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The Constant State of Change

Lisa F. CritesI believed my life would slow down a considerable amount once The SHOWER SHIRT™ was introduced to the market. The obvious, I no longer had to be concerned about designing a mastectomy garment to perfection while trying to fit every female body size known to man. With that said, I had no idea the stress which was heading my way, and how to acclimate to the changes which were going to create such abruptness in my life, my finances and The SHOWER SHIRT Co. in general.

To recap, we had sold 500 Shower Shirt units in our first order. We had one national television story which had aired on LIFETIME Television network, and one FLORIDA TODAY newspaper article under our belt. We had delivered the initial 500 units to our customer. Though once their competitor found out they would be carrying The SHOWER SHIRT product, the competitor then placed a 200 unit order to sell at their Home Medical Equipment location.

Since our initial order was essentially depleted. It was time to place our second order. My Chinese liaison, Mike, had been great in working to not only make sure the product was produced as directed, but also deal with financials and minimum order negotiations with the manufacturer. Our initial order requirement was 675 units, a $10-thousand dollar investment. After placing the second order, our manufacturer reneged on the 675 unit agreement and increased to a 2,000 unit minimum order. It doesn’t take an accountant to figure out our inventory order would now be a $30-thousand versus a $10-thousand dollar investment. I was naturally annoyed, discouraged, and scared to death by these new requirements.

Luckily, my Chinese liaison agreed to cover the additional costs until I could repay the investment. Though the reality was, I owed my Chinese liaison another $20-thousand dollars in a matter of seconds. I had no choice but to agree to the terms as I had no Plan B manufacturer. The moral of this story, always have a Plan B manufacturer if you bring a product to the retail market.

While this was going on, my employer, Wuesthoff Health System, a 70-year old, not-for-profit healthcare system, a staple on the Space Coast of Florida was sold to a national for-profit healthcare system titled Health Management Associates, otherwise known as HMA. It was a very sad day for the community, but of course a great day for the many individuals who were awarded major amounts of money to see the hospital system sale come to fruition. With that said, we all knew there would be changes and were preparing for those transitions, including imminent lay-offs. Obviously, I went through several sleepless nights concerned about The SHOWER SHIRT Co. being another $20-thousand dollars in debt, with the additional possibility of being laid off while also having two condo’s and a farm mortgage hanging over my head.

So the question is – do we ever conform to the constant state of stress and never ending change? Essentially, the last year and a half had been a whirlwind of altering and alternating changes. I was working, not working, on disability, off disability; in hyperbaric treatments, out of hyperbaric treatments, two breasts, no breasts, and a year with only one breast. My emotional state, my psychological state, my physical state had been in a constant state of flux since being diagnosed with breast cancer in 2009. Did I ever accept any of these changes without a fight? Absolutely not. Should I have just taken a deep breath, prayed for guidance and subsequently gone with the flow? Absolutely.

The famous quote, “To live is to suffer; to survive is to find some meaning in the suffering.” It was definitely time to find meaning in the suffering.

Stay Tuned,

Lisa F. Crites                                                                                                                                            Shower Shirt Principal/Inventor                                                                                                     Corporate Healthcare Consultant                                                                                                  Health/Medical Broadcast Journalist

Convenience vs. Medical Necessity

Lisa F. CritesDid you know the government is using your tax dollars, your hard-earned money, to pay for penile implants in some men? That’s right. You read correctly. The government considers penile implant devices, which allow men with erectile dysfunction (ED) to get an erection, a ‘medical necessity.’ That means your tax dollars are paying for penile implants for Medicare patients.

Exactly one week after The Shower Shirt was introduced to the US market, and while male senior citizens were getting a boost below the belt, the US government informed me my product was NOT a ‘medical necessity’ and considered a ‘convenience’ item. The term, ‘convenience,’ was rather self-explanatory, but what was the definition of ‘medical necessity,’ specifically, based on Medicare or managed care terminology? We did our research.

Medically Necessary:                                                                                                              

Managed care adjective: Referring to a covered service or treatment that is necessary to protect and enhance the health status of a patient, and could adversely affect the patient’s condition if omitted, in accordance with accepted standards of medical practice.

Well this was now more confusing to my team; The SHOWER SHIRT™ does in fact protect the health status of the patient; and could adversely affect the patient’s condition if omitted. 

Subsequently, I did additional research on what products are actually considered convenience items versus medical necessities. That led me to penile implants.

Before I begin this rant, I want to first say this initial rant will precede many future rants regarding this specific finding. So again, let me be very clear as to what I’m trying to communicate. Our government states, The SHOWER SHIRT garment, a product to help prevent illness, injury and infection in women after breast cancer and mastectomy surgery is considered a ‘convenience’ item, however penile implants for men are ‘medical necessities.’ Are you kidding me? Though painfully apparent what gender makes the decisions in our nation’s capital, does that gender power role need to be so blatantly obvious? Amazing, and by the way, communicating that little piece of information while speaking to large groups of women is the perfect way to get them fired up. (Ok, one rant down, many to go, and yes, we will revisit this topic)

During this time, the government also informed me the product could not be registered under the existing code I had requested (L8015 as the mastectomy camisole) because it was not of a prosthetic nature; frustrating, because neither was the mastectomy camisole. In summary, the group instructed our company to apply for our own government code since The SHOWER SHIRT™ product had never existed before now.

Hmmm? Well, it was definitely cool to have created a product that never existed before, especially in the eyes of the US government, though introducing any new, innovative product to Medicare was going to be a major struggle. We know how well our government handles new and innovative, terms that do not coincide well with status quo and bureaucracy. More hoops to jump through!

On a positive and more productive note, we had our first newspaper article hit announcing the creation of The SHOWER SHIRT, just one week after going on the market. It was cool to see some of the behind the scenes work actually be represented to the public for the first time, in print, anyway. For the first few weeks after the FLORIDA TODAY article ran, I was known as “the shower shirt lady.”

Florida Today Inventor

Shannon Wiley-Watson & Lisa

FLORIDA TODAY Newspaper Article: October 2010

Stay Tuned,

Lisa F. Crites
Shower Shirt Principal/Inventor
Corporate Healthcare Consultant
Health/Medical Broadcast Journalist

Introducing The SHOWER SHIRT to the US Market

Lisa F. CritesIt was September 2010. My extended medical adventures, or alternatively, misadventures were behind me, and the Shower Shirt order was being shipped from the manufacturer just in time for introduction to the market the following month. With a major amount of teamwork between my attorneys, friends, significant other, and the insatiable patience of my Chinese liaison, Mike, we had met my deadline to have the product ready and available by October for National Breast Cancer Awareness Month. I knew, for many reasons, this was the perfect month to introduce the product. First and foremost, there is always an unlimited amount of breast cancer information and publicity during the October timeframe. From a self-serving standpoint, I also knew both television news producers and newspaper print editors would be looking for unique breast cancer related stories. Since I had been a past television reporter, and had worked in healthcare media relations for years, I knew my story would resonate with those decision makers. The story line “past health reporter turns breast cancer survivor, turns inventor,” would be sellable for media coverage, thus help the promotional awareness of the product.

A week or so before receiving the first Shower Shirt shipment, I met with a local hospital-based Home Medical Equipment (HME) company to present the product. To my surprise, this group ordered 500 units! Within 48 hours, I received a call from the American Cancer Society’s Tender Loving Care (TLC) catalog department wanting to also offer The SHOWER SHIRT. In addition to those turn of events, a Lifetime TV producer from The Balancing Act (a nationally syndicated morning show focusing on women’s issues) asked if I would be interested in being a guest on their show. They requested I appear to discuss my experiences with breast cancer, and the events which led to the inception of the Shower Shirt garment, all to highlight Breast Cancer Awareness Month. With 500 units already sold, the American Cancer Society preparing to carry the product, and national publicity, I was feeling pretty darn good about the product’s debut.

In between finalizing brochures, preparing press releases, and producing an educational video, it totally slipped my mind to have a website created (seriously, how did I miss such an important element?). Once I knew I was a confirmed guest on Lifetime TV, I hired a website company to throw something together. I told them I didn’t care what it looked like; it just needed to be online for any inquiries or orders once the national morning show hit the airwaves. Nothing like waiting until the last minute, the website went live 24 hours before the Balancing Act aired.

Balancing Act

Danielle Knox & Lisa on the set of the ‘Lifetime TV’s The Balancing Act’                                                 

To View The Broadcast Feature: http://www.youtube.com/watch?v=Ixl8Ak3XL4k

Simultaneous to all of these cool, new, Shower Shirt happenings, I was back to work at my job in healthcare media strategy, full-time. However with the increased responsibilities involving bringing this Shower Shirt project to fruition, I was essentially working two full-times jobs. The down side was  only one job was creating income, while the other was only creating expenses. It really was a Balancing Act; no pun intended.

Stay Tuned,

Lisa F. Crites                                                                                                                                 Shower Shirt Principal/Inventor                                                                                                  Corporate Healthcare Consultant                                                                                                 Health/Medical Broadcast Journalist

The Luck of the Irish

Lisa F. CritesAfter many months of hyperbaric treatments and a few weeks of oral antibiotics, I was holding my breath I did not contract a third infection. I was constantly checking the left breast for any redness, while monitoring everything from energy levels to temperature. My last two infections were absolutely identical in terms of how my body reacted, so I was compulsively focused on any increased physical pain, fever, and nausea or dizziness.

I’ve always been an extreme person; extremely happy or sad, exceedingly excited or immensely pissed off, while often having an acute sense of hyperactivity, or the polar opposite resulting in days of sleeping. Familiar to these extremely inconsistent emotions, I have also experienced those extreme peaks and valleys in terms of personal luck. I either have been extremely lucky, or in contrast, extremely unlucky throughout my life.

Crites Family

The Crites Family

I was lucky to have a mother who loved unconditionally; though unlucky as she died at the early age of 60, and only a few days after the enclosed portrait was taken. I was lucky to have a father who was a phenomenal provider, though unlucky as with that privilege, there was always a myriad of controlling conditions and strings attached. I also was lucky to have three protective, ethical, and atypically respectful brothers, along with a multitude of solid friendships through my many stages of life. Though majorly unlucky in love through every stage of high school, college, and my 20’s and 30’s; luckily, my love life changed for the better in my early 40’s.

With that said, I was not sure I was going to have a lucky outcome at this stage. I believed I was destined to attain another infection and required to live with one breast the rest of my life. Would that be a life-changer? Absolutely not. Would it be quite disheartening? Absolutely.

At this point, I needed a lot of my mom’s Irish luck as the entire team of clinicians felt the infection would come back. Their opinions were based on medical theories related to placing foreign objects into infected bodies. Of course I would continually hear Dr. Z in the background saying, “If you get another infection, we are done. We cannot go back in and try to rebuild the breast due to the massive amount of scar tissue in your chest.”

Luckily, through the grace of God, many wise medical providers making wise medical decisions, and what I choose to believe was my mom’s inherited Irish luck, no infection reappeared.

YES, I could now look in the mirror and see two breasts, albeit a rather scarred and no-nippled pair of breasts. Unfortunately, they could not be tattooed to reflect nipples – sounds gross, but a normal process after a mastectomy. They felt any type of tattooing on the problematic left breast could possibly upset the entire apple cart.

As my life has continued to be a massive amount of peaks and valleys, this experience was no different. I was unlucky having been diagnosed with breast cancer in the first place. I was unlucky to have been required to have multiple surgeries because of the complications caused by two hospital acquired infections. However, I was extremely lucky to come out of this drama healthy, and with a decently positive attitude. Life is bittersweet; we are all required to deal with the good, as well as the bad. All in all, I’m blessed for many reasons, even though the valleys in my world seem to be more prominent than that of the peaks.

Now that I was finished with the final surgery, and again own two breasts, it was time to get The SHOWER SHIRT product on the market for those future breast cancer patient’s requiring mastectomy surgery.

 

Stay Tuned,

Lisa F. Crites                                                                                                                                         Shower Shirt Principal/Inventor                                                                                                  Corporate Healthcare Consultant                                                                                       Health/Medical Broadcast Journalist

Product Liability Insurance, A Strange Odor & Back In The Chamber

Lisa F. CritesI was in and out of the hospital within five hours between admission, surgery and recovery. Luckily, no post-surgical drains were needed after this procedure; therefore, less pain and no showering issues.

It was June 2010. The last surgery was complete, though we were holding our breath no infection “reared its head.” My primary care physician had prescribed a two-week course of prophylactic antibiotics one week before undergoing surgery, and around the same time I had completed hyperbaric oxygen treatments. If the infection was coming back, it would happen within three to four days after finishing the final course of antibiotics. During that timeframe, something very odd began happening. So odd, I contemplated not even mentioning, though I was outvoted by my Blog editor. My left armpit (same side as the two previous infections) began protruding an extremely rank odor. Not a typical perspiration odor, but something which smelled comparable to a putrid bacterial infection. I knew not to even mention to Dr. Z. since he had a repetitive habit of blowing me off. I did however speak with my infectious disease physician. With his anxiety already at high levels due to my history, he decided to send me back to hyperbaric treatments for one more week as an additional precautionary measure. Therefore, I had seven more days under an oxygen helmet. I was not happy, but if this is what was required to keep two breasts in place then I was in agreement.

Hyperbarcis - 4                                                            Back In The Chamber

Within that same week I heard from the Anson Group, the organization which had been retained to navigate us through the required FDA procedures. Luckily, we attained a Class 1 Medical Device rating, with no requirement to go through any type of FDA approval process. A nice relief seeing we were still waiting to hear from the Centers for Medicare and Medicaid Services (CMS) on the Healthcare Common Procedural Coding System (HCPCS) process and if we could attain an existing, already approved Medicare code. In addition, we were able to secure product liability insurance through a contact of my Chinese liaison. Another several thousand dollars spent between the FDA research group and the insurance company, but we were now protected from repercussions of litigation and knew where we stood with at least one of the many US government healthcare related entities.

In terms of the strange odor, my clinicians felt it was caused by, or somehow connected to, bacteria being excreted from the previous infections and recent surgery.  Essentially, they had no solid explanation since there were no evidence-based medicine theories on odorous armpits.  I was told to purchase Hibiclens, an extremely potent antiseptic skin cleanser to control the odor. I was also told by more than one physician not to get the soap in my eyes as it could cause blindness. The Hibiclens helped for a few days each time but the odor always came back. The smell was severe for about six months and finally subsided.

Imagine being required to use such a strong cleanser which could cause blindness. What’s more intriguing, would be to explain to someone that complications from breast cancer surgery ultimately led to blindness. 🙂

Stay Tuned,

Lisa F. Crites                                                                                                                                         Shower Shirt Principal/Inventor                                                                                                  Corporate Healthcare Consultant                                                                                       Health/Medical Broadcast Journalist

Finishing Hyperbaric Treatments, Surgery #5 & Placing A Shower Shirt Order

Lisa F. CritesIt was time. It was time to complete four months of hyperbaric treatments, prepare for my fifth surgery and place our first official Shower Shirt order. My head was spinning as this meant more checks to be written, additional downtime for surgery, but no more living under an oxygen helmet for half of each and every day.

As my overall stress levels continued to increase (a trifecta of potential mental, physical, and emotional implosion), my significant other, Phil,  would often look at me and say, “Don’t even think about quitting, you can’t quit now.” Quitting? Of course not! Now, leaving it all behind and chalking it up as a life experience didn’t sound uninviting. My relationship with the Shower Shirt was comparable to having a new boyfriend (yes, I’ve had many). I wanted to trust it, but not sure I could. I liked the thought of it on some days, and really disliked it others. In actuality, I just feared the hell out of it.

With thousands of dollars invested in this little cathartic venture, I had no choice but to finish what I started. The manufacturer required our first order be 675 units. You can easily do the math, 675 units of anything is not inexpensive. I literally stayed in bed for two weeks after that first Shower Shirt order. Overwhelmed with fear, I created a myriad of reasons not to move forward. I would often hear a voice say, “Lisa, just keep doing what you are doing.” I would then respond by saying, “I don’t know what I am doing.” I would then hear the same voice again say, “Just keep doing what you are doing.” That voice helped me re-engage and think about what I just might attain through bringing this project to fruition. I heard from ‘the voice’ on several occasions over the next few months and will revisit those conversations at a later date.

In the meantime, I received a call from one of our local physician’s offices asking if I was open to having one of their patients test a Shower Shirt prototype. I said “Absolutely, please send them my way.” Within a few days, I had met Mara Hixon, a local children’s book author who was having a prophylactic bi-lateral mastectomy due to both an abnormal mammogram and MRI results, coupled with an extremely strong family history of cancer. I explained, and over-explained the directions for use, as if she was an idiot and couldn’t figure it out. I was just so nervous seeing this was my first real Shower Shirt customer, well sort of. She used the Shower Shirt post-surgery and said it worked great! She then gave it to a friend who was also having a mastectomy. Her friend was also happy with the products results. Whew! Two happy customers already.

Caring Hearts Benefit                                                                        Mara & Me

It was time to be admitted into the hospital for my fifth and final surgery. With months of hyperbaric treatments under my belt, my physicians were hoping my body would have no further infections. Essentially, this last procedure was to replace the left breast tissue expander with a permanent breast implant. It was an outpatient procedure which would only last a couple of hours, that is, if there were no additional complications.

On a final note, it’s absolutely amazing the people who come into your life you might not know if you weren’t trying to make a difference in their lives. Mara is one of those individuals. She’s become a special friend. Check out Mara’s book at: http://www.seaturtlebook.com.

Stay Tuned,

Lisa F. Crites                                                                                                                                         Shower Shirt Principal/Inventor                                                                                                  Corporate Healthcare Consultant                                                                                       Health/Medical Broadcast Journalist

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