Advice You - Business

Many companies have annual medical examinations and health screening for their employees but are negligent when it comes to their own corporate check-ups. Poor management and financial inform

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

ation systems typically get blamed for management's inability to 'see it coming'. This is because the checks were done too late. Similar to handling of diseases and illness, early diagnosis a

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

Examples of combination products may in

d detection can mean the difference between life and death. Medical science has proven that even terminal diseases such as cancer can be cured if detected early. This is why doctors encoura

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

e their patients to go for regular check-ups. Regular checkups are critical to facilitating early detection and helps to remedy ailments.

Likewise for companies, if the problems are discove

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

ed early enough, help can be rendered. Otherwise, the danger of late detection may mean that help can come too late and the sick company will have a lesser chance of recovery. Thus companies

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

Combination pro

need to know their current health status and should go for regular health checks.

Companies should know their current fitness level as part of the regular health check. The fitness level ass

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

sses the state of health of the global, local economic and political arena, the industry specific issues and dynamics as well as the issues relating to the company. The trouble is that compan

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

es do not know their state of fitness and often adopt a 'firefighting' approach whenever the companies are in trouble. Early diagnosis is always better than a post-mortem.

On the economic fr

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

nt, the check should evaluate some of the leading economic indicators such as GDP growth, consumer confidence and stock market growth. Political stability is also critical as political chaos

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

an severely upset economic and business confidence.

On the industry front, the check should include reviewing the business trends, consumer spending, the competition as well as the product l

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

fe cycle.

At the company level, the check should reveal a full picture of the company's profit and loss, balance sheet as well as cash flow positions. The use of financial ratios as key perf

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

Following aspects would a

ormance indicators will help to identify current and potential troubles. Control procedures should be reviewed to ensure that the company does not undertake too much risks and financial burde

dd to the challenges in developing combination products:

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

s.

It is useful for companies to hire turnaround experts to review the company's operational, financial and sales/marketing matters. This is a business audit. Unlike the annual external au

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

it which focuses on the financial checks and balances. The business audits will check on the overall corporate health including studying into the viability of the business model. Turnaround

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

xperts are better positioned to do this job as they have undertaken corporate turnaround assignments and therefore understand what make a company tick. An external accounting auditor will no

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

cut it as he or she will not have the business acumen to understand the overall health.

Through these fitness checks, the company can then determine whether the impending problem is financi

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

Professional from academic institutions, pharmaceutical industries, health care indust

l in nature, which may be a case of over-gearing and cash flow problem. Operational and control issues may be involved too, such as frauds, financial scandals, etc. These checks can prepare t

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

e top management for some exigencies such as a change of political regime, government or terrorist attacks, etc.

When the checks revealed any areas of weaknesses, the company needs to prescr

.

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

be the appropriate treatment. The company may need to employ some form of financial reengineering to resuscitate the company. If necessary, enlist the assistance of turnaround specialists. Th

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

Companies that provide selfless information through particip

refore knowing the state of one's health is inadequate, one needs to take appropriate actions to remedy the situation.

Have you done your health check lately and got your temperature checked

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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