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Advice You - Change Stinks or Does It?
This morning as I walked the two miles around a neighborhood lake, I noticed that the leaves have begun to change and I marveled at the consistency of nature’s changing schedule. I realized that change is constant. There is always something changing in our lives. Some changes have more of a life impact than others: changing a hair style, a career path, a vehicle, a 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 marriage. So if change is constant, what we have to examine is how we respond to change. Two years ago, after almost 18 years with Pearle Vision, I learned that I was no longer needed. I wasn’t alone in this discovery. Over 800 of us learned that we would be unemployed within a few months of the announcement. Luxottica, parent company of Lenscrafters, purchased Col ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in National, parent of Pearle Vision and moved all the home office functions from a suburb of Cleveland to their Cincinnati offices. In all fairness to Lux, they were gracious about the decision and made job search resources available for us. One of the first seminars they provided was a workshop on Change Management designed to teach the phases of change and learn how lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. best to handle change. Here’s what I learned. Change stinks. No, no, I’m sorry; did I say that out loud? No, what I learned is that there are four phases to change: • Denial • Resistance • Exploration • Commitment Each participant took a test to see where they were in the change process and then the leader walked us through a description of here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe he phases and offered tips to assist us in the process of moving through to commitment. I would like to confess that the October 5 announcement truly wasn’t a surprise to me. When we learned ten month prior that the company attempting to buy us was Lenscrafters, I began to see the writing on the wall. As I look back, I realize that over the past several months I trul d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro had been working my way through these four steps, the first of these being denial. DENIAL Denial is the first phase people experience when they are faced with change. Whether the change is life altering, like the loss of a job, or minor like the discovery that we’ve gained weight. We first say: I don’t think so. Pointing out the facts – like holding up a mirror – 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 has no bearing when we are in denial. We change the subject. We ignore the facts. We put blinders on. If forced to face facts, we decide that the change is temporary. I did all of those things. I dreamed of a knight in shining armor successfully stopping the sale. I told myself that the FTC would never allow the two biggest optical shops to marry. But how can 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 we actively move from denial to resistance? We can seek out others to talk about the situation with; we can research what happens in similar situations. We can force ourselves to look in the mirror and say – yeah baby, the change, she is a coming. We need to ask ourselves: Why is the change happening? Is there an alternative to the change that I can control? What nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically are my true feelings about the change? I don’t know about you, but once I recognized that the change was inevitable I jumped wildly into anger mode. How could the CEO sell us out? Didn’t anyone consider what this would mean to me? After all it is all about me. RESISTANCE Anger is one of the primary characteristics of the second phases of change, resistance. And I 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 was very good at anger. My life is this company, how dare they make such a drastic change. Cut me and I bleed Pearle green. How could I possibly consider working for the enemy? I fell into a deep funk. During the day I continued to have my game face on, but at home I fell apart. At work the mantra was “business as usual”, but in my mind, I pictured the future and ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi t wasn’t bright. So how do you work your way from resistance to exploration? Well, I faced my anger and hurt and fear. I talked openly with my father and others outside the company who had personally experienced company takeovers. I gravitated toward people with positive attitudes because a positive attitude is contagious and I knew I needed to find the positive or ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a drown. To lead the way from resistance to exploration I needed to ask: What am I loosing because of the change? What can I personally control? What lies ahead? What is one step I can take now to manage the change? I think one of the biggest challenges when facing a change such as this, is the loss of control. As an extremely controlling pers dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod n, this hit me very hard. So by asking myself to consider finding one thing I could do to control the change, I gave myself a little control. And that one step was to consider what life would be like if I chose to leave Pearle Vision. And with that one step, I moved into exploration, the third phase of change. EXPLORATION I weighed and measured my options. To stay cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin with the company would surely mean a move to Cincinnati. To leave would mean having to interview and sell myself for the first time since I was 29. Not a pretty picture. The first thing I realized was that with either choice we’d most likely have to move. So once I realized that it, it opened up the possibilities. In the exploration stage you begin to find excitem tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen nt in the possibilities opening up before you. And even though things are up in the air, you start dealing with real issues. We had a family pow-wow at the end of March and the net result was resounding – we can’t move and “Mom please don’t take a job where you have to travel.” When I looked around at the jobs for my level, I found I would either need to move or trav 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 l. So I began researching “out of the box” alternatives. After much research, soul searching and prayer, I realized that I had a gift to offer businesses. Freelance writing. Could I make a business for myself? YES! And with that yes, I moved right from exploration to commitment. COMMITMENT As I started talking with family and friends at church and scouts and in ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust the community, I learned that my business had “legs”, as they say, and on July 7, 2004 I officially began AllWrite Ink, a freelance copy writing business with a slogan of “writing with the reader in mind”. In the final phases of change, commitment, you realize what a long way you’ve come. And you also realize that you couldn’t go back to the way things were before. Y y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products u even become comfortable with your new environment. I felt good about my decision and myself. I knew that although I loved my years at Pearle Vision and the people and experiences, it was time for me to move on. So when the announcement was made that the office was moving and I would be loosing my job, my first thought was “yippee, now I can work full time on my new . 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 career – a career where I’m in control and the decisions are made by me.” I looked around the room and realized that everyone else was back at the beginning. My heart went out to those around me because I knew they would have to work their way through denial, resistance, exploration and commitment before they truly feel in control again. I know the future will be fr elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip ught with fear and uncertainty and more change certainly lies ahead, but after working my way through the four phases of change, I feel confident that I can handle anything that comes my way. Think about the changes going on in your life right now: what phase are you in? Can you find some small way to take control of the change and view it from a positive perspective 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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