Showing all posts written by David Kim

David Kim
David Kim
David T. Kim practices intellectual property law, with a focus on patent prosecution and counseling in electronic and software technologies.
Prior to joining the firm, he has worked at General Electric for five years as an embedded systems software engineer. In his engineering role, he designed and programmed inter-device communications, device drivers, interfaces, complex signal processing filters, and more contributing on both the hardware and software fronts. He helped GE launch numerous high-profile and successful products.
During law school, David was a member of BU-MIT Entrepreneurship and IP Clinic and assisted student entrepreneurs in obtaining IP protections and counseling about legal ramifications of their business decisions.
Medtronic Pain Management Device Approved by FDA

Medtronic Pain Management Device Approved by FDA

Medtronic announced FDA approval and U.S. launch of its Intellis Platform for the management of certain types of chronic intractable pain.  According to Medtronic, the Intellis platform features the world’s smallest implantable spinal cord stimulator (SCS), which includes an implantable pulse generator that looks like an older-style pacemaker, but with wire leads that delivers mild current to a spinal vertebra.  The Intellis, and other SCS systems deliver, neurostimulation at the spinal cords to prevent pain signals from reaching the brain.

The MIT Technology Review reports that SCS systems carry promise because they represent an alternative to opioid-based pain management.  It is estimated that more than 20,000 Americans a year die from overdoses of prescription pain drugs.  Government and industry alike recognize the gravity of the opioid issue. FDA Commissioner Dr. Scott Gottlieb has stated that opioid abuse is is taking a staggering human and economic toll and is therefore a top priority.  Industries are also responding with ever-improving SCS systems (Medtronic’s pain-therapies business show $825 million in revenue during the company’s 2017 fiscal year).

According to Medtronic, the Intellis system allows physicians to better address the subjective and personal nature of patient’s chronic pain.  Based on recorded and tracked patient activity, including body positions and how patients self-administer their therapy, Intellis allows a physician to program and manage pain therapy for each patient with a wirelessly connected Samsung tablet.

Samsung Chief Medical Officer Dr. Dave Rhew said:

We are excited to partner with Medtronic in their aim to simplify programming, and streamline therapy management with the Intellis platform . . . Samsung’s Galaxy tablets — secured by the HIPAA-ready Samsung Knox mobile security platform — will support future Medtronic therapies and over the air (OTA) software upgrades to ensure clinicians using Intellis have access to the most up-to-date solutions.

Medtronic is not the only industry player to explore cross-industry partnership: at least one of its competitors, Abbott (which acquired St. Jude and its line of chronic pain treatment devices in January, 2017) offers SCS devices featuring controllers made by Apple.

 

Activity Trackers Eye Inactivity Tracking

Fitbit recently announced plans to build sleep apnea diagnostics into its wrist-worn activity tracking devices, stating that it expects do so within a year.  If successful, Fitbit may be able to address a market that is expected to have $6.7 billion in revenue by 2021.

Sleep apnea is characterized by pauses in breathing and shallow breath and comes with an increased risk of heart failure, obesity, and strokes.  While it affects about 18 million American adults today, one of the biggest concerns is that many affected people do not realize they are affected.  Traditionally, sleep apnea diagnosis involved capturing electroencephalograms (EEG) using electrodes that track brain electrical activity.  Such EEGs generally require cumbersome overnight visits to a sleep lab.  Alternatively, although potentially not as definitive as EEGs, non-EEG based methods that combine cardiac, respiratory, and movement data may be used.  However, alternative methods have not achieved broad use by the consuming public.  According to its announcement, Fitbit aims to fill that gap in the market.

The fashion appeal of activity trackers and ease of use (i.e., simply wearing it) have fostered widespread adoption of activity tracking devices.  Also, these devices have increased their functionalities over the years from merely counting steps to reporting heart rates and calories burnt, among others.  It’s likely that these devices are here to stay and will get “smarter” and more capable.  It may seem strange that “activity” trackers are seeking to carefully monitor inactivity, but they may prove up to the task — in fact, there is some evidence suggesting that the devices are better at measuring rest than activity.

In March, 2017, Fitbit released Sleep Stages, a feature that tracks whether the wearer is in a light, deep, or REM sleep.  By combining heart rate analysis with more traditional movement tracking, a study found that it could determine sleep stages with a reasonable degree of accuracy.  Fitbit has logged over 4 billion nights of sleep data, a data pool of over 23 million hours, from its users since 2010.  However, reliable detection of sleep apnea may require a more advanced analysis than reliably categorizing sleep stages.

CNBC reports that Dr. Conor Heneghan, author of the study and Fitbit’s lead sleep research scientist, is researching additional data sources that Fitbit’s trackers may be able to exploit as potential indicators of sleep apnea. He explains:

We’re leveraging the fact that Fitbit has experience in optical electronics, and making them small and power efficient.

Fitbit’s activity/inactivity trackers will not cure or treat sleep apnea.  Rather, CNBC reports that Fitbit seeks to provide reliable sleep apnea detection.  Even if its forthcoming technically is sound, challenges may wait for Fitbit.  The report notes that Fitbit isn’t yet certain how much it will need to work with the FDA and regulators in other countries. The device will most likely nudge a user to see a doctor rather than making a diagnosis.  And, Roy Raymann, vice president of sleep science at SleepScore Labs, and the former sleep expert on Apple’s health team, opined that:

Doctors are often ultraconservative, so it remains to be seen whether they’ll accept data from a consumer wearable.

FDA Approves Medtronic Melody TPV For Implantation in Failed Pulmonary Heart Valves

Medtronic recently announced that its Melody® Transcatheter Pulmonary Valve (TPV) is the first transcatheter pulmonary valve to receive FDA approval for implantation in patients with failed surgical bioprosthetic pulmonary heart valves. Medtronic touts the Melody TPV as providing these patients with a minimally invasive treatment option as an alternative to additional open-heart surgery.

The Melody TPV was previously approved under the FDA’s Humanitarian Device Exemption (HDE), a program for technologies that may treat fewer than 4,000 patients a year, subject to additional regulations, without meeting all of the traditional pre-market approval rules.

Commenting on the approval, Dr. Jeremy Asnes of the Yale School of Medicine said:

As the 1st commercially available transcatheter heart valve, the Melody TPV brought a breakthrough non-surgical option to treat failing pulmonary valve conduits. Thousands of congenital patients globally have benefited from this therapy in the past decade. With this expanded indication, we can further reduce the need for obtrusive open-heart surgery and allow even more patients to benefit from this minimally invasive treatment option.

Grand View Research predicts that the global transcatheter valve market is expected to reach a worth of $8.62 billion by 2024. According to the Centers for Disease Control and Prevention, congenital heart defects are the most common birth defect in America and the top killer of infants with birth defects. An estimated 40,000 babies are born with congenital heart defects in the United States every year.