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Digg It - Should Managers Solve Problems or Change their Thinking?
In many management situations we find in our consulting and coaching environment we are brought in to solve particular problems. Management and their teams have tried everything they could but like
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
our boiled frog they can’t get out of the soup. A consultant is brought in, wearing his bright red cape and carrying a magic wand. After several months’ intensive analysis and study a resolution is
; 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
ound. Plans are developed to implement a solution. Staff is communicated with; the involved members are trained in the new processes, policies and metrics written, a change management procedure is d
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
veloped and all is being returned to normal. The solutions are implemented and the problem is over. Productivity is up, quality raised, staff is motivated, and costs are down, customers happier than
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ever before. Management is impressed they chose such a great consultant
STOP Rewind… Not so fast whizkid, MBA wonder boy.
How long do you think it will take for that self same problem to reappear?
STOP Rewind… Not so fast whizkid, MBA wonder boy.
How long do you think it will take for that self same problem to reappear?
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
OK it might not be a week. You can rest assured it’s coming back within the quarter.
Taking snapshots of processes, looking at pieces of the whole and not developing an understanding of the structu
Taking snapshots of processes, looking at pieces of the whole and not developing an understanding of the structu
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
re of the problem in terms of the interactive systems and people’s input is not going to solve problems.
People develop a habit for doing what they think is right. Even when it starts going wrong t
People develop a habit for doing what they think is right. Even when it starts going wrong t
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
ey are not going to appreciate this. Managers will push harder, longer hours, more staff. Success , things improve, then they slump again. People get tired, new staff are not well trained and petty
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
olitics comes into play. Initial success at pushing eventually produces the opposite effects!
So the act of pushing growth actually inhibits the process! It reminds of a phrase we have in aviation.
So the act of pushing growth actually inhibits the process! It reminds of a phrase we have in aviation.
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
Pull back on the controls and the houses get small – keep pulling and they’ll eventually get big again. Yeah you’ll loop right over and scare yourself into diving right into the ground. Houses get r
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
al big.
So how do we change this and grow? This is where the concept of paradigms comes into play. We have to create new paradigms for the process. We have a limiting paradigm which we need to chan
So how do we change this and grow? This is where the concept of paradigms comes into play. We have to create new paradigms for the process. We have a limiting paradigm which we need to chan
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
ge to grow and solve our problems.
A business I know cannot grow; it gets to a half dozen clients and then loses two, if not them all. They have a mentor who has grown a successful company he tells
A business I know cannot grow; it gets to a half dozen clients and then loses two, if not them all. They have a mentor who has grown a successful company he tells
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
them what to focus on, new systems, new marketing materials, training, policies and procedures. Not once does he delve into the understanding of the limiting belief structure in the business. Why wo
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
ld he? What does that have to do with business, he may think?
“Yeah, we know we can’t handle half a dozen clients… Every time we get that many clients something goes wrong!”
Now if only the mentor
“Yeah, we know we can’t handle half a dozen clients… Every time we get that many clients something goes wrong!”
Now if only the mentor
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
could help the business turn that around into a powerful new paradigm that motivates the business. What if they came up with a paradigm where “half a dozen clients are only the beginning…”
The unde
The unde
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
standing of problems in such simplistic linear terms will never lead to real solutions. Yes, there may be some short term results but the long term effects will still be there to bite you. Bringing
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
in a new accountant solves some reporting issues. Not the reason the reports weren’t done in the first place. Developing a new measuring system brings in new data not a new solution.
So look at wha
So look at wha
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
you’re doing and how you’re doing it, what’s stopping you from doing it better? What’s stopping you from doubling your revenue? Halving your waste? Halving your staff compliment? Really? Is your fi
.
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
st answer a real reason or a limiting belief?
It’s amazing how seemingly logical limiting factors can be found to be beliefs. Check on yours. Look at the structure of your business and what interac
It’s amazing how seemingly logical limiting factors can be found to be beliefs. Check on yours. Look at the structure of your business and what interac
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
s with what. Then see who is involved and at what levels. If there is a problem, are you going to fix a symptom or an underlying structural issue? Are you sure?
If you can believe it; you can do it
If you can believe it; you can do it
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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