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Business today requires more ingenuity in operating profitably than ever before. High costs are not just related to labor, pensions and corporate benefits. Excessive costs can be found throughout the organization and ta

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

ke many forms.

Where does the company start to look for waste and excessive costs? What cuts that will assist, which will harm? The smart executive team must always understand their costs and weigh their options befor

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

Examples of combination products may in

e making the decisions necessary to maintain competitiveness. To be effective and not threaten the stability of the business, executive management must set the example for the business. They must be as open to, and acc

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

pt examination as they expect the balance of the company to be. Change starts at the top and flows down.

Cost cutting is not just about reducing staff, salaries and benefits. Indeed, these activities will reduce costs

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

but they also send a terrible message to employees, No job is safe! As this fear spreads, productivity will suffer, you may even be in jeopardy of losing key employees that the business requires. Replacing these peopl

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

Combination pro

e will increase costs in recruiting and training while producing a further negative affect on morale. Instead of placing salary and staff cuts topmost on the list of reductions, they should be left until all other optio

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

s have been exhausted.

Waste takes many forms; excess office supplies, inventory and redundant activities, to name only a few. Tasking the department leaders to find and identify excesses is an approach, but may not be

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 most effective method. First, they are too close to the operation and may not see the excesses. Second, they may not want to identify waste in their department, it isn’t always in their best interest.

Employees’

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

self interest and fear of corporate politics make it difficult to be objective. Admitting one’s faults or errors to another coworker is difficult at best, therefore, internal investigations are usually ineffective. Any

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

ndividual going against the “politically correct’ beliefs and attitudes held by the company or fellow employees, will be in jeopardy of damaging their career. For that reason alone, it is easier to report to management

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

what they want to hear rather than the truth.

The efforts of staff can ensure the business succeeds through implementing workarounds. The workarounds address the immediate problems, but do not solve the problem long-te

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

Following aspects would a

rm and usually contribute to more complexities than are necessary. Tasks that benefit the business’s bottom line may be sacrificed due to lack of time. The employees work hard to make the business a success, but are the

dd to the challenges in developing combination products:

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

working as smart as they should be?

Process improvements and metrics measurements are excellent tools for identification of excesses and lead the way to implementation of cost cutting and continuous improvement. The d

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

etailed examination of process and data flow within the company will uncover areas that can be improved and assist in reducing complexities. Management may be aware there are problems within the organization, but the ex

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

tent or depth of the problem likely is not known thanks in part to dedicated employees.

As mentioned above, employees’ and their self interests may hamper the examination of the business processes. Combine this with th

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

belief that they are going to fall behind on their regular duties and the natural result will be a less than thorough evaluation. The business will not be fully served and the effort will likely become just another inco

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

Professional from academic institutions, pharmaceutical industries, health care indust

mplete initiative.

To fully serve the interests business and perform an accurate examination, hire a consultant experienced in this type of work. The cost associated with this individual will be more than offset in sev

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

eral ways. The impact on your staff will be minimal, allowing them to continue with their regular duties. The consultant will not be influenced by politics and will deliver an accurate assessment of costs and potential

.

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

savings.

Simultaneously with the process examination, the consultant should mentor the staff and transfer the knowledge necessary to perform continuous improvements. To make the best use of these activities, the managem

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

Companies that provide selfless information through particip

ent team must empower all employees to participate in a free exchange of ideas for business improvements.

Following this outline will provide the answers you need to decide “Which cuts that will assist, which will harm?

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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