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    I suspect all of you out there have someone that you rely on for insight and perspective – that wise old mentor that seems to have an unlimited depth of experience to draw from in helping you navigate life’s little challenges. You know, those little parables and anecdotal tales that always relate perfectly that very problem you’re trying to solve. Today, I go to that well of experience in responding to a problem I know many of you are facing right now- squeezing that last dro
    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
    p of improvement that never fails to elude us.

    First, the problem: Most of you out there in the performance management world have worked for years trying to find hidden value inside your organizations. Along that journey, some of that value (be it cost savings, productivity improvements, or gains in service delivery and customer satisfaction) has come pretty easily.

    We’ve all heard the term- LOW HANGING FRUIT (I’ll refer to this as LHF). Problem is that many of us haven’t h
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ard that term lately. Why? Because most of your organization’s have already captured those kind of improvements… the kind that smack you in the face right away even when you’re not looking…and are very easy (perhaps too easy) to implement.

    And along the way, capturing that LHF has created some real superstars within your company. How familiar is this- upon finding a bottomless pit of LHF, one of your esteemed, but intellectually challenged colleagues becomes the “instant her
    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” overnight! Reminds me of that FedEx commercial where they go on that long retreat, and the woman gets the idea of using FedEx in the first 30 seconds, and proceeds to get showered with kudos.

    Of course now, months or years later, you’re now in the role of continuing in your esteemed colleague’s (aka new hero’s ) footsteps. Only the LHF you’re looking far has become much harder to find. Those “bit hits” and “home runs” have become fewer in frequency and impact. You work da
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    and night to make your assessments, ground your conclusions, align management, and facilitate the necessary organizational changes. You put in more (much more!) work than your esteemed colleague ever put into it, but capture nothing close to the impact of those initial wins. Where did all that LHF go?

    Truth is that it got replaced by the practice of “squeezing blood out of the proverbial turnip”. And you’re the corporate bloodsucker! You find yourself in that under-apprecia
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ted job that no doubt produces a lot a value, but not without several times the effort that used to be required. That’s life for many of our performance managers today. Boy, wouldn’t it be nice if someone made this job a little easier?

    Enter my mentor, and one of his anecdotal gems. He starts by asking me to recall the first time I went out to the golf course. I’m sure if you’re a golfer, his experience will bring back similar memories. If not, just read on, as I’m sure you
    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
    ll be able to relate, at least in spirit.

    He recalls his 1st time on the course: More misses than hits, a verrrrrrrrrry frustrating intro to the game…and probably one he’ll give up pretty quickly. But he continues despite his apprehension. It’s amazing how much one good shot (out of over 100) will keep you coming back, but I digress.

    5 rounds later, AT LAST, he has more hits than misses- that moment of truth when the golfer gets “hooked”, and alas, the confidence starts to
    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
    build

    Round 10, now he’s starting to get the hang of it, and feeling pretty good

    Round 15- end of his first full year- he’s cut his score by a whopping 25% (although he won’t mention our previous scores!)

    Round 20- the following season- after a couple of rounds dusting off the “off-season rust”, he shaves off another 10-15%, and he’s now shooting somewhat respectable scores (measured, of course, not by the total stroke count, but rather by the number of people who aren’t e
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    barrassed to have him in their foursome). He, on the other hand (although borderline delusional) is now thinking Senior Tour!

    Round 20-320 (over the course of 30 years), He spends the rest of his golfing career trying to cut his score by another 5%- Where the heck is the LHF now, he asks ???

    And, of course, the story gets worse….

    He has spent virtually no money (except for those second hand clubs) getting that first 40% improvement, but could damn near retire on the money
    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
    he spent chasing the next 5% (the latest driver, several hundred sleeves of those new balls that go farther and straighter (NOT), greens fees at clubs he has no business playing at,…you get the idea). How in the heck can I get that next 5%, he pleads ? Am I that poor of an athlete? Should I change my swing?

    Now here’s the punch line… Most professionals don’t have this problem. Why, you might ask. Are they just naturals? Sure, that’s part of it. But there is more. My mentor
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    calls this secret ingredient “the art of diagnosis”, something all of us could be much better at.

    If you’ve ever read about the trials and tribulations of pro golfers (a far better investment of time than that new triple titanium, variable weighted, moon dust infused driver !), you’ll find one common thread. They know how to diagnose their game at a level we would never think of.

    When we diagnose our game as an amateur (and it’s a stretch to call most of us amateurs!), - as
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    suming we diagnose it at all- we think about things like % of fairways hit, greens in regulation, # total puts, etc…and that’s ok for a first cut. But the pros go much deeper.

    I recently read some work by Dave Pelz- Phil Mickelson’s short game coach and advisor to several tour players. For those of you who don’t know, Dave is an ex-NASA engineer who worked on the first Lunar Module design who, over the course of the last several years, has applied his expertise to diagnos
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ng and fixing the flaws of pro golfers. Interesting career shift to say the least, but it has paid off. His mission, is to help them find that next 5,4,3,2, and 1% (more like .001%) improvements. And how exactly does he do that?

    Dave knows the art of diagnosis, which is no doubt driven by his engineering, scientific and technological prowess. Last weekend, I saw a special Dave ran on the Golf Channel in which he encouraged us amateurs to come up with a “short game handicap”
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    . Without going into a lot of detail, this SGH didn’t just deal with one or two metrics, but many that worked together. Things like shot dispersion with different clubs, hit/miss ratios from points inside 30 yards for a variety of shot types, putting success from a half dozen different putt lengths and types, etc. You can see an example of this at http://www.golf.com/institute/sgh/sgh.aspx Whether you’re a golfer, or identify better with another sport, the message is the sa
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    e.

    Many of us would cringe at the depth of analysis that goes into this one area of focus. In this case, the SGH only deals with shots inside 100 yards. But if you talk to pros, they’ll tell you that this guy is a miracle worker. Not because of his athletic ability, but because of his savvy at the art of diagnosis. He makes a living off of people (pros and amateurs alike) who have fully captured the LOW HANGING FRUIT, and want to begin sucking that turnip for some more bloo
    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
    d. And that’s very similar to our jobs in today’s business environment as performance managers.

    As performance managers, we must think like Dave. We must design scorecards that operate effectively at the executive/ “results” level. But we must also possess diagnostic measures that explore strengths and weaknesses in the very processes that PRODUCE and/ or CONTRIBUTE to those executive level results. We must be BRUTALLY HONEST with our baseline, and diligent in our goal setti
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    g. We must diagnose, challenge, and set new goals at the work-face- Goals that if achieved will make a difference in one or more sub-processes. In short, we must develop the equivalent of Dave’s breakdown of the TOTAL handicap in to SUB HANDICAPS like his Short Game and Putting-Only metrics.

    There are many tools available to us that can help us achieve this. Tools that help us design these kind of narrowly focused, but strategically connected metrics and scorecards. Tools t
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    hat help us integrate these scorecards so that we can see the rollup and rolldown effects on the bigger picture. Tools that help us translate our strategic plan into its manageable components. Tools that help us baseline and set targets. Tools that help us benchmark against the outside world. One of the things that our company (ePGI) http://totalperformancemanagement.com has spent many years focusing on is developing these types of integrated scorecards for business, and help
    .

    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
    ng organizations use them to manage the small but vital pieces of that equation.

    But whatever tools you select, the biggest challenge you will face is changing the culture and mindset of the business. Essentially, developing a mindset that recognizes the new game we are in, and that those 1% gains are going to be a lot harder to come by. A game where the entire focus is on that Turnip, and how to get that last drop of blood out of it. It is a culture of ACVTIVE diagnosis and
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    analysis, not one of PASSIVE enterprise level KPI tracking and reporting.

    And that challenge starts with you, the performance manager. The bad news is that it will take the right tools, the right culture, and a lot of hard work. The good news is that if you can apply this art of diagnosis in the corporate world, you’ll begin to find that next tier of performance improvement, not to mention, a much lower golf handicap.

    …And with any luck, I’ll see you on the Senior Tour!

    -


    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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