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I must be very pro college because, between us, my wife and I have four degrees. But I sometimes wonder if they are for everyone. We were lucky and used our respective degrees in our chosen fields. Yet we amassed a combined stud

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

ent loan debt of nearly $100,000 along the way. And that wasn’t the entire cost of the college experience. I lived on campus, and then on my own, incurring dorm and food expenses along with student fees and books. It was a

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

Examples of combination products may in

constant struggle to keep up with the ceaseless costs. However, I could always justify the money because I saw it as an investment in my future.

My mother was of the old world belief that a young man without college would be r

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

legated to saying, “Do you want fries with that?” or pumping gas, for the rest of his life. Although we were poor, she pushed me forward to go on with high school college curriculum. Later, I would apply for grants 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

nd scholarships for the needy. I managed to get several and still required a National Defense Student Loan to complete my four years bachelors because I chose a pricey college, Pratt Institute in Brooklyn. I could have gone with

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

Combination pro

a cheaper school, but I decided that the more prestigious university would gain me entry into a better paying job.

So how did that work out, you ask? Well, I was hired by a small New Jersey advertising agency as an artist inter

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

n assisting the art director in the summer of my junior year. For all they knew, I could have gotten my degree from a mail order ‘learn-to-draw’ school. They only chose me based on my portfolio. So, was the ‘Pr

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

tt’ name important and did it open any doors? That’s highly unlikely. Later, I was the art director for Fedders, ran my own ad agency in Phoenix, Arizona, and finally was employed as a Yellow Page consultant by the B

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

ell System. While college gave me a good head start, the on-the-job training was far more crucial. If I had to do it again, would I? That’s a terrific question and I’m glad you were astute enough to ask it.

Suppose

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

had gone to that ad agency with my high school portfolio, instead. I’m not sure they would have given me the chance, but they might have. And Fedders? Probably not. But I could have learned enough at the agency to get a b

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

etter job and still eventually open my own agency. Also, I would have started with $50,000 more: the loan amount I borrowed from the government. Which brings me to a larger issue. How much is it really worth to get that diploma?

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

Following aspects would a

You always hear the tales of Bill Gates (left Harvard in his junior year) and Steve Jobs (left Reed college after one semester) who founded Microsoft and Apple Computers, by working out of their garages. There are hundreds of

dd to the challenges in developing combination products:

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

illionaires and multi-millionaires that never set foot inside a university. But, what about the average Joe or Joanne? Can they do well in the business world without that degree and what about the total college experience? On th

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

ing at a time, please.

If someone has no idea what career path to take they have three options: (1) get a business degree, (2) try for a technical skills school offering courses like computer programming, electrical repair, or

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

uto mechanics, or (3) got to work for a large company, starting at the bottom. With choice (3), they have the opportunity to receive benefits and work their way upward. Of course this doesn’t garner the young adult the &ls

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

quo;college experience,’ which I sometimes think is overrated. Even though I enjoyed mine immensely, my wife went to college from home and worked full-time. Is she any less well-rounded or fulfilled than myself? I doubt it

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

Professional from academic institutions, pharmaceutical industries, health care indust

and therefore here’s a final thought.

Suppose the family has the college money saved, but junior isn’t sure what to do with his life and has no particular skills or direction. If the parents then took junior’s

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

college fund and financed him into a family business that they could help run and lend advice to, would that be so bad? It’s still an investment in his future, right? It’s an option I’m sure that the average p

.

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

rson doesn’t often consider. But keep an open mind and weigh the pros and cons of the college expense. If they choose to be an entrepreneur, they can always decide to go to college later on. If you’re a parent with a

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

Companies that provide selfless information through particip

college-age son or daughter, this is a tough decision, but allow them to have input. Who knows? They may be the next business super star. By the way, do you have an empty space in your garage? Need a college degree? Myth busted

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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