Smart Pill Helps Patients With Drug Compliance

San Jose Convention Center, December 6, 2011. During the luncheon at the conference part of the BIOMEDevice Expo and Conference, I met Patricia Johnson, Director for Pharma Integration, at Proteus Biomedical, Inc. , a medical device maker.  She explained to me about one of the company’s products.  She said that they have developed ingestible event markers (IEMs) that use the body to power the device.

IEM’s are tiny (the size of a grain of sand), digestible sensors made from food ingredients.  The IEM can be integrated into any drug tablet or capsule without changing its properties or performance.  After the pill is swallowed, the stomach fluids activate the pill.  The IEM creates a digital signal that is then detected by a microelectronic recorder, which can be configured as either a skin patch or a tiny device implanted under the skin.  The detector records the information that includes the type of drug, dose, and place of manufacture, etc.  It also measures and reports vitals such as heart rate, activity, and respiratory rate.  The information is sent up to the cloud where it can be retrieved and reviewed by the doctor.  Two of its partners include Novartis and Medtronic.

Drug non-compliance as well as making sure a drug regimen is working is a big problem with older or chronically ill patients.   This can reduce the number of doctor visits and relieve some of the stress felt by family caregivers.   It is especially helpful for patients that live alone and in remote areas.  Being a caregiver myself, I am excited about the potential of this product.

IBM Speaker Discusses Experience with Email App. at USENIX/ LISA Meeting

The USENIX/ Lisa (Large Installation System Administration) ’10 Conference was held at the San Jose McEnery Convention Center during November 7-12, 2010. The event supports attendes from the community of large IT systems administration with education sessions, BOF meetings, vendor exhibitions, receptions, and social networking opportunities.  About 1,500 attendees participated at this interesting event.

I attended a talk about Postfix.  Wieste Venema, a researcher from  IBM’s T.J. Watson Center, gave a talk called Postfix: Past, Present, and Future. Wieste discussed his experience that he had with the postfix mail system over its 12-year history. He said that since its release by IBM as an open source mail system, Postfix has gone on to become a proven part of mail system infrastructure. Postfix is used in ISP server infrastructures that manage millions of email boxes.  Wieste explained that after IBM completed Postfix in 2006, development work shifted the focus to expanding its functions, making it extend to other areas and to become more adapatible to changing demands such as resisting external threats from malware.

Speaking of external threats, Wieste made a special observation about the problem of persistant overload that occurs before the smtpd connection filter.  He noted that there was prior work in the field such as OpenBSD spamd, MailChannels, TrafficControl and work by M. Tokarev.  He said that spammers can setup networks of millions of hijacked PCs called ‘zombies’ to invade and overwhelm email servers with spam junk.  Postfix helps email systems resist zombie attacks.

I also attended a few more talks, the vendor exhibition, and two receptions. My observations of this conference made it clear to me that attendees can gain many benefits of the various educational sessions, BOF meetings and personal networking opportunities that the USENIX made available.

Healthcare Reform and Its Impact on the Medical Device Firms

I recently attended the The BIOMEDevice Exhibition and Forum held at the San Jose McEnery Convention Center so that I might learn more about the medical device industry.  During the opening luncheon I listened to an interesting keynote talk given by Robert Grant.  Mr. Grant is a the President of Bausch and Lomb’s Surgical Division. He previously worked at Allergan, the company known for Botox and various eye care products.  Robert gave out some interesting information about national healthcare spending, a key regulatory and legal case involving a medical device and his comments about the impact of the recent ‘Healthcare Reform’ law on the medical device industry.

Robert said that the annual US healthcare spend has reached about $2.5 trillion. That figure works out to about $8,000/year,  for each person living in the US.  The US spending figure exceeds healthcare spending in other industrialized nations. Compared to the US, the country with the next biggest healthcare spend is Sweden, with $5,000/yr per person.   Australia and the UK are about the same, at $3,400/yr. per person

According to Robert, the high costs in HC are driven mainly by aging and obesity (diabetes). He also asserted that another spending driver is by how we educate doctors in this country.  It takes 4 to 6 years longer in the US to train doctors than it does in other countries.  For example, in other countries, students go from high school straight into medical school. In contrast, the costs of malpractice in the US is going up every year. Other countries have limits on malpractice claims against doctors.  Furthermore, all payors, device manufacturers, and so on, are profit-centric organizations that are looking to get higher earnings per share.  None of tese economic drivers have been addressed in the recent healthcare reform law.

The FDA is the safety watch-dog and is really tightening down now on device manufacturers.  This situation is especially likely following  the outcome of the Riegal vs. Medtronic case. Charles Riegel and his wife, petitioner Donna Riegel, brought suit against respondent Medtronic after a Medtronic catheter ruptured in Charles Riegel’s coronary artery during heart surgery. The catheter is a Class III device that received FDA premarket approval. The Riegels alleged that the device was designed, labeled, and manufactured in a manner that violated New York common law. The District Court held that the MDA pre-empted the Riegels’ claims of strict liability; breach of implied warranty; and negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of the catheter, and their claim of negligent manufacturing insofar as the claim was not premised on the theory that Medtronic had violated federal law. The Second Circuit Court affirmed this case.

Medical device manufacturers go through the FDA, therefore the FDA is on the hook for the safety of medical devices.  The FDA is not motivated to get products to market.  As a result, they are not in a hurry to approve devices because of risk of products.

Robert summarized his observations and concerns with the following points:

• Companies are having trouble raising money so they are leaving the country.
• Aging and diabetes will break our healthcare system.
• The High Cost of Malpractice Cases
• The Doctors’ Education System Needs to Change
• The FDA is not willing to take needed risk to get products on market sooner. Top people left the FDA since the Obama election.  Dan Schultz left FDA.  All that has led FDA to become more risk adverse.

He said that smart companies understand that the best opportunities often arise during the more difficult situations such as recessions or economic downturns. We’re going down such a time right now.  Republicans say ‘No’ to everything, but that’s not a good idea.

Robert said that its OK for companies to take reasonable business risks and make mistakes. People learn from mistakes, innovate, and improve their companies.  His company’s product is Crystalens, an intraocular lens.  Actress Florence Henderson is their spokesperson.  Their product is for cataract surgery. Cataract surgery patients can only get 20/40 vision from the procedure.   He said that their product is better than Lasik.  CMS has agreed to reimburse for their product.

For example, Robert said that when he was at Allergan, Cindy Crawford went up to him while he was attending an industry event and asked to be a spokesperson for their product Latesse, an eyelash grower. Robert was surprised that she knew about him and was very flattered.  He discovered that Baby Boomers want premium outcomes. Robert believes there’s a great opportunity in bad times.  Healthcare is at a precipice at this time.  It is unfortunate that medical device companies have to pay a new tax now under the new ‘Healthcare Reform’ law.

In closing his talk, Robert recited from memory the opening sentence from US Constitution, which listed several visionary points.  He talked about these points and also talked about President John Adams, one of the writers of the constitution.  He said that he viewed a TV show about him on HBO.  In 1776 John Adams described what should happen every July 2, but it actually turned out to be July 4^th.  July 3^rd he predicted future celebrations which continue to do every year.