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Main Subject - What 'Balanced' Really Means for Measures
When most of us hear the term 'balanced measures' we see the Balanced Scorecard flash before our eyes. The success of this decade-and-a-half old framework has been both a windfall and a worry. Yes, our mid-1990's fe
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
ver for good measures that actually measured what mattered was somewhat tempered by Kaplan and Norton's medicine. But it's unprecedented success brought on a new fever: the expectation that a balanced suite of measu
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
es is a simple plug-and-play bolt-on to your business' performance scorecard. No thinking required, just grab some KPIs and stick 'em in the right perspective (financial, customers, internal processes or learning an
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
d growth).
Many of the organisations I work with share with me this rationale for seeking help from a performance measure specialist: the Balanced Scorecard hasn't made measurement any easier for us. They aren't us
Many of the organisations I work with share with me this rationale for seeking help from a performance measure specialist: the Balanced Scorecard hasn't made measurement any easier for us. They aren't us
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ng the four original Balanced Scorecard perspectives, and if they are, they aren't really comfortable with the fit to their unique organisation. The natural remedy is to turn our brains back on, and think more deepl
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
about what balance really means to our unique organisation, BEFORE we worry about balanced measures. Here are some prompts that will help you improve the balance in your organisation's overall performance.
Stakeho
Stakeho
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
lder Groups
How does each stakeholder group with some investment in your organisation define success for your organisation? What's important to your shareholders, regulators, owners, customers, partners, employees,
How does each stakeholder group with some investment in your organisation define success for your organisation? What's important to your shareholders, regulators, owners, customers, partners, employees,
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
and community, important enough that doing it better would mean they feel your organisation is more successful, and they ramp up their support for it's future success?
Business Processes
How you do business is mor
Business Processes
How you do business is mor
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
e important that what business you do. Your end-to-end processes impact very significantly on the results your organisation gets through their very design. What are the impacts of service delivery, research and deve
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
opment, marketing and sales, procurement, and other essential business processes on your overall organisational success? Ignoring any of the important processes is balance-heresy, and makes it too easy for parts to
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ucceed at the expense of the whole organisation.
Strategic, Tactical and Operational
You don't have one scorecard, a single basket of measures. If any one person in the organisation wants to know all the measures
Strategic, Tactical and Operational
You don't have one scorecard, a single basket of measures. If any one person in the organisation wants to know all the measures
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
throughout the organisation, they are micro-managing and thus mis-managing. Which results are strategic, which are tactical, which are operational? Better balance comes hence when there is a logical cause-effect rel
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
tionship between these layers of results (and thus their measures). This balance does wonders for throwing resources at the right initiatives for success.
Lead Versus Lag
If you're like me, you are completely over
Lead Versus Lag
If you're like me, you are completely over
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
hearing the "driving a car by looking in the rear vision mirror" metaphor for managing organisational performance with lag measures. But it's still a good point. Which results are the end products or ultimate outco
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
es for your organisation? Measures of these are your lag measures, and it's still important to track them. Which results offer clues about what those end products or ultimate outcomes might look like in the future,
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
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
ased on how things are now? Measures of these are your lead measures, and you need to track these too!
Short Term, Medium Term, Long Term
The Japanese apparently plan with future generations in mind, decades into
Short Term, Medium Term, Long Term
The Japanese apparently plan with future generations in mind, decades into
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
the future. The Western world considers long term planning to be 5 or maybe 10 years from now, but really only manages within a 12 month timeframe. Better balance will come from sorting which results are day to day,
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
which are month to month, which are year to year, and which are truly longer term. This balance helps put the right measures into the right decision processes.
Test your strategy for balance before you design measu
Test your strategy for balance before you design measu
.
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
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
res.
One of the most frequent reasons (if not the supreme reason) for poorly balanced measures is starting with a poorly designed strategy. If your strategic plan reads like a case study of motherhood statements an
One of the most frequent reasons (if not the supreme reason) for poorly balanced measures is starting with a poorly designed strategy. If your strategic plan reads like a case study of motherhood statements an
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
management-speak, you're in trouble. Tease out the results you understand this strategy to be implying (dig deeper behind the jargon) and examine those results for balance using the above prompts to get you started
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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