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Growing companies must always be ready for the next challenge. If you fail in meeting critical business challenges you will not grow. Challenges often require some type of breakthrough. But do not be misled. A business breakthrough does not have to be something no one has thought of – it just needs to be a solution to your

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

problem that you can act on now. Breakthroughs may involve simply finding the solution to a common, nagging problem or it may be nurturing a more complex way of thinking. We all must be ready and observant of breakthrough opportunities. What keeps us from moving forward can easily be overcome by incorporating one or all of

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

Examples of combination products may in

the following tips. There is nothing magical about growing a business – it just takes the right effort.

Tip #1 Encourage sales training that is not selling

Insist on learning from all personnel beyond their functional area. Learning should not be limited to top managers. Yes, employees may receive a lot of training, but it

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 usually limited to how to do their job. The more they know and understand general business concepts and specific operational issues, the easier it is to provide input and answers to business challenges. This does not mean that everyone needs to become experts in strategy, leadership, finances, marketing, sales, operation

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

, distribution … but as they learn a little about each category and then more in the areas that interest them, the better able they will be to provide a valuable contribution. Do not encourage sales personnel to only learn about selling. Remember that learning comes in all forms and does not have to be provided by the organ

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

Combination pro

zation – reading publications, taking seminars, listening to subject matter authorities, observing the successful etc.

Tip #2 It is not about your weaknesses

We tend to concentrate on what is wrong and ignore what is right. It is surprising how many managers are unable to identify the top three strengths of their organizat

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

on. If you have not uncovered the company’s true strengths - what you do better than most - then how can you take these strengths and apply them to other aspects of the operation? Knowing your strengths is just the beginning. Understanding how you got there and why you are able to excel in a particular area is what will all

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

ow you to duplicate these assets. This should not be limited to the “top” strengths of the organization. Break down what you do well by division, function, even by individual. Share with others and teach where necessary. Be fruitful and multiply – applying your strengths to all aspects of your business.

Tip #3 Mine your ex

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

sting resources

This may be the most overlooked gem of business success. We are too quick to just purchase a new gadget or hire more staff or obtain outside counsel without fully utilizing the talent and resources at hand. It is essential to evaluate your existing resources. Where is there an opportunity to leverage what y

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

u have? Could your IT system be used to collect needed data? Is there a way to get existing data in a format that will assist decision-making? Does your IT system already contain the information? You get the idea. Untapped resources are not limited to IT systems. How you utilize manpower, square footage, product development,

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

meetings, call centers… all are potential areas for performance improvement and growth. Tip #4 Automate

Do not jump to conclusions. This does not mean replacing people with machines. If a task can be automated, it should be. Do you know why? Automation replaces repetitive tasks. Repetitive tasks can then be replaced with

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

Following aspects would a

higher cognitive activities. If an individual spends 30 minutes a day on, let’s say, inputting data into a stand alone spreadsheet and this activity could be inputted directly into an existing integrated system, then that individual would have 2.5 more hours a week to spend meeting critical objectives or creating solutions.

dd to the challenges in developing combination products:

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

ultiply this by many individuals and you can see the impact.

Tip #5 Schedule time to think

This does not imply that thinking is not going on; it’s just that we get too caught up in action and seldom take the necessary time to stop. Stop to think through a challenge, stop to evaluate strategy, and stop to contemplate about

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

nything. Since inaction is perceived as not progressing, we discourage “thinking time”. This is why outsiders are often able to see what we cannot. It isn’t that we cannot see it; it is just that we have not taken the time to slow down, observe, think, and contemplate. When planning your week, schedule time to think.

Tip

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

#6 Beyond the customer experience

We all know that servicing the customer is paramount. We know it, but many fail to meet the minimum expectations. And sometimes we do not realize we are not meeting expectations. Customers are more demanding than they used to be. Develop a profile of the most discriminating customer for yo

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

r product or service. Describe them as best you can.

· What do they want in the product or service

· How quickly do they want it

· What are there expectations regarding phone inquiries (When they have a question, how do they most prefer to access the information)

· What is the optimum sales experience from first contact

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

Professional from academic institutions, pharmaceutical industries, health care indust

to order taking to actual purchase

· What is their packaging preference

· How do they define the perfect transaction

· Etc.

Once you have developed this profile, start by taking action to provide the level of service expected by the most demanding customer outlined above, to all customers. Once you have achieved this, t

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

en take just one profile element point and determine how you can expand on the experience, giving even more. Then take the next and the next.

Tip #7 Go out on a limb

Remember the old saying, nothing ventured, nothing gained? Well, it is true. Do not limit yourself by being afraid to take chances. Of course, you will not a

.

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

ways succeed, but not only will you learn great lessons, but you will also create breakthroughs. Each failure should be viewed as a step closer to success. The odds are on your side. This does not mean that you should take action without proper preparation. Take the necessary precautions, evaluate the alternatives and try it

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

Companies that provide selfless information through particip

Do you see how these tips can improve your performance? Improving performance will allow you to grow in a number of ways. Grow by being more responsive, understanding the customer better, increasing your flexibility, utilizing employees better, encouraging creativity, reducing bad decisions, and multiplying your strengths

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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In this second of a two part series of articles on uncommon interview tips, William Mitchell, Certified Resume Writer, takes us through the remainder of the interview process, from waiting room reading selection through interview wrap-up. This is a must-read for job hunting candidates looking to fine tune their interview preparation, planning, and technique.

EDM in an engineering term referring to electrical discharge machining. Wire electrical discharge machining or EDM is a metalworking process with help of which a material is separated from a conductive work piece, by means of electrical erosion. In this process, the wire never comes in contact with the conductive work piece. The wire electrode leaves a path on the work piece, which is slightly larger than the wire. Most often a 0.010' wire is used, which creates a 0.013' to 0.014' gap. The wire electrode once passed through the work piece cannot be reused.

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