Advice You - Business

When I was a child, there was a pool nearby and every year my parents bought us season tickets. My brother and I swam there everyday. One day we were swimming the length of the pool underwater. As I came up at

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

the edge of the pool gasping for air, the lifeguard was there to meet me. He asked if my brother and I would join the swim team. We were so excited; we talked about it for days.

The next few weeks we prepared

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

Examples of combination products may in

for competition. That day arrived and our first meet took us to a pool across town. We all piled out of the car and I still remember how our excitement was shattered. As I looked across the parking lot at the o

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

her team, each member was in a matching uniform. At that moment, I knew the thoughts of my teammates, “We were going to get creamed.” Our coach saw our faces and quickly said, “Shake it off, they just look prett

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

.” Yes, they did and we lost. After all, we looked like a bunch of kids from a watering hole. The other team even told us that. We all felt it. They were a real team with real uniforms.

That’s how it is in

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

Combination pro

the business game. You're judged by appearance. That’s because when you first meet a person, visual appearance is the first item sent to the brain. It’s the only data the brain has at that time. The minute I sa

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

w the other team in those splendid matching uniforms, my brain said, “They’re better than you.”

Hey ladies, get the Uniform! Since your image is the first piece of information the other person sees, that’s when t

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

eir mind forms an opinion of you. Your clothes are your uniform. If you wear the uniform of business, the suit, then you’re considered one of the team. If you don’t wear the uniform, then you are not taken serio

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

sly.

Women often tell me that they don’t get respect from their male counterparts in the office. Their opinions are not taken into consideration. That’s because they look like us kids from the pool. Each of u

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

picked our swimsuits and they showed our personality. I wore a two-piece pink swimsuit with white ruffles. My brother wore a yellow and purple boxer type suit. We looked colorful, but not focused!

Think about

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

it. You walk into a boardroom full of men and they all have on suits. Their business attire is very similar and each is in a power color, gray, navy, or black. All men’s suits are alike. They have those splend

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

Following aspects would a

id matching uniforms. How focused they look, just like that swim team. Now check out the business attire of the women in the office.

Oh, you see a pink dress with white ruffles and a yellow dress with tiny purp

dd to the challenges in developing combination products:

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

e flowers. What about that beautiful peach colored dress with burgundy and peach shoes? Just look at that teal colored pantsuit with a floral jacket. How colorful they look. Oops, I just described your wardro

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

e. It’s okay, I felt that way too. One of the guys who taught me how to play this game politely handed me a book about dressing for power in business. I went home and discovered every piece of clothing I owned

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

as either peach, pink, baby blue or lavender. Heck, I thought those were power colors. After all, I felt powerful in them. The guys teased me about it. They told me in jest, “No Gina, we said POWER colors, not

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

POWDER colors.”

Wait, don’t grab that credit card and run to the store yet. There are a few things you should know before you go shopping. If you’re petite, you must have a black suit with a white blouse. Thi

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

Professional from academic institutions, pharmaceutical industries, health care indust

s is pure power. If you’re tall, skip the black suit because it could be too intimidating, and go with burgundy. If you do business with men, stick to the solids colors such as gray, navy, and beige. Stay aw

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

y from stylish suits and colors unless you have the money to buy the new style and new color next year. The suit styles that are “in” today will scream “out of style” next year.

While you’re at the mall, pick u

.

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

a book about body types and how to dress them. You can usually find these books in the sewing or fashion section of a bookstore. Remember, a suit that looks great on that plastic model may not be advantageous

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

Companies that provide selfless information through particip

o your figure. If you’re still not sure about what to buy, watch TV newswomen and see how they are dressed. Professionals dress these women and you get this wisdom for free.

###

Gina Novelle (copyright 12-2004

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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