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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 Valuing Employees and Partners which is one of the eleven core values and concepts used in Malcolm Baldrige Criteria. As before, I will use case s

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

tudies 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 | Organizational and Personal Learning | Valuing Employees and Partners | Agility | Focus on the Future |Man

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

Examples of combination products may in

aging for Innovation | Management by Fact | Public Responsibility and Citizenship | Focus on Results and Creating Value | Systems Perspective

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 Valuing

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

Employees and Partners which is one of the eleven core values and concepts used 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:-

Visionary Leadership |

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

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

Combination pro

mployees and Partners A diverse background, knowledge, skills, creativity and motivation of all its employees and partners are seemingly contribute to an organization’s success. An organization should commit to the satisfaction, development and well-being of the employee. However, the challenges in val

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

uing employees include the followings:-

Commit to employee’s success
Have a systematic reward and reorganization beyond normal compensation system
Plan for development and progression within the organization
Create an environment and policy that advocate risk tak

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

ng and innovation

Create an environment to support diverse workforce

Advocate Internal partnerships close labor-management cooperation.

Create an atmosphere that encourages high performance work team. Knowledge sharing

Organization should considered external pa

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

rtnerships with customers, suppliers, Strategic partnerships or alliances for business advancement. All terms and condition for such partnership should be clearly stated to reduced unneeded conflicts of interests.

Case Study on Valuing Employees and Partners Traditionally, most companies I worked wi

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

th understanding the concept of Valuing Employees and Partners. Organization has policies that reinforce employees reward and recognitions, performance compensation schemes etc. However, these are merely the norm due to market employment forces.

Employee training and development has been considered selectiv

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

ely depends on the job positions. Many of the companies faced the problems with big performance gap between senior managers and next level of staffs. While recognize the need of a successor, there is not concrete plan to plan for succession. Perhaps, there may meant additional headcounts in the employee hea

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

Following aspects would a

dcounts. Partnership with external parties such as vendors, strategic partners etc are done very selectively. Perhaps it may due to some sensitive issue when dealing with vendors. On the part of Strategic Partners, it is done quite selective due to the fact that company has to disclose several pertinent in

dd to the challenges in developing combination products:

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

formation which are confidential.

Issues with Valuing Employees and Partners Companies are not able to keep good employee for too long in the employee as most of them are good in performance and most wanted by employment agencies. Employee felt that companies is not compensate them fairy according

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

to the market changes. Obviously, we cannot expect companies to make adjustment too often for the sack to keep up with the external employment market. External partners remain low priority in the management strategies unless are force by example material shortage etc.

Opportunity for Improvement T

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

is is one of the eleven Values and Concepts in Malcolm Baldrige that most of the companies I work lacking. Considering the management thinking and culture, it is not like an easy task to motivate leaders to benchmark their counterparts in Baldige winners. No doubt leaders in these companies tried to fulfill

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

employee reorganization with clearer performance expectations; there is no written policy to document such practices. This is an areas with will not be changes unless perhaps the employment market forces companies to do so.

Increasing partnership with external parties remain an issue so long as the leaders d

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

Professional from academic institutions, pharmaceutical industries, health care indust

o not see it as one of the strategic objectives.

In summary, having understood the Organizational and Personal Learning in Values and Concepts of Malcolm Baldrige, leaders might benchmark their CEO of Baldrige Winners on their TQM successes in this value. My next article will articulate the next Core

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

Values and Concepts in Agility

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Disclaimer

All rights reserved. This article is written by the author based on his practical application experience. All definitions and interpretation of terminology are his point of view and has

.

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

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

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Free to reprint or re-publish
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
> All rights reserved. You are free to reprint 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. ----------------------------------------------------------------

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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Digg It - Malcolm Baldrige Values and Concepts Part 4 - Valuing Employees and Partners

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