Hydrocephalus Mobile App hopes to be new mHealth Test

The DiaCeph Test was created in 1997 to evaluate CNS shunt performance in patients with the disorder, hydrocephalus. It is a mathematical formula and algorithm born out of my experiences as a patient and patient advocate, and from 18 years of experience in diagnostic nuclear medicine, including, with hydrocephalus and software.

DiaCeph’s algorithm uses a weighted probability of a patient user’s clinical complaints, or complaint markers, to the most likely of (17) types of malfunctions that can occur with a CNS shunt. The results are displayed and ranked in order of probability. In addition, the markers are plotted on time vs complaint level graphs, where they are compared to the patient’s baseline markers and earlier shunt outcomes. The impetus for creating the DiaCeph Test came from my poor post surgical outcomes and frustrating diagnostic experiences as a patient user for hydrocephalus following a 1992 auto accident. I’ve used my DiaCeph methodology (paper forms) to track the shunt outcomes, make shunt valve pressure predictions, and diagnose shunt malfunctions for my last (8) shunt revisions. Still in 2016, there is no reliable diagnostic means to determine how well a CNS shunt is working. The DiaCeph Test could readily be made into a mobile app, providing the necessary funding, administrative, and FDA regulatory requirements can be satisfied.

The DiaCeph paper methodology could easily be produced as a mobile data app.
The DiaCeph paper methodology could easily be produced as a mobile data app.

DiaCeph Test born out of FDA Petition/Unmet Need in Hydrocephalus

Hydrocephalus is the leading neurosurgical disorder in children, often resulting as developmental changes in utero, shortly after delivery, or by brain cysts early in life. It occurs in seniors in the form called NPH, or normal pressure hydrocephalus, and in the past NPH was often confused with dementia and/or Parkinson’s Disease. It can also occur following trauma and tumors in the brain. It is most often treated by surgical insertion of a “CNS shunt,” which the patient will live with the remainder of their life, and which are very problematic technology often requiring surgical replacement.

My DiaCeph data app slide above is from my original (1997) design of the DiaCeph Test. This came out of my research in authoring an important 1996 FDA petition on anti-siphon shunts. I was familiar with hydrocephalus and CNS shunts from my many years of diagnostic work in nuclear medicine, where I worked with software and regularly wrote procedures, and occasionally basic software code.

Stephen Dolle invented his DiaCeph Test following his 1996 FDA petition that was then used to direct this 1998 shunt surgery
Stephen Dolle invented his DiaCeph Test following his 1996 FDA petition that was then used to direct this 1998 shunt surgery

I had been a patient user of CNS Delta valve shunts for hydrocephalus since 1992, and had experienced unexplained poor outcomes from three surgeries over a period of four years. In 1996, I learned of a new critical study published in the Journal of Neurosurgery by a well known Japanese neurosurgery group, that cited specific safety & performance issues with Medtronic PS Medical Delta Shunts & Anti-siphon devices that seemed remarkably similar to complaints I was experiencing. Sadly, neither my treating physicians, shunt manufacturers, or the Food & Drug Administration were able to help me.

In November of 1996, I petitioned the U.S. Food & Drug Administration (FDA) Center for Devices and Radiological Health with this important FDA petition on CNS anti-siphon shunts, concerning problematic CNS shunt technology which I had been implanted for 4 years, and was experiencing unexplained poor outcomes. It was in 1996 that a critical study was published in the Journal of Neurosurgery regarding the risks of using anti-siphon devices. The petition took me almost a year to prepare, and required that I obtain supporting FDA records on microfiche, obtain and learn the federal government’s applicable CFRs to CNS shunts, pay a librarian consultant for many of the (52) cited studies, and carry on correspondence with Ralph Nader’s group Public Citizen.

What I learned, was that between 1976-1996, many thousands of patients had been implanted with Medtronic Delta valves & Heyer-Schulte anti-siphon shunts and that about one-third of these were experiencing the kinds of poor outcomes as cited in the Higashi et. al. J. of Neurosurgery study. Higashi and his team described these shunt performance issues as “functional obstructions” of the CNS shunt system, most of which occured in the upright posture. However, some were reported with sleeping and other external pressure over the body of the shunt valve. What made the problem particularly challenging, was that there was no available (in-vivo) diagnostic test to identify and quantify the issue in patients. Available CT/MRI and shunt patency testing was usually “negative” for shunt malfunction, which is termed a “false negative.” Higashi and his team then cited the need for a new type of diagnostic test to identify these shunt outcomes issues in affected patients. Once I authored my petition, my next challenge was in creating a new type of test to evaluate these shunt performance issues.

I sought out a method to chart & analyze non-invasive clinical markers in hydrocephalus in different postures, and during different times of the day. This was 1997, and the same year researchers at the U. of Pittsburgh and Henry Ford Institute, were quietly doing this to monitor sports concussion. It took me more than a year, during which I also consulted aerospace scientists on possible math formulas. Once it passed the first proof of design phase, I expanded my test to evaluate any type of problem with any type of CNS shunt. And then I aptly named it the DiaCeph Test. Dia– meaning to diagnose. And Ceph– meaning of the brain. The design and proof of concept were completed in Sept. of 1997. And then I began using it to evaluate my Delta shunt for corrective revision.

Initially, I was going to “give my method away” to one of the shunt manufacturers. But it was a friend from little league baseball who convinced me to try and PATENT it. Which I did via the law firm Knobbe Martens Olson & Bear. The photo above was taken just days after my Feb. 1998 shunt revision where I used the DiaCeph Test to help determine which type of shunt would fit my CSF outflow needs.

 

My experience in nuclear medicine and working with hydrocephalus and diagnostic software proved invaluable in the creation of the DiaCeph Test. Over my 18 years of nuclear medicine (beginning in 1975), I had authored hundreds of diagnostic procedures, set up hospital imaging procedures, started and run an imaging company, and provided diagnostics for a wide range of medical conditions. Two of those tests for hydrocephalus were cisternograms and shuntograms.

In 1997, my DiaCeph Test was so new, it didn’t have a category name. But today, these type of applications are widely termed, “mHealth.” As such, my DiaCeph Test design was one of the earliest mHealth tests, and remains state of the art still in 2016. But, designing it was no simple task. I had to contend with frequent cognitive or memory difficulties, shunt malfunctions, terrible headaches, and lack of funding.

In 1998, I filed my full patent on the DiaCeph Test and formed the start-up, DiaCeph, Inc. DiaCeph was to be a dedicated PDA app, like the Palm Pilot that had just become available. The Internet at that time was just mature enough then to allow patient data and results to be sync’d with a PC either at the patient’s home, or at the physician’s office. I proposed how a server could allow uploading & sharing of patient results.

DiaCeph can analyze non-invasive user data and render a diagnosis of the type of shunt malfunction. I created a series of clinical markers (as can is seen in the slide above), and by establishing a patient’s baseline normal values, incident results could be compared and produce a diagnosis based on the change from normal. Where there was no comparitive data, the program still aggregated resulting data and compared it with the most likely data known by the program for the different types of shunt malfunction. I was advised that patients not be given access to the results by FDA and others involved in the project. Today we know its best to give patients this information. Below, is earlier web site information on the DiaCeph Test. Below that, an Orange County Business Journal‘s 1999 story about the DiaCeph Test entitled, “The Accidental Inventor.”

DiaCeph Test at DolleCommunications.com 

Stephen Dolle, Dr. Eldon Foltz, and Stephen Natawpski of Knobbe Martens are interviewed by the Orange County Business Journal regarding the invention of the DiaCeph Test, and Stephen's FDA efforts in Washington, D.C.
Stephen Dolle, Dr. Eldon Foltz, and Stephen Natawpski of Knobbe Martens are interviewed by the Orange County Business Journal regarding the invention of the DiaCeph Test, and Stephen’s FDA efforts in Washington, D.C.
Stephen Dolle interviewed in the Orange County Business Journal for his FDA efforts and DiaCeph Test invention Page 2
Stephen Dolle interviewed in the Orange County Business Journal for his FDA efforts and DiaCeph Test invention Page 2

DiaCeph underwent initial evaluation and development at the University of California Irvine (UCI). My lead physician was the long time neurosurgeon and professor, Dr. Eldon Foltz, who was excited about the DiaCeph Test and offered to mentor me. He shared he had been trying to develop a similar test since 1980. Dr. Foltz helped me form a board of medical advisers at UCI, and introduced me as an mHealth pioneer.

After the FDA granted my shunt petition in Sept. 1998, I was invited to attend the FDA’s STAMP Technology Conference in Bethesda, MD, which was to address shunt safety issues as cited in my petition. However, the conference never did! Nor were these CNS anti-siphon shunt challenges discussed, nor DiaCeph mHealth concept. And neither was I was not invited to appear on the conference panel, despite being the person who helped create the conference. As a result, my DiaCeph Test and similar solutions never received the exposure they deserved. It no doubt hurt prospects for the DiaCeph Test at a time it was badly needed, and amid my limited resources as a patient developer.

As time went on, I looked for new novel ways to utilize the DiaCeph methodology. Below, are SlideShare.net slides of new (July 2016) DiaCeph Test NPH Instructions, a NPH 6-Marker Form, and a new Chronological Outcomes Form or “flow chart” for creating a patient record of many years with various shunts, opening pressure settings, and hydrocephalus outcomes (complaints/status) in a patient. There are instructions on how to complete the historical flow chart in the back of the NPH instructions.

These materials are FREE to use. But if you have questions or would like my assistance with monitoring or related hydrocephalus and shunt issues, please contact me directly. My consulting rates are $125 per hour.

Diaceph 5 day 7 marker NPH hydrocephalus shunt monitoring form
Diaceph 5 day 7 marker NPH hydrocephalus shunt monitoring form

DiaCeph Test MONITORING INSTRUCTIONS

DiaCeph Test MONITORING FORM

DiaCeph Test FLOW CHART

DiaCeph, Inc. as a Brain Software Company

By 1999, I was exploring other brain apps & software and making plans for this as part of DiaCeph, Inc., to be an innovator in this space. This was prior to the advent of Google apps, social networking, and mobile tech leaders like Samsung and Apple. At that time, the only two mHealth apps under consideration were by Aetna’s health division for CHF and asthma. I was also in communication with Hewlett Packard, Microsoft, the Coleman Institute, and other institutions involved in assistive cognitive technologies. I presented DiaCeph to a number of university centers and medical device companies. But I could not get any committments to partner or fund it. Apparently, no one saw my vision.

By 2003, I had begun to move on to other neuroscience interests. My brain also remained significantly swollen due to unresolved and mis-understood hydrocephalus, and kept me on disability, working only part time. I could not get a neurosurgeon to undertake additional surgery without diagnostic documentation. It was a Catch 22! I believe if the DiaCeph Test were available then, it would have answered these diagnostic questions.

In the end, the DiaCeph Test was never made into a PDA app due to lack of fundingFDA regulatory barriers (costs), and lack of support from medical device companies in the field of neurosurgery. However, DiaCeph could still be produced today as a mobile data app. I wrote up a “creative brief” in 2014. The challenge now lies mainly in the FDA regulatory costs of mHealth apps, where estimates have said to be in excess of $1M. It is doubtful this cost could ever be recouped in sales of the app. So I prepared wider prospects for other neurological apps in my expanded Creative Brief.

Hydrocephalus today still faces considerable mis-diagnoses due to unavailability of imaging and mHealth solutions. Radiologists regularly mis-interpret CT and MRI brain scans, which leads to undiagnosed shunt malfunction and incorrect settings of programmable shunts. This in turn has resulted in significant quality of life issues and costs for patients living with hydrocephalus.

Below, is a screen shot of a CT/MRI mHealth Display method I’ve been using since about 2002. This helps to organize CT and MRI scans into useful formats for review by your physicians, especially when there are many scans over a period of years. At present, the link is to a blog I authored on LinkedIn. I hope to sometime elaborate further on this in a new company blog. I also consult on preparing these at my same $125 per hour rate.

Method of Organizing CT & MRI Images for Chronological Review

Innovative Dolle mHealth method allows CTs & MRIs to be chronologically oarranged and compared.
Innovative Dolle mHealth method allows CTs & MRIs to be chronologically oarranged and compared.

You should obtain CDs of all your CT/MRI brain scans. The method allows for review of 1000s of CT & MRI images by placing the most critical images in a chronoligcal sequence for comparison. These displays can also reduce interpretation medical errors.

To create these, I first create folders on my PC for each CT or MRI series. Then I export the images as JPEGs into the respective folders using the media software included in the radiology CD disc. Next, I review, select, and label the relevant images and copy them to special forlders where I arrange them in chronological order for better viewing. This format makes interpretation much more scientific, and it minimizes any human (visual) error during interpretation.

This method is particularly important in hydrocephalus care – where it is common to have dozens of studies and 1000s of CT and MRI images for review. This mHealth display method would benefit radiologists, neurologists, and neurosurgeons involved in hydrocephalus care and other care involving CT and MRI studies.

This method allows for more detailed evaluation of shunt settings, shunt performance, and shunt malfunction. I put these mHealth methods to good use in my hydrocephalus consults and shunt monitoring services.

Once you have assembled the critical MRI/CT Images Folders, they can be easily sync’d and copied to folders on your mobile phone and tablet device. Then when you see your physician, you’ve got all your CT and MRI images neatly organized for review.

Below, is a diagram of my current shunt valve, the Codman Certas valve, which was implanted in Nov. 2012. However, in May 2013, it was recalled due to stability issues during MRI exams.

Illustration of the Codman certas valve, an externally adjustable programmable CNS shunt valve with 7 pressure settings, and is used in the treatment of hydrocephalus.
Illustration of the Codman certas valve, an externally adjustable programmable CNS shunt valve with 7 pressure settings, and is used in the treatment of hydrocephalus.

The DiaCeph App today could be made as a mobile data app and text app (for use in developing countries). It would enable 24/7 monitoring of hydrocephalus and could be coupled with a variety of neurological, EEG wave, and other apps now available.

Additional Resources on Hydrocephalus Monitoring

Hydrocephalus NPH Monitoring by Stephen Dolle/Dolle Communications

NPH/ Hydrocephalus Monitoring

Mobile Apps, mHealth, and other Solutions for Hydrocephalus

 

I’ve been providing NPH/Hydrocephalus Monitoring Services & Patient Consults with DiaCeph paper forms/instructions since 2009. I also host FREE monitoring forms and information on hydrocephalus. My experience with hydrocephalus now spans 18 years of diagnostic work in nuclear medicine, and 21 years in FDA regulator affairs, CNS shunt reviews, mHealth design, cognition and assistive technology, drumming & music therapy, and global patient consults for affected individuals/families around the world.

I also host two consult reports on the top blog above (Hydrocephalus NPH Monitoring by Stephen Dolle)The first report was completed by a legally blind man. I provide each patient a custom set of forms and instructions. If an mHealth app were available, it would direct patients or users in the collection of this data, and then offer physicians the data in a finished format for earlier diagnoses, intervention, and surgery.

HydroPowered.org – Super Heroes

The Terminator is the ultimate super-hero for adults and children affected by hydrocephalus.
The Terminator is the ultimate super-hero for adults and children affected by hydrocephalus.

Early on, after I was implanted with a VP shunt for hydrocephalus, I began to seek creative comfort in stories about Super Heroes. As an inventor, I also began to equate living with a CNS shunt implant to the Terminator character in the movie of the same name. Eventually in 2013, I created a fun web site and Facebook page for hydrocephalus – where I began to write about “super-heroes” for hydrocephalus. Here I am today pictured below in a current photo following a speaking engagement. My rates are very reasonable, and I have a list of topics I speak on. Contact me for more information of this.

I have undergone 12 brain operations, or shunt revisions as they are termed, since my initial diagnosis in 1992. I became a shunt device, hydrocephalus “expert,” and early inventor of an mHealth mobile app, the DiaCeph Test. It was my 1996 petition to the Food & Drug Administration as a CNS shunt patient that led to my designing the DiaCeph Test. My efforts then helped bring about the 1999 International STAMP Conference in Washington D.C. At that time, many in industry felt the conference and FDA upholding my petition were heavy handed actions designed to hinder innovation in industry. But in the years since, it has been shown to be just the opposite, that without mHealth tools and patient engagement, there will be less innovation, more challenges for physicians, higher costs & disability rates for patients, and a lower quality of life for those affected. It is time for industry, FDA, and Congress to stand in our shoes! In 2015, I also published my current health challenges with hydrocephalus and a related neuromuscular disorder on my blog in this case study.

Many of the CNS shunts in use today are programmable shunts, where pressure and flow rate can be externally adjusted for each patient. But, many of these devices have been susceptible to inadvertent reprogramming from household appliances and technology magnetic fields. At present, FDA does not allow patients to own the reader or programming tool to help manage these unforeseen events. I would love to develop a mobile app or accessory tool to allow patients to check the setting of their shunts.

Other Brain Apps

I use other brain apps on the Android Play Store to help with the management of hydrocephalus, including, a Decibel Meter, EMF Detector by Smart Tools, and a Weather & Barometric Pressure app by Elecont Software. The more recent availability of EEG readers has further elevated the prospects of brain apps in neurological care, and in meditation and mindfulness – SEE my other blogs for information on these.

I advise and write about brain apps, often helpful in hydrocephalus and other neurological disorders. In this blog, I share tips on design & using apps:

Design & Best Use of mHealth Apps

And in this very popular mHealth blog, I discuss how to use a weather app for management of migraine headache:

Weather Apps and Web Sites for Management of Migraine

The slide image below is the barometric pressure reading from my Elecont weather app.

The Elecont HD app provides an hour by hour barometric pressure reading that can be used to help manage migraine headache.
The Elecont HD app provides an hour by hour barometric pressure reading that can be used to help manage migraine headache.

DiaCeph Development Costs and Other Barriers

Estimates to develop a hydrocephalus mHealth app are as high as $1M. Requirements by FDA are driving these high costs. In developing countries, FDA guidance does not come into play. And for those regions, a “text app” version of the mobile data software could be created to do monitoring on a standard mobile phone, and text the results to a regional hospital or clinic. My DiaCeph Creative Brief is currently 16 pages. I understand this is too large for most reviews. So I am preparing a “short” and “long” version.

I understand there are organizations who could help develop or fund my mHealth app project. My wish would be to work with a mHealth software group and provide the guidance and expertise to develop the DiaCeph app, and then advise on other applications.

Currently, development of mHealth apps for disease management have become a political ball game between patient advocates, the Food & Drug Administration or FDA (backed by big corporations), and Congress. Earlier this year, a bill was introduced in Congress by Senators Deb Fischer (R-Neb.) and Angus King (I-Maine), identified as the PROTECT Act (Preventing Regulatory Overreach To Enhance Care Technology). The bill has garnered the support of IBM, athenahealth, the Software & Information Industry Association, and Newborn Coalition and McKesson.

Shortly after introducing the act, the legislators penned an editorial in USA Today calling FDA’s regulatory process burdensome and a hindrance to innovation. One organization, with connections to big pharma lobyists, calling itself the mHealth Regulatory Coalition (MRC), has come out and opposed it. But I suspect they don’t live with a medical condition like hydrocephalus, that would benefit from these mHealth app innovations.

PROTECT Act Bill S2007

Protect Act Story on Protect Act

Groups Opposed/Conflicts of Interest to mHealth

Protect Act under Fire

Pediatric Hydrocephalus Foundation supports PROTECT Act

Many individuals with hydrocephalus have had 100 and 200 surgeries, and live a very poor quality of life. Quality of live, and unnecessary brain surgeries, would no doubt be improved with the availability of mHealth app diagnostics.

If you are interested in development of the DiaCeph Test, obtaining a hydrocephalus consult, mHealth consulting, or my speaking at an event, please contact via the information below.

Stephen Dolle
Dolle Communications
Email: contact [at] dollecommunications.com
http://www.dollecommunications.com/
http://www.hydropowered.org

Advertisements

Overcoming Barriers in the Adoption of mHealth Mobile Apps

I wrote an in-depth response to the “12 barriers” presented in the blog below on the LinkedIn Mobile Health Association group, and am posting my discussion public here.

The title of the blog post is “12 Barriers to Adopting Mobile Technologies in the Healthcare Industry”
http://www.integratedchange.net/barriers-to-adopting-mobile-technologies-in-the-healthcare-industry

This blog presents a nice concise overview of the issues, and I took it as an opportunity to share my knowledge on the subject. As to my qualifications, I designed & patented one of the first mobile health apps in 1997, the DiaCeph Test, a disease management & diagnostic app for the disorder hydrocephalus. It was to run as a stand-alone app on a PDA. I formed my start-up company, DiaCeph, Inc., and for 3 or 4 years I followed all of the developments during those years. Today, mobile data apps are different from the earlier stand-alone & PC applications. However, we can learn a great deal from those early years, and individuals such as myself have experience in working earlier apps. So, it’s just a matter of picking up where we left off. As such, I feel that I have an astute understanding of mHealth app prospects today.

The blog lists 12 distinct barriers that need to be addressed in order for mobile health, or Mhealth apps, to be put into widespread use.

1) Security
2) Health Devices
3) Remote Places
4) NHS Network – N3
5) Difficulty Understanding the Technology:
6) Difficulty for NHS Staff
7) Hacking
8) Lack of Incentives for GPs
9) Mobile Does Not Mean Only Mobile
10) User-Friendly
11) Human Appeal
12) Lack of Support

Let me begin by addressing No. 8: Lack of Incentives for GPs (Physicians). Just as it were proposed 15 years ago, I believe it still holds true today. There needs to be a reimbursement code & fee for physicians to examine patient data from health apps, particularly, disease management apps for chronic illness. If the app provides [invaluable] clinical information that the physician would not otherwise have, the app data must be viewed as clinical testing. Even though the results might only require a quick check or interpretation, there is an interpretation taking place and doing so could/should involve a fee (esp. where there are no other charges for the monitoring). Another way physicians could earn a fee, is thru cost savings and capitation in managed care practices.

In chronic illness, which today accounts for 75% of all health care spending, health apps can make an invaluable contribution to clinical care & outcomes. Digital monitoring has been used in CHF, asthma, diabetes, and a few other disorders with good success. But there’s not yet been the widespread and seamless integration to drive the needed adoption and support.

As to No. 3 Remote Places: I believe “text apps” could be used on standard phones, and operate a bit like my earlier DiaCeph app on a PDA, and the resulting file texted to a care facility.

With most of the other barriers, notwithstanding those of security (which in my view applies to all mobile data), the challenges I believe can be answered by physician and plan reimbursement, which will then drive adoption.

Briefly, my view of apps is in one of three (3) categories: 1) Fitness & light wellness; 2) Disease Management; and 3) PHR or personal health records. The latter category poses the key hurdles with secutity, whereas the 2nd category is for management of chronic illness, which is critical to care outcomes, and is also where much of my experience lies.

If physicians are reimbursed for reviewing or interpreting app data in chronic illness (which I believe can happen), then physicians will lead adoption and tech support – which is how it should be. App recommendations, use, adoption and support will then go thru their office, much in the way prescriptions are written thru their office today. I also envision “app centers” where patients can get support and the latest user information on apps. These app centers could also serve of the types of apps, relieving AT&T, Verizon, and Sprint of this responsibility. Just imagine the marketing efforts that would ensue to physicians, the reimbursement, and the value-cost savings in medicine. We’ve seen leaps and bounds of progress in UIs and adoption of apps in only a few years. So many users are ready for this next wave of technology. It’s the seniors and slow learners next that must be brought on board tech and mobile apps. But just imagine what a coordinated effort could do. There’s so much money & cost savings at stake in mHealth not to do this. Yet, UIs and accessibility must improve.

One of my pet peeves is “cognitive accessibility” of web sites, apps, and product labeling, and store shelves. It is an area that I became involve in, and advocate and write about, as a result of a brain injury and CNS shunt placement in 1992 (I have underwent 12 shunt revisions to date). Times when I am tired or otherwise not feeling well, I have limited patience for misdirection and poorly designed UIs. I have become particularly adept in cognition, artificial intelligence, and learning. In recent years, though, much of my work has been with drumming for the brain. Yet, I am an accomplished neuroscientist & patient advocate, and as mobile technology has progressed, it has attracted my interest. I earlier spent 17 years in nuclear medicine imaging and worked with some of the most poorly designed instrument interfaces you could imagine. Having been adept in technology enabled me to apply it to my needs post brain injury. Plus, 35 years ago, I considered going into instrument design work. All of this affords me a unique perspective with mobile apps & mHealth today. I also provide neurological consults around the world with paper forms based on my DiaCeph design. So I know how mHealth would fit into care.

In closing, I believe we have 90% of the information that is needed to make mobile health succeed today. We must primarily solve the outstanding integration, platform differences, and security issues. Once this is done, the developments will transend the millions of mobile apps coming available, and making them much more integrated, and much more secure. Dare to dream!

Stephen

Orange County is Fast Becoming a Boon for Tech Startups

Last night, I attended Start-up Events Orange County’s event, Women in Tech Part 2, and was very impressed. I found a great variety of mobile app, gaming, web-enabled, and personal & social tech-ware. There is no doubt the OC is fast becoming a haven for tech startups, of course, with a little help from the big success of the Oculus Rift virtual reality gaming, and their acquisition by Facebook. And these smart girls are really cute too!

Startup Events Orange County

Irvine, CA
1,325 OCpreneurs

Startup Events Orange County is a fluid collective of networks, highly customizable to suit customized events. . .sometimes about startups, sometimes about entrepreneurship, s…

Next Meetup

All Access Q+A – Hardware, Products & Going to Market – From…

Wednesday, Jul 22, 2015, 6:00 PM
2 Attending

Check out this Meetup Group →

I was able to peruse and talk with most all of the exhibitors, some 15-20 up & coming tech startups, that I expect to be around next year. One of the exhibitors, LynxFit, was there with a Google Glass set up for fitness training. Another, Zuul Labs, showcased their 1st art gaming app, Tall Tails, and shared how their using coffee & their new gaming app to save rescued dogs. Another, MotorMood, makes a LED device to go in the rear window of your car to let other drivers know what you’re feeling.

I continue to stay abreast of area tech and frequent several of the tech Meetups. I am still hoping to develop my earlier DiaCeph mHealth test for hydrocephalus as a mobile data app. I’m also offering to consult for groups involved in mHealth, and others involved in assistive cognitive technology and cognitive accessibility. My entire 40 year career has been in tech, from my years in nuclear medicine technology (1975-1992), where I became a guru of sorts and founded my own company, to my design of the DiaCeph Test, and efforts with assistive technology, mobile apps, and now cognitive accessibility. My skills with tech in nuclear medicine were so well established, that my first job out of college I set up a nuclear medicine department from scratch, then taught staff physicians about it.

It was in 1997 (after my brain injury & living with shunt complications), that I designed & patent my DiaCeph test, originally because of hidden issues with my Delta anti-siphon shunt – which I petitioned FDA on in 1996. I was having problems, and nobody would revise me – because there was no diagnostic proof of a shunt problem. I designed DiaCeph in 1997 as a stand-alone PDA app – and I was in fact, one of the earliest people to design a mobile type of app. It just took tech 15 years to catch up with me. Many of the things I wanted to do previously in assistive apps, are now more possible today. And the business model for DiaCeph as a data app is almost completely different today. As a data app, it would still be ahead of most mHealth apps today. My biggest concerns are the costs of coding & development, and getting it done within the restrictions of new FDA guidance.

If I had my caruthers, I’d create “open-source” CNS brain shunts with new features and capabilities, and tell the FDA to go pound sand! Their Phase II and PMA regulations are much to blame for many of the current shunt problems.

Sometime soon I will publish new content on my DiaCeph Test, and content on other brain apps & such I’ve used and can endorse. I only have so much time, and currently have quite a few projects demanding my time. My neurosurgeon, Dr. Muhonen, has also asked if I might be able to create a mobile app or other means to read the setting of programmable shunts. It looks unlikely that it can be done via the phone itself. It would have to include an accessory plug-in or some stand-alone reading mechanism. I’m not sure if you heard, but it was discovered a few weeks ago that my Certas valve suffered a changed setting and may have gone on for 4-5 months undetected. That was fun!

I am still doing my drum circle facilitation work. But I am being much more selective now to better account for my time. I’ve got some new applications & methods in drumming, and will write about them when the time is right. I am pleased to know they are a lot of people doing drumming today because of my efforts.

Here’s a link from one tech startup from the event I expect to use.

http://www.yourkidvid.com/

Stephen

mHealth will Revolutionize Modern HealthCare

Google play-store-logo.mHealth

We are on the verge of revolutionary change in health care delivery in the U.S., of the likes we have not seen in the last 50-75 years. And I believe physicians, the corresponding medical organizations, and the U.S. government are scared to death of these changes – because THEY will lose CONTROL! In fact, I think the U.S. government is more fearful than even of drug trafficking. And this revolution will come via new mHealth technologies & mobile apps.

Clearly, the U.S. government & industry have resisted changes to health care delivery. But mHealth apps will transition control of health care from the clinical setting/utilization review over to the patient as a consumer, and armed with many new customizable apps and combined with the power and offerings of the Internet. These new technologies and capabilities will enable Americans to be healthier, stronger, wealthier, happier, and more independent – and that just scares the crap out of you-know-who! These new technologies would also help make health care spending more transparent, and likely reveal huge amounts of spending wastes. And that too scares the crap out of you-know-who!

FDA and Congress would have us believe that they have been protecting our privacy through legislation such as HIPAA all along. But, I believe this has ever been about protecting our privacy. It’s been about stalling the capabilities and independence that mHealth would bring, and it’s transitioning control from the current clinical setting and utilization review, to a more transparent system that would give patient’s far more control and say so in their care.

With ObamaCare now coming into the fold in 2014, it will be interesting to see how these new features & coverages play into the new mHealth-concentric care model.

ABOUT ME: Began my career in 1976 as a nuclear imaging technologist, founded my own imaging company, and dev’d skills as a medical intuitive in 1981. Today I put on drum circles for the brain, and provide neurological monitoring & consults for the disorder hydrocephalus via my DiaCeph monitoring method I developed back in 1997.

I had also suffered a brain injury and CNS shunt placement in 1992, and have undergone 12 surgeries to date, with 7 of the devices that were used, and failed, not having been reported to FDA! In 1996, I had successfully petitioned FDA on several problem CNS shunt devices, then in 1997 designed & patented the DiaCeph Test, an early mHealth PDA app for hydrocephalus. Since then, I created many different AI methods for cognition & memory, and cognitive accessibility. I am also a writer & speaker. Based out of Newport Beach, California.
Read More »

Cool Math use in Music, Science, and Technology for Math Awareness Month

In honor of Math Awareness month #MathAware, here are my cool uses of math in music, science, and technology.

In music, I use math in my percussion with drum circles in the various time structures & types of rhythms. Rhythm is everywhere: in dance & our body physiology, in our brain waves, and around us in nature, the planets, and universe. Do you have a favorite musical rhythm?

In my neurological monitoring work for the disorder, hydrocephalus, I use math by assigning numerical values to a patient’s neurological markers, then I interpret the data into medical discussions and diagnoses. I designed & patented this method back in 1997, and named it the DiaCeph Test. “DiaCeph” is from the Latin root of two key medical words. Do you know which ones? It is still a very relevant method today. You can find it on my web site and SlideShare.net. If I find $100K, or my own software developer, I’ll make it into a really cool mobile app!

Then I use math again in the layouts of many of the reports I write, especially in the formats I create, in logic & reasoning, presentation of subject matter, and analysis and conclusions. Can you think of one of your own reports, where math & reasoning were pivotal?

Lastly, I use math in many of the mobile apps & software I use. My own memory can be poor at times, so I regularly use software and technology to keep myself organized, connected, and productive. And of course, math & logic is at the core of all these apps and software. Which of your favorite apps or software is the most math oriented?

Here’s the web site for Math Awareness Month.
AI Number Code
http://www.mathaware.org/index.html

Enjoy.

Stephen Dolle

How’s your Implant Functioning (My BWE Sub-title to Terminator 3 Movie)

This is my Brain Awareness Week (BAW) photo which illustrates what we need to aim for in our brain science efforts: “Self Sufficiency.”

If you recall, oTerm3 Hows your Implantne of the primary themes of the Terminator movie series was the Terminator’s wherewithal to correct its own body breakage & malfunctions. For more than 50 years, Western Medicine has been surgically putting in a wide array of medical implants from bone screws and plates, to heart valves, CNS shunts for hydrocephalus, and neurostimulators for Parkinson’s Disease and seizure disorders. The most problematic of these are CNS shunts, which I have been living with for 20 years.

Over the last 20 years, I have worked feverishly to educate medical science of the needs for self-sufficiency and home diagnostics & solutions to keep the shunt and individual functioning. But medical science in nearly every branch, from FDA to device mfrs to practicing physicians, have remained oblivious to the needs of the patient, and what is technologically possible today.

In 1997, after petitioning the Food & Drug Administration on widespread oversight and needless failures with many CNS shunt devices, I designed and patented a home monitoring system for hydrocephalus and CNS shunt users based on non-invasive methodology which I named, the DiaCeph Test. When I introduced it to scientists at the University of California at Irvine (UCI), I was heralded as a pioneer and visionary by Dr. Eldon Foltz, a long-time practicing neurosurgeon & researcher in hydrocephalus. And when I showed my concept to NIH, they fell in love with it and urged me to find a credentialed university scientist or physician to write the NIH grant application. Later, however, UCI would inform me they would have to own everything, or it wouldn’t be possible for UCI staff to write the grant. I was given no other alternative other then giving it to them, which didn’t make any sense. So I continued to show my DiaCeph system to companies and others in the field, all to no avail. Back then, it was going to be a stand alone software device where we’d be seeking insurance reimbursement, a Medicare code, and industry distribution.

Today, however, the DiaCeph Test could be an app for a mobile phone! The future is now and we need to grasp it! We need to develop cost-effective neuro-technologies for common disorders of the brain, take mind-body modalities, music therapy, mobile apps & AI technology to the next level!

In support of my Terminator 3 BAW photo, I added the caption, “How is your Implant functioning?” I added this from years of frustrating experiences w/ CNS shunt implants where one is left w/ a malfunctioning CNS shunt implant, yet limited to no means to get it fixed. It would seem the age-old saying applies here, “IF you want something done right, do it yourself!” So goes the Terminator! — with hydrocephalus association and national hydrocephalus foundation.

Stephen Dolle

20-year hydrocephalus survivor

Inventor & Neuroscientist

Drum Circle Facilitator

Medical Intuitive

http://www.DolleCommunications.com

Newport Beach, CA

Availability of Patient Medical Apps in U.S. now under new FDA Regulations

After more than 75 years, medical questionnaires that patients use to share information to physicians, are yet to innovate. Here’s what our FDA is doing now in regards to this innovation. See the accompanying story link.

 

Having spent many years in clinical nuclear medicine, and more recently, the neurosciences, I always viewed myself as an innovator. But, when I’m a patient undergoing any type of medical treatment, I’m less forgiving of an industry’s unwillingness to innovate, and their insistence to hold the marketplace hostage for their failures.

 

Way back in 1997, some 5 years and four failed surgical attempts later to get one of my CNS brain shunts to correctly drain CSF fluid needed for my hydrocephalus condition, I designed a patented a software-based monitoring system & named it the “DiaCeph Test.” It was to be a stand-alone software device. Fourteen years later, the DiaCeph Test still sits on a shelf, while new diagnostics needed for hydrocephalus and many other disorders, are not brought to market. This, and tech monitoring of many other disorders today, could be done via mobile phone apps.

 

Here’s the link to info on my DiaCeph Test, though it’s not been updated in a while: http://www.dollecommunications.com/DiacephPatent.htm

 

Also, visit your Android or Apple store to see what’s available today.

 

My frustration boiled over recently as I was passed between physician specialists and a slew of lab and other diagnostic tests. Truly the medical field is failing to innovate both in the collection of relevant patient information, and in IT systems that should be mining patient tests results for the appropriate steps to follow. Widely today, physicians still use the same patient questionnaires that were introduced over 75 years ago. And no to very few clinical apps have made much of a dent in care in the doctor/patient relationship. And with all the money spent in health care in the U.S., and all of the political wrangling over Obama Care, why is no one talking about these key failures to innovate, and the difference it could make in care today?

 

I’ve enclosed a link to an industry story on the Food & Drug Administration’s new law and guidance regarding health apps. It remains unclear whether these regulations will help or hurt the cause for innovation. But it is certainly a story and topic you should follow, at least if you think there’s chance you might need medical treatment any time soon.

 

Of course, you could seek alternative medical care for what ills you, such as the drum circles and healing (that I do), or chiropractic, meditation, energy work, essential oils, vitamins & herbs, and energy water, to name a few of the alternative options that are available today. These each have some efficacy in bringing about positive outcomes. But, if you have a serious or more chronic illness, you probably want a more proven medical treatment. But, you’ll need supporting technology to make this all work, and you had better stay atop these developments in the industry, and in Washington.

 

Enjoy the reading.

 

http://www.informationweek.com/healthcare/mobile-wireless/new-fda-law-paves-way-for-mhealth-regula/240004268