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I received a telephone call yesterday. It was someone I’d met at a networking group months ago. She reintroduced herself, mentioned the group where we’d met and said sh

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

e was calling to follow up. She did not say about what. I asked the question for her, “Why are you calling? What did we discuss?”

She told me that she makes customized

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

Examples of combination products may in

covers for laptops. I thought that was nice, but I didn’t need one and still didn’t understand why she was calling me. She then told me she makes other types of custom

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

ized covers too. I said, “Oh.”

We had now been on the telephone for a couple of minutes. I still really didn’t understand why she was calling me. She seemed to want me

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

to lead—but she was the one who had made the call!

I try to be nice, I always talk to people who call me—it’s my business. Other people are not always so nice or willi

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

Combination pro

ng to give time to strangers who call for no apparent reason.

Finally my caller asked if I was developing products that might need covers. I’m currently developing a n

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

ew product that will go in a binder. I told her about that. She said they also could do customized packages for products. She continued to point out that the work was c

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

stomized and I could get “whatever I wanted.” Now what I wanted was binders, I could get them in Staples or some internet discount site or from a vendor who specializes

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

in these types of products, so telling me I could get “what I want” doesn’t make a lot of sense.

I asked if she could give me an example. She had no samples to send 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

nd no brochure or catalogue with appropriate examples. She had a web site, which only showed laptop covers. The caller kept reiterating that her creations are “customiz

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

d” and that I could get “whatever I wanted.” She kept reiterating this as if it was important. It wasn’t.

She was selling features, “It’s customized,” rather than bene

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

Following aspects would a

fits, “It will make your product unique and it will make it stand out. It will add value. It will help with your brand and image. You will sell more because of the way

dd to the challenges in developing combination products:

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

it is packaged.” These are benefits. What a better outcome to the conversation if she had only mentioned one of them!

Think also what a better outcome if she had sugge

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

sted, “Let’s get together and talk about your product. We could do some brainstorming as to how it might look and what you want to accomplish with the packaging and I c

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

uld make some recommendations.” I would have gladly met with her. Who knows what might have followed that meeting?

At that point it was time for me to get off of the t

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

elephone. I had a coaching client calling in 5 minutes and I needed to get ready. As we ended the phone call she said, “I’m here if you need me.” That’s nice, but she h

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

Professional from academic institutions, pharmaceutical industries, health care indust

ad never given me a compelling reason to think that I might need her.

I was annoyed. She was probably very frustrated.

So what are the lessons learned?

1. Understand

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

your sales cycle and the goal of your telephone call. This caller had no agenda beyond calling to “follow up.” After that, she expected me to lead.

2. Focus on the ben

.

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

efits not the features! Imagine your prospect thinking to themself, “Why should I be interested? What will this do for me?” If you want your call to succeed, you must a

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

Companies that provide selfless information through particip

nswer those questions.

3. Ask for what you want. (See #1.) Once you know the goal of your phone call, you must ask for what you want.

4. Keep asking for what you want

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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