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We’ve all worked for some ‘not so great’ managers and we love to talk about it. Just listen in the airport, on the golf course or at the latest social gathering and you’ll know what I mean. But what doe

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

s a good manager look like?

I took my wife to the airport yesterday morning at 0 dark early and stopped at the grocery store, a national chain, to get a couple things. While checking out I struck up a

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

Examples of combination products may in

onversation with a nice lady who I’ve seen for some time while shopping there. She’s always pleasant and helpful, as a customer she’s surely a good employee.

“How are you today?” I asked, taking my tim

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

e, since no one was behind me. “Oh I’m doing okay.” She replied a little less enthusiastically than usual.

Being in my line of work I couldn’t resist asking about just being ‘okay’. About that time a

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

oice came over the stores intercom calling someone to the office.

“That’s why I’m just doing okay. That’s all you can do around here is be ‘okay’.

She went on to explain that was the boss on the inter

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

Combination pro

om with one announcement he could get you in a bad mood. I asked why and she quietly and I might say, kindly, told me how he had no respect for anyone who worked for him and it showed in how he treated

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

them. About that time he came on the intercom again asking for yet another employee.

Now this isn’t a big super store, he could have walked out of his office or scheduled these folks ahead of time. I’d

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

actually had dealings with the guy before so this news didn’t surprise me. He violated the first principle of sound management. That is you treat your employees like people, with respect. Managers like

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

his one don’t understand that a team is built as a result of their actions and not going off to some nonsensical offsite (they were talking about doing just that I was told) for team building.

Here are

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

five things a manager must do to build a thriving team.

1. Respect: As outlined in the story above you must treat those who work for and with you with respect. Treat them as human beings with lives, h

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

pes and dreams and a big part of that is learning something about them, like their expectations of the job.

2. Job clarity: When you hire them or when you takeover the group you must sit with each indi

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

Following aspects would a

idual and be clear about their position and what it is to contribute to the bottom line. There should never be a doubt about why they come to work each day.

3. Expectations: Set clear expectations abou

dd to the challenges in developing combination products:

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

t the results you expect, the acceptable personal conduct and the results of non-compliance. You should live by the maxim of ‘no surprises’. If people choose either to not perform to expectations, provi

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

ed they have the skills, or to not adhere to the rules you outlined … then they ‘choose’ not work there. Be clear and when people aren’t performing in any area ask yourself this question. Is the non-per

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

ormance caused by a deficiency of knowledge or a deficiency of execution? When you know the answer … act.

4. Create a safe environment: You must create an environment where it is safe to talk to you an

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

d to tell you the truth; even if it is a truth you don’t want to hear. Don’t just think you are that way; make sure you have people in the workgroup who will tell you if the environment is safe. If you

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

Professional from academic institutions, pharmaceutical industries, health care indust

on’t have a ‘safe environment’ you are doomed like Enron.

5. Follow up: It is important that you routinely follow up with your people both as a group and individually. No excuses. You should be providi

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

g group updates weekly. It doesn’t have to be an elaborate meeting, fifteen minutes. Keep it simple, short and sweet. For individuals with performance problems it needs to be right at the time of incide

.

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

nt, fair and documented. For everyone, that is everyone who works for you, you owe them a sit down quarterly; quit whining about it, you have the time to let them know how they are doing.

Management is

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

Companies that provide selfless information through particip

about getting results through people. To get those results in the most effective way you’ll make these five principles a practice and you’ll leave work knowing you and your group is a success.

Ed Kugle

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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