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The people in your team may feel a bit uncomfortable when you sit down and spend time with them, particularly if they're not used to it. They might no

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

t be used to you doing it or perhaps a previous manager didn't do it. It's often the case that people are uncomfortable because they associate their

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

Examples of combination products may in

manager sitting down with them as a prelude to a reprimand.

As Kenneth Blanchard and Spencer Johnson say in their book 'The One Minute Manager' - "Ca

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

tch people doing something right" Too many managers think that their job is to - "catch people doing something wrong."

Many old style managers belie

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

ved that their job was to check up on what their people were doing and "sort things" as required. Many employees today still feel that's still the si

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

Combination pro

uation. If a manager comes close to you then they're checking up. If you've got that culture amongst your team members, then you need to change it.

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

hink of it this way - are you the kind of manager who spends time with your team to find out what they're doing or to find out how they're doing. Make

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

sure it's the latter.

Some of your people may even be a bit scared of you particularly when they first join the team. You may believe that - "you're

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

much too nice a person for anybody to be scared of little old you" - however I used to believe that too.

One day I was discussing a new salesman wit

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

h John, one of the more experienced guys. "Young Patrick's scared of you" he said. "Don't be ridiculous" was my reply, "What have I ever done to make

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

him scared of me, I'm always really nice to him." - "Well he is scared of you and just wants to please you" said John.

This was something that really

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

Following aspects would a

made me think because there was no way I wanted any of my team to be scared of me. Now that I was aware of it I took more care in my dealing with Pa

dd to the challenges in developing combination products:

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

trick and our working relationship worked out okay.

So always be aware of the impact you're having on your people; you may think that you're the nices

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

t most reasonable person in the world but how do they see it. Sadly, there are some managers who quite like the fact that their people are a bit sca

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

red of them and they see it as a positive situation. These are also the managers who spend a lot of time recruiting new people.

I can remember times

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

hen I've taken over a new team. I've had many strange looks and defensive body language when I've stopped to have a chat with some of the team. Some

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

Professional from academic institutions, pharmaceutical industries, health care indust

field sales people would get extremely uncomfortable when I told them I'd be spending some time with them visiting customers. However, I always knew t

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

hat I was getting it right when at later date a salesman would ask - "When are you coming out with me again Alan to see some customers."

There's alw

.

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

ays going to be members of your team who are really keen to spend time with you and others who are less so. However, you must spend time with everyone

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

Companies that provide selfless information through particip

- more with some and less with others. If you do it right, then your people will start to get used to it and start to see the benefits to themselves

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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