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Fixing bugs fixes symptoms: like taking aspirin for a headache, it may provide temporary relief but does

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

nothing to prevent the next headache. It’s ok, and often necessary, to relieve the symptoms but you hav

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

Examples of combination products may in

e to dig deeper if you’re going to prevent problems from recurring.

The reasons and benefits for gettin

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

past the symptoms to the root causes are well-known, but many companies still tend to confine their roo

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

t cause analysis efforts to well-defined technical problems such as physical component failures. We need

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

Combination pro

to apply the same philosophy to general business problems, especially if they are chronic.

The firs

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

difficulty in getting to root causes of business problems is in identifying that a problem is chron

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

ic in the first place. To continue the headache analogy: taking aspirin and forgetting about it is appro

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

priate behavior for the occasional headache that most of us get. However, if the headaches are chronic,

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

t’s time to find out why they’re happening. In the business world, we tend to treat customer trouble cal

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

ls as isolated incidents—the occasional headache. We treat the symptoms, get the customer back in busine

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

Following aspects would a

ss, and move on to the next one. To get past the bug mentality, we need to look actively for the pattern

dd to the challenges in developing combination products:

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

that will tell us if a chronic problem is developing.

The second key difficulty is maintaining

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

focus (and resource commitments) long enough to finish identifying and eliminating the root causes of a

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

problem. When a crisis situation occurs, we correctly focus on treating the symptoms and getting things

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

perational again. That’s when the root cause analysis effort should begin to determine why the crisis oc

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

Professional from academic institutions, pharmaceutical industries, health care indust

curred and take the appropriate steps to eliminate those causes. What usually happens, though, is everyo

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

ne involved heaves a huge sigh of relief at having survived and moves on to the next crisis. To get past

.

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 bug mentality in this situation, we need to change the business model so we don’t consider a crisis

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

Companies that provide selfless information through particip

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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