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When our daughter was born three years ago, I had no idea on how to purchase gifts for baby showers, newborns and birthday parties. If we were invited 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

o a baby shower or kid’s birthday party, I always offered to watch the baby so my wife could go out and purchase the items. Have you ever been to a “Bab

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

Examples of combination products may in

es R Us”, it’s stressful!

Well a few months ago we had child number two. This now meant that I had to start contributing to the gift buying. I noticed

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

once you get past the initial shock of the “Large” factor, you are able to concentrate and figure out what to buy. Of course, this would make my wife ne

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

vous when I first started purchasing without a list. I was able to prove myself worthy of the task.

I looked at purchasing items that are easily return

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

Combination pro

able. I also looked at items that might not be as time sensitive for usage. Other criteria are items that could be helpful to the parents for either wat

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

hing their children or keeping them occupied.

Baby leather shoes can always work wonders. They’re cute and are a great source of protective the baby’s

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

feet. They also come in a variety of colors and with some great patterns. The patterns range from fire trucks to flowers. The baby shoes we liked come i

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

soft hand stitched leather.

Another great idea is children’s furniture. Not a bed or dresser, something that is big and soft that the kids can use for

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

reading. We purchased a Bear Chair for our daughter that was soft and comfy. Our daughter loved it. No matter what room she was in, she would drag that

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

chair with her. She loved it!!

One gift I wished we would have received earlier was an Activity Saucer or sometimes called an Ultra Saucer. Our daughte

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

Following aspects would a

and now our son love this item. It’s like a plastic table with the center cut out of the center. It allows the baby (our son has used it since he was 4

dd to the challenges in developing combination products:

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

months old) to stand on his own and have access to 10 or 12 toys. This keeps them occupied for a while. Our son will stay in it for 30 minutes at a tim

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

!

The last gift I like…being a “Gadget” person is the baby monitor. The baby video monitor allows you to watch your child with a video camera while you

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

are in another room. I’m not into spying or nanny cams, this is a tool that was very helpful for us. A few years ago, our daughter had high fevers and

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

he baby video monitor, gave us extra security knowing we had the ability to hear and see how she was sleeping. The baby monitors are better now from whe

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

Professional from academic institutions, pharmaceutical industries, health care indust

n we purchased ours. They now come with a color monitor and have a better range.

So if you’re like me and have been spooked by the large baby gift stor

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

s, there’s hope. I hate to sound like I was a wimp at first but it was an overwhelming experience at first. Once I figured out a few gift ideas that I c

.

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

ould rotate amongst friends I felt better. Just remember, keep it simple and always give a gift receipt.

Lawrence Shapiro is the owner of elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

//www.BestNineMonths.com" TARGET="_new">BestNineMonths.com, a unique baby products store offering baby shoes, diaper bags, baby accessories and more

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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