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We've all had them, those poorly illustrated guides to putting a retail product together or instructions on how to use a new piece of electronic equipment. What gives? For those of us who are mechanically chall

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

enged, this can be really frustrating. The world of electronics holds a special frustration for many, such as setting up a piece of computer equipment, for example. Once learned, they are usually not that bad,

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

Examples of combination products may in

ut it just takes getting used to.

My new printer came today. Once again, I dropped everything to figure out how to set it up. What a job. Programming things is definitely not my strongpoint. It is good there's

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

nobody watching when I'm working on these projects, as I get really annoyed with lousy directions, programs that don't load right (and have to be re-installed), along with other inevitable mishaps that come wit

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

buying new electronics. Programming my vcr is a nightmare, and setting up an all-in-one fax/printer/scanner isn't too far behind in my list of things that make me mental.

Now, the printer is set up, and worki

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

Combination pro

g fine. Phew. I always go through the phase of blaming it for things going wrong, only to find out later that it was my errors all along. I even called the toll-free number on the instructions, and the phone te

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

h walked me through part of the process, all the way from India. Thank goodness for phone techs. Surely, he was laughing to himself, thinking this dumb lady doesn't know the box from the printer. But, in the en

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 problem was a simple, overlooked step on my part.

It would help us all out a great deal if companies put more thought into not only designing their products for those of us who need a little extra help i

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

figuring out complicated instructions. Make sure all steps in the diagram are fully explained, don't just draw a picture and leave us to figure out what goes where. As an illustrator, it bugs me to see drawing

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

that are poorly done, omit critical details or steps, and print useless information. It doesn't take endless time and money to put together a truly accurate drawing of a product, then label the steps in puttin

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

it together. The right illustrator should know how to do this without question. Don't skimp on money and let your cousin's brother who took one drawing class somewhere do the work. Hire someone who knows what

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

Following aspects would a

to do, and how to do it.

Recently, I bought a new tabletop convection oven. The manual was a complete disaster. It came filled with a bunch of strips of paper, each giving a correction to mistakes in the manua

dd to the challenges in developing combination products:

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

. The whole booklet was maybe ten pages of crudely printed instructions. There was no 1-800 number to call for more information, and the recipes that came with the oven were mislabeled with the wrong baking tim

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

s. Reading customer reviews of the product, others had similar complaints. With practise, on my own, I got used to the oven, but the company lost sales for those who didn't want to deal with that and asked for

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

efunds. To make sales stick, they needed good instructions..what a big "Oops!"

Once the project is figured out on one's own, there is a feeling of mastery. I put together a whole exercise bicycle once, and act

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

ally did it right. That was a major miracle, given the large pile of nuts, bolts and other various mystery whatchamacallits that needed to be figured out. In the end, it sure is great to have the project in one

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

Professional from academic institutions, pharmaceutical industries, health care indust

piece, and working properly. If you're one of us, the mechanically un-gifted, take heart. After trial and error, it will come together. Just be patient and use the toll-free number for help, if they have one.

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

t's evening now, and I'm starting to wind down. The printer sits in its corner, its led lights illuminating everything. I finally figured it out by much trial and error. The manual on this one wasn't great, but

.

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

was better than many products I've bought in the past. By the end of the day, all is good. The next time I buy another complicated piece of machinery, the process starts all over again. It sure would be nice to

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

Companies that provide selfless information through particip

have great directions, all across the board with all products. It would cut wasted time and save a little frustration. Come on, companies, give us manuals that anyone can understand. We sure would appreciate 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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