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The key to any successful electrical estimate, is organization and preparation! You need to develop a system for how you do your take-offs, and how you tabulate yo

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

ur information. Before doing anything else, read the plans and specifications cover to cover. As you read, note items of particular impact to the electrical scope

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

Examples of combination products may in

n a separate sheet, and hi-light the corresponding passage right on the specification documents. I usually note specific requirements, especially oddball ones dire

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

ctly on the corresponding plan sheet(s) as well, before I even start counting anything! Missing a restrictive note in the specifications can be disastrous.

The 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

t step is to develop a "Cheat Sheet" to ensure that you don't miss any items or phases that should be included. For most any type of estimate this can be as simple

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

Combination pro

as a full or partial list of CSI codes. List the phases that apply to your specific situation, or develop a master list, and then drill down from there. Treat it

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

ind of like a report outline similar to the ones you probably did in High School. For example:

General Conditions a) Temporary Electrical

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

Power i Temp Service & Panel w/ conduit & wiring, breakers

ii Temp Outlets w/ conduit & wiring, devices b)Temporary Lighting c) Site Tr

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

iler

Site Work a) Excavation & Fill i Equipment Rental

ii Trucking Service b) Underground Conduit
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
rong> i Transformer to CT Cabinet c) Concrete Encasement

You get the idea. There is NO SUCH THING as too much detail- remember

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

that. The goal is to itemize all the expected costs accurately. The cheat sheet should be as detailed as possible to act as a "memory jog" and will ensure that you

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

Following aspects would a

don't leave out a potentially costly part of the scope of work that you will later find yourself responsible for completing out of pocket! This is where a commerci

dd to the challenges in developing combination products:

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

al electrical estimating program can be invaluable. The entire program acts as your "cheat sheet". While pricey, the best ones will save you enough time to recover

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

the purchase cost very quickly. For links to our top picks, see our web site below.

The take-off should be done phase by phase, following the layout of your estim

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

ate "cheat sheet" closely. A key trick I use is to hang all the plan sheets containing schedules, riser diagrams, installation notes, etc. on the wall in front of

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

y estimating table. This can take up a lot of room, but I highly recommend it, as many times the plan sheets will reference each other or overlap, and you must be

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

Professional from academic institutions, pharmaceutical industries, health care indust

able to visualize the cross-connections quickly and clearly. If you don't have the luxury of that much space, consider making copies of key sections of the documen

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

s at your local copy center.

Once again, a commercial electrical estimating program is worth it's weight in gold for your take-offs. Alternatively, you can use a

.

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

spreadsheet, but you need to have the work experience and project track records to allow you to build one. Several examples are posted on our website to give you a

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

Companies that provide selfless information through particip

idea of what you need. If you are interested in learning more about electrical estimating, go to our site and sign up for the full series on electrical estimating

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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