Main Subject - Business

If you are one of the mesmerized millions who have tuned into the hit reality show American Inventor, you probably witnessed the importance of first i

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

mpressions and the power of branding. It only took seconds for the panel of judges to start formulating opinions on the worth and merit of the inven

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

Examples of combination products may in

ions, often based on nothing more than the product name and a brief introduction.

A good example was the child psychologist who created an invention

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

he named a "Tizzy". These were inflatable/foam devices that kids could put on, and bounce around in, without hurting themselves or others. Right awa

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

the impression was that it was some form of punishment. The one female judge, Mary Lou Quinlin, took special offense to the "Tizzy" and used words

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

Combination pro

ike "suffocating" when describing her opinion of the idea. She took the aspiring inventor to task and questioned her credentials, asking how she cou

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

ld possibly create such a horrible thing. You could see she had formed that impression the very second the child psychologist introduced the idea...

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

The Tizzy". A kid having a "tizzy" is a kid that needs to be disciplined or reprimanded. So she could only view the product in a punitive, restricti

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

e sense. Needless to say the inventor, with all her years of study and training, was in tears from the misunderstanding. She loved kids and developed

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

he whole idea as a way to allow children to express their energy safely.

Now what if we could rewind the tape and instead she had introduced the prod

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

ct in a very upbeat way and called them...

Romper Bots!

or

Play Palz!

And then, let's say she talked about how all kids need a positive outlet for

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

Following aspects would a

their abundant energy, and how this was a fantastic way for them to safely play and interact with other children. She could have taken it one step

dd to the challenges in developing combination products:

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

urther and added a quick tag line/positioning statement such as...

"Play Hard. Play Smart. Play Safe!"

By seizing control of the thought process fro

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

the outset and leading the way, it would have been very difficult for the judges to form the opposite opinion -- to think of words like "suffocatin

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

" and "stifling." Perhaps safety questions would still have been asked, such as "Do the kids have enough breathing space?" or "Do the outfits come i

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

bigger sizes?" But the tone would have been completely different. It would have been open,inviting and inquiring vs. angry, harsh and judgmental. Ju

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

Professional from academic institutions, pharmaceutical industries, health care indust

st suggesting a "Play Pal" is a dangerous/horrible idea sounds contradictory. By creating a name with positive benefits you put the power of words t

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

work in your favor, adding momentum to your idea, instead of derailing it.

So inventing is not just about having a great idea. It's about packaging

.

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

hat idea with the right language to establish the right mindset. If not, a great invention can really bomb, just for lack of framing the idea proper

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

Companies that provide selfless information through particip

y. So when inventing a great product, it's just as important to invent a great name and tag line. Even if you're not quite convinced... "Just Do 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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