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    Heather and Mark work at a leading attorneys’ office in Seattle. They order fresh ground coffee for the office every month, and sent me this comparison between two major coffee vendors.

    Coffee company ‘Torrefazione’ (I name the winners)

    • We received a call fro
    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
    m a customer service representative about a coffee order placed at their website earlier in the week.

    • We were informed that shipments are sent by UPS, but their coffee warehouse is only a few blocks from our office. So they offered to send future orders via co
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    rier the next day without a shipping charge.

    • They also noted we order coffee monthly and provided information on how we could qualify for a frequent customer discount.

    Coffee company ‘********’ (the losers know who they are)

    • We had problems ordering ground
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    coffee from their website.

    • By default we ordered over the phone during office hours.

    • One telephone representative asked us, ‘Why don’t you just go to one of our retail stores to buy the coffee?’

    Guess which coffee company this attorneys’ office now patroni
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    es each and every month?

    ***

    Abdul Rahman is one of my students based in Singapore. He was visiting a nearby country when his wife’s purse was stolen, including her credit cards from two different Singapore banks. Before he could report them stolen, they were u
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    sed by someone else. He reports two totally different service experiences:

    UOB Bank (I name the winners)

    • $650 fraudulent charges

    • The bank expressed sympathy at our predicament and assured us they would do their best in investigating the case.

    • They asked
    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
    if we could scan and e-mail the police report instead of sending by regular mail so that they could investigate immediately. (I did.)

    • They called back immediately after receiving the e-mail and promised to get back to us as soon as possible.

    • A few weeks lat
    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
    r, the bank called and explained that their investigation showed the signature on the charge slips was different from the cardholder’s. Therefore, all charges had been reversed.

    *** Bank (the losers know who they are)

    • $65 fraudulent charges

    • I was told by s
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    meone at the bank, ‘Our minimum charge for lost cards is $100 so you’d better pay the $65. Otherwise, we’ll charge you $100.’ (He must think I am an idiot.)

    • After a loud outburst from me, he admitted that I am only liable for $65.

    • I asked whether the bank,
    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
    out of goodwill, can absorb this amount. He told us to write in and make the request.

    • When asked whether we should send the letter to him, he replied that he was ‘not yet in charge’ of this case and that we should just mail the letter to ‘*** Bank Cards’.

    • O
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    e week later I followed up. They said, ‘No, we have not received any letter from you.’

    • I faxed the original letter together with a cover letter explaining that the original was sent to them earlier.

    • I called them to confirm if the fax was received.

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

    Following aspects would a
    weeks later the same person called us from the bank at 8:30 am and said, ‘We think you’d better pay the $65.’

    • I mentioned the other bank’s investigation showed the charges were fraudulent. He replied, ‘Different banks have different policies.’

    • When asked if
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    we could appeal, he replied, ‘You have appealed twice so it’s not likely to be accepted.’ (Our lost original letter and subsequent faxed copy of the same letter equals two appeals?)

    • One week later, a letter from the bank arrived stating, ‘Our investigation sho
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ws that you lost your card on April 13, but the report was only made on April 14. As such, you are liable for the minimum payment of $65.’ From the tone of the letter, we speculate that nothing was actually done to investigate.

    • I called the Fraud Control Depar
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ment but was not allowed to speak to the person responsible for our case. I was told, ‘He’s busy.’

    • Finally, we conceded and made the $65 payment.

    Guess which bank Abdul patronizes today, and will continue to patronize enthusiastically tomorrow? Guess which ba
    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
    k his family will avoid?


    Key Learning Point
    --------------------------------------------------------------------------------
    Coffee company ‘********’ and Singapore bank ‘***’ are both very big in their markets. They are major players with many
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ustomers, huge budgets and profits (for now). But big bureaucracies can quickly become impersonal and remote. Staff can become more interested in doing things easily for themselves and pleasing their bosses, than serving their customers with a smile.

    Meanwhile,
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    smaller players who want more market share, greater customer loyalty and positive word of mouth can teach their staff to be pleasant, helpful, motivated and appreciative toward those who really count – the customers.


    Action Steps
    -------------------
    .

    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
    ------------------------------------------------------------
    Ask yourself which are you right now: Are you the big dog who risks losing touch with your market? Or the underdog, keen to run an extra mile and keep your customers delighted?

    Big dogs don’t have
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    to lose touch, but they have to work harder to keep their staff focused on genuine customer care. There’s always room for an underdog – or a big dog – to be a bit more sensitive, more innovative and more helpful. Customers will notice and tell others all about it


    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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