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Advice You - Leaders Make the Difference
"There's no avoiding it. The eternal search for sustainable competitive advantage is leading us straight into the squishy softness of culture and character. Many business people won't like it. They won't be comfortable talking
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
with colleagues about trust, honesty, purpose, values, and other topics out of the self-help section of the bookstore. They will have to face the fact that they will likely be eaten alive by competitors who confront these issue
; 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
with relish." — Geoffrey Colvin, "The Changing Art of Becoming Unbeatable," Fortune Magazine
All organizations have access to more-or-less the same resources. They draw from the same pool of people in their markets or geograp
All organizations have access to more-or-less the same resources. They draw from the same pool of people in their markets or geograp
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ic areas. And they can all learn about the latest tools and techniques.
Yet not all organizations perform equally. In fact, there is a huge gap between high-and low-performing organizations. What accounts for this? Quite simpl
Yet not all organizations perform equally. In fact, there is a huge gap between high-and low-performing organizations. What accounts for this? Quite simpl
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
, it's people. As the venerable Peter Drucker points out, "Of all the decisions a manager makes, none are as important as the decisions about people because they determine the performance capacity of the organization."
In his
In his
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ook, Inspirational Leadership, Lance Secretan reports on the role of leaders in the healthcare system:
One hospital had significantly better results (61 predicted but 41 observed deaths) while another had significantly worse r
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
sults (58% more deaths than predicted). Technically, there was very little difference between the hospitals being studied. The significant variable proved to be the quality of leadership. What the researchers found in particula
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
r was the better performing hospitals achieved superior interpersonal dynamics among the intensive care unit staff. When leaders served their [staff] well, the medical staff was able to serve their patients better. The research
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
rs reported that 'the degree of coordination of intensive care significantly influenced its effectiveness.'
And when it comes to people, the big difference is leadership.
"People are our most important resource." This managem
And when it comes to people, the big difference is leadership.
"People are our most important resource." This managem
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
nt clich? dates back to the beginning of the modern organization. Yet all too often it's perceived as a tired old phrase with a high "snicker factor" in many organizations. Eyes roll as the boss dutifully mouths these words.
M
M
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
anwhile, investments in assets such as physical buildings, equipment, technology, products, and strategy development vastly outstrip investments in people. Little care is given to hiring and orienting the right people. Training
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
is often an afterthought, given little strategic consideration and even less management planning and follow-through. Performance appraisals are bureaucratic "check off the boxes" exercises that cause more angst than development
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
Promotions are based more on technical or management factors than on proven people-leadership abilities. Teams exist in name only. Opinions and input from frontline people are rarely sought and often discounted. Processes and
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
ystems enslave rather than enable servers or producers.
For such an "important resource," people are assigned remarkably low priority in many organizations. The folly of this choice is recognized not only by the proponents of
For such an "important resource," people are assigned remarkably low priority in many organizations. The folly of this choice is recognized not only by the proponents of
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
soft skills and values but is also supported by solid statistical studies and surveys.
"A Wharton [School of the University of Pennsylvania] study found that 'capital investments may be a strategic necessity to stay even with
"A Wharton [School of the University of Pennsylvania] study found that 'capital investments may be a strategic necessity to stay even with
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
he competition,' but the investments in workers yielded far greater returns. Says Patrick Harker, one of the study's authors: 'Machines can't give you a competitive advantage. It's all about people.'"
A survey of the world's m
A survey of the world's m
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
st admired companies echoed this viewpoint in the Fortune Magazine article, "What Makes a Company Great". According to the piece: "An MIT global auto industry study found that a major reason Toyota's productivity is far ahead o
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
Nissan is because Nissan poured money into robots and computers while Toyota focused on people and processes. Toyota then used automation to support its people and processes.
A major international company studied their worker
A major international company studied their worker
.
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
compensation claims and attitude surveys and found that where supervisors and managers are perceived to be more caring about people injuries and compensation, claims were much lower.
In the most admired companies, the key prio
In the most admired companies, the key prio
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
ities were teamwork, customer focus, fair treatment of employees, initiative, and innovation. In average companies the top priorities were minimizing risk, respecting the chain of command, supporting the boss, and making budget
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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