Digg It - Business

1. Elimination of waste.

The single most important factor contributing to costs is wastage. Eliminating waste can by itself cut costs from 10 to 20%. The main areas of waste are:

(a) Input Waste: Substandard quality rawmaterials and other inputs w

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

hile appearing cheaper work out to be very costly in the long run. They affect the end-product's quality directly. Indirectly they cause frequent damages to men and machinery and add to maintenance costs. Frequent purchase returns, consequent alternate sourcing, resultin

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

Examples of combination products may in

g delay in production, involve additional costs. A system to screen all inputs for quality compliance is a must in addition to a good quality policy with reference to all inputs.

(b) Process Waste: While converting the rawmaterials into finished products wastage

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

is very common in all industries. Providing for process waste is taken for granted. While a certain amount of waste is inevitable in the process there is always the possibility to minimise waste. How much is subject to the type of processing and specific to the industry

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

. Avoidable waste will include improper storage and handling, inputing excess quanitties of rawmaterials, interrupted process flows, avoidable movement of materials, mix up among works in process at various stages etc. The resident time of materials inside the processing

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

Combination pro

area may also matter.

(c) Product Waste: Defective products, second quality products, damaged products come under this category. Minimising or rather avoiding seconds production by implementing an optimum quality system should be given first priority since the c

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

ost of making a second grade product equals that for a good one. Interchanging of components to get good ones from out of a lot of seconds may be a choice. Damage or deterioration due to improper storage is another common cause for wastage of finished product. Coordinati

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

n of order position with production schedule so as to minimise finished product inventory would be advised here.

(d) Logistics Waste: This is another common waste taken for granted. Merely insuring the product for transit risks and damage may not be advisable. It

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

will only recover the cost at a later date. There will also be another cost for resending the product to the intended destination. The customer will not be served on time and will create doubt on the reliability of supplies. Proper packaging for transport as well as sto

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

rage in shelves of sales points is to be carefully planned without increasing the cost of packaging. Outsourcing logistics services with assurances of safe and timely deliveries will eliminate such wastes.

1. Maximising Productivity.

(a) Production per

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

unit machine capacity: Adequate engineering and maintenance practices will maximise the productivity per unit of machine capacity used. Relating the production schedule with the production capacity will help in planning for full capacity. Identifying idle capacities

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

Following aspects would a

and putting that capacity into use is essential. Idle capacity can be put into production of increased number of the same product, add new products, add value addition (quality, functional advantage etc) to the existing products, or do jobworks for outsiders.

(b) Pr

dd to the challenges in developing combination products:

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

oduction per unit manpower: This is a tricky issue but is necessary in almost all businesses. Preliminary determination of skills, aptitude and efficiency while recruiting is necessary in all employments. While allocating duties and responsibilities to employees thei

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

r fitness to particulars tasks should be checked. A lot of ground work has to be done while planning the manpower requirements which should be optimised to provide various administrative, production, supervisory and managerial functions within a minimum over all workforc

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

. Utilisation of human resources should also be properly planned to provide for substitutes and alternates, even among departments to ensure uninterrupted flow of work. Avoidance of duplication of work, automatic check of ones work by another in the natural flow of the j

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

ob, automation wherever possible, ensuring an error free documentation, proper management information systems will provide minimum hindrance to people in their prompt accomplishment of the tasks.

(c) Production per unit investment: Investments made in machinery,

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

Professional from academic institutions, pharmaceutical industries, health care indust

equipments, buildings, and other fixed assets, vehicles and supporting infrastructure, investments in working capital including cost of carrying inventory, costs of financing etc should all be taken into account. Turnover or Profit on Total investment and also on individ

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

ual components of investments should be worked out to find out where the return is not optimal. Care should be taken not to indulge in too much arithmetics which are of statistical importance only. When areas of sub-optimal profitability or productivity is noticed, measu

.

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

res to minimise investments in these areas or ways to increase their individual productivity should be explored. This is more difficult than it sounds and a careful judgement has to be made to recover monies invested already.

These principles apply to any business wheth

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

Companies that provide selfless information through particip

er they are manufacturing or marketing or provide of services. A simple study is normally enough to find out where there is possiblity of cost reduction. A better approach would be to make such an analysis a regular affair because the real world conditions are not static

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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If you are looking to leave your old career or job behind to start up your own business, then you are already half way there. The idea of you having something more has already been planted in your head, now all you have to do is have the courage and determination to follow through on your business ownership goals.

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