Advice You - Business

The last fifty years have seen tremendous prosperity in the United States. This prosperity has not only been experienced by the baby boomers who were born after World War II, but also by t

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

he generations that have followed. If there has been so much prosperity, why have so many people lost jobs in various industries since the 1960s? First the steel industry followed by manuf

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

Examples of combination products may in

cturing was hit as jobs began to move from the historically industrial regions to lower cost regions and then to outside the U.S. Following the break-up of the Bell Systems on January 1, 1

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

984, telecommunications changed forever and continues to change. While some jobs were created, many jobs were lost forever. The build-up of the internet and the dotcom revolution was follo

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

ed by the dotcom bust and again many jobs were lost. More recently, the airline industry has been hit hard with bankruptcies, jobs losses and reduced pay and benefits for the remaining emp

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

Combination pro

oyees. Is any industry immune to massive jobs losses, bankruptcies, loss of benefits and reduced pay for employees who remain? In simple terms the answer is “no”.

The farmers became the f

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

actory workers who morphed into the white and blue collar workers who in turn became the information workers. While there are plenty of products you and I need every day: cars, shirts, foo

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

, gasoline, computers, light bulbs, desks – the list is literally endless – most are made, assembled or processed outside of the U.S. They are sold here. We buy them here with our hard ear

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

ned dollars but someone else, who generally makes much less than you or I and who either has no benefits or has their benefits provided by their government does all the work to make the pr

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

ducts we enjoy every day. Think about it. Am I saying “buy American”? No. Am I saying that employment and economies are global and very much in the midst of flux right now? Yes!

So, what

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

an you do?

- Whatever field you are in, stay on top of the latest technology. If your employer does not pay for it, do it on your own.

- Develop a professional network. Not just in your

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

Following aspects would a

current field and not just in your local area. Be active with your network.

- Build you own business. If you work for someone else, development you own business in whatever field in your

dd to the challenges in developing combination products:

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

ights and weekends. If you already work for yourself, make sure that you are not so narrowly focused that any bump in your field, technology or the economy will vaporize your revenue strea

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

m.

- Put yourself first. Corporate loyalty is dead. Take care of number one. No matter how valuable you think you are, you can be eliminated or replaced in a moments notice.

- Save. Make

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

sure you have six months worth of savings just in case you get laid off. While a year would be ideal, it may not be realistic while saving for you children’s education and your retirement.

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

- Stay flexible. Just because you always worked in a certain field does not mean you need to stay in that field for 40 years.

- Plan to never retire. Unless you are very good at saving a

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

Professional from academic institutions, pharmaceutical industries, health care indust

nd financial planning or you plan to live on Social Security, get it into your head now that you will always work – at least for as long as you physically can work.

- Think of work as a m

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

rathon. Sure there are some weekends and all nighters, but there are few crises that require you to work 60 hours per week for weeks on end. After a while that becomes a lifestyle. Mix wor

.

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

k, exercise and leisure (family, travel, outdoors, reading, etc.). Balance is the key.

Is there any good news here? Yes. It’s up to you. No one is going to take care of you. Not your empl

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

Companies that provide selfless information through particip

yer, not the government, not your mommy. You have got to do it yourself. And you can. Once you accept this fact, it is extremely liberating. Take advantage of that liberation and begin NOW

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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