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Subjects - What Consultants Want You to Know (But You Never Ask)
I’ve been both a CEO and a consultant, so I’ve seen from both perspectives what goes right and what goes wrong when a consultant comes in to a company. Generally the CEO or the manager who hires the consultant tells the consultant what he or she wants. Often the manager is frustrated with something that is h
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
appening at the company and expects the consultant will have the expertise to “just fix it”. While the manager needs to set the expectations, of course, the consultant rarely gets to voice what he or she knows would make the consulting engagement more successful for both.
Here is what your consultant would
Here is what your consultant would
; 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
love to tell you about making him or her successful working on your behalf:
1. Please Do Your Homework before I Come In
Too many owners and managers hire a consultant and then stop thinking. They present a list of general problems and expect the expert to conjure dramatic results. This approach almost alwa
1. Please Do Your Homework before I Come In
Too many owners and managers hire a consultant and then stop thinking. They present a list of general problems and expect the expert to conjure dramatic results. This approach almost alwa
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ys ends in frustration and many, many billable hours.
Instead, you have to take the initiative and stay involved. Discuss your needs, problems, and parameters in candid terms from the start. Set a budget or schedule upfront for each project a consultant tackles. Save your skepticism (or your staff’s) for th
Instead, you have to take the initiative and stay involved. Discuss your needs, problems, and parameters in candid terms from the start. Set a budget or schedule upfront for each project a consultant tackles. Save your skepticism (or your staff’s) for th
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
e interview process; once you’ve chosen a consultant, give him or her the benefit of everything you know and access to all important information.
One of the biggest costs in hiring outside expertise is bringing the consultant up to speed on your company’s operations. If you can prepare reports and numbers i
One of the biggest costs in hiring outside expertise is bringing the consultant up to speed on your company’s operations. If you can prepare reports and numbers i
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
nternally, you can help the consultant stay away from data gathering and other basic reporting functions; keep the consultant focused on analysis. You can tabulate numbers yourself; you’ve hired the expert to help you move forward from there. When you hire consultants, keep in mind that their most important
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
skill should be critical analysis and problem solving.
Another point to consider is that many consultants have a steep sort of half life as to enthusiasm for a project. They are consultants because they like variety. In other words, their best thoughts and greatest creativity come early in their relationshi
Another point to consider is that many consultants have a steep sort of half life as to enthusiasm for a project. They are consultants because they like variety. In other words, their best thoughts and greatest creativity come early in their relationshi
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
ps with clients. Being prepared from the start allows you to take full advantage of short attention spans.
2. Please let me stay focused on what I came in for and keep the distractions and new requests to a minimum if you want me to stay within your original budget (or expand the budget).
A consultant’s ex
2. Please let me stay focused on what I came in for and keep the distractions and new requests to a minimum if you want me to stay within your original budget (or expand the budget).
A consultant’s ex
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
pertise is so welcome in certain environments that they number of projects multiplies beyond the hiring manager’s original intent, but often with their knowledge. The original project may be just the tip of the iceberg of problems within a company, some of which are best solved by a consultant but many of wh
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
ich are best hired within the company after working with the consultant to develop a plan.
Like any outside contractor or vendor, consultant services are a commodity—and consultants want to sell as much of this commodity over as long a time as they can. That’s their understandable inclination as business pe
Like any outside contractor or vendor, consultant services are a commodity—and consultants want to sell as much of this commodity over as long a time as they can. That’s their understandable inclination as business pe
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ople. However, it’s your understandable inclination as an owner or manager to minimize the amount you pay them.
The consultant may be right to say there aren’t quick fixes to serious problems, but don’t let that lead to open-ended engagements. Most consultants agree that restructuring involves two phases: a
The consultant may be right to say there aren’t quick fixes to serious problems, but don’t let that lead to open-ended engagements. Most consultants agree that restructuring involves two phases: a
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
design phase, in which new ways of doing work are fashioned, and an implementation phase, in which the new ways of doing work actually are put in place. Have the consultant schedule these phases. This helps set up an exit strategy for the consultant, which is an important cost control tool. In addition, the
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
consultant will see the project as a limited engagement, rather than open ended.
3. Please set regular times to meet so that I have access to the person who hired me to get clarifications and not waste your time (and not waste my time).
Set regular times to meet (weekly or monthly) when the consultant wil
3. Please set regular times to meet so that I have access to the person who hired me to get clarifications and not waste your time (and not waste my time).
Set regular times to meet (weekly or monthly) when the consultant wil
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
l review conclusions, answer questions, and challenge you on better ways to run your business.
Make sure these are working meetings. Avoid meetings that turn into administrative updates. By meeting with the consultant regularly, you can compartmentalize—and better control—the amount of time you spend with h
Make sure these are working meetings. Avoid meetings that turn into administrative updates. By meeting with the consultant regularly, you can compartmentalize—and better control—the amount of time you spend with h
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
im or her. It also forces the consultant to be succinct and not draw on too much of your time. In this context, you can expect more from a consultant than from an employee. The consultant’s attention should focus squarely on problems you’re paying him or her to consider, not on operational details.
Remember
Remember
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
that you are paying bigger dollar amounts for this help, so you don’t want a consultant to be billing you for time in your office unless you are using that time wisely. Too many times employees don’t understand how a consulting arrangement works – they want the consultant to be available to them during thei
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
r working hours. Consultants shouldn’t be at your company every day where they can be distracted. They should only be there in order to meet with other people. Otherwise, they need to be doing their analysis in the peace and quiet of their own offices. 4. Please Don’t Kill the Messenger
The manager or CEO
The manager or CEO
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
who hired the consultant may be very excited at the beginning of working together and feel like he or she just unloaded their burden onto some capable shoulders. Then the consultant prepares an analysis and the recommendations all rely on additional work to be done by managers and employees inside the compa
.
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
ny. The recommendations may also involve actions that aren’t fun to carry out, such as demoting or terminating non-performing employees. They may call for additional reports or extra meetings. Expect that the consultant will come to some conclusions you won’t like immediately, but they may be the only way to
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
end some long-term problems.
In conclusion, when you keep consultants disciplined and focused, you can use them to great advantage. Be clear on the purpose of hiring the consultant and what you can and can’t expect their work to produce. Up front clarity will lead to a productive and valuable relationship.
In conclusion, when you keep consultants disciplined and focused, you can use them to great advantage. Be clear on the purpose of hiring the consultant and what you can and can’t expect their work to produce. Up front clarity will lead to a productive and valuable relationship.
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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