Advice You - Business

With all the talk about outsourcing today, many companies are using it to accomplish more and more tasks. But there IS a limit. In fact, there are three of them:

Co

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

st – When it is more expensive to outsource than to do it in-house, outsourcing is a bad idea. This isn’t often easy to determine. Sometimes the outsourcing expert m

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

Examples of combination products may in

ay quote more than in-house costs because the expertise is rare and the market rate for the service is high. You might be better off hiring and training in this case.

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

Take into account the employee training, salary and benefits vs. the outsourcing firm’s quote. There are some intangibles that need to be considered as well. Outso

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

urcing may come with some expertise that you might not have in-house. How much will that save you in working out issues?

Loss of Control – No matter what the project

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

Combination pro

you always want the reins to be in the hands of company employees and executives to thoroughly understand not only the project, but also the overall company goals and

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

direction. Without that essential link, the project could inadvertently veer off in an unwanted direction. In addition, the company will be responsible for the resu

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

lts of the project; so it needs to be a vital part of every decision made. The best case scenario is an every-day contact and update. When this cannot be worked out

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

ith the proposed outsourcing firm, strong consideration should be given to looking elsewhere, including in-house.

Contractual Restrictions – Of course you should neve

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

r outsource tasks when you are contractually obligated to perform them yourself. Check your client contracts carefully for such language and be sure you get permissio

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

s needed before embarking on any possibly conflicting outsourcing arrangement. You need to review each contract individually, not just your “standard” contract, as i

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

Following aspects would a

t is well within the rights of any customer to insert such a clause. Breaching this agreement could result in non-payment with little chance of legal recovery.

You’l

dd to the challenges in developing combination products:

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

l notice that the three reasons given do not include what is usually considered a rule of thumb – outsource support functions, but never core functions of your company

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

In general, this IS true. But there are examples where outsourcing a core task turned out to be a wise idea. For example, a paper called “Pasadena Now” in Pasaden

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

a, CA hired two journalists in India to cover local news and events in Pasadena.

Wait, what??

It turns out this is a highly competitive market. And since California

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

has very open public access laws, virtually all government documents, meeting minutes, press releases, etc. can be regularly found on the Internet. Publisher James M

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

Professional from academic institutions, pharmaceutical industries, health care indust

acpherson said, “We do not believe that geographic distance between India and California will present insurmountable problems and that working together with you will r

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

esult in your development of a keen working knowledge of this city’s affairs. This will result in accurate and authoritative news reports”.

And the cost savings glea

.

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

ed from this surprising action? Well, we’re not sure how much they normally pay reporters, but they hired these two for $20,800 annually. Combined.

When it makes th

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

Companies that provide selfless information through particip

is much financial sense, can you blame the company for doing it? Perhaps not. But if you’re an unemployed reporter from Pasadena, CA, you might have a different view

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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