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Digg It - How To Select A Consultant - The Three Imperatives
As a manager many years ago when faced with my first challenge of selecting an external consultant, I found myself all at sea. Fortunately for me, I intuitively hit two of the three selection targets. The project was to produce a communication video, so it was relatively easy to see and compare what each consultant had previously produced. I had a numb
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
er of consultants to choose from, but finally chose the one that I felt most comfortable with and whose work impressed me most. The project was succesful and in the process, I learned a lot.
Since that time, I have had to employ a number of consultants, I have been a consultant myself for almost 20 years, and I have worked with many other consultancies
Since that time, I have had to employ a number of consultants, I have been a consultant myself for almost 20 years, and I have worked with many other consultancies
; 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
oth large and small. The following suggestions for selecting a consultant are based on my experience as a manager and in the consultancy field.
What are the three targets that one must hit to successfully select a consultant? (Note; I am using the term “consultant” to refer to either one person or a consultancy firm). Firstly and most obviously, the c
What are the three targets that one must hit to successfully select a consultant? (Note; I am using the term “consultant” to refer to either one person or a consultancy firm). Firstly and most obviously, the c
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
onsultant must be able to actually do the work. Secondly, the consultant must be able to fit in with the people in your organisation and particularly those who will be working on this project. Finally, if the consultant is good, you should always improve your own knowledge as a result of the project.
1. Can the consultant do the work? Seems obvious, b
1. Can the consultant do the work? Seems obvious, 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
t there are some traps. For instance, I remember when starting out as a consultant in partnership with another (who was also new to the role), submitting a tender for a fairly large job and being selected in the final few for interview. Individually, we’d had some experience in the type of work, but not as a partnership, nor had we worked in the prospec
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ive client’s industry. We won the job. Why? The client saw in us some creativity and freshness that was not evident in our competitors. However, this was an unusual client. Normally, I would not suggest taking on a consultant (like us) who has not had the depth nor breadth of experience in the project. So, unless one of your criteria is “freshness”,
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
in terms of selecting for experience here are some tips:
• What are your specifications? Be very clear on the outputs you will require in the project. These should always be measured in terms of quality, quantity, time and cost. Use these output criteria to compare consultants.
• Who has recommended this consultant? Check their references – ask for
• What are your specifications? Be very clear on the outputs you will require in the project. These should always be measured in terms of quality, quantity, time and cost. Use these output criteria to compare consultants.
• Who has recommended this consultant? Check their references – ask for
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
the contact of the last job they did. When checking references, use your above “output criteria” as a guide.
• Are you looking for someone to implement solutions to a problem you have identified, or are you looking for someone to help you identify and clarify the problem? Or both? Sometimes it can be useful to split the project into these two parts.
• Are you looking for someone to implement solutions to a problem you have identified, or are you looking for someone to help you identify and clarify the problem? Or both? Sometimes it can be useful to split the project into these two parts.
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
In discussion with the prospective consultants, do they really give you the time to say what you want before jumping to conclsuons? If they appear to “have all the answers”, chances are they do not listen very well.
• Does their suggested solution appear to be specifically designed for you or is it a “one size fits all”? Be wary if it is not specifica
• Does their suggested solution appear to be specifically designed for you or is it a “one size fits all”? Be wary if it is not specifica
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
lly designed to meet your project criteria.
• Do they explain the things they can’t do as well as those they can? This is always a good test of integrity, truefulness and reliability.
• Is their initial response to your request up to your quality standards, sufficiently detailed (but not overly so) to make a decision, and within your time expectations?
• Do they explain the things they can’t do as well as those they can? This is always a good test of integrity, truefulness and reliability.
• Is their initial response to your request up to your quality standards, sufficiently detailed (but not overly so) to make a decision, and within your time expectations?
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
• Does the consultant have depth of expertise in the subject matter and breadth of expertise in its application?
• Ask the consultant what is unique about him or her? What makes them stand out from all the other consultants you might choose?
2. Secondly, will the consultant fit in with the people they will be working with? This is a critical implemen
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
ation issue, as whilst they might be able to do the work, if they can’t work harmoniously with the people, the results will be less than optimal. For instance, we once worked on a major government project (total budget in excess of M$43) where the client continually kept us at arm’s length (for example, on a residential workshop, we were not encouraged t
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
o eat or mix socially with the client project leaders). We met the output requirements for the client, but had we been allowed to work more closely with the client, they would have received a lot more value added service. In this case, the client should have selected another consultant.
The following tips will help ensure you get the right client/consu
The following tips will help ensure you get the right client/consu
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
tant match.
• Is the consultant likely to be able to gain the respect and trust of your key stakeholders?
• Could you trust this person (people)?
• What is the process they will use? i.e, How will they work within the organisation? How will they be seen? Try to visualise the consultant working with you and the other people as they complete the projec
• Is the consultant likely to be able to gain the respect and trust of your key stakeholders?
• Could you trust this person (people)?
• What is the process they will use? i.e, How will they work within the organisation? How will they be seen? Try to visualise the consultant working with you and the other people as they complete the projec
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
. Will it work? Is it likely to be a good partnership?
• Who specifically (from the consultancy) will be working on the project and what will be their role? For example, will the people you are interviewing be carrying out the work? Be wary of consultancies that have “front people” that win the jobs, then send in less experienced people to do the wor
• Who specifically (from the consultancy) will be working on the project and what will be their role? For example, will the people you are interviewing be carrying out the work? Be wary of consultancies that have “front people” that win the jobs, then send in less experienced people to do the wor
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
k.
• Ask the consultant to describe what a “good working relationship” looks like to them. Is the description the consultant gives you of a “good working relationship” likely to be, and to be seen to be, a partnership?
3. Thirdly, will you be able ot learn from this consultant? One of the reasons you hire a consultant is that you (or your organisation
• Ask the consultant to describe what a “good working relationship” looks like to them. Is the description the consultant gives you of a “good working relationship” likely to be, and to be seen to be, a partnership?
3. Thirdly, will you be able ot learn from this consultant? One of the reasons you hire a consultant is that you (or your organisation
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
does not have the depth nor breadth of experienece to successfully carry out the project. One of your aims should be to increase your own experience through this project. For example:
• Why did you decide to employ a consultant? What were the gaps you could not fill internally?
• What will you be likely to learn from this consultant?
• Will you inc
• Why did you decide to employ a consultant? What were the gaps you could not fill internally?
• What will you be likely to learn from this consultant?
• Will you inc
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ease your knowledge of both process management (how the consultant works) as well as content management (their area of expertise)?
• Will the consultant strengthen and support your role in the organisation?
Finally, if all of your criteria have been met and you cannot decide between two apprently equal consultants, consider setting them a small task or
• Will the consultant strengthen and support your role in the organisation?
Finally, if all of your criteria have been met and you cannot decide between two apprently equal consultants, consider setting them a small task or
.
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
part of the project to complete as part of the selection process. For example, some years ago we were in competition with another large consultancy for a sizeable project with an initial budget in excess of M$1. The client could not decide between the two of us, so he asked us each to undertake a small project (for which he paid us both), which would ul
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
imately become part of the larger project. When we each completed the small project, he had an excellent idea of both our capability and the manner in which we worked. After all, isn’t the final selection criterion is actually trying the consultant out?
Oh, yes. In case you’re wondering, we won the job!
Copyright © 2006 The National Learning Institut
Oh, yes. In case you’re wondering, we won the job!
Copyright © 2006 The National Learning Institut
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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