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Ah, the wretched pain of delegation. It comes easy to some people. But others – you know who you are – would rather undergo a double root canal than hand over a task and walk away from it.

The good news is that this is a disease you can recover from. And the better news is that when you choose to give up control you benefit along with the delegatee.

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

As with most things in my life this knowledge was hard come by for me. I had just received a huge promotion to a project which was mind-numbingly large. The first day on the job I asked the assistant of the woman I had replaced why he thought she had had difficulty. He said that she had been unable to delegate; had given him virtually nothing to d

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

Examples of combination products may in

and had only emerged from under her staggering workload to complain about how overwhelmed she was. This was sobering news for me as this was also my M.O. at the time. I figured I needed to change – and fast.

At that time I believed that if I wanted a thing done well I absolutely had to do it myself. Or micromanage it to death. Unfortunately events

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

sometimes proved me right. This only encouraged me. Every once in a while I would loosen my death grip a little and delegate to someone who did a half-assed job. This just reinforced my belief system that I was the only one I could rely on. What I didn’t realize was that by excluding my staff I was slowly diminishing the possibility that I would

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

ver get any quality assistance

I didn’t think I was arrogant. That would have been bad. I thought I was a perfectionist. Which is good, right? Well. Yes and no. I’ve now come around to the idea that perfectionists are not God’s gift to business. Except in their own alternative universe.

I didn’t think that I mistrusted other people - only that I

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

Combination pro

ad great intuition about them.

And I didn’t realize that my constantly telling myself that I was the only one who could be trusted to do a good job was fueling my view of an untrustworthy Universe.

It wasn’t the case that I couldn’t trust my staff to do work well. It was the case that I didn’t trust them to do well. My problem – not theirs.

Eventua

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

lly I came to love delegating. I relished the free time it gave me. My staff thrived on the added responsibility and appreciated my faith in them. After a while they were bugging me for more work; asking what else they could do and how could they help me.

Here’s how it can work for you.

First. Drop the attitude. Your staff knows you’re a control fr

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

ak and they know you don’t trust them to do a good job. You may think you’re in the closet on this. You’re the only one who thinks it’s a secret.

Get familiar with Chunking. Don’t start by delegating an entire project. Certain psychologists believe that anyone can learn to do anything by Chunking. Chunking is when you break down a large task into

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

maller pieces which are more easily mastered and remembered. Chunking also has psychological advantages. Instead of focusing on the larger outcome ,which might be far away and overwhelming, you are focused on the more immediate goal. So don’t delegate an entire task. Delegate a part of it which is within the skills and time constraints of your empl

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

yees. Better to have several people working on different parts of a project and have one of them get into trouble than have one person dealing with everything and self-destructing.

Delegate according to strengths. Everybody is good at something. If not – then why are they working for you in the first place? Take some time to find your employee’s

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

ompetencies. For example if you need a customer service follow-up choose someone on your staff with a personable phone manner. Preferably someone who is well-liked by your customers. For research - choose an employee who has a good eye for detail and who always needs to know the reasoning behind your decisions.

Give clear instructions and structure.

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

Following aspects would a

Set your staff up to succeed. Never give an open-ended task and tell them to bring it back when it’s done. Give them a time frame so that they can pace themselves and their other tasks accordingly. If they have a clear idea of when they need to be completed they will get an early heads-up if they’re not running to schedule. Set a date and a ti

dd to the challenges in developing combination products:

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

e when they will report to you on their progress. If you are particularly control-challenged or if the task is really important you can even make it a daily progress report. For Heaven’s sakes leave them alone in between reports. Don’t ask them how it’s going. Try and put yourself in your dad’s position. Remember when you would be in the back seat

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

n family vacations whining “Are we there yet” every few miles. Ever wonder why he blew up? Don’t hover. Make it clear, though, that you or someone else is always available for questions in between reports.

Give them the tools to succeed. Give them checklists, punch lists, computer time, sample reports or forms to copy. Ask them if there is anyt

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

ing they would need or like in order to organize the task their way. Let them organize the tasks their way. People learn and work differently. Some are visual; some are intuitive; some need daily "to do" lists. Concentrate on the outcome and not the process. If you give free reign over the process - chances are good you will get the outcome yo

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

want.

If possible delegate tasks to the same people on a consistent basis. In a work situation familiarity often breeds confidence. It also facilitates ownership and pride.

I once had several different janitors on my staff who cleaned a very large multi-story building every day. There was no organization or structure to their work. They just showe

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

Professional from academic institutions, pharmaceutical industries, health care indust

d up and all started at the same place at the same time and went on cleaning whatever was in their path until they were done. I can think of nothing more draining than doing a good job cleaning the same bathrooms and floors and elevators each day only to have them messed up overnight and have to come back and clean them all over again the next day.

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

felt bad for them and wanted to make their job a little more bearable – but who likes cleaning?

I hit on the idea of assigning one floor to each janitor so that now they had their own territories. Because they had the same area each day they had pride in their floor. They also got to know the people on that floor so the element of relationship becam

.

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

a factor in their day. They even grew to be competitive with each other as to whose floor was the cleanest. This system also helped me. I could tell right away when I walked off each elevator who was slacking off and who was working.

Don’t forget to say thank you. Say thank you when they give you the work back and then go back later and pick out

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

Companies that provide selfless information through particip

ne particular detail which you appreciated. Maybe it was the way the work was organized or laid out; the fact that it was turned in early etc. Let your employee know that you noticed and appreciated it.

Finally, remember that martyrdom is not an attractive quality. You didn’t list it as an attribute on your resume and you wouldn’t hire anyone who did

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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