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There is a saying about management that suggests some managers are so focussed on the details of a business, that when the Tit

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

anic was sinking those particular managers were still straightening chairs in the dining room. Whether we love ‘em or hate ‘em

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

Examples of combination products may in

, managers are here to stay, and their job is fundamentally to manage the resources within an organisation for optimum efficie

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

ncy and effectiveness, and by doing so to achieve the organisation’s goals. To help them do this they have the gift of authori

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

ty and power over the organisation’s resources.

Managers have a reputation for working with limited resources, and getting th

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

Combination pro

e most out of money, materials, time and people. And today we hear so much about global competition, and the need for creativi

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

ty and innovation, that organisations need more than good management; they need inspirational and transformational leadership.

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

And so we are presented with a conflict that, when handled well, can create a dynamic tension between order and chaos; or sta

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

tus quo and change. So if managing is about keeping things under control, leadership is about creating the climate or conditio

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

ns for change. The challenge then, is to decide where you can be most effective and useful to your organisation – as a manager

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

, a leader, or a subtle balance of both?

As a manager:

o Leaders will be planning to undo what you have under your control.

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

Following aspects would a

o Employees who prefer structure and procedure are likely to perform well in your team and be easily motivated.

o Employees

dd to the challenges in developing combination products:

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

who prefer autonomy, variety and change may seem awkward or distant to you and resist your attempts to motivate them.

As a le

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

ader:

o Managers may be cautious and/or suspicious of your unpredictability.

o Employees who prefer structure and procedure

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

may appear to have a limited range of capability and find it difficult to respond positively to new ideas.

o Employees who pr

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

efer autonomy, variety and change are more likely to work well with you.

As a manager / leader:

o You may appear to others a

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

Professional from academic institutions, pharmaceutical industries, health care indust

s inconsistent and/or unpredictable.

o Without some consistency in your approach to situations you may find that people will

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

not trust you.

o Your success will require continuous communication for the need to innovate and improve whilst having system

.

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

s and processes in place that work for both customer and company.

o With a consistent approach, incorporating both structure

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

Companies that provide selfless information through particip

and creativity, you will have an influence with people from both management and leadership ends of the working style continuum

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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