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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 Systems Perspective which is the last Values and Co

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

ncepts in Malcolm Baldrige 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:

Visiona

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

Examples of combination products may 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.

d Citizenship | Focus on Results and Creating Value | Systems Perspective

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

Articulated Systems Perspective

The Baldrige Cri

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

teria provide a model which is a systems perspective for managing organization and its key business and operation processes to achieve performance excellence. The seven Baldrige Categories and its Values and concepts for

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

Combination pro

m the building blocks and the integrating mechanism for the system.

However, successful management of overall performance requires organization specific synthesis, alignment, and integration.

Synthesis means loo

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

king at your organization as a whole and builds upon key business requirements, strategic objectives and action plans.

Alignment refers to key linkages among requirements between all stakeholders. It is well desi

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

ned in the Baldrige Categories to ensure consistency of plans, processes, measures, and actions.

Integration builds on alignment so that the individual components of your performance management system operate in

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

a fully inter-dependently.

Case Study on Systems Perspective

This is the most challenging of all the eleven values and concepts. While most companies can operate its operation by units systematically, it still

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

struggles to align all the business unit to a fully integrated manner. It has been a regular exercise try to pull all business unit together as a whole, maintaining it is requires persistency and perseverance of a leade

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

rs.

The Baldrige criteria form a unit model to assist in this integration effort. Its seven categories call for alignment between each other as well as across each others. However, companies lack understanding the these

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

Following aspects would a

“build In” integration of criteria categories hence neglected a focus effort to strive for improvement in the adoption of the categories to suit its business.

Opportunity for Improvement

Taking the Baldrige cri

dd to the challenges in developing combination products:

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

teria as a fully integrated system, regular assessment of each categories would provide an feedback to companies where it needs improvement and the level of achievement would indicate a priority ranking.

It is not attem

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

pted to score high in each categories but to strengthen the process and criteria requirement of each categories such that it build into the business systems. By doing so, it can sustain its effort to maintain a high stan

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

ard of fulfillment of the criteria requirements.

In summary, a focus effort should be established by the leaders to constantly improvement the practices in the criteria requirements. Having understood all the Values 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

Concepts of Malcolm Baldrige, it should be taken as a strategic issue to improve the adoption of the criteria and assess its deployment regularly. This concludes my write up of all the Eleven Values and concepts of Bal

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

Professional from academic institutions, pharmaceutical industries, health care indust

drige Criteria.

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Disclaimer: This article is written by the author based on his practical application experience. All definitions and interpretati

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

on 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. Full Baldrige Criteria are availab

.

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

le at http://www.nist.gov/quality

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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

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

Companies that provide selfless information through particip

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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