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Just Other Articles - Discover 10 Reasons Why Businesses Implement Change
In many small and medium sized businesses there is little or no strategy to improve the fortunes of the organization. This may happen in good times as well as bad and may result from a belief that:
- If it is not broke don’t fix it
- The
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
business is in a niche market with no competitionNo skills are available in-house to make proposed changes The business owner is retiring – it will be someone else’s problem And so on The lack of a desire to contin
; 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
ually develop and improve the business encourages a reactionary mode within the business, rather than a more desirable pro-active stance. Why is this important? Generally a reactionary organization fails to take business planning seriously and is mor
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
e focused on resolving current issues than establishing a mechanism to allow problems to be anticipated and actioned prior to becoming an issue. The import of this can be found when comparing organizations that:
- gain success on an on-going b
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
asisare able to more easily attract skilled staff train staff in order to raise the skill set within the business have set their goals and know how they are to be achieved with those businesses that do not. Pro-acti
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ve focused businesses are generally the winners. Businesses do move into a pro-active mode, but what inspires the business owner to take such a step? Ten of the most frequent reasons for change within a business are:
1. Third Party Interven
1. Third Party Interven
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
tion
A financial institution that has supported the business may seek improvements in the business performance to reduce a potential risk to their investment. This may prompt the business leaders to take improvement actions that were previ
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
ously alien to satisfy the institution and reduce the risk to their own assets that may be held as a guarantee against the investment.
2. Sales Decline There may be a serious decline in sales. Competition, new technologies, a fail
2. Sales Decline There may be a serious decline in sales. Competition, new technologies, a fail
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ure to meet the customer needs and expectations, a history of poor product development and introduction or poor marketing may all be contributory factors in reduced sales and be the catalyst for the business owner to change the approach to the busine
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
ss development.
3. Management Buyout The chief executive is removed through a buyout by the other directors and a changed business approach ensues.
4. Takeover The business is acquired and the
3. Management Buyout The chief executive is removed through a buyout by the other directors and a changed business approach ensues.
4. Takeover The business is acquired and the
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
policies and practices of the acquiring business are adopted and introduce a proactive approach to the business. This may follow the appointment of new executive directors.
5. Lack of Internal Skills The dearth of management skil
5. Lack of Internal Skills The dearth of management skil
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
ls within the business may trigger the appointment of an external senior executive who brings new methodologies, planning and enterprise to the business.
;6. Family Business ‘Turmoil’ The autocratic control of an owner may at times
;6. Family Business ‘Turmoil’ The autocratic control of an owner may at times
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
only be changed through the realization that permanent family divisions are undesirable. It may well be the opportunity for perhaps the ‘university educated next generation of family’ to demonstrate their abilities in setting and achieving sustaina
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
ble growth strategies and managing the culture change.
7. Raise Capital The success of raising new funding may be dependent upon the appointment of an executive or non executive director to oversee the business on behalf of the pro
7. Raise Capital The success of raising new funding may be dependent upon the appointment of an executive or non executive director to oversee the business on behalf of the pro
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
vider. Such an appointment will add new skills to the management team as well as promote improved business practices.
8. Exit Strategy A business owner may realize that in order to optimize business value at the expected time of h
8. Exit Strategy A business owner may realize that in order to optimize business value at the expected time of h
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
is/her exit, changes in the way the business is run will be necessary. The delegation of responsibilities, training of staff and implementation of strategic plans may be areas exploited to reduce the dependence of the owner on the business.
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
>9. Delegation or Renegade Action
When the business owner does not have the skills necessary to effectively manage the organization authorities may be delegated to or sized by an opportunist director to manage the business. A weak unskille
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
d business owner may be relieved that some responsibilities have been re-assigned, however, should the delegate or opportunist fail to match expectations more severe difficulties may arise for the business.
10. Project Based Change
10. Project Based Change
.
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
>Should implementation of an improvement project be planned, but internal resources are not sufficient or capable of managing the change, the appointment on a fixed term contract of a consultant or interim manager may be a desirable option. Change c
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
an be implemented with less interruption on staff conducting their normal duties.
The business owner should always control the business and this is easier to achieve if change is planned, well managed and is aligned to the goals of the organization.
The business owner should always control the business and this is easier to achieve if change is planned, well managed and is aligned to the goals of the organization.
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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