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The workplace has evolved over the years. At one time, most people worked from their homes as farmers or craftspeople. A few were merchants. Then the industrial revolution changed ever

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

ything. Many people left their homes and trades to live in and around cities and work in factories of all sorts. In the factories people repeated the same task over and over with many c

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

Examples of combination products may in

o-workers doing the same thing. People now had a home separate from their place of work. As industrialization matured, there was more and more paper work, administration and ultimately

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

the advent of professional managers.

In the last quarter of the twentieth century, as manufacturing began to recede, information workers came to the forefront with the rapid growth of 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

chnology in telecommunications, computers and ultimately the internet. During this period, globalization began to squeeze American companies to be more competitive. Companies consolidat

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

Combination pro

ed and launched wave after wave of layoffs in both the blue and white collar ranks. Few industries or companies were immune from this trend.

Where does this leave us today in 2006? Tod

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

ay there are fewer office-based white collar workers working for large corporations in the same way that there were fewer craftspeople working out of their homes after the industrial revo

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

ution. We have experienced the information revolution and in many ways, the effects have been much more staggering than what occurred in the nineteenth century. This can be seen clearly

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

when viewing the current variety of working environments. Some white collar workers gain the few cherished slots for the executive corner office. Many more are finding themselves spend

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

ing their mid and late working years typing on a computer and talking on the phone in a cubicle. And an ever increasing number are home-based. Where they work for corporations, small bu

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

inesses or themselves. They find the kitchen table, the local Starbucks or if they are fortunate, a home office, as their workplace.

Whether one is in the corner office, a cubicle or wo

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

Following aspects would a

rking from Starbucks, there are a few office “rules” that you should consider.

- The most important tools for every business person are a cell phone, a notebook computer with wireless ca

dd to the challenges in developing combination products:

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

pability, a legal pad, a pen or pencil and business cards (and yes, you do need access to a printer too from time-to-time).

- Everything else, whether it’s a desk set, bound organizer, c

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

locks, manuals, journals, photos, certificates, Post Its, paper clips, boom box, manila folders (I admit – I have a thing for manila folders; always have) or calculators should be conside

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

ed ranging from nice to have to useless clutter.

- I have worked with some people who carry almost nothing and those who carry more than enough for an Arctic expedition. I have known e

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

xecutives who have only one piece of paper on their desk at a time. I have also experience co-workers who have mounds of paper, journals, sandwiches, utensils and other materials on thei

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

Professional from academic institutions, pharmaceutical industries, health care indust

r desk always – and yet somehow they seem to function quite well. And I count among my contacts business people who have more framed photos, memorabilia and mugs on their desks than a ve

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

eran politician. And finally, there are those I have encountered who believe that anything personal, such as a photo of the wife or kids, in a place of business is offensive – and tend t

.

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

o be quite vocal about it.

The point is this – it does not matter whether you work in an office, a cubicle, the kitchen table or Starbucks, surround yourself with only what you really ne

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

Companies that provide selfless information through particip

ed to do your job effectively. Everything else is clutter and will keep you from effectively accomplishing your objectives.

I look forward to your thoughts and experiences on this topic

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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