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One morning at the airport, I overheard an employee talking about her new boss. “He’s a nice guy,” she said. “He makes me feel good about working here.”

Like many employees, this you

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

ng woman is more influenced by her boss’s “soft” skills than his technical skills. His interpersonal skills were what mattered most: including his ability to communicate, motivate and

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

Examples of combination products may in

showing genuine concern. These interpersonal traits influence people to decide to quit or stay. When a manager lacks these skills, or actively cultivates their hard-edged opposite,

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

workers who have choices will jump ship or lower their productivity.

I experienced this myself when I went into the military service right after college. My boss was a special perso

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

—a great boss. An experienced veteran and a former Special Forces medic, he was the type of person who always put the needs of others before his own.

One night I pulled duty that req

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

Combination pro

uired me to stay up all night on New Year’s Eve. It was a night that seemed it would never end. I was tired and miserable. Saturday morning, when I still had several more hours to go

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

, the phone rang. It was Joe, my boss. He asked if I had plans for lunch and that his wife had made something and wanted to bring it over to me. While I don’t remember what food they

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

brought over, it was a meal I never forgot.

That one small act of kindness showed me he cared. It taught me more about leadership than all the degrees and diplomas hanging on my wa

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

l. It confirmed the truth of the old military saying, “If you take care of your troops, your troops will take care of you.” It’s still true today, no matter what kind of business you

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

are in.

The older I get and the more I see reinforces that leadership techniques and fads change with the times, but caring about individuals holds constant. Caring for people can’t

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

be faked or replaced.

On the other hand, no manager should be a pushover. A caring manager must also be respected. He or she must be able to generate results.

Soon after my boss tr

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

Following aspects would a

eated me to that special meal, he gave me the worst chewing out I’d ever had. I deserved it and did something to deserve it. It hurt more—and made a deeper impression on me—because of

dd to the challenges in developing combination products:

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

the respect I had for him. When you respect someone, you always value what he or she has to say.

Businesses that do a good job selecting, training, and developing their managers will

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

enjoy higher productivity and lower turnover. While it’s hard to measure the impact soft skills have on productivity, I strongly believe an employee who feels good about working for

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

a company or a boss will want to contribute much more than the minimum acceptable level.

In the years I led people, I never met an “average” worker—only people I saw the potential t

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

o become much better. I think it was General Omar Bradley who said, “There are no such thing as bad soldiers, only bad leaders.” Sure--the workplace has its share of problematic and

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

Professional from academic institutions, pharmaceutical industries, health care indust

difficult to manage individuals. There are many bad managers. But what I notice is good managers are able to transform difficult people into better people. Exceptional workers have

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

exceptional managers as their leaders. The only difference between the two groups is the quality of the leader.

I imagine my first boss saw me as an “average” individual with a shor

.

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

t attention span, high maintenance, inexperienced, and scattered brained. Fortunately for me, he took the time to train and develop me, even though it often frustrated him. He was a

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

Companies that provide selfless information through particip

true leader. He understood leadership of people is a transformation process, and with the right tools and a willing attitude, he could make the transformation happen.

Gregory P. Smit

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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