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A Top-Level Balanced Scorecard is a great tool to summarize an organization’s top objectives that stem from its Strategic Planning process. The tool has more than a decade of application

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

and proven results, so a well-deployed Balanced Scorecard is a sure way to provide focus, accountability, communication, and a predictable way to achieve strategic goals.

The first step

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

Examples of combination products may in

in building an organization's top-level Balanced Scorecard is to copy elements from its strategy map, if one has been created. A strategy map is a simple, visual depiction of an or

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

ganization’s highest-level strategic objectives, grouped into high-level focus areas, called perspectives. These groupings should take the organization’s key "stakeholders" into ac

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

ount. The four most common perspectives that frame a company's strategic objectives are Financial, Customers, Internal Processes, and Learning and Growth. These may be modified to reflect

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

Combination pro

different or additional stakeholders.

Perspectives become “buckets” into which the high-level objectives fit on both a strategy map and on a top-level Balanced Scorecard. Objectives<

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

/b> are the eight to ten most critical organizational goals from the current year's strategic plan. They take the form of short verb-noun statements. For example, an objective under the

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

Customers" perspective could be "Improve Customer Satisfaction." These critical objectives may often be derived from a “SWOT Analysis,” which uncovers key Strengths, Weaknesses, Opportun

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

ities, and Threats that should be addressed.

The next step in building the scorecard is to identify measures that will best determine if the company is on track to achieve each objective

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

. Measures, also called Key Performance Indicators (KPIs) or metrics, are the one to three strategic indicators of success per objective. Using the example objective above, "Improv

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

Customer Satisfaction," a company could measure "Average Customer Satisfaction Score," plus one or two additional proven indicators for this objective, such as “Product Return Rate” and

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

Following aspects would a

“Number of Customer Complaints.” The measure should also have a specified goal or target. By comparing actual performance data to this goal, a Stoplight Indicator can be triggered,

dd to the challenges in developing combination products:

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

which provides a quick visual reading – typically a red, yellow, or green arrow – of each measure’s current status.

Key to a good top-level scorecard is maintaining focus. By adhering t

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

o the maximum numbers of objectives and measures suggested above, focus will be clear. To help achieve these rules of thumb, keep in mind that day-to-day tactical or line-level quality me

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

sures should be contained in lower level, “cascaded” scorecards.

The final step in building a top-level Balanced Scorecard is to

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

identify initiatives that will address critical areas of underperformance. Initiatives are time-specific projects with identified start- and end-dates that should be aligned to cri

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

Professional from academic institutions, pharmaceutical industries, health care indust

tical underperforming measures or objectives. These help close the gaps and turn red or yellow stoplight indicators green.

A few best practices to remember:

Perspective

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

, objectives, measures, and initiatives should all be aligned with the strategy to ensure that the correct road map will be followed.

Only the critical few (eight to ten) object

.

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

ives should make it onto the top-level Scorecard and no more than three measures should be tracked for each objective.

Finally, a single, top-level scorecard will not drive resu

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

Companies that provide selfless information through particip

lts. Scorecards must be cascaded down and across the organization to really see results.

For information on cascading Balanced Scorecards, please visit www.activestrategy.com

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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