Many children in developing countries need help with their hearing, and Dr. Tomi Browne has done something about it. Dr. Browne, a McLean Va. audiologist, sold her audiology practice and started a non profit to help children in Kenya gain access to hearing health care. The organization, HEARt of the Village, raises funds for children at the Nyumbani Children’s Home in Nairobi, Kenya.
The mission of Heart of the Village is to ‘raise awareness in the United States about diseases of poverty and provide direct assistance to survivors with emphasis on programs that sustain wellness, education and job opportunities.’ This foundation has three areas of focus which include wellness, education and jobs, and sustainability.
The Nyumbani Children’s Home was the Kenya’s first facility for HIV-positive children. The story about Dr. Browne, and her foundation, includes pictures of Andrew Dickson Mungai, one of Nyumbani ’s children with a profound hearing loss. Mungai lost his parents at age three. Now 13, he has suffered numerous diseases, including tuberculosis and pneumonia. A bout with spinal meningitis in 2005 left him with a profound hearing loss, and no way to communicate with his friends.
Dr. Browne brought young Mungai back to the US for a cochlear implant, which is a neural prosthetic device that will allow him to ‘hear’, and improve his communication skills and overall chances in life. She will continue to travel to Kenya to help Mungai, and others with hearing loss, as she serves them through her foundation.
Dr. Browne’s actions are inspirational, and she is to be commended for her vision, courage, sacrifice, determination, and heart to help children in the developing world who cannot help themselves. It is through the efforts of people like Dr. Browne that others in the world will be given a better chance at life.
Meniere’s Disease is a condition which afflicts about 615,000 people in the US. Meniere’s Disease is caused by a dysfunction of the endolymphatic sac in the inner ear.
Since Meniere’s is associated with the cochlea, it can potentially impact hearing, balance, and perceptual disorders, such as tinnitus. Tinnitus is most often related to hearing loss, and most people experiencing tinnitus have some degree of hearing loss, although not all people with hearing loss have tinnitus.
Silere Medical Technology is developing a medical device that will suppress chronic tinnitus, which can be debilitating for many people. Although many products and therapies are available that present an auditory signal designed to alleviate the condition, there is nothing available today which suppresses tinnitus.
Dr. Michael Merzenich, a professor, author, businessman, and leading researcher in Neuroplasticity of the brain, was recently inducted into the Institue of Medicine (IOM). Dr. Merzenich is also co founder and Chief Science Officer of Posit Science, located in San Francisco, California. Posit Science provides brain fitness software for consumers.
I first became aware of Dr. Merzenich’s work in brain science and neuroplasticity after reading ‘The Brain That Changes Itself’, by Norman Doige. Dr. Merzenich’s early work in neuroscience research was focused on the cochlea. He contributed to the development of the cochlear implant, which is designed to help people with profound sensorineural hearing loss gain the ability to perceive sound, and potentially improve their speech and ability to communicate.
Dr. Graham Clark of the University of Melbourne is often credited with being the first to ‘invent’ the cochlear implant, a neural prosthetic device with an electrode array that is tonotopically aligned within the cochlea. But others, including Dr. Merzenich, had great impact on this wonderful medical innovation from the early days of the 1970’s.
The health care bill under debate in Washington and around the country includes a $40 Billion excise tax on sales of products developed and sold by medical device companies. This innovation tax is a key component of the current plan, and if implemented will be devastating to the medical device industry.
Many medical device entrepreneurs are forming a lobbying group called Entrepreneurs for the Advancement of Medical Innovation, (EAMI). I will consider joining this group because of its focus on this critically important topic.
We have excellent medical products in this country, which are developed by engineers, medical doctors, and many others searching for better solutions to our health needs. Many of these products require long development paths. They are subject to rigorous review and approval by the FDA, whose regulatory process includes costly clinical trials designed to demonstrate product safety and efficacy. Our health care system is dependent on new product development and product innovation, and our country is stronger as a result of the activities of many of these device companies.
Our own company, Silere Medical Technology, was formed to develop prosthetic devices focused on disorders of the auditory processing system. Our initial objective is the suppression of chronic, debilitating tinnitus. The development process for this device will require many years of research, clinical trials, and patient monitoring. It will require a great deal of venture financing before we can market our first commercial product.
Many people, including the entrepreneurs involved in founding the company, are investing time and resources to ensure a successful start. To be burdened by an excise tax when we first go to market would stall our progress, and take much needed capital away from our further research and development efforts.
My recommendation to the Obama administration is to consider the negative impact this tax will have on the development of future products, and remove the related language from the bill under consideration. Without the tax, our industry can continue innovate, which will positively impact the health care and quality of life of patients in the USA and around the globe.
In a recent article from Express Healthcare India, people with profound hearing loss in India are benefiting from the innovative hearing technology developed by Cochlear Corporation. The cochlear implant system allows people with profound hearing loss to perceive sound, and gives them an opportunity to improve their speech.
Some of the great new designs from Cochlear Corporation recently approved and introduced worldwide include the Nucleus 5 and the Cochlear Hybrid. The Cochlear Hybrid benefits those with profound high frequency hearing loss, but more normal hearing in the low frequencies. The Nucleus 5 implantable hearing system is designed for those individuals with profound sensorineural hearing loss, either unilateral or bilateral.
The cochlear implant has been approved by the FDA for marketing in the US since 1985. The market size for the cochlear implant is impressive, but so far only 180,000 systems have been implanted in hearing impaired patients worldwide.
Our company, Silere Medical Technology, www.silere.com is a start up medical device company in need of capital. We are working on an implantable neurostimulation prosthetic device that will suppress chronic tinnitus, which for many can be debilitating. We have a great management team, proven technology, encouraging human data from clinical research that is the best in the world, and a very large unmet clinical need. This is a ’shovel ready’ project, and will add jobs once funded.
We have been searching unsuccessfully for venture capital to finance our business since September 2008. We are changing our tactics for securing financing, but will continue to build value, increase our portfolio of intellectual property, and operate remotely with minimal headcount and limited overhead.
We continue to work with consultants for product design and prototype development, and are making great progress in the important areas of clinical research and regulatory strategy. Recently we decided to pursue the CE Mark in Europe prior to seeking FDA approval, due to the high cost and risk of uncertain outcomes of the regulatory process here in the US.
Lacking venture capital investment, our financial plan will include a seed stage round of angel investment (convertible note) combined with grants from sources such as VA, DOD, and SBIR, the small business research arm of the National Institutes of Health. The grant requests will be written after we have selected our design engineering and manufacturing source.
I am actively networking nationally and internationally to build awareness of our efforts. Last week I travelled to Washington DC, and visited with the office of Senator Patty Murray, who is active on the Senate Veterans Affairs Committe, a potential source of grant money. Senator Murray also recently sponsored the National Neurotechnology Initiative Act. The NNIA seeks to accelerate development of new treatments for brain and nervous system conditions. This Act resulted from the efforts of Zach Lynch, CEO of Neurotech Industry Organization, www.neurotechindustry.org
To complain about the economy and claim victim status is non – productive. We can’t rely on bailout money from the government, or welfare. Instead, we must work hard, rise above it all, get very creative, lean, and capital effiicient, think entirely out of the box, and run independently and as a virtual company. As a result, we will retain more of the equity in our company, and emerge stronger and better as a result.
Thank goodness for Video Conferencing, Skype, ‘freeconferencecall.com, Go To Meeting, and other great productivity tools that will allow us to manage through this difficult time.
As Vince Lombardi once said, the only time success comes before work is in the dictionary.
As a parent of a child with profound sensorineural hearing loss, the challenges of communication are very real to me. Our oldest daughter Andrea acquired her hearing loss as a result of spinal meningitis when she was 2 1/2 years. She is now married with a child of her own, has her masters in teaching, and is an itinerant teacher in a large metropolitan school district.
Andrea is the recipient of a cochlear implant, an implanted prosthetic neural stimulation device that allows her to listen to sounds that she otherwise could not hear. Of course, she had years of hard work learning how to listen, and to talk. In fact her mother is involved in a school in Seattle Washington by that name…www.listentalk.org.
Many people have helped her along the way, including her devoted mother and a very loving younger sister Marie, and other professionals who utilize an oral approach to communication known as auditory verbal therapy.
Had it not been for the therapists, educators, and devoted family, Andrea might have had a different communication outcome. But because of the combined work of many, and the technology that enables sound to be digitally presented to the auditory nerve, she has a much more full and complete life.
A documentary by Director Saj Adibsis entitled Louder than Words features a family with hearing loss who have decided to embrace this technology, and enter the world of hearing. Dr. Dana Suskind, a pediatric otolaryngologist from the University of Chicago is also involved in the production of the documentary.
My hope is that this family, featured in the trailer below, will never regret their big decision, and that other parents of children with profound hearing loss will be inspired to enter the world of hearing!
The newly revised AdvaMed www.AdvaMed.org for HCP was presented yesterday at AdvaMed’s 9th annual Emerging Growth Company Council meeting in Newport Beach, California. It was a compelling presentation, and any emerging growth life sciences company, or any company interfacing with HCP need to pay attention. R. Michael Scarano, a Partner with the law firm Foley & Lardner presented a compelling story that included 7 elements of a compliance program.
The 7 elements include
1) Written polices and procedures
2) Compliance Officer and committee
3) Effective training and education
4) Effective lines of communication (including anonymous reporting function)
5) Internal monitoring and auditing
6) Disciplinary enforcement
7) Mechanisms for resonding to detected problems
Conflict needs to be managed in several areas. The example used in the presentation included a sales representative that offered to take his HCP client to lunch, with golf, hotel, airfare, and a tour of a company in the medical device business. Putting it in plain terms, the day of the branded pen and paper, or logo golf balls, are over. Lunch is acceptable as long as it is subordinate to the conversation, and it has to be reasonable. Golf is definitely out, unless the HCP pays his way.
It would be wise to take a tour through the code, available for members on the AdvaMed website, and adopt it as part of your company if you are interfacing with health care professionals.
Rep. Jan Schakowsky (D-IL) is shown in this video relating her plans to get rid of private pay health care insurance. She favors a one payer system, which effectively will put the private pay system out of business. Rep. Schakowsky observes that the public option will put the private options out of business. She relates that the goal of the health care reform system is not to protect private payers, but will in effect eliminate them. This will be coming soon!
