Useful Advices - Business

1. Big Red Flag. No website? If the person you are planning to hire doesn’t have a site of his or her own, this is a big red flag. How will they know w

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

hat works or doesn’t work if they haven’t tested it on their own site? If they are a professional in business they will have a website. Their website i

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

a true reflection of them – study it carefully looking for anything that may indicate “this company looks great!” to “I have some doubts in working wi

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

th this company”.

2. Listen to me. Can you hear me now? Are they really listening to what you want/need? OR immediately writing out a prescription li

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 a bad doctor based upon what they think you need. If it is the latter – run-Forest-run.

3. Experience. How many years of experience does this perso

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

have? How will this benefit you?

4. Resources. How many resources does this person utilize? If they work only with one program or have one resource

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

and derive all information/facts from that one source – probably not in your best interest to hire someone with such limited resources.

5. Speak to m

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

. Do they speak your language? If they are speaking in technical terms you don’t understand ask them for the plain English version. If you still don’t

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

nderstand and they aren’t patient with explanations – keep looking.

6. Questions. Are they asking you the right questions? What is the goal of your w

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

ebsite? Who is your target audience? How we will reach that audience online and offline?

7. Follow Through. How long does it take the person to retur

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

your phone calls or emails? This is a strong indication of what it will be like to work with this person. A good businessperson will respond in 24 hou

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

s or less.

8. Get it in Writing. Will you have a written agreement outlining the scope of work and pricing details? It’s important to get it in writ

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ing so both parties are clear on the expectations, time frame and other details.

9. Stories. Ask them to tell you success stories of working with dif

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

erent clients/companies. Who is their favorite client and why? Have they had any situations where clients have been unhappy? How did they handle those

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ituations?

10. References. Call at least two or three people that they have worked with or are currently working with. Check the Clients, Portfolio o

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

r FAQ pages at their website. Ask three important questions:

a. Can you tell me what type of experience you’ve had working with _______?
b. Hav

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

there been any surprises while working with ________?
c. As an XYZ company is there anything in particular you’d recommend I be mindful of before

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

hiring a web professional?

Finding a good web professional can be a tedious process. Ask lots of questions. Go with your gut. Your own personal feelin

.

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

g about working with the person is going to matter more than anything else. Also remember that web professionals will be interviewing you at the same t

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

me to see if you’re a good fit for them. It’s a good idea to talk with at least three businesses to see who best fits your needs, timeframe and budget

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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