Advice Pool - Health and Fitness

So you're going to have surgery and you'd like to use music during the procedure. How do you t

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

alk to your surgeon about this? Nowadays many surgeons use music themselves while they operate

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

Examples of combination products may in

on a patient but they are not actually aware of how much the right music can also help the pati

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

nt. The problem is that what the surgeon listens to is the exact opposite of what the patient

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

needs. So how do you let your surgeon know that you want to use music during your surgery.

It

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

Combination pro

s tricky when the patient knows more about some part of a surgical procedure than the surgeon b

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

t hey, nobody can know everything, right? And unfortunately music is still not considered a fr

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

ontline treatment o invention in the medical field. So, you're going to need to be armed with

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

ome strong, documented medical research findings if you want him to take you seriously (and act

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

ally it's the anesthesiologist that really needs to be persuaded!).

There have been numerous a

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

ticles in the medical and popular press recently about the value of the patient having music de

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

Following aspects would a

livered through headphones during surgery. Among them:

1. a decrease of up to 50% the amount

dd to the challenges in developing combination products:

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

of anesthesia needed
2. a stabilizing of the main biorhythms...heartbeat and breathing

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

3. a significant decrease in the amount of anxiety medication needed prior to surgery
4

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

. a significant decrease in the amount of pain medication needed in the recovery area after su

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

gery
5. faster recovery from the entire procedure
6. lower morbidity rates because

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

Professional from academic institutions, pharmaceutical industries, health care indust

f anesthesia-related complications

Think about it, if you can accomplish all of these thin

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

gs with something as simple as using the right music, isn't it worth having a conversation with

.

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

your doctor before he operates? Stay tuned for the next article about how to choose the perfec

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

Companies that provide selfless information through particip

article for yourself! And please feel free to contact me through my website if I can help you

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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Advice Pool - How To Talk With Your Surgeon About Using Music During Your Surgery

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