Write You - Home Based Business

Is it really your time to take that a leap and move from your home office to a commercial property?

To help you answer this question, let's take a step backwards for a moment and answer two

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

other questions. Why do you want to move? Why is this move necessary?

The first question is -- why do you want to move? Sit down, grab some paper, and make a list. Put down as many reasons 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

s you can think of. Put your list aside for a day or two and revisit it a few more times. You obviously have some of your reasons already or you would not be thinking about the possibility of

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

a move.

The second question is -- why is this move necessary? For each reason, jot down a few notes on why each reason is valid. Let's look at some of the more common reasons and discuss yo

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

ur rational behind each.

Do you get a lot of clients coming to your home? Most of us do not have the luxury of a separate entrance for our office that keeps the clients from tramping through

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

Combination pro

our messy house and down the hallway to our office that was once that spare bedroom.

Can you arrange to use a meeting area at a shared office complex for a half day per week as a permanent

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

off-site location in order to have a special time each week to meet with clients? It might even be better for some of your clients if they do not have to trek into the wilderness of suburbia

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

ach time they need to meet with you. You might even become more productive by limiting meetings to one or two specific days each week. Should you make the trip once in a while to visit your c

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

lient instead?

Is your reason that a commercial location would provide better visibility and this would lead to more clients? Perhaps? I just love questions that can be answered with "it all

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

depends". Outside of a retail store where out of sight is truly out of mind, most of your customers likely come from advertising and word of mouth anyway. When was the last time you hired a

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

plumber to fix something? Did you drive done to the local mall and visit the plumber store or did you look in the phone book?

Do you have employees coming to your home every day? If so, your

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

Following aspects would a

probably already are in violation of most residential zoning regulations and need to move your business out. If employees come on a less frequent basis and do not cause a problem for your ne

dd to the challenges in developing combination products:

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

ighbors, then stay home.

Do you feel the need to socialize more with humans that are not at the other end of a phone or via e-mail? That is a whole other issue. People are social animals by

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

nature and need the company of others. Maybe working at home is not for you but more likely you need to get out more. Join some business associations or special interest groups where you can

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

eet with other people on a regular basis. Your local chamber of commerce likely has some monthly programs. How about groups like Toastmasters? Find some non-work interests. Take a course. Jus

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

t get out of the office for a while each week.

Is the cost necessary? I recently read an interesting statistic. What it said "approximately" was that if you keep your car for ten years rathe

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

Professional from academic institutions, pharmaceutical industries, health care indust

r than trading into a new car every few year, you will end up with $500,000 more in the bank when you retire, even after accounting for the increased maintenance costs of the older car. This

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

is a bit of an analogy to our home office but the reason most of us work is so that someday we can stop working. The less we spend on our day to day costs of running an office and the more we

.

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

can sock away, the more savings we end up with and sooner we hit our goal to stop working.

What else did you come up with? Look at your reasons. Look at your justifications for each reason.

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

Companies that provide selfless information through particip

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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