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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 Organizational and Personal Learning which is one of the eleven core values and concepts used in Malcolm Baldrige Criteria. As before, I will use case studi

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

es 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 |Managing for Innovation

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

Examples of combination products may in

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

Articulated Organizational and Personal Learning A systematic and well-executed Continuous Learning Approach to achieve highest business performance is essential Organization and Personal Le

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

rning. It should be develop as a way of life in the day-to-day function. This may result in major changes or minor changes to strategies, process, products and service. Organizational and Personal Learning should results in enhancing values to all stakeholders such as shareholders, customers, employee and partners.

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

mployee success depends on opportunities for personal learning either to gain knowledge of new topics and acquire new skill.. Invest into personal learning for employee through education, training, benchmarking and other opportunity for growth and development. Such opportunities include job rotation, job enhancement,

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

Combination pro

nowledge sharing and reward and recognition for increased knowledge. This learning should enhance value creation for the employee.

Case Study on Organizational and Personal Learning At the corporate level, there is a concerted effort to deploy a systematic approach to several programs for organizational Lear

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

ing. If you recall, I have indicated in Part 1 of this topic, that Visionary Leadership would include setting direction for company to achieve Investment and Financial Discipline as well as Operational Excellence. A systematic approach to Strategic Planning that enable companies to develop meaningful KPI for achieving

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

Operational Excellence such that Investment and Financial Discipline can be attained. The result dog using this systematic approach to Strategic Planning has resulted in several major break-through in business advancement.

For operation improvement, a systematic Methodology to Continuous Improvement was developed and

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

tested over the last 6 years by the corporate office at several companies. It has helped companies who adopted this methodology improved their product and service by reducing waste, rejects and increased productivity etc. Many companies have benefited from using this systematic approach both financially and value crea

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

ion to the employees.

At the organization level, a compulsory one percent of the employee wages are allocation to the Human Resource Development Fund (HRDF) as a way to mandate organization to spend on employee Personal Learning. While all companies I worked with utilized this fund very well, some training managers h

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

ve systematic approach to prioritize allocation of this fund to training course for employee..

Issues with Organizational and Personal Learning Some leaders remain the way they develop strategies and focus very on financial results as a way to of strategies. For some reason, they failed to understand that it

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

Following aspects would a

is not the strategies that failed but the deployment of the strategies. Often, companies that remain in a fire-fighting mode do not implement their strategies systematically. There is a lack of aligned actions and KPI to track the progress of the strategies.

Although a systematic methodology was developed and even t

dd to the challenges in developing combination products:

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

sted its application, there are few companies remain in the side line chosen not to adopt it. They view this methodology take up too many resources and take long time to achieve desired results. Obviously, they look for a quick fix solution hence fire-fighting seems to be popular as a way to resolve problem. Ho

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

ever, there are some training managers lack the skill to align the employee training needs with organizational learning needs. As a results, employee learning seems to be unbalanced between the two.

Opportunity for Improvement A systematic alignment tool is needed to help leaders to developed aligned actions a

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

d KPI. Strategic Map from Balanced Scorecard is an excellent tools for this purpose. It has been adopted into the corporate Strategic Planning Process and has been used by several companies.

A systematic approach to Continuous Improvement methodology is established but requires leaders to adopt it as their way for 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

provement. At corporate office, perhaps a road show is needed to demonstrate the power of the improvement methodology

A systematic Training Needs Analysis should be developed to balance the organizational and personal needs in terms of continuous learning so that the HRDF is properly utilized. Perhaps, company need

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

Professional from academic institutions, pharmaceutical industries, health care indust

o allocated separate fund for Organizational Learning programs.

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

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

ext Core Values and Concepts in Valuing Employees and Partners

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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 hi

.

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

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

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Free to reprint or r

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

Companies that provide selfless information through particip

-publish 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.

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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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What experience are your customers receiving? Do your customers walk out of your business pleased, elated, or ticked off? In this article, I will show you what has gone wrong with customer service and how we all (customers, employers and employees) can turn that around!

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