Advice You - Business

Restructuring is not a slash-and-burn exercise, but one that calls for the surgeon’s skills. It does not require the use of a parang or long knife but the

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

surgeon’s lancet. The restructuring process may involve re-engineering, downsizing, rightsizing and delayering. These all require the use of the same b

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

Examples of combination products may in

asic techniques and approaches.

During the restructuring exercise, remember to use the 4 Cs.

Communication: The manager needs to communicate personally th

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

restructuring plans truthfully to the staff. Similarly, a doctor does not delegate to a nurse the task of briefing the patient about his ailment and tr

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

eatment. You need to communicate the restructuring plans personally. Regular communication with all the staff, shareholders, board members, customers an

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

Combination pro

d business associates is necessary to get their buy-in and support for the restructuring plan. It is also very important that whatever you promise, you ne

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

d to implement and deliver. There are many anxious and impatient people waiting to know the progress and outcome of the restructuring programme. You nee

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

d to keep them duly informed. You need to “walk the talk”, otherwise it is like shouting at a dead body to leave. The dead body will not leave but your

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

friends may.

Concentration: The surgeon operates on only one patient at a time. Similarly, the sick company needs to concentrate on its core competence.

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

uring bad times, you need to concentrate even more as resources are scarce. If possible, sell away all non-core businesses. In desperate turnaround situ

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

ations, your focus should be as sharp as laser. You cannot afford to be hazy, sloppy or uncertain as these will impinge on your limited resources. Dives

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

Following aspects would a

t away non-core businesses so as to concentrate on the focused areas. Cost cutting: It is an important antidote or effective remedy to administer especial

dd to the challenges in developing combination products:

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

y in desperate situations. Cut costs to the bones without injuring the muscles and organs. If circumstances permit, amputate non-profitable businesses r

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

ather than try to bandage and apply stitches. Investigate into cutting your fixed and variable overheads by outsourcing, downsizing, delayering and acro

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

ss-the-board salary cut. Every cent saved or cut goes right into the bottom line.

Cash flow improvement: Cash flow is your lifeblood. Slipping into losse

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

may give you a migraine but a sudden shortfall in cash flow will cause immediate massive heart attack. Try to reduce your inventory, purchases, perks,

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

Professional from academic institutions, pharmaceutical industries, health care indust

credits to customers, outstanding debts and related items without hurting the company further. Ensure that your receivables are promptly collected. Nego

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

tiate with your creditors for extension of the credit limits or source for more credit lines or more time to pay back the debts. You need to do whatever

.

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

you can during the financially tight situations to quickly improve the cash flow position.

Typically in a major restructuring exercise, the timing is extre

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

Companies that provide selfless information through particip

mely short for you to deliver the positive results. There are many things to do and remember. However, you need to prioritise and remember these four Cs

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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When managing change the truth about the status of your project, the timeline or many other details is often times missing in action. You cant let this happen on your watch. You have to create a safe environment where it is okay for your folks to tell the truth. Read on and find out the truth...

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Advice You - Four Cs for Restructuring: Communication, Concentration, Cost Cutting and Cash

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