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Another interesting study was done. One that should really catch our attention. It reveals that employees who are happier and

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

treated well, produce better results than those who are unhappy. And most frontline workers are unhappy and are looking elsewhere for work.

No, it shouldn’t surprise

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

Examples of combination products may in

us. But somehow it does. It surprises us first, because we are stunned that a study had to be done to prove something that is so obvious. The outcome of the study shoul

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

not be as surprising as the fact that it was done at all! When we recover from that, then it may surprise us because we aren’t aware that most frontline staffers aren’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

happy and they don’t feel that they are treated well at work.

Ugh! This must make us look at ourselves if we are managers. But we have to give ourselves a break…we’re

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

Combination pro

ot the bad guy! I think I know why and how this happens.

The position somehow changes us whether we know it or not! My own research, and my work with thousands of fron

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

tline supervisors, lead me to believe that there is a clear and simple answer: We become so consumed with the position, we lose the ‘person’ we think and know ourselves

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

o be. This is too bad too, because it was probably that personable person who got us this higher position!

The fun-loving, spontaneous, smiling person we think ourselv

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

es as, has morphed into a serious, unapproachable, distracted, frenzied boss, concentrating on the demands of the position, losing the person we were and forgetting the

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

eople who work for us. The moment we concentrate on the work and the final product and not the people who produce that product, we become the ‘position’ and leave behind

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

the person who relates to others on a personal level. We want to be successful and do a good job. We think taking the job so seriously is part of the package. Oooops. B

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

Following aspects would a

ig mistake.

This serious approach to the position not only negatively affects our workers, but us, too. When we reach a toxic level of ‘position’, it is usually painful

dd to the challenges in developing combination products:

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

we feel misunderstood, overwhelmed, crisis-oriented, over-stressed and we begin to hate our job, and maybe our co-workers, which we may have previously loved. Others s

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

ee this and they begin to shy away from us. This cycle happens so often that many supervisors quit within 3 years of the promotion.

So here’s where the results of the s

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

udy comes in. Supervisors need to remind themselves that no matter what work they think are in, they are really in ‘human services’. No matter what the company does: ma

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

ke widgets, produce soft or hardware, sell via the phone; once you become a frontline supervisor your priority must be the human beings who are responsible to you, as it

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

Professional from academic institutions, pharmaceutical industries, health care indust

is those humans who produce the final product. The work or the final product is no longer your priority. No work is done well if people aren’t happy doing it. So don’t l

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

ose your ‘person’ to the ‘position’.

And here we must be reminded why people leave their jobs (this, from yet another study). Most people leave because they see their s

.

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

pervisor as a jerk, and second they leave because they don’t feel acknowledged, recognized or appreciated. We can again become the ‘person’ known to be talented, liked

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

Companies that provide selfless information through particip

and therefore, promoted, by remembering the importance of the people who do the job. Stop the vicious cycle. Lighten up! Smile. Visit. Have fun. It’s a win-win situation

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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A client e-mailed me yesterday about her student loan debts that netted her 3 college degrees and a job without a commensurate income and future. I had to break the news to her that there is no real correlation between education and income, and that not all degrees are equal. How can a person with a high school degree earn a six-figure income without any degree? Learn how it happens in this second installment of a two-part article that exposes colleges and universities for what they are and are not.

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In January 1986 the space shuttle Challenger disintegrated in a fiery explosion, and the capsule plunged into the Atlantic Ocean. The death of all seven crew members shocked the world. As we learned in the months that followed, the tragedy could and should have been avoided. The root cause of the disaster was something known as Groupthink.

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