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Have you ever been sailing on a beautiful summer’s day, the wind perfect, the water ideal? But when you look around, you notice there we

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

re a number of other sailboats, with their sails as full as yours, but some are much faster, and you feel like you are standing still!

Y

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

Examples of combination products may in

ou look around and find your anchor is running along the bottom of the marina. You were still moving forward, but no where near the spee

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

as the other sailboats out that day.

Is this happening to your business? Are your sails full of great opportunities? Is your competit

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

ion passing you by? Does your business lack the momentum to get you out to the open water?

Many businesses are dragging their anchor. W

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

Combination pro

hat do I mean by “dragging their anchor”? This anchor can refer to employees who just don’t have what is takes to be successful in your

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

usiness line or are the type of employee who brings down the rest of the team. The anchor stops or slows down your momentum in your comp

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

any.

Having employees on your team who consistently challenge the corporation in a positive manner is a good thing! They keep your comp

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

any competitive in the marketplace. However having an employee or group of employees who weigh down your company in a negative manner, i

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

something you need to act upon.

Negative employees can knock the wind out of your company’s sails! The team members who fill your comp

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

any’s sails daily, with great ideas and forward momentum will soon become tired and lack the energy, required to move your sailboat forwa

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

Following aspects would a

rd. Eventually these same employees will find an easier boat to blow their powerful wind into, while your anchors will continue to slow

dd to the challenges in developing combination products:

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

own your progress.

Many organizations continue to work on developing their anchors instead of harvesting the wind that blows into their

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

sails. Anchors will always be anchors, and they may have moments of promise in transforming into a sail, BUT the trend is, they almost a

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

lways revert back to being an anchor. A good read on this topic is a book titled “If You Don’t Make Waves, You’ll Drown” by Dave Anderson

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

One of the book’s lessons is, many of today’s leaders spend the majority of their time on the non-performers, instead of their performe

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

Professional from academic institutions, pharmaceutical industries, health care indust

rs. Again, continuing with this practice will have your performers looking for another stage to perform on.

Can you imagine a sailboat

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

with no sails and all anchors? Business owners need to remove the anchors or at least secure your anchors onto your sailboat and focus o

.

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

the sails in your organization. Sails do not need a lot of effort, however, they do need attention, regular support, and care.

Harvest

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

Companies that provide selfless information through particip

the winds in your company so you can have full sails to allow you to compete in the marketplace and keep pace, ahead of your competition

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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Developing an effective brand strategy will give you credibility. It will make you more attractive to customers, and if you do it right, you will knock out all your competitors with the least effort on your part. Focusing on your brand is an essential part of marketing. You can’t win without your brand.

Khadi is an Indian fabric. Khadi is also known by another name ‘Khaddar’. It is made by spinning the threads on an instrument known as ‘Charkha’. During pre-independence era the movement of khadi manufacturing gained momentum under the guidance of father of nation Mahatma Gandhiji. This movement of khadi manufacturing and wearing started as to discourage the Indians from wearing of foreign clothes.

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