Advice You - Business

The old phrase comes to mind, "If you want something done right, do it yourself." Th

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

ere are a million other phrases that come to mind but I won't bother you with them.

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

Examples of combination products may in

In a nutshell many companies feel that they can build something internally versus goi

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

ng outside the company. There could be many reasons for this, "we control the code"

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

or "we'll save money", etc... But the real question that should be asked is TCO or "T

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

Combination pro

tal Cost of Ownership." What's it going to cost you to build versus buy?

The realit

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

y of this situation shows itself only too late for most companies who make the unwise

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

choice. There are a miriad of consulting firms out on the web who are chomping at t

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

he bit for an opportunity to get your business. Why should you try to take on a larg

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

e project in an attempt to save a few bucks, or feel that you control the code when a

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

the end of the day, outsourcing will yield all of these things and more for most.

I

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

Following aspects would a

t really boils down to the scale and scope of a project. If you have a project that

dd to the challenges in developing combination products:

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

you really feel your company can handle internally and keep TCO down then by all mean

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

s go for it.

However, if you have any second thoughts at all about the project you s

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

hould really think about outsourcing. Unless you are a development firm you really s

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

ould be spending your energies on whatever you do best, which probably isn't programm

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

Professional from academic institutions, pharmaceutical industries, health care indust

ing.

There are hundreds if not thousands of quality companies out there who can do i

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

t better and much cheaper than you can; not to mention get your product to market fas

.

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

ter.

So, the next time you think about build vs buy, why not submit your project for

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

Companies that provide selfless information through particip

proposal to a few companies and see what they come back with. You will be surprised

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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