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Surviving in business long-term means having the ability to evolve profitably over time. In order to evolve profitably you must learn from the things gone wrong, (TGW) and things g

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

one right, (TGR) in the past. Learning from events of the past allows you to turn the knowledge gained into educated continuous improvement plans based on fact and data that will 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

llow you keep up with the highly competitive markets of today.

The importance of data collected from past successful events and unsuccessful events as well is critical when determ

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

ining future plans geared toward keeping your competitive edge and boosting profits at the same time. Data and records are the backbone of your business. In this collection of note

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

s, facts, figures and other records of activity lies the history of your successes and failures. If you believe the previous statement, then it will be of great significance to you

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

Combination pro

knowing that in this collection of data lies the facts needed to lead your business to success.

Previously written in an article called, Small Business Tools, "Measuring your Eff

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

orts", the basic areas of overall business success were defined.

Financial

Operations

Customer Service

Research and Knowledge

Keeping these areas in mind, the data collected

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

rom them provide you with individual maps and sub-maps to where you have been and what happened as a result of the roads traveled. From here you will extract the data necessary to

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

make fact-based decisions on where you need to go from there.

How is this data collected and what determines the criteria necessary to collect for these fact-based decisions? The

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

answer lies in you. Your business needs will define the data you need to collect based on your overall business plan objectives. From there you will need to determine how that data

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

will be collected and analyzed.

Determining the data and how to analyze it is not a complicated task. You don't need to be a statistics major or marketing professional. In genera

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

Following aspects would a

l the four areas of business success mentioned above form the areas of analysis. Your business needs will determine the sub elements you will define. Below are some simple forms of

dd to the challenges in developing combination products:

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

collecting and analyzing the defined data that are extremely useful.

Checklists- These come in many formats. Extremely useful in collecting attribute data that comes mainly in th

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

e form of yes/no answers. Once collected over time they can provide you many answers to customer preferences, advertising strategy success, responses, etc.

Ledgers- We all know of

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

these types of records. This method provides variable data in the form of facts and figures over time. Perhaps the commonly known and without a doubt the most powerful form of data

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

. Sales volume, profit margin, overhead, costs are just some of the many valuable figures that can be used to predict slow periods, heavy periods, advertising effectiveness, etc.

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

Professional from academic institutions, pharmaceutical industries, health care indust

Charts and Graphs- These tools can not only be used to analyze the data collected from checklists and ledgers, such as, production times, shipping and delivery times, return rates,

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

complaints, and many other items critical to business productivity and efficiency.

Data of this nature, once analyzed, can put your business in a position to make decisions based

.

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

on facts. These facts can point to key trends that will allow you to predict the actions necessary to improve or get an edge over your competition. They can also give you direct f

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

Companies that provide selfless information through particip

eedback on the efforts put forth vs. the results achieved. In short, this knowledge gives you the ability to progress from things gone right and prevent repeating things gone wrong

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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Warehouses are necessary for the storage of inventory. As a result, management of the inventory and stock is equally important. The processes involved, include the recording and tracking of materials on a quantity and value basis. The warehousing management includes planning, entry and documentation of stock movements, such as goods receipts, issues, physical stock transfers and transfer postings, as well as the performance of physical inventory or stocktaking.

Now Government wants to eliminate LIFO. LIFO stands for Last In, First Out. It is an inventory costing methodology. The last in, first out, or LIFO method, selects the most recent purchases whose quantities add up to the total number of items sold during the year. The last in, or most recent purchases, are the first charged out to expense. The primary theory of the LIFO method is that products sold have to be replaced to continue in business and that the most recent (i.e., the last in) costs are the closest to the costs of replacing the products sold. From a tax standpoint, LIFO minimizes tax consequences by using the highest cost of inventory which reduces reported profit.

Thousands of dollars are spent on career employment preparation i.e. high education by millions of young people and their parents. Yet, are these dollars delivering a positive return on the investment?

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