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Main Subject - Strategy Cycle
The strategy cycle is a simple tool that will help you to achieve the goals of your organisation. Consisting of four main phases, the cycle is an iterative process that you can use to build and improve your business year after year.
Research
Successful bu
Research
Successful bu
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
siness relies on informed decision making. Managers with access to information on the market, competitors and their own business will be better placed to set goals and devise strategies, than those who are less well informed.
Larger organisations often have busin
Larger organisations often have busin
; 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
ss intelligence units, specifically tasked with the collection and analysis of data, but there is nothing to stop managers from smaller businesses from spending a couple of hours each month collecting their own business intelligence.
Often a manager's personal kn
Often a manager's personal kn
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
wledge and experience of the market can be just as effective as expensive research studies and decisions are made through 'market sensing' as opposed to 'market research'.
As the strategy cycle is an iterative process, the results of previous strategies should fe
As the strategy cycle is an iterative process, the results of previous strategies should fe
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
d into the business intelligence, along with any important experiences or key learning's gained.
Planning
After analysing the business intelligence to identify the most important internal and external factors affecting the organisation, managers can begin
Planning
After analysing the business intelligence to identify the most important internal and external factors affecting the organisation, managers can begin
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
to formulate appropriate strategies for meeting their goals.
Organisational goals are the aspirations that the business seeks to achieve. These generally revolve around growing the business and increasing profitability, but can also be industry specific, such as
Organisational goals are the aspirations that the business seeks to achieve. These generally revolve around growing the business and increasing profitability, but can also be industry specific, such as
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
technology company wanting to become the leading innovator.
To make these goals possible, managers set objectives which provide a more tangible destination for the business to move towards.
For example, a business seeking market leadership would probably set ob
To make these goals possible, managers set objectives which provide a more tangible destination for the business to move towards.
For example, a business seeking market leadership would probably set ob
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
ectives around increasing sales and reducing costs. It would then be up to the heads of finance, marketing, HR, R&D and production to develop strategies to achieve these objectives.
A strategy can be described as a collection of activities that will enable the or
A strategy can be described as a collection of activities that will enable the or
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
anisation to reach it's objective. A cost reduction strategy may involve staff redundancies, renegotiation of contractual terms with suppliers and the development of more efficient supply chains.
Throughout the planning process, managers should constantly consult
Throughout the planning process, managers should constantly consult
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
with other heads of department and with employees further down the line who will be responsible for implementing the strategy activities.
Without suitable levels of communication, the different parts of the business will not be able to take an integrated approach
Without suitable levels of communication, the different parts of the business will not be able to take an integrated approach
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
towards the objectives, often resulting in duplication of effort or inability to deliver to customers.
A good example of this would be the marketing department implementing a campaign to increase sales, without informing the production department, who will not ha
A good example of this would be the marketing department implementing a campaign to increase sales, without informing the production department, who will not ha
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
e had enough time to prepare for the increased level of demand.
Other important factors to consider during the planning process include:
-- Determining how the success of the strategy will be measured
-- Outlining the key milestones and stating when these w
Other important factors to consider during the planning process include:
-- Determining how the success of the strategy will be measured
-- Outlining the key milestones and stating when these w
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
ll be achieved
-- Financial planning to agree appropriate budgets for each activity within the strategy
-- Undertaking a risk assessment and identifying ways to mitigate major risks
-- Establishing an approval and sign-off process for each activi
-- Financial planning to agree appropriate budgets for each activity within the strategy
-- Undertaking a risk assessment and identifying ways to mitigate major risks
-- Establishing an approval and sign-off process for each activi
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
y
Implementation
Strategy implementation involves the delivery of a number of inter-related activities to an agreed standard and schedule. This is often referred to as project management.
To successfully deliver projects, managers need to have good commu
Implementation
Strategy implementation involves the delivery of a number of inter-related activities to an agreed standard and schedule. This is often referred to as project management.
To successfully deliver projects, managers need to have good commu
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
ication, financial and time management skills, so that they can liaise with staff, contractors and customers (both internal and external), whilst ensuring the project remains on schedule and within budget.
In larger organisations there may be a number of inter-re
In larger organisations there may be a number of inter-re
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
ated projects taking place in order to meet an objective. This is often referred to as programme management, with a programme board regularly monitoring each project to ensure it is delivering.
As each milestone activity in the strategy is completed, it should be
As each milestone activity in the strategy is completed, it should be
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
reviewed and signed-off by designated managers. Activities that are not delivered to time or quality should be reviewed to understand why and corrective action undertaken to try and get the delivery of the strategy back on track.
Measurement
Once implemen
Measurement
Once implemen
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ation of the strategy is complete, it is important to assess the degree to which it enabled the objective to be achieved. Without proper measurement it will be difficult to accurately understand what worked and what improvements might be needed for future strategi
.
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
s.
The method of measuring the strategy should be closely related to the objective that was set. Therefore an organisation whose objective was to increase sales turnover, would use the increase (or decrease) in actual sales as one of its measurements.
On some oc
The method of measuring the strategy should be closely related to the objective that was set. Therefore an organisation whose objective was to increase sales turnover, would use the increase (or decrease) in actual sales as one of its measurements.
On some oc
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
asions it will not always be possible to use internal data to measure strategy success, especially for less tangible factors such as brand awareness. In these cases it will be necessary to seek external data in the form of market research surveys and opinion polls
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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