Digg It - Business

Leading vs Managing

Whether you are the owner of your own business, the chief executive of a corporation, or a manager rising through the ranks, it is critical to develop your le

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

adership skills. Great leadership brings great results. A great manager can get great results but the results reflect on a project or goal, not on the long term process of leading

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

Examples of combination products may in

people. A manager can bring a project in on time or perhaps under budget, but a leader gets great results working with people, building relationships, and empowering all members

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

hich motivates even better results in the future.

Managers can be useful and successful at achieving project goals, but leaders are essential for long term growth, profitability,

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

quality of work life, and positive results in major challenges from business crisis. You know, and possibly have worked with, or for, good managers. Perhaps you have been fortuna

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

Combination pro

e and worked with, or for, a great leader. The great leaders are not soon forgotten and are always appreciated. When an organization has great leaders in their management ranks, t

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

hey suffer less from sabotage and turnover. These organizations are known for their leadership and find it easier to recruit the best and brightest personnel.

David Packard and B

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

ill Hewlett were industry leaders that influenced many major business practices with their successes at Hewlett-Packard. Their leadership created an environment that took their pr

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

ducts and then their company to the top. Their leadership style has been mimicked by many successful startups. Many technology engineers wanted to work for HP, driven by the leade

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

rship and respect driven work environment. These business principles have been studied and taught in business management programs with continued development for open minded execut

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

ves and top striving organizations.

Another business leadership expert, Bill Bonnstetter, founder of TTI, has researched the most successful leaders and has defined the common qu

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

Following aspects would a

alities that these leaders possess. Though everyone has these skills to some degree, great leaders achieve mastery of these common skills.

Bill states that there are 5 essential

dd to the challenges in developing combination products:

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

leadership skills that great leaders have in common. These include:

1. Influencing others – the ability to personally affect other’s actions, decisions, opinions or thinking.

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

. Personal Accountability – the ability to answer for personal actions.

3. Self-management skills – the ability to prioritize and complete tasks in order to deliver within allott

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

ed time frames… the ability to control oneself under stress.

4. Goal Achievement – the overall ability to set, pursue and attain achievable personal, professional and team goals

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

egardless of obstacles or circumstances.

5. Interpersonal skills – the ability to interact with others in a positive manner.

If you want to develop your leadership skills and be

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

Professional from academic institutions, pharmaceutical industries, health care indust

come a successful and memorable business leader, you can get the coaching and training that lead to mastery in these key skills. Consider beginning by using a self-discovery proce

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

ss which uses assessments to discover where you are on the continuum comparing your skills and behaviors with the most successful leaders. By knowing your strengths and your chall

.

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

nges, you will be able to move forward. Find a mentor or an executive coach who will assist you in moving toward the highest levels of mastery of all of these skills. Very few of

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

Companies that provide selfless information through particip

us are born to be leaders. Most of us require experience and sincere motivation to develop into top flight leaders.

The world needs great business leaders as positive role models

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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