Advice You - Business

Remember when your business was an infant? It was cute and cuddly and lots of fun. But somewhere along the way the infant became an out of

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

control adolescent and started ruining your life. Is there any hope or should you just ship your spoiled brat off to Brat Camp?

Caroline

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

Examples of combination products may in

Jordan, small business consultant and mentor, and owner of her own sometimes misbehaving business, The Jordan Result, has this to say abo

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

ut businesses that just won’t behave:

“Building a business is a lot like raising kids. You have to keep the upper hand or you’ll suddenly

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

find yourself asking, ‘When did I lose control?’ I see many business owners who are frustrated and in despair over the way their businesse

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

Combination pro

s have taken over their lives. Many of us become self employed because we want more control over our lives but often what happens is the b

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 takes over and business owners find themselves working constantly and never feeling like they’re getting anywhere.”

Jordan offers

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

these tips for owners of bratty small businesses:

1. Take a time out. You can’t think clearly if you’re in the midst of chaos and despai

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

r. Go for a walk, have an ice cream cone, take a day off. The business will still be there when you get back.

2. Breathe and Count to Ten

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

. When fear and desperation start to well up, you tense up and start feeling like your life is unraveling before your very eyes. No one ev

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

r makes good business decisions from a point of fear. Go do something that makes you feel confident.

3. Take your business out to the woo

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

Following aspects would a

d shed. You remember the woodshed? That place where you got an attitude adjustment…That’s where your business needs to go. Remind it and y

dd to the challenges in developing combination products:

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

ourself in no uncertain terms that YOU are the one calling the shots.

4. Set boundaries. Decide how many hours you can physically and emo

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

tionally work each week. Take the number of hours you can work and the tasks that must get done each week, decide which tasks have to be p

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

rformed by you personally. Delegate the rest to an employee, a subcontractor, or a family member.

5. Remember what your real work is. Whe

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

n you’re raising kids your real work is to teach them how to take care of themselves without you. It’s the same thing with your business.

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

Professional from academic institutions, pharmaceutical industries, health care indust

Start to develop a plan to get your business to a point where it can operate even if you’re not there.

6. Dealing with a whiny business.

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

hen your business starts whining and wheedling and trying to get you to let loose the reins again, sit it down and firmly explain that you

.

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

are in charge and you are following a plan that you will not deviate from.

7. Call in the cavalry. If your business still won’t behave,

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

Companies that provide selfless information through particip

get expert help fast. Most business owners wait until too late to get help. Most business failures are preventable with early intervention

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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