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Most business owners fall into two categories when it comes to technology purchases such as software, computers and telephones. Either they have too much of

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

it and they are frustrated, or they are confused by it and they are frustrated. If you are in either category, you are probably frustrated!

While technology

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

Examples of combination products may in

is important to your business, you might find that you put off purchases because it seems too expensive, you don't know how it works or you think it's faster

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

just to do it yourself. If you don't know the right questions to ask when you are purchasing the product, you probably will spend too much money for not enou

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

gh results.

Here are three questions to ask yourself and your potential providers (always get two to three estimates) the next time you are thinking about ma

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

Combination pro

ing a technology purchase.

What do you need?

Before you start looking for software and hardware, begin by sitting down and writing out a list of feat

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

ures and functions that are important to you. Be very specific. Ask someone you know, what they like and dislike about similar products. Keep a list handy o

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

f hardware and software that you already have, noting the versions that you have. Break the list into two categories: Required, and Nice to Have.

Keep this

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

ist handy as you talk with the product representative. They may offer to provide a list for you, but it's important that you do this list yourself. Only you

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

can define what is really important to you.

What does it do?

While this may seem like an obvious question, it's common to settle for a simple answer

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

For example, it's obvious that shopping cart software manages your software, but many shopping carts also provide the ability to send out newsletters and au

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

Following aspects would a

toresponders. So keep asking the question, "What else does it do?" until you have really exhausted the answers.

As you go through the conversation, make che

dd to the challenges in developing combination products:

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

ck marks on your needs list. Be sure to ask if the software or hardware works with software and hardware versions you already have.

How does it do that?<

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

b>

This question requires a great deal of patience on your part. You can hone in on whether something works automatically or manually. You can ask how long

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

something takes to set up. You can also find out if something requires an expert with the product, or if a mere mortal can struggle their way through it.

T

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

is is also the perfect time to ask about customer support and help. Ask to see a sample page of the manual, if there is one. Can you read it? Does it make

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

Professional from academic institutions, pharmaceutical industries, health care indust

sense to you? If you have to pay extra to talk to a live human being, note that in your list.

Delay your purchase

(A bonus tip!) Wait until you hav

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

e finished collecting the information about each product before you make the decision. And then, wait another week while you consider if you really need this

.

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

product. What will it add to your business? Does it fit in with your marketing plan, budget and business plan?

If the answer to all these questions is "yes

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

Companies that provide selfless information through particip

," then pick the product that most meets your needs at the best price. Have a great night's sleep knowing you have done the best job you can for your company

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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