Cases - Business

“It is not the strongest species that survives, nor the most intelligent, but the most responsive to change”. -Charles Darwin

The world today is changing faster than ever before. Technological developments, f

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

inancial constraints, expanding markets, restructure and mergers, new philosophies and government legislation are all putting pressure on organizations to change. Yet the process of change is far easy from easy

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

Examples of combination products may in

and implementing it successfully makes considerable demands on the managers involved.

In our fast moving, highly competitive global marketplace, change is continuously required, if an organization is to remai

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

n competitive. A company can’t remain on the cutting edge by standing still. The key to effective organizational performance lies in the competence and commitment of the people. The clue to effective and succes

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

ful management lies in understanding the nature of people, their behavior, drives, hopes, fears and expectations, and the circumstances and activities necessary to bring the best act of them. To respect and val

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

Combination pro

e people is a basic pre-requisite for effective managing of human resources so organizations have to create the conditions for fostering managements need to create structures and cultures that are positive and

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

organic and develop individuals and groups to their full potential to face emerging challenges.

Kinds of change:

At present scenario basically four kinds of change process is emerging and prevailing in any ec

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

nomy.

1. The first kind of change is the overall change in structures, composition and management of the company because of various mergers and amalgamations taking place in companies. These mergers and amalga

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

ations are of three types. First one is of Vertical mergers, i.e, merger of small organization with a bigger organization. The second one is Horizontal mergers, i.e., similar kinds and strengths coming together

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

to form a big company,. The third is cross mergers, i.e, different types of companies collaborating to capture more market share and size.

2. The second kind of change process begins in an organization when a

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

new product is launched in a market. Further this kind of change is made for two reasons, that is, follow market skimming to earn Goodwill, money and reputation in the market. The second policy is of market pen

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

Following aspects would a

tration just to capture more market share and to expand customers base by lesser price policies.

3. The third aspect of change is incorporated whenever a new leadership is introduced in an organization. This r

dd to the challenges in developing combination products:

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

esult into major shiftovers from in policy to another which can sometime lead to productive changes and sometime can attract retaliations from the staff members.

4. The technological advancements and latest de

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

elopments is the fourth major driving force to initiate the change process in any organization, because it can result into major capital expenditures and complete change of existing structures.

Major Preparati

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

n for change:

For any organization to incorporate the change it must prepare in advance and follow some of the following mentioned steps to handle Change:

1. To implement any kind of change the first and fore

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

most an important element is that the leaders must be respected and effective in the management so that they are effective enough to enforce the change process easily.

2. Secondly the motivational processes an

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

Professional from academic institutions, pharmaceutical industries, health care indust

techniques must be carried in such a planned way and manner that each and every employee must be highly motivated enough to implement the change easily.

3. Thirdly an organization must remove the aspect of Co

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

placency in it. This can be done by

- Generating in formations about organizations situations about current and prospective problems.

- Creating opportunities for employees to educate management about dissati

.

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

sfaction and problems.

- Creating a dialogue on the data and statistics so collected and generated.

- Setting very high standards and expect people to meet them.

Conclusion: - Change is a complex phenomenon.

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

Companies that provide selfless information through particip

Whenever an organization imposes new things on people there will be difficulties. Participation, involvement and full communication are the important factors to bring effective change process in an organization

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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