Advice Pool - Health and Fitness

After over 15 years of successful procedures and continual development, Lasik eye surgery has blossome

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

d into an extremely safe and predictable procedure. However like all forms of surgery, complications can arise

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

Examples of combination products may in

Complications can occur at the preoperative, intra-operative, and postoperative stages of the Lasik procedure

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

A thorough medical examination before Lasik is recommended to unearth any preoperative complicati

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

ons. The physician can then determine early on whether Lasik is possible at all or if there are conraindicatio

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

Combination pro

s. Preoperative complications can result from such factors as dry eyes or eye infections.

To minimize the pos

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

ibility of such occurrences, surgeons can make various recommend. They recommend patients stop using contact l

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

enses a week before the surgery, for example. Other complications include keratoconus (a genetic condition tha

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

causes the cornea to become thinner after the surgery).

Intra-operative complications may result from the in

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

xperience on the part of the surgeon or inadequate hygiene in the operating room. A slipped flap is one of the

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

most common complications. It happens when a corneal flap detaches itself from the rest of the cornea. In this

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

Following aspects would a

case, the surgeon would advise the patient to go home and sleep to give the flap a chance to heal.

After the

dd to the challenges in developing combination products:

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

operation, the patient may suffer from an eye infection, usually under the corneal flap. This might result fro

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

a lack of hygiene or the carelessness of the patient after surgery (he must not expose the eye to any dust or

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

smoke, for example). Such infections are treatable with antibiotics.

Another postoperative complication is t

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

e possibility of developing persistent dry eye. Persistent dry eye is caused by a reduction in the number of c

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

Professional from academic institutions, pharmaceutical industries, health care indust

rneal nerve fibers resulting from the Lasik procedure. Up to a half of the fibres can be lost and since they a

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

re responsible for the production of tears, dry eyes can result. Incidence of sub-conjunctival hemorrhage is 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

other possible complication, too.

These complications are rare and most have remedies. Remember that thousand

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

Companies that provide selfless information through particip

of people have undergone Lasik without any problems. Lasik is a very safe and problem-free surgical procedure

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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Outsourcing: a complex series of tradeoffs Outsourcing originated and became popular as a cost-saving strategy during a recessionary environment. In today’s economy and labor market, organizations looking for differentiated growth solutions should avoid outsourcing when based solely on cost savings. Organizations have now begun to recognize the real costs and inherent risks of outsourcing. Instead of simplifying operations, outsourcing often introduces complexity, increased cost, and friction into the value chain, requiring more senior management attention and deeper management skills than anticipated. Companies Are Concerned About Intellectual Property and Confidentiality Risks, Loss of Institutional Knowledge, and Loss of Control Over Outsourced Functions. In this situation it becomes very important to analyse the whole scenario once again in the light of the fact that weather “outsourcing” is fulfilling its purpose of cost saving , enhanced efficiency etc, or it is backfiring. Keeping in view the advantages of outsourcing this paper tries to highlight the complex series of various tradeoffs like cost savings versus growth, speed versus quality of service delivery, and maintaining organizational cohesion versus knowledge and innovation. This paper tries to find out the profitability of the tradeoffs & suggest the viability of outsourcing in various fields.

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