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Back in the day when I was still apart of corporate America, I found myself tasked with the huge job of figuring out what spiffy new company wide software system we needed and what would work best for us.

Which computer system would work best? How do I

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

know? Hour after hour of boring computer system presentation, endless trade shows and phone calls and I still didn't have an answer. By the time you figured everything in, each system I looked at was priced somewhere around $170,000.00.

With $170,00

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

Examples of combination products may in

0.00 on the line, you can imagine I was not about to make a snap decision. So I changed my approach a bit. I really dived into why the old software wasn't working and what the team really wanted the system to do.

What kind of difference could finding o

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

ut what the team wanted make? Well, it turns out that 85% of the system we had was fine. But because I was able to nail down the processes behind what we needed, I hired a programmer at $25.00 per hour to come in and make the upgrades. The whole project

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

cost about $2500.00 NOT $170,000.00.

You're probably not sitting around thinking about spending $170,000.00 on new software, but you, like many of my clients may be scratching your head wondering if you should buy that new database or new software prog

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

Combination pro

ram that your friend has been raving about.

Your pal maybe raving about a software packages like Outlook, ACT!, Goldmine, Filemaker Pro, or Access, which are all excellent programs. BUT, (there's always a big but) in order for them to be effective for

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

YOU, you need to figure out what you need them to do for you.

Here's what I mean. Think of a blank piece of paper. That paper could be anything. A love letter, a list, a piece of stationary, you could fold it and make it a card, you could crunch it up

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

nd make it a ball or you could get out your origami instructions and make it a swam. There are tons of things that you can do with that piece of paper.

You have to think of software the same way. While it may not seem like it on the surface, software i

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

s really like that piece of paper. You have to decide what you want it to do for you. So before you make a snap decision and spend $170,000.00 or what might feel like that, ask yourself a few questions.

What will I be using this software for?
Do

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

you really know what you want the software to do for you? Or are you secretly throwing money at a problem. Have you thought through your systems and processes to know what you really need? Think about what you want to track. What kind of reports you wan

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

. What information you want to keep that the software can spit out at you. (For more help on developing your systems check out my home study kit, Your Business Machine Basics.)

Does it really do that?
Now that you know what you want the software

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

Following aspects would a

to do, find out if it really does that. A client of mine jumped the gun a bit when she bought a new software program before making sure it did what she needed. She wanted a contact manager, but what she got was an accounting program. Lots of money, time

dd to the challenges in developing combination products:

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

and frustration later, she ended up scrapping it and going back to some she already owned. Speaking of which . . .

Do I already own something that will do what I need?
Look at the software you already own. Do you fully understand all the feature

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

s and benefits? If not, call the customer service line, call a friend who uses it or play on the internet to learn about the items you have already paid for. I've been using Outlook for years and a friend of mine just gave me a tip that helped streamlin

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

my process. In other words, look through your closet, before going shopping.

What will I need to do to get this set up and implemented?
So now you know what you want the software to do, you know it really does what you need it to and you are 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

dy to buy. Do you have the skills to set it up? If you are buying ACT! or Goldmine, it might make more sense for you to hire an expert to make sure your program does exactly what you need it to. It's kind of like hiring someone to fold a piece of paper

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

Professional from academic institutions, pharmaceutical industries, health care indust

into a swan for you, rather than struggling with the origami instructions.

Buying new software doesn't have to be scary (or cost and arm and a leg). The right tools will enhance your processes and make your business run smoother giving you more time, m

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

ney and freedom.

© 2005 Beth Schneider. Want to reprint this article, feel free as long as you include the following: Beth Schneider, Chief Infopreneur of Process Prodigy, is a business process consultant who helps solo-entrepreneurs, small business ow

.

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

ners and network marketers who want to systemize their business to increase profits, increase productivity and grow their business without having to give up the family oriented, flexible, balanced lifestyle they desire. Beth works one-on-one with her cl

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

Companies that provide selfless information through particip

ients, offers home study courses, and teleclass boot camps. For more information visit http://www.processprodigy.com and sign up for your FR*EE 5- Step Process Starter Kit and FR*EE Process Tips

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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The European Union is fining yet another American Company that it cannot compete with. Why? Because this time Microsoft has just become too efficient in its operating systems. The Computer companies of the EU will not seem to get off their rears to build a better system or better features for personal computers and small business work stations.

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