Main Subject - Business

Traffic lights – the decoration de rigueur for performance dashboards and reports. Have you gotten more carried away with the decoration, than with the rigueur? Take a look at these four common a

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

pproaches to traffic lights, and see if you’ve got some room for improvement.

Approach 1: % difference from month to month

When this month is 10% worse than last month, the traffic light turns

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

Examples of combination products may in

ed. When it’s 5% worse than last month, the traffic light turns amber. When it’s 10% better than last month, the traffic light turns green. Obviously, this approach works for time periods other t

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

han a month, and for cut-offs other than 10% and 5%.

Such traffic lights encourage us, usually, to ask questions like “what caused such a big difference?” In turn, such questions encourage us, u

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

ually, to find some way to explain the difference. If we’re clever, we’ll already have added a comment to the performance measure explaining that the difference is due to something outside our co

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

Combination pro

trol. If we’re not so clever, we’ll be putting up different explanations every month, and have a list as long as Santa Claus’ of improvement projects.

There’s no advantage I can see to this appr

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

oach to traffic lighting. It tends to encourage us to knee-jerk react to data, tamper with business processes or blaming something we don’t have to do anything about. Time gets wasted chasing pro

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

lems that aren’t there and we miss problems that are.

Approach 2: up and down, good and bad

When some performance measure values increase, it’s a good thing (like revenue, satisfaction and on-t

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

me performance). There are others whose values decrease and it’s a good thing (like rework, cycle time and pollution). Combine this with whether there’s an upward change or downward change in act

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

ual performance values and you get a complex range of traffic light signals to deal with: upward change that is good, upward change that is bad, downward change that is good, downward change that

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

is bad. This “solution” probably resulted from a confusion that erupted when upward and downward arrows were chosen as the traffic light symbols.

When we sort out the confusion, these multi-face

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

Following aspects would a

ed traffic lights encourage us to ask questions like “what’s behind the trend?” and the trend is concluded from maybe 3 consecutive points of data. Marginally better than approach # 1, and only j

dd to the challenges in developing combination products:

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

ust.

Any system of traffic lighting that moves us away from point to point comparisons (the essence of approach # 1) is a step in a good direction. But we still risk drawing the wrong conclusion

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

from trend analysis that is based on not nearly enough data to be valid. And does upward and downward really matter nearly as much as good and bad?

Approach 3: statistically valid signals

Stat

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

stical process control is an analysis method that discerns variation that is typical from variation that signifies change has occurred. It’s like filtering the signals from the noise, something t

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

he other two approaches don’t do (they assume that any arbitrary difference is a signal, irrespective of the typical size of differences over time). The signals are defined from a set of rules th

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

Professional from academic institutions, pharmaceutical industries, health care indust

t test the probability that a difference is due to just normal variability (no change) versus atypical variability (change). Signals include sudden shifts in performance, gradual shifts in perfor

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

ance and instability in performance.

When our attention is moved from point to point variations to patterns in variation over time, we ask questions like “what caused that shift in performance t

.

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

o occur at that time?” and “why is performance so chaotic and unstable?” and “what do we have to focus on improving to improve the overall average level of performance?”.

These questions seek ro

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

Companies that provide selfless information through particip

t causes, not symptomatic causes. They lead us to find the solutions that don’t just fix next month’s performance, but fundamentally improve the baseline performance level further into the future

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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