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E-Folder - Pave the Way to a Successful Strategic Plan
Many very successful business owners may never have had a formal strategic plan. Some think, “Why do we need to do strategic planning? We’re doing great just like we are.”
It’s not unusual for a small business owner to have the following questions:
• Why do I need to have a strategic
It’s not unusual for a small business owner to have the following questions:
• Why do I need to have a strategic
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
plan? Can’t I just tell everyone what our goals will be?
• How do I get started?
• Can I facilitate the planning sessions, or do I need to hire a professional facilitator?
• Will this be like other plans which, after spending time and money, just sat on a shelf?
If you’ve determ
• How do I get started?
• Can I facilitate the planning sessions, or do I need to hire a professional facilitator?
• Will this be like other plans which, after spending time and money, just sat on a shelf?
If you’ve determ
; 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
ned that you are indeed ready to begin a strategic planning process there are several steps to pave the way and ensure the plan gets executed.
Step One: Get Ready
We recommend using a professional facilitator for the initial part of the planning. The role of the facilitator will be to
Step One: Get Ready
We recommend using a professional facilitator for the initial part of the planning. The role of the facilitator will be to
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
o Lead the group in an objective/neutral way.
o Make sure ideas and decisions are not lost.
o Make sure the desired outcomes are kept in front of the group.
o Be more objective and therefore handle difficult situations.
o Challenge assumptions.
o Encourage equal participatio
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
n.
After you’ve decided you’re going to create a plan, you’ll need to think about who to include in the group. Everyone who will be affected by the decisions or the information should be represented.
o Whose input do you need?
o Who is needed to make a decision?
o Who must buy in
After you’ve decided you’re going to create a plan, you’ll need to think about who to include in the group. Everyone who will be affected by the decisions or the information should be represented.
o Whose input do you need?
o Who is needed to make a decision?
o Who must buy in
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
o the plan?
Those in management positions often think they know what’s going on with the business, but the people in the ranks are the ones that really know. They can offer honest feedback on what’s working, what’s not working or what’s missing. The more input you have, the stronger y
Those in management positions often think they know what’s going on with the business, but the people in the ranks are the ones that really know. They can offer honest feedback on what’s working, what’s not working or what’s missing. The more input you have, the stronger y
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
ur decisions will be.
If you involve everyone affected by the plan, you’ll build a company understanding and commitment to see it through. Everyone will feel a sense of ownership in carrying it out.
Step Two: Plan the Meeting
What you do before a meeting and how you follow up after a
If you involve everyone affected by the plan, you’ll build a company understanding and commitment to see it through. Everyone will feel a sense of ownership in carrying it out.
Step Two: Plan the Meeting
What you do before a meeting and how you follow up after a
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
meeting are equally important to what happens during the meeting. When planning the meeting, clarify your desired outcomes. “What do we want to accomplish?” For example, at the first meeting you might determine company values, brand promise and vision. At the second meeting you migh
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
set goals, determine key numbers and develop your action plan. We recommend using a facilitator for these two meetings.
Let everyone know what to expect. Be clear with the group about how the meeting will run and about the decision-making process. The best way to create commitment a
Let everyone know what to expect. Be clear with the group about how the meeting will run and about the decision-making process. The best way to create commitment a
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
d participation is to be clear about why you’re meeting. This is important because nothing hurts morale more than a misunderstanding about why people are there, and what their role will be in the meetings and in the decision making.
Get the appropriate people involved early in planning
Get the appropriate people involved early in planning
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
the meeting. This will reduce their resistance. You’ll be less likely to hear comments like, “We’re too busy. Why do we need a plan? Aren’t we doing okay as we are?” If you get the right people involved early, commitment will be higher which will lead to the plan being effective.
S
S
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
tep Three: Conduct the Meeting
Spend some time at the beginning of the sessions with what is called “inclusion” or “group building”. If you spend time getting everyone on the same page, it will be time well spent. This is crucial, so don’t cut it too short.
Pay attention to the conte
Spend some time at the beginning of the sessions with what is called “inclusion” or “group building”. If you spend time getting everyone on the same page, it will be time well spent. This is crucial, so don’t cut it too short.
Pay attention to the conte
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
t and the process of the meeting. The content is the agenda and decisions to be made. The process is how the discussion happens and how decisions are made. Be assured, paying attention to process increases the likelihood that the tasks get done and will go a long way toward making the
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
meeting more effective and productive.
Listen to everyone. Make sure everyone has a chance to speak – the more involved everyone is, the more accountable they will be to the decisions made in the strategic planning session. When people are involved in making decisions they are much mo
Listen to everyone. Make sure everyone has a chance to speak – the more involved everyone is, the more accountable they will be to the decisions made in the strategic planning session. When people are involved in making decisions they are much mo
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
re likely to carry them out. This builds a sense of ownership – they are more invested in the outcome
Step Four: Don’t Let it Sit on a Shelf
Don’t just write up the plan, pat yourself on the back and put it away. Write it up and then make sure everyone gets a copy. Develop a system
Step Four: Don’t Let it Sit on a Shelf
Don’t just write up the plan, pat yourself on the back and put it away. Write it up and then make sure everyone gets a copy. Develop a system
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
for reviewing and tracking the plan.. Whatever system you choose, make it consistent. Have weekly, monthly and quarterly meetings. Verne Harnish, in his book Mastering the Rockefeller Habits talks about developing a “rhythm” that will help keep everyone focused and consistent on knowin
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
how they fit in to the company goals and plans. They will be performing at a higher level. There will be better alignment around the strategic decisions made in the planning session.
Communication will be more effective. Regular meetings give the opportunity to ask important questio
Communication will be more effective. Regular meetings give the opportunity to ask important questio
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ns such as, “Are we doing the right thing?” If not, then you have the opportunity to stop and re-think the decisions. Regular meetings give the opportunity to make the best decisions you can as you progress, and manage the plan as a team. By keeping your plan dynamic, you can relate
.
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
t to the issues that come up on a daily basis. You can use your judgment and intuition to strategize about new issues in relation to the plan. It helps you keep the priorities clear.
The plan needs to be solid yet flexible enough that when new insights and ideas emerge you can be ope
The plan needs to be solid yet flexible enough that when new insights and ideas emerge you can be ope
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
to them. You want to have the freedom to keep your meetings creative.
Step Five: Celebrate!
Whatever you do, don’t forget this step. Although your strategic plan doesn’t have to be perfect, you and your team deserve to celebrate your hard work and accomplishments.
©2005 Julane Bort
Step Five: Celebrate!
Whatever you do, don’t forget this step. Although your strategic plan doesn’t have to be perfect, you and your team deserve to celebrate your hard work and accomplishments.
©2005 Julane Bort
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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