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Today’s economy is characterized by is a lot of insecurity in the workplace. People are becoming aware of the fact that job security is now really a thing of the past. Some have replaced job security with the idea of emplo

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

yment security. Employment security is a concept that states that if you concern yourself with being a valuable person and employee, someone that is of value to an employer, you may not be guaranteed to keep your job but y

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

Examples of combination products may in

u will most certainly be able to get another one. To a large extent this will probably hold up in many situations. However it still assumes an employer - employee relationship.

The original relationship between the employ

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

er and the employee will probably be around for a long time. However in the future it will not be as commonplace as it is today. People who used to work in a single department in a single function for most of their profess

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

onal lives are now getting used to working more on a project by project basis. In most situations they are still on the same company's payroll, however this is already starting to change.

Many employers are starting to ou

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

Combination pro

source some of the work that was traditionally performed by employees to freelancers and small businesses. The disadvantages of having people on the payroll are starting to weigh in on their hiring decisions. With today's

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

high speed of technological change the necessary expertise to perform certain functions can literally change from year to year. In some areas it's even more extreme. In many of these cases it's simply easier and cheaper to

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

hire different people on a limited time basis instead of continuously having one employee trying to keep up with all the different tricks of the trade.

This trend will have far reaching consequences for today’s workforce.

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

Even the more experienced employees will have to stay sharp. They can't sit on their laurels anymore because they will continuously have to prove their worth in new situations, more now than ever before.

Some consider 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

s a huge threat to their career. The truth is, they probably should. Then again, some seem to be adapting to this phenomenon by looking at the opportunity that this brings them. More and more people today are starting thei

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

own part time businesses. Many do this while still working on their day job, either full- or part time. Scott Adams, author of the famous Dilbert comic, identifies this trend in his book "The Dilbert Future". He claims th

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

Following aspects would a

is trend will become more prevalent in the years to come. Many of these newborn entrepreneurs start businesses that perform a function that was formerly performed by an employee. Sometimes people even come back to their or

dd to the challenges in developing combination products:

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

ginal employer who has now become their customer.

Everybody knows running your own business can make you more money. There are a number of reasons for this. Of course you are probably more motivated and more results orien

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

ted than you would be working for someone else. You can also control your overhead better. Larger companies are not as efficient as they should be in many areas. Company policy sometimes drives up operating costs significa

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

tly. Certain companies hand out cell phones and laptops to all employees without taking proper notice of the need for such items. Also employees are less aware of many costs and business expenses. The bottom line is simply

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

not a priority for them. If they had to pay for everything out of their own pocket this would probably be very different. The fact is: when you are in you're own business you have to keep a very close eye on your bottom li

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

Professional from academic institutions, pharmaceutical industries, health care indust

ne or you'll probably be out of business in no time.

This raises questions for many people who currently hold a job as well as the people they work for. Which functions will continue to be performed by employees and which

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

jobs will be outsourced? It would be hard if not impossible to make an easy distinction at this point. Some companies may choose to retain employees for the same jobs that are outsourced by other companies. Each may have t

.

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

heir reasons and who's to say what's right. It will depend on many different factors like: the importance of the job for that particular business, the ability to attract the right people and the company's culture. Nobody c

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

Companies that provide selfless information through particip

uld accurately predict what the situation will be ten to fifteen years from today.

One thing is for sure though: for many of us it will be vastly different than our current situation. The question is: Are you ready for it

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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