Advice You - Business

We have probably all had this experience, just as I have on a regular basis. You start your day, open your email, and no matter how good your Spam filters are, someone across the Atlantic pond slips through using machine translated English. They are tryi

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 to win you over with cheap prices, wanting you to believe you can have glorious profits with all the money they can save you.

The "Buy American" bumper stickers had very little impact on the buying habits of consumers in America. So now, manufacturer

; 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 places such as India, Taiwan, Korea, and China are aggressively seeking to capture the business market in North America too. Many American companies have learned the hard way that the savings are not what they appear to be, and it can also have devas

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

tating consequences.

Imagine how it would feel to create your own foreign competitor who can sell a knock off of your product using your very own tooling and trade secrets. Once they have the specs and tooling, they have everything they need to compete

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

gainst you or sell to your competitors. You are legally protected from that using domestic suppliers, but that protection mostly stops at our shorelines.

When you use a domestic supplier, you are usually getting expertise and design assistance. They can

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

Combination pro

often help you make a good idea even better. If you go offshore, you may have a language barrier and cultural differences to make things more difficult. Instead of a helping partner, you often get a management nightmare, missed deadlines, and poor qualit

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.

International law experts, market research analysts, and global commerce consultants do not come cheap either. This can quickly consume the apparent savings being offered with offshore outsourcing. If you do not consult with these types of profession

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

ls, you could easily be inviting disaster.

Even in a best case scenario, your regular physical presence will be required overseas. This will involve a great deal of travel expenses. Relying on a third party already located overseas to provide management

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

services may not be a good option. The experiences of those who have tried this approach would strongly suggest it is not worth the risk. You need to be there, it is your business.

If you are considering the move to offshore outsourcing, making sure yo

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 quality specifications are consistently met is exponentially more difficult than using a domestic supplier. If your product fails due to manufacturing defects, an offshore manufacturer is much more shielded from responsibility. If product liability is

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

nvolved, you will most likely bear the burden alone.

As a web designer, I face the same competition from offshore outsourcing that manufacturers face. There is a potential liability to this practice that will inevitably find some unsuspecting buyer faci

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

Following aspects would a

ng serious legal problems. One highly publicized case could open a floodgate of trouble for many businesses.

Offshore designers routinely steal content from various sources. I have had content stolen on a regular basis, which falls under copyright infri

dd to the challenges in developing combination products:

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

gement in the US. It is very difficult, probably impossible, for content owners to legally prosecute the thieves located offshore. However, if a US company had stolen content provided by an offshore source, they would be extremely vulnerable to a copyrig

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

ht infringement lawsuit. It is very unlikely they would be able to hold their offshore provider accountable either.

In a case study cited by the North American Die Casting Association, a restaurant kitchen equipment manufacturer encountered a serious pr

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

blem with one of their vendors using offshore outsourcing, resulting in a lawsuit against the vendor. The vendor was having door handles cast in Taiwan that were made of low grade materials which were pulling right off the units they were installed on.

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

hese units were made in such a way that the door handle could not be replaced without replacing the entire door. The Taiwanese company would not cover the losses caused by their defective product, so the vendor refused to cover the cost of replacing the

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

Professional from academic institutions, pharmaceutical industries, health care indust

door. All relationships have been severed, the vendor lost a customer and gained a lawsuit, and there are no winners. This is a case of offshore outsourcing devastating an entire supply chain.

The good news is that many of those who have learned hard le

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

sons are now back to dealing with North American suppliers. Some companies have used offshore outsourcing with great success, but that does not mean it is right for your business. The horror stories that real businesses have experienced mean you can lear

.

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

n from their mistakes instead of making them yourself. Before making the jump across the pond, serious research is a prudent thing to do.

If offshore outsourcing works for your company, it is not an inherently evil thing to do. If it does not fit with y

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

Companies that provide selfless information through particip

ur business model, offshore outsourcing can have hidden costs that make it more expensive than just keeping your money here and supporting your neighbor. If you jump in without due diligence, you might end up adding your horror story to the casualty list

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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