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Capitalizing on Opportunities in the NonHospital Market, Rick Almasy, NightingaleAlan MES, LLC As consumers, we know that patient care has shifted from the inpatient, acute-care setting, to various non-hospital sites, including clinics, surgery centers, imaging centers and physician offices. How can the specialty distributor penetrate these various sites? Which ones offer the most opportunity? Take part in this valuable, member-led information exchange. Hospitals Diversifying? Medical Professionals Diversifying? • • • • • • Used to be Doctor, Nurse, ancillary personnel. Now Specialist, Doctor, PA, Nurse Practitioner, Nurse, Pharm D., PT, RRT, Radiology Tech, etc… The past Century has seen the growth and transformation of existing professions and the introduction of new health care workers. These changes are the results of developments in technology, education, research evidence, and new systems of purchasing, organizing and regulating the workforce. Recently disciplinary boundaries have come under pressure as a result of staffing shortages in medicine, nursing and the allied health fields. Unskilled works such as healthcare assistants and support workers are taking on tasks previously only performed by professionals. Orthopaedic surgeons are a good illustration. There are approx 20,000 in the US. Some claim this is an oversupply of 20-50%. The V.P. of the American Academy of Orthopaedic Surgeons stated: A decade ago when we were fat and sassy, we decided to limit our practices to those aspects that were fun and well remunerated. We chose not to counsel little old ladys about osteoporosis; we chose not to provide foot care services in our offices or put casts on in the E.R. Other providers including podiatrists, internist and E.R. docs filled the void. Do we need to look for who is filling the voids, or who will fill the voids in the future? Are GPOs Diversifying? • G.P.Os are pursuing customers in the nonacute care market, and asking distributors for help. Article in repertoire magazine March 2011 • If you don’t receive it …get it. Should we diversify? The Big Box Movers Are. • • Cardinal’s Maturing Non-Hospital Strategy Edition: December 2009 - Vol 17 Number 12 Article#: 3330 Author: Repertoire Cardinal Health’s penetration of the non-hospital market has matured over the past 10 years. And it continues to do so today, as the company rolls out a multiyear transformation of its entire medical segment. When Cardinal Health purchased Allegiance Healthcare in 1999, it inherited Allegiance’s Care Continuum non-hospital program, which relied primarily on telesales and a core group of about 25 field reps to penetrate the surgery center and physician office markets. Its primary targets were non-hospital sites owned and/or operated by the distributor’s big hospital and IDN customers. Then, when Cardinal acquired Bergen Brunswig Medical Corp. in 2000, the strategy shifted. In addition to telesales support, the company now had a full contingent of field reps to pursue customers who had no affiliation with existing hospital and IDN customers. Top 10 Medical Areas 2011 • • • • • • • • • • Diagnostic imaging (nuclear imaging, interventional radiology, capsule endoscopy and others); Drug delivery (needle free injections, transdermal systems, inhalation system, infusion system); Molecular diagnostics (biosensors, proteomics, nanotechnology, and others); Mobility aid technologies; Minimal/non-invasive surgery (stents, bariatric surgery, medical robotics and others); Micro-fluids and MEMS (Miniature medical pressure sensors, bio chips, protein chips); Non-invasive monitoring (continuous blood glucose monitoring); Biomaterials (bionic limbs, joint replacement, antimicrobial wound dressing and others); Bio-implants (neurostimulation and others); Telemedicines. Top Medical Device Manufacturers • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • 1. Johnson & Johnson $23.6 B 2. Siemens Healthcare $17.4B 3. GE $16B 4. Medtronic $14.6B 5. Baxter International $12.6B 6. Philips Healthcare $11.2B 7. Abbott Laboratories $8.4B 8. Boston Scientific $8.2B 9. Covidien $7.8B 10. Becton Dickinson $7.2B 11. Stryker $6.7B Biggest Medical Device Trends of the Next 10 Years from WHO • • • • • • • • • • Medical Device Patents and Obesity According to CBS News, Americans spend about $35 billion a year on weight loss products. And that number is sure to grow. The following chart shows the rate of increase of overweight and obese Americans since 1960. If you look closely you'll see that obesity has risen from about 12% of the population in 1960 to over 30% today! Meanwhile, overweight individuals have hovered at about 30%. What this means is that more and more people will be looking for creative solutions to lose weight. So, where are the opportunities for inventors? Obviously, products that help people lose weight. There are thousands of patents for different exercise machines and the market is littered with trademarked diet schemes and marketing approaches. Also, I believe there will be more products that promise to keep the weight off in the first place. For example, at my local grocery store they sell a version of an avocado called a "slim-cado". It has about half the fat of a regular avocado. I'm not sure how they did this, but it sounds like a candidate for a patentable procedure. And of course there are the drastic procedures like gastric-bypass which uses specialty medical device patented tools that could be improved. And the market for medical device patents doesn't stop here. The growing obesity epidemic will create an even greater need for patents in other areas of medicine. Medical Device Patents and Heart Disease • • • • • • • Heart disease accounts for roughly 616,067 per year, giving it the dubious distinction of being the leading cause of death in the U.S. The surprising thing about this number is that it is just a fraction of how many lives were predicted to be lost to heart disease. Why is this? Maybe it’s greater awareness of the hazards of smoking. Dietary changes. Or more exercise. I think it’s because of greater funding for treatments and cures. A quick web search will return thousands of charities and donations that host venues to raise money for heart disease. With that in mind, I believe research and development into medical devices to treat heart disease should be big business for years to come. And then of course there are the patents on the inventions and improvements to surgery devices (think stents for coronary artery blockage). And don’t forget about post-surgery needs. The average hospital stay after heart surgery is 5-7 days. During this time there are all sorts of tubes, wires and diagnostic equipment involved, all of which can be improved (which I’m sure some smart inventor is working on right now). In part two of this article we’ll see where the next wave of new medical devices will come from by exploring one of the fastest growing health problems in America…and…the commonly over-abused drug that is quickly losing effectiveness (and is in dire need or replacement). Medical Device Patents and Diabetes • • • • • • • • Coming in as the seventh deadly killer in the U.S., Diabetes claims roughly 71,382 lives per year. 17.9 million Americans live with diabetes. And another 2.5% of the population does not know they have the disease. In fact, since 1988 there has been an across the board increase of instances of diabetes regardless of age, sex or ethnicity. Diabetes is up in Every Category (Click for larger view) Diabetes leads to greater incidences of heart disease and stroke, high blood pressure, blindness, kidney disease, neuropathy (disease of the nervous system) and even amputations. And diabetes is a $175 billion per year (and growing) industry. Surely, creative new patents and medical devices will need to be invented to fight this dreaded disease. What are some of the opportunities for inventors? There are two types of diabetes. People are either born with type-1 diabetes, or they develop type2 diabetes. Both versions result in the pancreas producing little or no insulin (a hormone needed to allow sugar to enter cells to produce energy). Traditionally, diabetics are treated with insulin injections to supplement the lower amounts in the bloodstream. Perhaps there is some invention-in-waiting that is less painful/intrusive than injections? Or maybe you could invent an "insulin pill" that slowly releases insulin over the day? An insulin patch? Medical Device Patents and Antibiotics • • • • • • • • Nearly 100,000 people a year die from antibiotic resistant infections in the United States alone. And doctors are fearing it's only going to become more common. The reason? Antibiotics are losing their potency. Here’s why, human beings are a vastly complex creature. We have multiple systems for pumping blood, breathing air and sending electrical systems back and forth. Bacteria are so primitive they don’t even have a nucleus. Our complexity betrays us. The simple antibiotics we’ve used for the last half century have prompted bacteria to evolve. To develop biological countermeasures that are rendering antibiotics harmless. This wouldn’t be a problem if we were still discovering new antibiotics. But the vast majority of antibiotics were developed over twenty years ago. What can inventors do? Inventing new antibiotics is NOT the answer. I think the more lucrative area for inventors is preventing bacterial infection in the first place (if you’ve seen the explosion in antibacterial products over the last twenty years, then you know what I’m talking about). More and more people will be scared by news accounts of these new “super-bugs” and will look for different ways to protect themselves. Medical Device Patents and Cancer • • • • • • • • • • • • • Cancer is responsible for roughly 562,875 deaths per year, making it the second leading cause of death in the U.S. What's worse, the World Health Organization (WHO) predicts cancer rates could increase 50% by 2020. The reasons? Too much smoking, poor diets and infection. Top 10 Cancers According to the CDC The WHO suggests three ways to curb cancer related deaths. "Action now can prevent one third of cancers, cure another third, and provide good, palliative care to the remaining third who need it, "said Dr. Paul Kleihues, Director of the International Agency for Research on Cancer (IARC) and co-editor of the World Cancer Report." For inventors of medical devices, the third piece of advice "good, palliative care" could be a goldmine. Obviously, there could be advances in chemotherapy. And any other sort of drug that treats cancer would be welcomed with open arms. There are varied forms of radiation therapy used. And cryosurgery…or using extreme cold to treat tumors sounds like an area ripe for improvements. But those are after the fact. There are opportunities for inventors to improve early detection methods. Specifically screenings. For example, advances in screenings for cervical and breast cancers have increased the odds for prevention and successful cure. And the list goes on. Medical Device Patents and Elder Care • • • • • • • • • • Since 1960 the average American lifespan has increased by 8.6 years (to 78.4 years up from 69.8). With this growing elder population comes a greater tax on the nation's nursing homes or at home care options. The latest census data (from 2007) shows 7.4% of Americans aged 75 and older lived in nursing homes in 2006, compared with 8.1% in 2000 and 10.2% in 1990. While the data are trending down, I'd bet that the global economic meltdown in 2008 has dramatically reversed this trend. To make matter worse, most people who enter nursing homes can't even afford to be there. According to a 2007 USA Today article: "The average nursing home patient runs out of money within six months and must go on Medicaid, Markwood says. That, she adds, "will not only bankrupt individuals but also the Medicaid system." All these statistics add up to a sobering reality. The number of people in nursing homes is only going to grow and it will cost more money to keep them there. So, where are the opportunities for inventors? I see two areas. First, new patents for medical devices for people who opt for in-home care. At the core of these inventions will have to be making life easier for the caregivers. Think walk in tubs instead of tubs you have to step over. Or handrails for bathroom facilities. Second, new patents for medical devices for nursing homes. These will have to focus on reducing operating costs for the homes. Maybe less expensive lift devices. These medical trends are not going anywhere and could be an on-going goldmine for any smart inventor. • In the United States, more than 22 million surgeries a year are performed in more than 5,000 ASCs. ASCs are in all 50 states and can be found throughout the world. In the US, most ASCs are licensed, certified by Medicare and accredited by one of the major health care accrediting organizations. • The three main accreditors of ASCs are American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF), Accreditation Association for Ambulatory Health Care (Accreditation Association or AAAHC) and The Joint Commission. • • Our imaging centers database directory has over 3200 entries as of June 6, 2011. New York state has the most with 384, about 12% of the total. Ambulatory Surgical Centers • • • • • • • • • • • • • • • • • • • • • • • Top 20 Surgical Procedures by Volume, CY 2009 ASC Claims Rank Procedure Short Descriptor Volume 1 Cataract removal with IOL lens insert, 1 stage 1,150,342 2 Upper Gastrointestinal (GI) endoscopy with biopsy 441,591 3 Colonoscopy with biopsy 341,161 6.1% 4 Colonoscopy, diagnostic 290,385 5.2% 5 Laser surgery (lens) 272,248 4.9% 6 Colonoscopy with lesion ablation or removal 232,258 7 Injection spine: lumbar, sacral (caudal) 229,137 8 Injection foramen epidural: lumbar, sacral 207,053 9 Inject paravertebral f jnt l/s, 1 lev 125,918 2.3% 10 Colorectal cancer screening; high-risk individual 92,715 11 Cataract removal, IOL lens insert prosthesis, complex 12 Colorectal cancer screening; low-risk individual 76,093 13 Colonoscopy with lesion ablation or removal 74,091 14 Upper GI endoscopy, diagnostic 73,003 1.3% 15 Cystoscopy 72,286 1.3% 16 Injection, lumbar or sacral, add-on 60,674 1.1% 17 Injection spine, single 53,220 1.0% 18 Destruction paravertebral by neurolytic agent 45,035 19 Flaps with excessive skin weighting down lid 44,936 20 Injection procedure for sacroiliac joint 41,499 Total Surgical Procedure Volume 5,577,280 71.7% Volume % of Total 20.6% 7.9% 4.2% 4.1% 3.7% 1.7% 76,136 1.4% 1.3% 0.8% 0.8% 0.7% 1.4% Depending on FEMA Money? • The House Appropriations Committee approved an additional $1 billion for the Federal Emergency Management Agency on Tuesday to ensure the agency has enough resources to cover disaster response efforts in Missouri and in other states recently hit by natural disasters. • Alabama Republican Robert Aderholt, who chairs the spending committee's panel that oversees FEMA's budget, pressed for the additional money to be added to the bill funding the department for the upcoming fiscal year. • "FEMA is projecting that under the best-case scenario, the disaster relief fund will essentially run dry before the end of the fiscal year," Aderholt said in a statement after his committee approved the bill. • Under House rules, any increases for one agency's budget must be offset with cuts to another program. To pay for the boost to FEMA's budget, the committee cut money from a Department of Energy program that promotes the development of energy-efficient vehicles. Homelessness? • • • • • • • • What are Community Health Centers? Community, Migrant, and Homeless Health Centers are non-profit, communitydirected providers that remove common barriers to care by serving communities who otherwise confront financial, geographic, language, cultural and other barriers. Also known as Federally-Qualified Health Centers (FQHCs), they: are located in high-need areas identified as having elevated poverty, higher than average infant mortality, and where few physicians practice; are open to all residents, regardless of insurance status or ability to pay; tailor services to fit the special needs and priorities of their communities, and provide services in a linguistically and culturally appropriate manner; provide comprehensive primary and other health care services, including services that help their patients access care, such as transportation, translation, and case management; provide high quality care, reducing health disparities and improving patient outcomes;1 and are cost effective, reducing costly emergency, hospital, and specialty care, and saving the U.S. health care system $24 billion a year.2 • In the U.S. and Territories, there are: • Approximately 1200 Health Center Organizations • Over 8000 Delivery Sites • Serving 20 Million Patients, including • o 941,000 Migrant/Seasonal Farmworker Patients • o 1 million Homeless Patients • The new business person must see his or herself not as someone who is out to count chips, but as someone who is passionate about making the world better through the products they sell. It may be to make someone laugh, to save their lives, or even to provide more freedom. The point is that the new business person must take on the responsibility of creating a better world. It is the new business person that seeks glory in the name of honor, instead of the mountain they climb. • Are there any products that you currently have that can be marketed outside of Hospitals? • Stand Alone Surgical Centers, EMS/Fire Departments, Government Facilities ( Schools/ Prisons,) • Are their similar products to market outside of Hospitals that would not be such a steep learning curve for your sales group? • Do you need to hire other sales persons? Hospital Experts Predict Ten Emerging Technologies That Will Shape Health Care Next Year! • From pill-sized cameras to radioactive compounds that let doctors “see” inside a patient’s brain, Cleveland Clinic’s Top 10 Medical Innovations for 2011 showcases new techniques, therapies and approaches to treating a host of diseases. • The list of breakthrough devices and therapies was selected by a panel of Cleveland Clinic physicians and scientists and unveiled during Cleveland Clinic’s 2010 Medical Innovation Summit. The Top 10 Medical Innovations for 2011 are: • 10. Capsule endoscopy for diagnosis of pediatric GI disorders • A pill-sized camera captures 50,000 highresolution images during its painless six- to eight-hour journey through the digestive tract, proving better than x-ray at detecting small bowel ulcerations, polyps and areas of bleeding. • 9. Oral disease-modifying treatment for multiple sclerosis • Before fingolimod was approved by the FDA this year, MS drugs had to be injected or infused on a regular basis. This oral medication effectively stops T-cells from attacking the myelin sheaths that cover nerve fibers. • 8. Exhaled nitric oxide (NO) breath analysis for diagnosing asthma • A new hand-held diagnostic testing device measures a patient’s level of exhaled NO, which is a biomarker for asthma. Monitoring NO levels allows doctors to more accurately tailor treatment strategies. Not What I thought a Toga was? • 7. Transoral gastroplasty, or TOGA • A new experimental weight-loss option for obese patients who want to lose weight and improve their health without undergoing major surgery. This “scar-less” procedure represents a significant improvement in minimally-invasive bariatric surgery and losses approaching 40 percent of excess body weight can be expected within a year. • 6. Telehealth monitoring for heart failure patients • Miniature implantable monitors to measure pulmonary artery pressure daily and at-home devices to monitor weight, heart rate and blood pressure of heart failure patients allow doctors to adjust medication quickly, improving patient outcomes and quality of life, while reducing re-hospitalizations. • 5. Hepatitis C protease-inhibiting drugs • Two drugs awaiting FDA approval treat hepatitis C using protease inhibitors, which work by blocking a key enzyme that viruses need to copy themselves and proliferate. In clinical trials, cure rates for the protease inhibitors are higher than current hepatitis C treatments, with fewer side effects. • 4. JUPITER study and statins for healthy individuals • The JUPITER (Justification for the Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin) trial pointed out for the first time that many seemingly healthy people are at higher risk for heart disease than previously thought, suggesting that statins should be prescribed even to people with low LDL (bad cholesterol), if they have high C-reactive protein levels. • 3. First therapeutic cancer vaccine approved by the FDA • While not a cure for prostate cancer, sipuleucel-T is the first cancer vaccine to receive FDA approval. Prescribed to men with advanced prostate cancer, the drug coaxes their own immune systems into attacking and removing the cancer, reducing the risk of death by 24 percent compared to placebo. • 2. Anti-CTLA-4 drug (ipilimumab), a targeted T-cell antibody for metastatic melanoma • The effectiveness of ipilimumab in treating melanoma confirms the role of immunotherapy as an effective treatment. In patients with advanced stage III or IV melanoma, 23 percent were still alive after two years compared to 14 percent of patients who received standard treatment. • 1. New molecular imaging biomarker for early detection of Alzheimer’s disease • Currently, positive diagnosis of Alzheimer’s is only possible upon autopsy. But a radioactive molecular imaging compound called AV-45 and a PET scan can allow doctors to “see” inside patients’ brains to detect beta-amyloid plaques, the tell-tale signature of Alzheimer’s.