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"Too many managers treat "their people" as assets with skin wrapped around them."

High-performing teams and organizations balance the discipline of systems, processes, and technology managemen

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

t on a base of effective people leadership. Here are some key of the key distinctions between the two:

The Management-Leadership Balance

Management:

• Systems, process, and technology

• Goa

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

Examples of combination products may in

ls, standards, and measurements

• Control

• Strategic Planning

• A way of doing

• Directing

• Responding and reacting

• Continuous Improvement of what is

Leadership:

• People – context

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

and culture

• Preferred future, principles, and purpose

• Commitment

• Strategic opportunism

• A way of being

• Serving

• Initiating and originating

• Innovative breakthroughs to what co

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

uld be

Both management and leadership skills are needed at the organizational, team, and personal levels. It's not a case of either/or, but and/also. Futurist, Joel Barker provides another hel

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

Combination pro

pful distinction between the two roles; "managers manage within paradigms, leaders lead between paradigms". Both are needed. Trying to run an organization with only leadership or management is

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

like trying to cut a page with half a pair of scissors. Leadership and management are a matched set; are both needed to be effective.

Systems and processes (management) for example, are critic

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

al to success. You and your organization can be using the latest technologies and be highly focused on customers and those serving them (leadership), but if the methods and approaches you're us

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

ing to structure and organize your work is weak, your performance will suffer badly. People in your organization can be "empowered", energized, and enlightened; but if your systems, processes,

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

and technologies don't enable them to perform well, they won't. Developing the discipline and using the most effective tools and techniques of personal and organization systems and processes is

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

a critical element of high performance.

But as the sweeping movement to teams, "empowerment", and involvement intensifies, many more daily management tasks are moving to the front lines where

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

Following aspects would a

they belong. So leadership becomes even more critical. Unfortunately, many people in so-called leadership positions aren't leaders. They're managers, bureaucrats, technocrats, bosses, administ

dd to the challenges in developing combination products:

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

rators, department heads, and the like; but they aren't leaders. On the other hand, some people in individual contributor roles are powerful leaders. Leadership is an action, not a position.

A

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

leader doesn't just react and respond, but rather takes the initiative and generates action. A leader doesn't say "something should be done", but ensures something is done. An effective leader

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

is a "people person". Effective leaders connect, stay in contact with, and are highly visible to everyone on their team and in their organization. Leaders have developed the skills of supercha

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

rging logic, data, and analysis with emotion, pride, and the will to win. Their passion and enthusiasm for the team or organization's vision and purpose is highly contagious. They fire the imag

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

Professional from academic institutions, pharmaceutical industries, health care indust

inations, develop the capabilities, and build the confidence of people to "go for it". Leaders help people believe the impossible is possible, which makes it highly probable.

Do you like to be

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

managed or led? You're not alone. Very few people want to work for a manager. Most of us would much rather be led by a leader. To manage is to control, handle, or manipulate. To lead is to gui

.

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

de, influence, or persuade. You manage things -- systems, processes, and technology. You lead people. The roots of the rampant morale, energy, and performance problems found in many organizatio

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

Companies that provide selfless information through particip

ns are Technomanagers who treat people as "human resources" to be managed. If you want to manage someone, manage yourself. Once you master that, you'll be a much more effective leader of others

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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Magazine has come a long way since it started being published in the US less than three centuries ago. Even Benjamin Franklin published one himself.

Once you've determined that buying a franchise is the right choice for you, your next decision will be to decide exactly which service or product you want to invest in.

Each day employees do many things right, and some things wrong. What should we do when their actions leave something to be desired? Do we chastise them? Do we humiliate them in front of their peers?

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