References - Recreation and Sports

It is inevitable that if you are active in the water with your wetsuit at some time you will get a rip or tear in the neoprene. In most cases, there is no need to

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

panic or despair. With a few simple items, repairing a torn or damaged wetsuit is a fairly easy procedure. It may not look as good as new when you are done but

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

Examples of combination products may in

he function of the wetsuit will be maintained.

A lot of times when you rub up against rocks or coral or some other rough object the surface of a wetsuit will get

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

roughened up and expose the softer more vulnerable black neoprene below. Short term your wetsuit will work just fine this way but eventually the abraded area will

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

grow and it may deteriorate to the point of causing a tear or hole. The best way to repair this kind of damage is to apply neoprene glue to the area. What is cal

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

Combination pro

led neoprene glue is usually a special contact cement formulation for gluing pieces of neoprene to each other. You can usually get it where you bought your wetsui

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

and it is usually black or yellow in color. Aquaseal and Black Witch are two popular brands of neoprene wetsuit glue. Lay the damaged area out flat if you can a

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

nd apply lots of the glue to the area. Spread the glue out with a flat wooden stick, application brush, or other spatula type tool to at least a centimeter or two

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

past the abraded area. Try to spread it out as evenly and smoothly as you can. It is almost impossible to make it look pretty but that isn't the goal anyway. Yo

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

u want to reinforce the area as best you can and still maintain the flexibility of the wetsuit. Neoprene glue is very smooth and slippery when dry. If the damage

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

area needs to be used for gripping with most neoprene glues, you can sprinkle a small amount of dry sand over the glue approximately 30 minutes after you apply it

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

Following aspects would a

. This will give the area some texture for gripping. When you are done let the glue dry at least overnight. Some glues will need longer to dry so follow the dir

dd to the challenges in developing combination products:

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

ctions on the glue containers label.

If the damage to the wetsuit is a simple straight cut or tear with no missing material, you can simply glue it back together

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

using the neoprene glue. Very carefully separate the two edges of the cut and apply glue to each of the sides. Try not to increase the cut when you do this. The

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

hold the two edges together for a few minutes to let the glue set. With some neoprene glues, you have to let the glue air dry for a minute before pushing the two

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

sides back together. As above, let the glue dry at least over night.

If the damage to your wetsuit involves missing material, repairs get more complicated. Mos

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

Professional from academic institutions, pharmaceutical industries, health care indust

often, the best thing to do is patch the hole like you would a hole in a bicycle tire. Most dive shops have patch material or old neoprene lying around you can b

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

uy for patching. Cut a piece of neoprene patch material a few centimeters bigger than the hole, apply glue to the top edge of the hole and the underside edge of t

.

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

e patch and apply the patch. Sometimes you will need to fill the hole with material and glue and sew it to the edges of the hole and apply a patch over that but s

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

Companies that provide selfless information through particip

ewing neoprene is often not recommended. The thread usually will not stretch with the neoprene when you dive and over time the thread will cut through the wetsuit

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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