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Some companies are jumping into software outsourcing before they are ready. They hire a team, sometimes the wrong one, and then expect them to start producing software right

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

away. In their rush, they skip the planning, goal setting and careful evaluation of how outsourcing fits into their organization.

What does it mean to be ready for outsourci

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

Examples of combination products may in

g? Is there a way to measure your readiness? Now you can answer a set of twenty questions on-line to get an idea of where you stand. The results will tell you if you are read

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

to go, if should proceed cautiously, or that you should seek immediate help. Here is the link to this free, no obligation, outsourcing readiness test:

http://www.acceleran

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

e.com/readinessTest.php3

One company I met with recently is already doing outsourced software development from their engineering group. "How is it going?" I asked. "It depen

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

Combination pro

s on who you talk to," I was told. The executives of the company thought it was going great. The company was paying less for engineering talent. Board members seemed satisfie

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

.

But after further conversation, I learned the engineering department had never really bought into the concept of outsourcing. They resisted working with the outsourced tea

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

. Their results were actually less than spectacular. Clearly this was a company not completely ready for outsourcing.

And look at this email I received the other day:

We ar

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

looking to get started soon. I would like to get a quote from your firm for its services. I need an auction style web site to be built that could withstand up to 10 million

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

its per day. I need to know how fast it can be built and how much it will cost. I look forward to hearing from you...

I replied asking for more information about what was ne

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

ded. At least a few additional details or some sort of specification are required to give any meaningful answer. If you do not have these details prepared, you are probably n

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

Following aspects would a

ot ready to outsource.

And if you are not ready to outsource, you face the risks of extra costs, huge delays and the complete failure of your outsourced software development

dd to the challenges in developing combination products:

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

Why do people start outsourcing without planning? There are different reasons. Sometimes it is ignorance. Other times it is an intense desire to get the software developed

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

s quickly as possible.

Before you jump into outsourcing make sure you are ready. Take this free test and think about your answers. Be honest. Then seek out advice and other

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

esources to help in areas where you need improvement.

The on-line readiness test divides the questions into four areas - Your Previous Outsourcing Experience, Technology, Bu

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

iness, and Management Approach.

Even if you are not completely ready for outsourcing, you can get help to compensate for areas of weakness. That is the other benefit of the

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

Professional from academic institutions, pharmaceutical industries, health care indust

eadiness test - just by answering the questions honestly, you can focus on areas where you may need help to minimize your outsourcing risks.

The help you need in these areas

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

can come from several different sources. It might be books and articles that describe proven methods for outsourcing. It might be software tools to help you manage outsourcin

.

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

. Or it might mean hiring additional resources that have outsourcing experience.

Don't get discouraged if you get a low score on the readiness test. Remember that one of the

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

Companies that provide selfless information through particip

seven deadly dangers of outsourcing is not taking advantage of outsourcing at all. Learn from your test results and make the changes needed to make your outsourcing risk-free

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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Healthy brand names require periodic checkups. See if your company is suffering any of these branding ailments.

If you are of a certain age you will vividly remember the following names: Helena Rubenstein, Faberge, Germain Monteil, Trigere, Revlon, Elizabeth Arden, Max Factor, Schwinn, W. T. Grant, Montgomery Ward and Chuck Taylor. Each name represented a hugely successful consumer product brand. Each of these brands was grown from the entrepreneurial seed of a visionary. Unfortunately, each was subsequently abused, in several cases terminally, by non-visionary corporate bean counters.

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