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Useful Advices - Get Out of Crisis Mode and Stay Out: Utilizing Resource-Based Decision-Making in Your Organization
Two economic sectors dominate the field when it comes to decision-making: one operates on a resource-based model and the other runs on a continuous crisis model. Many organizations choose the latter model because they place tremendous emphasis on saving money minute to minute, not on investing in future need. But resource-based decision-ma
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
king offers a process that helps you make instant decisions, and more important, introduces small changes that, over time, prevent your organization from getting into future bad situations.
Once you have assessed a situation, you need to determine the best course of action. But before you can make a decision about what to do, you must hav
Once you have assessed a situation, you need to determine the best course of action. But before you can make a decision about what to do, you must hav
; 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
e the resources to put that action into place. Giant retailers operate on the principle of building “surge capacity,” and your organization can, too. Basically, surge capacity involves investing in plenty of extra resources and having people trained and at the ready to use those resources when necessary.
Here’s how it works: a super-store
Here’s how it works: a super-store
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
like Wal-Mart may have thirty cash registers, and while they may have fifty employees trained to work in check-out, at most times only five to ten clerks staff the registers. However, the store prepares based on its assessment of when business is likely to be slow and when it will suddenly mushroom to a point that necessitates bringing on
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
additional staff to utilize those empty registers. On the day after Thanksgiving and Christmas Eve, for example, the retailer will need to add temporary workers and all available permanent staff to get customers’ money and then get them out the door with a minimal wait.
With Resources, Timing is Everything
The idea of surge capacity ori
With Resources, Timing is Everything
The idea of surge capacity ori
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
inated in hospitals that brought in additional help when necessary to utilize their reserve resources in the case of pandemic outbreaks or massive accidents. Ironically, most hospital administrators have now given up using the idea of surge capacity in their emergency rooms, which is why patients must sometimes wait as long as twenty-four
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
hours to see a doctor.
Business models in every industry provide similar examples when they function without back-up resources or surge capacities. In manufacturing, does it cost more to store parts (resources) than it does to shut down the line and pay everybody if a strike means you’re unable to obtain just one necessary part? In your b
Business models in every industry provide similar examples when they function without back-up resources or surge capacities. In manufacturing, does it cost more to store parts (resources) than it does to shut down the line and pay everybody if a strike means you’re unable to obtain just one necessary part? In your b
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
usiness, how often is a similar situation likely to happen? Knowing this will determine your risk model. What is your tolerance for risk? And what are your customers willing to accept as a failure?
In your own organization, you must look at what resources you have and make decisions about those resources on an ongoing basis. When you have
In your own organization, you must look at what resources you have and make decisions about those resources on an ongoing basis. When you have
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
resources in reserve and aren’t doing a lot of business, financial prudence may be wise, but as you approach the end of your available resources, you must reorganize priorities. When that happens, you get out of your comfort zone and front-load the system with more resources. Otherwise, you will provide worse customer service when your re
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
sources are only sufficient to meet immediate needs and face disaster when your resources exceed your needs. In extreme cases, you could end up with a full-blown catastrophe on your hands, where your needs exceed all ability to respond or recover. Fortunately, this doesn’t happen often, but when it does, it’s usually in the form of a total
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
business failure.
To keep your organization from holding too many resources—whatever you consider your equivalent of too many empty registers—you need to start as soon as possible to notice patterns. When you begin to experience back-up, should you restrict product outflow or availability? Increase business through incentives at off-peak
To keep your organization from holding too many resources—whatever you consider your equivalent of too many empty registers—you need to start as soon as possible to notice patterns. When you begin to experience back-up, should you restrict product outflow or availability? Increase business through incentives at off-peak
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
times so you need to concern yourself less with the peak times? These are all early resource-based decisions that keep you from getting into or exceeding your surge capacity.
Resource Availability and Adaptability are Key
You have to know your resource availability. This may seem like common sense, but cost arguments will arise, so prepa
Resource Availability and Adaptability are Key
You have to know your resource availability. This may seem like common sense, but cost arguments will arise, so prepa
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
re for opposition to this model in the majority of corporate value systems. While super-centers operating on the surge capacity system accept the necessity of only using fifty percent of their registers the vast proportion of the year, the airlines’ practice of overselling flights is far more common. For many such industries, angry custome
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
rs seem like a small price to pay until the system is maximally stressed.
As you move further into your surge capacity, you need to bring in additional resources so you can utilize those physical resources you’re holding in reserve. In the retail model, this means spreading work throughout the store by pulling people off their positions a
As you move further into your surge capacity, you need to bring in additional resources so you can utilize those physical resources you’re holding in reserve. In the retail model, this means spreading work throughout the store by pulling people off their positions a
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
nd on to the registers.
With resource-based decision-making, you’ll learn that you need to adapt; sometimes it’s easier to get employees, and sometimes it’s easier to get equipment. If you’re an auto detailer, all you need to do routine business is your car and cleaning supplies until a surge period like Valentine’s Day, when you may need
With resource-based decision-making, you’ll learn that you need to adapt; sometimes it’s easier to get employees, and sometimes it’s easier to get equipment. If you’re an auto detailer, all you need to do routine business is your car and cleaning supplies until a surge period like Valentine’s Day, when you may need
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
to hire additional office help to handle calls for service while you go out and detail cars, or you may need to hire other detailers while you stay in the office booking clients.
Many of us learned to make resource-based decisions but rarely as an ongoing practice. You’re taught to plan, but as situations develop, you’re likely to go off
Many of us learned to make resource-based decisions but rarely as an ongoing practice. You’re taught to plan, but as situations develop, you’re likely to go off
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 plan, making up new plans as you go, thinking outside the box. But you need to think outside box before the box careens off the cliff. If you’re trying to make resource-based decisions in the middle of the crisis, you’re behind, and if yours is a resource-limited situation, you’ll stay behind.
Make Your Case for Resource-Based Decisio
Make Your Case for Resource-Based Decisio
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
n-Making
No one’s likely to listen to a lone wolf advocating a resource-based decision model, especially in the midst of a crisis. To achieve buy-in, work patiently to change the corporate culture, introducing the ideas before the organization hits crisis mode. If you’re already at the disaster point, prepare to wait until the organizatio
No one’s likely to listen to a lone wolf advocating a resource-based decision model, especially in the midst of a crisis. To achieve buy-in, work patiently to change the corporate culture, introducing the ideas before the organization hits crisis mode. If you’re already at the disaster point, prepare to wait until the organizatio
.
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
n moves through the emergency, and then seek out key decision makers and suggest half-day conferences to familiarize them with the system’s principles. Post-crisis, many leaders are open to new thought processes that will provide a way to avoid future calamities.
In the end, resource-based decision making beats the crisis model 100 percen
In the end, resource-based decision making beats the crisis model 100 percen
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
t of the time. The key is to keep at it consistently and to always be evaluating your resources and making adjustments as necessary. By adopting this practice in your company, you’ll have an edge over the competition, happier customers, and less stress in times of challenge or change. And those are the true keys for a business that thrives
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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