Main Subject - Business

I believe the media and our culture sends the wrong messages about how to manage people and this makes it difficult for Business Owners and Managers.

We've all heard the old clich? "nice guys don't finish first

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

" and that has a huge impact on how managers deal with their people. We're led to believe that successful managers are tough, courageous "no nonsense" type of people. And if you're weak or soft with your people,

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

Examples of combination products may in

then you'll get walked on and taken advantage of.

A manager will often look at "successful" managers in business or sport to try and understand what makes them successful. The media often portrays these people

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

as tough guys who drive their people by the force of their personality, shouts and threats - no wimps allowed.

Jack Welch the ex CEO of General Electric writes in his book "jack" - "Strong managers who make t

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

ugh decisions to cut jobs provide the only true job security in today's world. Weak managers are the problem. Weak managers destroy jobs".

Now that statement may be true however it leads managers to believe tha

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

Combination pro

they most certainly have to be strong. There's no way that a manager wants to be perceived as weak. However, it's how you define tough and strong that decides how successful a manager you'll be.

We're all awar

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

e of the big tough sports coaches who run successful teams. In the United States the legendary Red Wings coach Scotty Bowman, often billed as the greatest coach in hockey, was well known as a relentless, heartle

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

s and humourless task master.

Another legend, football coach, Vince Lombardi, was known to work his teams hard. He pushed his players and made them repeat plays over and over till they got it right. He yelled

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

t his teams for any mistakes, even after games they had won. One of his famous lines is - "Winning isn't everything. It's the only thing." He had rigid rules, imposed discipline and had no tolerance for mistake

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

s.

Sir Alex Ferguson, Europe's most successful soccer coach was once in the news due to a dressing room incident at Manchester United. The team had just lost a game that he felt they shouldn't have lost and he

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

as letting the players know how he felt about that. Apparently, in his temper, he kicked a football boot across the dressing room and hit one of his star players, David Beckham, just above the eye.

Unfortunatel

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

Following aspects would a

the media presents these situations and character traits as what makes a successful manager. Managers and particularly those new to a leadership role, try to model themselves on those that they read about and

dd to the challenges in developing combination products:

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

see on TV.

In a recent seminar I asked a young manager why she thought Roy Keane played so well under Sir Alex Ferguson at Manchester United - "It's because Alex regularly kicks his ass" was her reply. Now Roy

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

eane is a real tough guy player known for his hard and uncompromising style on the soccer field. I asked this young manager how she thought Roy would respond to having his ass kicked regularly. She didn't seem

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

o have an answer to that.

Here are some other comments I've read about successful sports coaches and managers -

John Wooden -
"One of the true gentlemen in sports or any other walk of life" "He taught the

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

m to be good people, good sports and still be competitive"

Scotty Bowman -
"A great sense of humour that people never see" "Deep down, a caring man"

Mike Krzyzewski -
"You cannot mistake the fact that

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

Professional from academic institutions, pharmaceutical industries, health care indust

he loves his players. He cares about their schooling and them being model citizens" "Coach K still puts up the wins proving once and for all nice guys can finish first"

Wayne Graham, baseball coach, Rice Univer

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

ity:
"A demanding coach is redundant. If they are going to be happy with you and produce, they have to know you care"

Managers are misreading the signs sent by the media and our culture and it's creating di

.

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

fficulty for them. Some managers can adopt the tough guy approach very easily but most feel uneasy with it. The ones, who're uneasy, in an attempt not to be seen as weak, then manage their people in a way that

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

Companies that provide selfless information through particip

akes them as a manager feel uncomfortable. This ultimately causes problems with their teams. I think we should look at what really makes a successful manager and it certainly isn't just about being a "tough guy.

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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