KEEN DEVICES INC
C R O W D F U N D I N G
Assisted Reproduction
Technology
Everyone Can Afford
​New technology for Assisted Reproduction at 1/100th the cost.
Help fund FDA study and submission
Overview
Most people either know someone who has had trouble getting pregnant or who has struggled with infertility themselves. We want to help.
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Medical intervention through Assisted Reproductive Technology (ART) is currently a difficult and expensive process. Millions of heartbroken women worldwide cannot afford it or do not have access to a fertility clinic at all.
We have prototypes of a new ICF™ medical device designed to be more effective than the current alternatives at 1/100th the cost. We need your donations to help offset the high initial legal and government costs and bring this new medical device to the world.
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"This is a Big Deal - our backers are disrupting an industry."
-- Dr. Allen Lu, Medical Director
"ICF™ is a new patent-pending medical device that will make reproduction assistance available to almost anyone. With our long term studies, we expect to show effectiveness considerably higher than IUI and at less than 1/100 the cost.
This price point is important as finding an affordable solution is what inspired us to create ICF™ in the first place. Our primary goal is to empower as many women as possible worldwide and allow them to take charge of their own fertility. This breaks the traditional model for most companies where they are trying to prioritize profit. We are not here to make the most money possible, we are here to maximize the number of women helped.
We have chosen to Crowdfund Donations to help with the initial costs and government approvals so that we can avoid investor pressure and keep our prices as low as we can. We are asking for your help. You can help women next door and worldwide simply by making a donation and by spreading the word."
--Laurie Swingle, CEO Keen Devices Inc
Our Story
Choosing to have a child is one of the most basic of human rights and desires. While there are significant resources dedicated to Family Planning with respect to contraception, there is much less help available to women who want to have a baby but have not been able to conceive. This remains a service that is out of reach to many women worldwide. Fertility help has been traditionally reserved for well off women in well off countries. We want to change that. This campaign is for anyone who wants to help break down the barriers surrounding infertility and make options available to anyone, regardless of their income. You don't need to want a baby yourself to participate. You can be a part of it. You can help disadvantaged women both where you live and worldwide realize their greatest desire, and all you have to do is donate money and spread the word. This is what happened:
The Science
While it varies some by age it is recommended that you try getting pregnant for a year first before seeking help. Many of you may know someone that has been diagnosed with some type of infertility problem or that simply did not get pregnant after trying for a long time. The Mayo Clinic says the main symptom of an infertility problem is failing to get pregnant. Uhm, great thanks doc. So the actual diagnosis itself is actually not complicated or satisfying. In many cases finding the causes can be complex, expensive, and imprecise. In the end there are only a few treatment options available and the price tag on those options can be out of reach for many. A.R.T. is a wonderful thing it is just not very inclusive.
For various reasons, infertility is a growing problem worldwide and many countries are actually below their target birth rate.
As a global issue, it is of note that the United Nations has 17 goals to transform the world. Helping disadvantaged women with fertility fits nicely into goals 5 and 10.
The Inspiration
We knew several people who followed the guidelines and tried for well over a year to conceive and did not have any luck getting pregnant. One went through a difficult IVF experience and was blessed with a child. One was not as fortunate and the treatment did not work after several tries. The others could not afford professional help and it was not covered by their insurance but they continue to keep trying. One day while discussing their heartbreak, we decided that the problem was sufficiently interesting and difficult that we should look for a better way. We would try to help them achieve this basic but life altering goal.
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Research shows that in overall about 18% to 20% of women will have trouble getting pregnant and it is an increasing problem worldwide. That is well over 340,000 women per year in the USA alone. In the EU is over 300k, and in Canada it is over 80k, Mexico is nearly 50k, and worldwide there are well over a million women per year that have been trying and have not been able to become pregnant.
It it is generally agreed that women should try to conceive in the least invasive and most natural way possible. Today this means they should plan on trying 3-6 cycles of IUI, possibly with medication before then considering moving on to IVF. Each cycle of IUI may cost up to $3,000 with all the doctors’ visits, tests, and medications considered. Due to the expense involved many women don't wait the recommended 6 cycles before moving on to the next therapy. Just two tries for IVF will average about $27,500 and multiple cycles are often required with no guarantees. The new ICF™ device is very inexpensive and by far the most natural and least invasive solution.
Our efforts to find a better way paid off. After lots of research, discussions with experts, and dozens of versions, we created a new Assisted Reproduction device called ICF™ and applied for patents. Due to the profit driven nature of the medical device and fertility industries, only by creating a purpose-built company designed to minimize cost to the public could we make sure the prices were kept affordable for everyone. In keeping with the goal of providing an affordable solution for all, we founded a family-owned company dedicated to developing, manufacturing, and distributing the new ICF™ devices globally.
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The advantages of ICF
ICF™ will be the clear choice for the first step in reproduction assistance for women wanting to have a baby as soon as possible.
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We need your help
We have now gone as far as we can with limited resources and through the generosity of our advisers and volunteers. Even for the cause of helping women everywhere, the next round of upcoming expenses can't be waived or avoided.
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Help us help women worldwide by making a donation we will use to met some costs such as legal, tooling, FDA Registration, a short term study, approvals from various governments, and bringing ICF™ to market worldwide.
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What We Need & What You Get
Bringing a new medical device to market is extremely expensive. Expanding it globally is even more expensive as you deal with all the different regulations and processes in various countries. Typically, this has been done by very large companies with deep pockets.
According to a Stanford University report, the portion of costs directly related to winning 510(k) clearance for a medical device and satisfying FDA rules average $24 million, That is just for the United States and our goals are to help women worldwide.
Compared to the typical INDIEGOGO campaign, a $5,000,000 goal may seem like a lot of money until you consider that we are creating a new category of medical device and significantly changing a 40 billion dollar worldwide industry. We are also making reproductive assistance available to women who have never had access before. We could use 4-6 times our initial crowdfunding goal for a rapid worldwide roll-out, but this will help get us started in the USA. A typical medical device company may spend many many times more money and take several years to accomplish what we intend to do in six to twelve months.
While we have had offers, we have not accepted any traditional equity investors to help with these costs because with that comes pressure to increase pricing and profits. By funding some of these up-front costs with your donations we can keep our prices low because we won’t have to maximize profits to pay investors huge returns. We just need to charge enough to stay in business and fund the worldwide expansion making assistance available to disadvantaged women.
With your donations, we will take creating our prototypes out of the garage and into FDA approved
ISO 13485 clean room manufacturing facilities using certified bio-compatible in-vivo materials. We will complete a short-term clinical study and apply for a new DeNovo class of medical device with the FDA. It will also help with legal, R & D, licensing, accounting, consulting and other business expenses. The more money that is contributed the faster we can get this to market globally and the lower we can keep the cost to the public.
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"We strongly believe that all women wanting to have a child should be able to afford some medical assistance"
--Dr. Judy Wei, Clinical Director
The Impact
You will be effecting change and contributing to the disruption of the fertility industry. You will not personally receive any direct tangible benefit from your donation. A.R.T. is currently very expensive and most often not covered by insurance. In some cases where it is covered, there is a years-long waiting list. Not only are new ICF™ devices expected to be less than
1/100th the cost of current technologies, but by virtue of its simplicity and that affordability, ICF™ will make reproduction assistance more inclusive and available to almost all women. Millions of women that currently have nowhere to turn will be empowered with 1st level reproductive assistance
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Risks & Challenges
Even though we have protected our IP there is always a risk that someone may try to make a knock-off product. While this is a risk with any product, it may be particularly true with a new medical device. A poorly made or unsafe imitation device could harm our reputation, hurting the sales that allow us to keep it inexpensive for all. We are aware of these risks and have plans in place should this occur.
Our decision to sell our products at such a low price compared to the existing alternative products and treatments can actually create a potential problem with the public perception of value. Some may wonder if it is so cheap, how can it work or be any good? It will be a significant part of our task to assure everyone the devices work and the pricing is designed to make infertility assistance available to everyone. We will use our testimonials, published study results, articles, and respected medical experts to testify to the effectiveness.
While not considered a risk, we have still a lot of work remaining to bring a safe and effective device to market globally. We still need to switch to clean room manufacturing and conduct a Short-Term clinical study for the US FDA. After that, many governments have their own processes and rules that we will need to comply with.
Untested: Note that ICF™ devices are currently prototypes. It has not been mass produced or tested with an approved FDA study. This is an entirely new product and while effectiveness is expected to be higher than IUI we do not yet have clinical study results. One of the primary goals of crowdfunding is to finance a study to prove the effectiveness of the new device.
We don’t need any scientific breakthroughs to get the product to market, but there is still more engineering work to be done. We know what to do and how to do it, but there is time and money required to complete this effort.
Even though the function of the ICF™ the device itself is simple, it is very difficult to manufacture. Many times we were told by large global medical devices manufacturers that this device simply can't be made because it is technically too complex. Fortunately, we did not know it was impossible and we went ahead and did it anyway. Under non-disclosure agreements we showed a select group of global device
manufacturers our prototypes and they are now believers. It is indeed hard to make and will require new purpose built equipment and new techniques, but these are now well understood and we and our manufacturing partners are ready to begin when we have the funding in place.
Other Ways You Can Help
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In addition to your contributions, we are asking you to help us by spreading the news of our campaign. We are addressing a global problem that no one else is working on. The success of our funding and the speed of global market deployment depends on help from the general public worldwide. For maximum effectiveness, we also need you to call upon your contacts with, institutions, insurance companies, philanthropists, athletes and celebrities, influencers, publications, the large community of people that have been through fertility treatment, foundations, governments and anyone who wants to help women get access to reproductive assistance. No one is
trying to help these women today because it is not profitable and it is not a life-threatening condition. Be a part of it and help get the word out, help us help them.
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Finally, If you are a woman 18-38 near Irvine, CA, USA you can volunteer to be in the engineering and clinical studies. You do not need to want to have a baby yourself to help with our studies.
The fertility industry is big business and CAGR is projected to be over 10% per year through 2030. There could be some participants that do not want an inexpensive solution for fear of competition. We understand that, however, to make help available to the large under-served community of women that cannot afford traditional Assisted Reproductive Therapies and to those who live in areas where A.R.T. clinics are not available, we have chosen to sell our products at extremely low prices compared to the alternative. Naturally, this will include some women that would have gone to the existing clinics so some business will be taken away from the current system. There are many types of treatments today. Due to their safety, effectiveness, and extreme low cost the new ICF™ devices should become the first step to try for most women. It will not work for everyone and some patients will still move on to the traditional more invasive and expensive therapies. Additionally, because ICF™ is inexpensive and will not require a prescription, many women will use it simply to get pregnant as fast as possible even if they are not aware of any problem keeping them from finding their way to the traditional clinics.
Frequently Asked Questions
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What is A.R.T.?
According to CDC A.R.T. or Assisted Reproductive Technology is a branch of medicine where fertilization occurs in the laboratory. In a more general sense, according to the World Health Organization, many definitions are used in describing assisted reproduction including various fertility medicines and procedures. For the layman, you may consider any assistance in fertilization or conception to be ART.
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How much does A.R.T. cost?
The cost varies, but IUI is about $3,000 and IVF is nearly $20,000 for the first try and totals about $27,000 for the first two tries. Multiple cycles are usually required. Most insurance companies will not cover ART procedures. The new technology being funded here, is designed to be less than 1/100th the cost of IUI making it affordable to virtually anyone.
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How do I know if I have a fertility problem?
You are not getting pregnant. It sounds too simple it is almost condescending, but according to the Mayo Clinic failing to get pregnant is the main symptom of infertility.
How can ICF™ be so inexpensive?
It is a re-thinking of the problem from an engineering perspective. The combination of the simplicity of the device, putting the profit motive as secondary, and not having an obligation to maximize profit for shareholders will allow us to help many more women through extreme low pricing.
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How long will it take to get pregnant with ICF™?
Typically, pregnancy rates are measured in pregnancies per year of trying and there are many factors involved. ICF™ won't work for everyone, but it is designed so that more people can get pregnant faster. It increases your chances on each try and addresses several types of potential infertility problems. Even if you don't have any known fertility issues you can still use ICF™ to get pregnant sooner.
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Is there anything wrong with traditional A.R.T.?
No. Conventional reproduction technologies have been miraculous for those that have access to and can afford them and we applaud their success. Keen Devices Inc was created to expand fertility assistance to women worldwide that do not have access to or cannot afford conventional ART as well as to be a first step to try for everyone considering getting assistance. Because ICF™ will be about 1/100th the cost it can be affordable for many more women.
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When will ICF™ be available?
That depends. Currently, we are planning to make it available in the USA first, and there is a planned roll-out to other countries. A lot of the timeline depends on the funding support we get from the public. Each political jurisdiction has its own rules on medical devices and each has its own costs involved in bringing it to market. The more money we have up front, the faster we can expand the availability by working on multiple jurisdictions at once instead of funding expansion from profits.
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Do I need to want to have a baby to help?
No, not at all you only need to have a heart (and a few bucks). You don't need to want to conceive yourself. You probably know of someone or have an acquaintance that has tried to get pregnant and not had any luck. In some countries, it is even worse and women just don't have access to help at all. Your gift will help women everywhere have access to first level infertility assistance. If you live near Irvine CA you may be able to participate in our study.