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Strategic planning, the what and the why of planning, is often overlooked by organisations who concentrate on tactical planning, the how of planning. The resultant business plan is overwhelmed by tactical initiatives and pet projects. Alignment with a strateg

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

y to attain the organisation's goals is achieved by accident.

Strategic planning is often seen as unnecessary or at times, not even contemplated in an environment benign to the organisation, e.g. high levels of market growth or monopoly situations. In my exp

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

Examples of combination products may in

erience, a strategic plan based on basic critical thinking is a precursor to developing a competitive advantage where often none has previously been seen.

The dotcom boom and bust during the last decade is the clearest example of the adage, “failing to plan

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

is planning to fail”. A Boston consulting study in 2000 revealed that the key problems resulting in failure of companies were 59% poor revenue cost and profit model, 55% no competitive advantage and 34% lack of consumer benefit. It is clear from the study tha

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 many fewer dotcoms would have started and many fewer would have failed with some strategic planning.

In the arena of public organisations the discussion of the last few years in Brazil, California, Queensland and Fiji over the adequacy of planning for elec

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

Combination pro

ricity requirements leads one to consider what level of strategic planning occurred in those organisations over the previous five to ten years. The problem of capacity is not of current management's making, but of management five or more years ago.

Strategic

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

planning is a fairly simple process. Unfortunately it has been made to appear difficult by many of my current profession. Consultants desire to use tools to explain strategic concepts in a graphical sense, combined with their use of acronyms or two and three

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

word descriptions of their pet methodology has shrouded strategic planning in an unnecessary mystery.

Who can or wants to remember what Porter's five forces analysis, PESTLE analysis, directional policy matrix, Anshoff matrix and game theory are? They are c

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

onsultant tools to help explain the current or future environment of the organisation. For some consultants however they become the end rather than the means.

Strategic planning must start with the end in mind. Take care not to fall into the consultant-speak

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

trap taking two days of management time to carefully craft a vision statement which nobody understands. It is better to actually think about what you want the organisation to be doing in three to five years time. So that you know whether you have successfull

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

got there, the “end” or goal had better be quantifiable. The “statement” will take care of itself.

After sorting out what success looks like, the next step is to understand both your current external and internal environments. That is, what things are happe

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

Following aspects would a

ning external to your organisation, e.g. public tastes, government policy, global trade and within your organisation, e.g. employee competence, productivity, systems integration, that will have an impact on reaching your goal? There are tools that can help, b

dd to the challenges in developing combination products:

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

ut all that is really needed is your team armed with data about your organisation and the external environment.

Data comes in four levels of increasing dependability, internal opinion, external opinion, internal fact and external fact. The dependability rang

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

es from when three salesmen have a talk over a beer about what customers want (internal opinion) to quantitative research using appropriate quota samples (external fact).

The required outcome of the analysis is to understand what strategic changes (what and

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

why) your organisation needs to make to reach your goals in your current and future competitive environment, taking into account your current level of capability.

In private enterprise, the outcome will include quantitative time based goals (usually financia

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

or market related), brand, products and services, external customers (consumers or businesses), internal customers (other functions or company owned supply chain members) and channels (where do customers buy from).

In public enterprise the outcome will incl

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

Professional from academic institutions, pharmaceutical industries, health care indust

ude time-based goals (usually service or public outcome based), services, external customers (the public), internal customers (other government departments), and channels (who does what to deliver the service).

Unsurprisingly, strategic planning in the priva

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

te and public sector have similar outcome deliverables, even though the nature of the products and services and their environments differ significantly.

Business planning, the how, in both cases will have outcomes which include competence, intellectual prope

.

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

rty, policy, assets, processes, organisational design, measures, rewards, systems and risk management.

Developing a business plan in a static environment without understanding what services and products we are going to deliver to which external and internal

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

Companies that provide selfless information through particip

customers through which channels for what benefit to our organisation and our customers is a risk. Doing it in our rapidly changing environment is a folly that will manifest itself as a problem for future managers.

The time to begin strategic planning is now

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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