects

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

has direct impact to the key actions in the Strategic Plan

There is no cross departmental alignment on key action plans and target to achieve company level key performance indicators (KPI)

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

i>

In summary, the above are only sample of common assessment findings. Normally, a full assessment report is given to company being assessed. The report would include details and scoring. It i

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

a value-added feedback for senior leaders to use as an input to Strategic Planning. My next article will share assessment case study on Market and Customer Focus, Category 3.

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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

tion 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.

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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

e 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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