Subjects - Business

In my previous article entitled: Market and Customer focus - Baldrige Assessment Case Studies for Category 3, I shared about common assessment findings of several companies being assessed by a group o

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

f trained and experienced assessors. In this article, I will provide similar findings but on Information and Analysis, of the Baldrige Criteria. It is provided in the form of case studies whi

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

Examples of combination products may in

ch include Criteria summary as described in year 2001 Baldrige Criteria, assessment findings in terms of Strengths and Area for Improvements.

There are seven categories in the Baldrige Criteria. In

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

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

ocess Management | Business Results

Criteria Summary – Information and Analysis
The Information and Analysis Category examines your organization’s information management and performance

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

Combination pro

measurement systems and how your organization analyzes performance data and information.

4.1) Measurement and Analysis of Organizational Performance
Describe how your organization provid

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

es effective performance management systems for measuring, analyzing, aligning, and improving performance at all levels and in all parts of your organization

4.2) Information Management
D

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

escribe how your organization ensures the quality and availability of needed data and information for employees, suppliers/partners, and customers.

Common Strengths

Key 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 (KPI) at company level are well established and track regularly in various forum with Shareholder, Senior Leaders and Management team. Data are analysis using various tools for decision ma

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

king.

Company level KPI are communicated to all departments using the Tree Diagram as a communication and alignment tools. At departmental level, key personnel are involved to set targets fo

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

r the departmental measures and target.

Key information and data are made available to all departmental heads as well as at strategic location to enable decision making

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

Following aspects would a

>Common Area for Improvement

Benchmark data is lacking for most company and departmental level for comparison of performance. Target set for each KPI are available but is unable to keep

dd to the challenges in developing combination products:

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

up the pace of improvement needed

Deviation of performance level for some departmental level measures and target are not well communication across other department such that actions are not

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

repeated

Data analysis on operational indicators are not well managed to synergize improvement effort across the organization

In summary, having understood the core va

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

lue and concepts of Malcolm Baldrige, leaders of company would have a better idea TQM success may be represented by Malcolm Baldrige Assessment. Its assessment report both Strengths and Area 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

ovement is a value-added feedback moving forward. My next article will share some case studies on assessment of several companies in Human Resource Focus - Category 5

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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

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

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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