Advice You - Business

If you were to research the horror stories of offshore outsourcing gone wrong, you will find countless examples. You will find many cases where visions of savi

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

ng money turned into hopeless legal battles and expensive lessons that would send chills to your innermost soul. You will also find examples of success. Since

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

Examples of combination products may in

offshore outsourcing is such a hotbed of controversy, I hope I can bring some balance to the issue.

The question on the minds of many small business owners is

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

"Should I consider offshore outsourcing?" The leading problem and cause of horror stories usually results from lack of due diligence. Before you consider the

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

possible savings, you will benefit from extensive research.

If you understand the cultural differences and make allowances for whether or not the laws will pr

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

Combination pro

otect you in a dispute, it can help you make informed decisions. You must also understand international banking and how funds will be tied up during these tran

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

actions. Intellectual property and trade secrets should be a paramount concern.

While these are important considerations, let's look at this from some common

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

sense perspectives. Whether you are manufacturer or a service provider, even if your competitor's are using offshore outsourcing, you could gain some competiti

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

ve advantages by not following the crowd.

Any kind of outsourcing often involves surrendering control. If you are in manufacturing for example, the company th

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

t plans, engineers, develops, creates its own tooling, produces, and services their own product, is going to naturally be more responsive to their customers. T

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

hey are in a position to further improve the product and answer any customer support issues.

If you can structure your company so that a single team of people

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

Following aspects would a

sees each project through from beginning to end, and continues to serve as a single point of contact after your product goes out the door, those people will b

dd to the challenges in developing combination products:

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

come the most knowledgeable. By nature, they will develop a sense of pride in what they do and take ownership if you allow them to. If you are willing to liste

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

n, these are the very people who will help you streamline your costs and increase efficiency.

Your organization may need to form strategic alliances and outso

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

urce to better serve your customers. Even with modern communications, having these partners in close physical proximity is usually more of an advantage, even i

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

the costs appear to be lower elsewhere.

In an age when so many are going overseas in pursuit of cheaper labor, you may want to ask yourself if they are creat

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

Professional from academic institutions, pharmaceutical industries, health care indust

ing an opportunity you can take advantage of. While your competitor's are throwing their labor force away, you could hiring grateful people who have experience

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

. If you can't beat your competition by being cheaper, you beat them by being better at a competitive price.

If you are in a position to responsibly consider

.

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

ffshore outsourcing, you are faced with spending your resources one way or another. You can invest in the expensive process of making sure it doesn't serve as

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

Companies that provide selfless information through particip

a detriment to your business, or, you can look at ways to make your business stronger by teaming up with people close to home who already understand the market

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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