Advice You - Business

1.

Be aware of what your competition is doing but don’t “compete” with them. To do so results in a game of “leapfrog” – this year your product’s a little

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

better, next year, theirs is a little better, etc. This is a tough way to do business. This is the way to stay at breakeven or less. Instead, keep your

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

Examples of combination products may in

focus on your customers and on how to “create” a better world for them. You’ll soon be so far ahead of the competition that it will just be you and your c

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

stomers in the game. Where does one start in getting out of this game of leapfrog? That leads us to the next tip…

2.

Start the ball rolling with strate

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

gy. Developing a strategy – a plan of action to reach a certain destination or goal – is the start. Think of all the most successful businesses that you

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

Combination pro

now of or have heard of. What is their strategy? They all have one. Some have referred to this as a big, hairy, audacious goal. This is how a business

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

oves away from reactive mode and into proactive mode. This is how you “energize” your employees – they become a part of something that is bigger than them

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

selves – really turning them on. Here are some questions to ask. What opportunities already exist that match and align with your strategy and will move y

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

u closer to its fruition? What new opportunities can be created to get you closer to the realization of your strategy? Now, apply massive action on ALL o

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

these opportunities to win – and win BIG! Strategy is the start. But, to really bring it on home, you must remember…

3.

Everything that happens in you

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

business is either a one-time project or an on-going process. If it’s a one-time project, that means your business better have one or more “project manag

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

Following aspects would a

ers” who set up the satisfaction criteria, the inputs and outputs, the deliverables, the milestones, the budget, all of the things that go into the mix of

dd to the challenges in developing combination products:

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

successful project – and you’ll find that projects are much more successful in your business and your business is much more successful. And if it’s an on

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

going process, that means people need to think through and document a “system”. Then, repeatedly communicate the system to everyone that is involved or re

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

lated to the system and ask them to “think” of ways to improve and enhance the system. This puts your business on success-autopilot. This puts the succes

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

of your business in the hands of the “system” instead of in the hands of people who are doing their own independent thing.

4.

There are still only three

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

Professional from academic institutions, pharmaceutical industries, health care indust

ways to grow your business: Find more people to sell to, sell more to people when they buy, sell to people more frequently. This is obvious. Most people

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

know this. Can you quickly and clearly articulate your plan for each of these three areas?

5.

Trying to sell “dimes for dollars” is extremely difficult

.

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

nd never works on a long-term basis. Selling “dollars for dimes” is much easier and will result in long-term business success. Think of the USE-VALUE tha

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

Companies that provide selfless information through particip

your customers are getting from your business. Now, are you trying to GET them to buy “dimes for dollars” or are you HELPING them buy “dollars for dimes”

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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