Advice You - Business

In “The Incredible Hulk”, mild-mannered scientist Bruce Banner discovered that when he was exposed to “gamma rays” he was transformed into a massive beast that could ferociously muscle his way to victory in any situation. Other than

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

being disfigured, green, and in nothing but his boxer shorts, the Hulk discovered that a single growth factor could drastically change his ability to handle his problems.

Unfortunately, gamma radiation is in short supply at most s

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

Examples of combination products may in

tartups, so entrepreneurs need to find their own “growth factors” to make their businesses huge. The growth factors of your business are the key drivers that, if tweaked properly, can give your company the boost it needs to grow fas

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

ter and stronger.

Get your gamma ray on

Chances are you already have an idea what the growth factors in your business are, but aren’t yet isolating them like you should be. For example, if minimizing the cost of acquiring a custom

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

er is critical to your growth strategy, it’s a growth factor. If converting a certain number of visitors at your Web site to convert to actual sales makes huge differences in your financial model, it’s a growth factor. And if buying

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

Combination pro

supplies cheaper and reducing your cost of goods sold enhances your ability to go to market, it’s a growth factor. Your business is filled with growth factors just waiting to be discovered.

It’s important to note, however, that a g

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

rowth factor is the cause of an outcome, not the outcome itself. For example, “making more money” isn’t a growth factor, it’s the outcome of growth factors like converting more sales leads or reducing operational expenses.

If you d

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

on’t know right now what the top three key drivers of your business are, it’s probably a good time to start defining them and burning them into your brain. Most companies succeed or fail based on just a few growth factors, so identi

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

fying them early is extremely important.

Focus, grasshopper

Knowing your growth factors is just the beginning. Once you realize what elements of your business drive the growth and overall success of your business, the next step is

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

putting as much of your time and energy as possible into focusing on those opportunities.

“Most entrepreneurs have very limited resources and their time is critical” says Kelly Perdew, winner of “ The Apprentice”. “I’ve found that

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

there are vital areas of every business that need the Founder’s direct attention the most and that you will get the most value from spending your time there.”

It’s easy to get distracted from driving your growth factors when you’re

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

Following aspects would a

busy finding office space, hiring staff, and addressing all the problems of a growing corporate culture. Keep in mind that while these duties are necessary, they aren’t necessarily doing an effective job driving the company forward

dd to the challenges in developing combination products:

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

. It’s a matter of priorities and your growth factors should be at the top of your “to do” list every day.

If it’s not core to the business, outsource it

Outsourcing isn’t just for large companies. It’s also for startups who need

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

to focus on their growth factors.

Kelly adds “It is important to know what you do well and what you don’t do well. Surround yourself with people who are experts at what they do and can augment your capabilities. If it isn’t one of

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

the critical aspects of your business have an expert take care of it. Software development, accounting, HR, legal and many other aspects of your business take up a significant amount of time and don’t add significantly to your growt

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

. Outsourcing firms are experts at what they do, can scale to meet your needs, and free you up to do the things you should be doing. Use them!”

Promote the growth factors

If you find it personally difficult to stay focused on the

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

Professional from academic institutions, pharmaceutical industries, health care indust

growth factors of the business, it will be nearly impossible for the rest of your team to stay focused, especially if they don’t know what the growth factors are.

Take advantage of every opportunity to promote the growth factors of

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

your business and how important they are to your success. Make them as ubiquitous in the company as possible, from the CFO to the receptionist. Post them atop every meeting agenda, on everyone’s mouse pad, at the bottom of every co

.

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

mpany memorandum and even on people’s paychecks if you don’t think you’re getting through to them.

“Look! I’m changing…”

Once you’ve begun to put focus on the growth factors, you may sense a change in the way things look. All of a

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

Companies that provide selfless information through particip

sudden you’re getting strong and faster, and things feel like they are coming together for once. Don’t fret, you’re not about to turn into a savage building-bashing beast! The only green you should be seeing is in your bank account

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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Whenever you deal with other people in business, they will have one question on their mind: what's in it for them?

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