Advice You - Business

Welding rods get no respect. Out in the field I've seen guys throwing 50lb. rod cans from the truck onto the ground, torchi

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

ng cans open diagonally, beating the wrong end open with a chipping hammer and every other conceivable tool, and leaving op

; 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 rod cans out in the open.

Let's look at what's wrong with each…

First and foremost, ALWAYS open the "right" end

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

f the can. Some cans and boxes even say "open other end", or "don't open this end", or "the other end moron!." (last one ma

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

e up by me.) The reason you need to open the right end is because you can damage the flux coating. You want to open it on t

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

Combination pro

e side where the rod is bare for the stinger, or electrode holder. There's a lot less chance of damaging the flux that way.

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

7018 is very prone to flux damage while 6010 is a lot tougher.

Most guys out in the field aren't gonna' be thinking about

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 welding rods inside the can as they toss them from the truck to the ground. When the cans get manhandled the flux gets

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

arred loose on the welding rods inside. It's bad enough when the flux gets chipped off the end of the rod, flux chipped fro

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

the middle and you can pretty much kiss that rod goodbye. It's worse, if you don't realize it's chipped because right in t

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

e middle of a good weld you'll suddenly be welding with no flux. No flux equals no shielding from the atmosphere, and th

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

Following aspects would a

t equals a garbage weld.

You can use a lot of different ways to open rod cans out in the field if you are careful. I'v

dd to the challenges in developing combination products:

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

even used the P38 C ration can opener I had in the army.If you use an oxygen/acetylene torch you need to be real careful n

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

t to burn the flux on the rods inside.

You can open a rod can with a chipping hammer, but it's not advisable. You gotta' b

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

e sure and hit it just right, at the edge of the can. You should hit the edge with the hammer follow-through swinging away

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

rom the can, not striking down into the can at the top. (I'm sure the electrode manufacturers are cringing when they read t

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

Professional from academic institutions, pharmaceutical industries, health care indust

is!)

Of course the best way is whatever the can is designed for, some of them open like a sardine can, but a lot of times

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

t doesn't work so you gotta' improvise.

Leaving open cans out allows moisture to get into the flux. Moisture in the flux 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

n cause porosity, or worm holes in the weld. Rods should be stored in a proper oven or unheated container if they don't

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

Companies that provide selfless information through particip

eed the moisture protection. 7018 needs an oven, while 6010 doesn't need the heat, but still needs to be kept protected

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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