Advice You - Business

This bizarre report arrived from a perturbed customer in Asia:

I wanted to play golf at a prestigious course in town, so I went t

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

o the Pro-Shop to book a time.

The attendant at the counter said she could not take my booking in person as she was only allowed to accept golf r

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

Examples of combination products may in

servations by telephone.

I explained that I wanted to make a booking right away. And since I was already there, wouldn’t she please make the rese

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

vation?

The attendant refused once again, repeating that she only took bookings by telephone.

A public telephone stood in the corner nearby. I w

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

lked over to it and promptly called the Pro-Shop. The attendant answered the telephone and proceeded to make my booking. The entire time I could s

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

Combination pro

e her at the counter while we were speaking on the phone. And she could see me, too.

This makes me wonder: If the customer had

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

sed his mobile phone to call the reservations clerk while he was standing directly in front of her, then would she have seen the absurdity of her

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

ways? And if she did, would she have told her managers about it? Or made a suggestion to change it?

Most likely, not.

Key Learning

Point Frontl

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

ne staff are taught to follow policies and procedures. Often they are hesitant to `break the rules'. Yet some rules should be broken, or changed,

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

r at least seriously bent from time to time. Are your staff bound by rules they cannot change? If those rules are outdated or problematic, will th

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

y tell you?

Action Steps

Bring your staff together in a mood of irreverent fun for a `Playful Policy Review'. Do something unusual to set the to

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

Following aspects would a

e: wear party hats, bring a cake to share, show five minutes of a stand-up comedian on video, put a funny sign in front of the room, or use bright

dd to the challenges in developing combination products:

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

magic markers with flipchart paper on the wall.

Make a list (in advance) of key policies and procedures your staff must work with every day. Go t

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

rough the list with your staff asking two questions: `What do you like least about this policy (or procedure)?' and `What do our customers find mo

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

st problematic about this policy?'

Write everything down. Keep the mood light and easy in a spirit of playful review. If you wish, ask a third qu

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

stion: `How would you change this policy if you could?'

After the meeting, carefully study the list, taking one of two key actions:

1. Modify th

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

Professional from academic institutions, pharmaceutical industries, health care indust

policy to eliminate or reduce the friction. If your staff have made good points and reasonable suggestions, implementing those changes will boost

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

efficiency, responsibility and staff morale.

2. If the policy cannot be changed (and there may be good reasons not to: security, credit risk, gov

.

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

rnment requirements, etc.), take the time to explain the rationale of the current system to your staff. Be sure they understand it so well that th

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

Companies that provide selfless information through particip

y can explain it in a positive and convincing manner to someone else. After all, this is exactly what they should do every day with your customers

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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