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The Build-It-Yourself industry is a growing sector of new home sales. Many people love the thought of saving thousands of dollars by not hiring a Bui

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

lder. However, there are a few secrets the Build-It-Yourself industry are not telling potential DIY Builders.

As a Building Consultant and Inspector

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

Examples of combination products may in

, I've set through several of these courses just to see what this sector is pushing on unsuspecting consumers.

Here are just a few things the Build-

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

It-Yourself companies either don't tell you or are not completely open and honest about.

"You can get the same discounts from vendors just

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

like Builders do." I'd say this is one of the biggest marketing ploys these companies use and it's not true, at least not as far as honest Builders

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

Combination pro

are concerned. You see, Builders have a network of sub-contractors and vendors they use. These subcontractors and vendors give them huge discounts if

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

they keep using their companies. These same vendors and sub-contractors are not going to give you the same discounts even though they tell the Build

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

-It-Yourself company they will. And how will you know if you're really getting that discount? You won't! You're a one time shot where a Builder is re

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

peat business for them.

"Builders gouge you on everything, our list of sub-contractors and vendors are the same one Builders use" Again, no

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

t entirely true. Many of the better Builders have certain sub-contractors and vendors they will only use. These are the sub contractors that charge m

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

re for their work and do not work for just anyone. Many of these type of subs will not work for you or me because they do not know us and because the

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

Following aspects would a

y charge twice as much as the sub on the BIY company list.

"We screen all sub-contractors and vendors on our list." Well, yeah, to an exte

dd to the challenges in developing combination products:

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

nt. You see, most of those sub-contractors and vendors have to pay to be on the "Preferred List" of the BIY companies. If you don't pay, you fail the

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

"screening" process. I've been on several of these list and the only screening I'm aware of was my ability to pay their fees.

"You'll be i

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

n complete control of the building process" To some extent yes, but more than likely the answer is "only as much as the subs want you to be." What th

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

ey don't tell you is that if you have a problem with a sub not showing up or doing less than ideal work, you've got to deal with it. A quality Builde

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

Professional from academic institutions, pharmaceutical industries, health care indust

r has the pull to get things done where you don't. It all goes back to the Builder choosing quality subs and those subs wanting to keep the Builder h

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

appy to they'll continue to use their services.

Before jumping into the BIY game, make sure you know the real score. You may save a litt

.

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

le bit of money or you may not. I meet with consumers every week that have tried to build their own homes and quickly were overwhelmed by the process

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

Companies that provide selfless information through particip

or the sub contractors. It's not as easy as it looks and more than likely it will cost you more than what you originally budgeted for if not careful

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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Answers - Building Your Own Home: Dirty Little Secrets the Build-It-Yourself Industry Won't Tell You

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