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Are you working very hard but your staff seem to be very inefficient and are holding you back? Maybe the problem is w

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

ith you and you don’t delegate properly?

Do you hear yourself saying:
* If only I had all the facts

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

Examples of combination products may in

br> * Every one wants a decision from me
* Why don’t my staff do what I want them to?
* What are my staff

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

oing?
* If only I had more time

You could be suffering from poor delegation:
* Are your standar

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

s so high only you can reach them?
* Do you constantly interfere with your staff’s work?
* Can’t make larg

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

Combination pro

decisions because of the small things that need doing?
* Do you have to do everything yourself?
* Do you ne

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

d to know all the minor details?
* Feel you mustn’t lose control of the situation?

Poor Delegation - Comm

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

n Symptoms:
* Constantly chasing staff for information
* Constantly checking up on staff
* You find

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

the work of your subordinates more comfortable.
* Poor staff morale
* High stress rate
* Work overload

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

br>

The poor delegater is the person who is uncomfortable, either because they are more comfortable working at a leve

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

lower or they do not like to lose control of any part of a decision. This trait is caused by insecurity and is a com

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

Following aspects would a

mon symptom with newly promoted people or people that have been promoted above their comfort level. Of course it coul

dd to the challenges in developing combination products:

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

be because they are not very proficient, but let’s just check if you are delegating properly.

Poor Delegation

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

- Solutions
* Be confident in your subordinates’ work and let them know this.
* Review PROGRESS – this m

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

ans only look at progress from one review to another. Don’t place the reviews too close together. Set your staff rea

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

onable time scales and achievements required and a mechanism for reporting upon this. Then leave them to do their wor

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

Professional from academic institutions, pharmaceutical industries, health care indust

.
* Look at the big picture, that is your role. Trust your staff to do the smaller things that make up the solut

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

on.
* Beware of the “upward bounce” - staff delegating to you – you are in charge remember.
* Encourage yo

.

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

r staff bring you problems AND their proposed solutions. This makes them feel empowered, valued and often brings alte

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

Companies that provide selfless information through particip

native solutions. Of course you need to act on them as well or give reasons as to why they would not work as well.

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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I've watched a few episodes of Nanny 911 and with the chaos, out of control children and seemingly irreparable behavior, it strikes me as a precursor to Workplace 911. No, not a new reality TV show, but everyday workplace problems.

Pay an individual outside of your company to complete a software project for you and you could find yourself saving money in the process. This is a concept which may seem counterintuitive to some but those who have embraced the idea of outsourcing realize the cost savings associated with the process is one of the benefits. Outsourcing results in an overall cost savings for a number of reasons. Outsourcing contributes to reduced labor costs and greater productivity. Additionally, outsourcing virtually increases manpower giving companies greater capabilities.

It's only November, far too early to be thinking about Christmas, right? Wrong! If you start planning now you can avoid all the hassle and stress that comes with this time of year.

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