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Off shoring, outsourcing, all are terms that are becoming very common in the market place. They are generally also associated with job loss as companies take advantage of more experienced but low cost resources in countries like India, Philippines

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

, Eastern Europe, etc. Large companies have been taking advantage of outsourcing and off shoring for years. Small and mid-sized companies have not yet taken advantage of this phenomenon and perhaps that that is the next big wave to come - once peo

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

Examples of combination products may in

le discover an easy way to do so.

Let us look at what outsourcing and off shoring mean and what some of the challenges associated with them are:

Outsourcing refers to giving work to someone outside your own company so as to only

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

focus on core competencies in house. Outsourcing can be done locally to others who are experts in a particular service. For example, a small business can outsource all their accounting functions to an accountant or their website management to a

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

other company who would manage it. This allows a small business to focus on growing the business and taking all the non-value added tasks out of their day to day activities. So instead of doing everything themselves, they can now retain experts t

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

Combination pro

perform those tasks that need to be done but are either not enjoyable or not ones that help the growth of the business.

But outsourcing has its challenges when the outsourced company is so busy that it cannot meet your deadlines or when they’ve

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

over promised and can’t really seem to perform to your expectations.

Off shoring refers to the taking of outsourcing to another level – outside the country where the business resides. In off shoring, companies take advantage of

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

killed resources in low cost countries where labor is cheap and there is a huge availability of skilled workers.

The main benefit of off shoring is being able to get work done at a third or fifth of the cost of doing it locally in most US and Wes

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

tern European countries.

But the cost benefit disappears pretty quickly when work takes much longer to get done and when it is completed, it has serious quality issues. For example, if you hired a company to do work for $10 per hour, but the work

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

took three times longer to do than if you were doing it locally for $50 per hour; your low cost advantage is severely diminished. Over a period of time, the hassles for such a minuscule saving can turn off a business completely and thus prevent t

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

em from using off shoring.

There are many reasons for quality and lack of timely delivery when people offshore work. The reasons include cultural issues that lead to scope and requirement misunderstandings that lead to missed deadlines, working s

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

Following aspects would a

tyle differences, time differences that lead to communication problems, infrastructure issues that cause delays and inexperienced or untrained resources who botch up even simple jobs. We all have heard horror stories of abandoned projects, simple

dd to the challenges in developing combination products:

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

ebsites that take 12 months to deploy, and help desk support that is provided by inexperienced people who make us want to scream in frustration.

Due to the internet, it is difficult for people to differentiate the real players from the fakes – pe

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

ople who have hung a shingle in the form of a website and claim to have 10 years or experience with large sized companies. How do you know who is lying and who is not? Most businesses are not in a position to visit a offshore partner in India or

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

omania to make sure that they are what they claim on their website.

Most of these companies will promise quality and blah blah certifications but when push comes to shove, many fail to deliver on time and many have serious quality problems in wha

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

ever they do deliver.

We recommend that companies ease the entry into the outsourcing or offshoring field by partnering with companies locally who have an offshore presence. Instead of partnering with offshore companies that have a local marketi

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

Professional from academic institutions, pharmaceutical industries, health care indust

ng office, identify local companies that have decided to open offshore offices.

The difference is huge. A local company within your own country is verifiable through various means. A local company can be easily researched by a quick trip to anot

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

er state if necessary or by checking local references. It is much difficult to do so with an offshore small company.

Once you begin the process, make sure you have level set expectations associated with daily communications, meeting time lines,

.

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

penalties when deadlines are missed, etc. And never assume that everything will work to your expectations the 1st time you begin working with an outsourced local company either. It is a huge paradigm shift when you are used to working with someo

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

Companies that provide selfless information through particip

e in your office who you can assign work to in person versus when you have to assign work by phone, email, and chat. If the right processes are put in place, long term success can be achieved. But it will take a lot of time and a lot of patience

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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Now that you have defined where you are and where you want to be as well as what you are willing to do to get there, you now have to get real about things that might hold you back from getting what you want and create a strategy for handling them.

Nowadays everybody speaks of Niche Marketing Strategy - But what is Niche Marketing really, and how can you use it?

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