Monday, November 3, 2014

Medical Device Sales: “Fascinating Captain!” Part 7

By Rick Fromme

Photo Credit:
Welcome to another segment of our medical device series, “Fascinating Captain!” This month’s article deviates slightly from previous ones in that not all the synopses below pertain to new, cutting-edge healthcare equipment.  Some of the information focuses on a “standard” surgical procedure that is now being executed using robotic surgery, or the importance of a key component used in thousands of different medical devices, or new guidelines pertaining to medical devices regarding cybersecurity.  Nonetheless, I think you'll still find that this month's segment "Spock's" your interest. 

Robotically Assisted Cardiac Bypass Surgery Offers Several Advantages

Robotically assisted coronary artery bypass grafting (CABG) surgery is a rapidly evolving technology that can shorten hospital stays and reduce the need for blood products, while decreasing recovery times. Importantly, it can also make the complicated procedure quicker, safer and less risky.

According to the Canadian Cardiovascular Congress: "Robotically assisted CABG is a safe and feasible alternative approach to standard bypass surgery in properly selected patients. It is a less traumatic and less invasive approach than regular CABG," says cardiac surgeon and researcher Dr. Richard Cook of the University of British Columbia. "It may reduce complications following surgery, and in the Canadian experience, has been associated with an extremely low mortality rate."

Photo Credit:
Traditional bypass surgery required that the surgeon cut the chest open at the breastbone and spread the ribsto expose the heart. In addition, to work on the heart itself, the heart is stilled and the patient's circulatory function taken over temporarily by a heart-lung bypass machine.

Robotically assisted Minimally Invasive Direct Coronary Artery Bypass (MIDCAB) is a procedure in which the surgeon makes several tiny incisions between a patient’s ribs, then inserts small robotic arms and a small camera through the incisions.  Special tools stabilize the part of the heart on which the surgeon must work, which enables the heart to continue beating throughout the procedure, unlike traditional CABG procedures.

Robotic surgery also offers several technical advantages to surgeons, including a magnified 3D view of the patient's heart, as well as the elimination of any kind of tremor, which makes for precise incisions. 

For this study, 300 patients (men and women 60 years or older) underwent robotically assisted CABG at three hospital sites in Canada. The doctors performed the surgery using the da Vinci Surgical System.
There were no deaths in this group of patients, with only one patient developing a deep wound infection after the procedure. 

There was also less blood loss, which translated into a lower need for blood products. The more precise incisions also caused less cosmetic scarring. 

With traditional coronary artery bypass graft surgery, the average hospital stay is five to six days. With the robotically assisted surgery, that was cut to an average of four days, sometimes even less. Patients from the study reported being back to near normal levels of activity within a couple of weeks. With standard CABG, patients are asked to avoid driving or lifting any weights over 10 pounds for six weeks.

 A Wearable Pill-Bottle Device


Photo Credit:
Amiko, headquartered in Milan, Italy, has created wearable for medication packages that automatically collects data about usage, helping patients stay on track with their meds, providing instant feedback and eliminating errors in taking medication with no additional self-reporting or other activities required. The new wearable helps users with: 

  • Medication Tracking
  • Intake and refill reminders
  • Real-time guidance and alerts
  • Reports history and constant connection to caregivers

 Studies show that something as simple as getting patients to take their medications, on time, in the right order, and in the proper amount, could actually prevent as many as 125,000 deaths per year in the U.S.  Prescription non-adherence results in $100 billion annually in excess hospitalization costs, and when all economic implication are considered, the problem may cause as much as nearly $300 billion in annual medical spending. 

Amiko is an affordable, lightweight sensor-packed plastic sleeve that is specially designed to fit on five common types of medicine packaging.  Amiko is placed on medicine packaging and detects both motion and the angle of motion using its MEMS sensors, accelerometer and gyroscope. It tracks the medicine taken and sends information to a connected app available to patients and caregivers.

Amiko’s product senses movement of the pill bottle and other dispensers, so it’s not reliant on the patient self-reporting that they’ve taken their medication. Other solutions tend to rely on a smartphone application and are both disconnected from the act of taking medication itself, and reliant upon someone (usually the patient) to manually input the data.

There are both health and economic implications from using Amiko. On a personal level, it ensures medication is being taken. It also makes the pharmacy process far more efficient in that reorders can happen automatically, which can also reduce costs.

Pulsing Magnetic Waves in the Brain Could Help Heavy Smokers Ditch Their Habit

Photo Credit:
A machine that pulses deep regions of the brain with magnetic current may help heavy smokers quit the habit,a new Israeli study shows.

In the study, which experts say is the most rigorous test of the technology to date, 44% of a group of heavy smokers who had failed to quit using other methods were finally able to stop after a few weeks of treatment.  One third of the smokers who were treated had still not lit up six months later.  It may not sound like a high success rate, but failure rates of other anti-smoking methods can reach about 90%.

Heavy smokers who failed previous attempts to stop smoking with medications, with nicotine patches, with psychotherapy all were able to quit after undergoing treatment with the machine, which is being tested at the Ben-Gurion University of the Negev. (For more information about Israeli healthcare innovations, see our previous blogs, “Which Young Country Leads the World in Medical Technology?” and “Israel ― The Land of Milk and Honey & Med Tech.”)

The magnetic current method stimulates regions of the brain that are central to addiction, using a specially designed helmet.  It is able to turn the brain regions’ electrical activity up or down, which makes quitting easier.  Based on the results of the study, published in the journal “Biological Psychiatry” this past summer, the FDA is now testing the machine for approval. 

The Deal with Seals

Photo Credit:
OEMs need to consider a number of factors — from materials to compliance — when choosing these vitalcomponents.

Seals play a vital role in a wide range of medical devices. They’re ubiquitous; found everything from syringes, to insulin pumps, to surgical power tools, imaging devices and more. Seals are used where liquids or gases are pumped, drained, transferred, contained, evacuated, or dispensed. Their primary functions are to keep out contaminants and protect both patients and devices from potentially harmful leakage.

For OEMs, selecting the correct seal in terms of design and materials is paramount as it influences both the life of the product and the ability to prevent friction, which in turn, helps to eliminate wear. The ability to seal and aperture and long life can be inversely proportional. That is, better seals usually create more surface contact, which increases friction and therefore expedites wear.   

When selecting seals, a manufacturer must understand the entire physical application requirements such as hardware specifications, media contact, temperature, motion, pressure or vacuum and the required life of the seal.  

OEMs should also consider whether the finished device will be subject to sterilization and, if so, which method will be used.  When designing a complex medical device, choosing a seal may seem like a small matter, but it’s one OEMs should take seriously.

Cybersecurity for Medical Devices


Photo Credit:
Cybersecurity issues pertaining to the healthcare industry has become a major concern as of late (read our previous blog, “Health Care Scare: Medical Identity Theft.”) 

In fact, the FDA states on its website: “There is no such thing as a threat-proof medical device,” says Suzanne Schwartz, MD, MBA, director of emergency preparedness/operations and medical countermeasures at the FDA’s Center for Devices and Radiological Health. “It is important for medical device manufacturers to remain vigilant about cybersecurity and to appropriately protect patients from those risks.”

Just recently, the FDA released guidelines regarding the security of medical devices.  Among its recommendations: 

“Manufacturers should address cybersecurity during the design and development of the medical device, as this can result in more robust and efficient mitigation of patient risks. Manufacturers should establish design inputs for the device related to cybersecurity and establish a cybersecurity vulnerability and management approach as part of the software validation and risk analysis that is required by 21 CFR 820.30 (g) [21 CFR Part 820 – Quality Systems Regulations: 21 CFR 820.30 Subpart C – Design Controls of the Quality System Regulation] The approach should appropriately address the following elements: 

  • Identification of assets, threats and vulnerabilities;
  • Assessment of the impact of threats and vulnerabilities on device functionality and end user/patients;
  • Assessment of the likelihood of a threat and of a vulnerability being exploited;
  • Determination of risk levels and suitable mitigation strategies;
  • Assessment of residual risk and risk acceptance criteria.” 

The Agency recommends that medical device manufacturers consider the following cybersecurity framework core functions to guide their cybersecurity activities: Identify and Protect; Detect, Respond and Recover.

In this seventh edition of our ongoing series, “Fascinating Captain!” I shared with you some of the innovative medical devices and procedures that are at the forefront of healthcare today, from robot-assisted cardiac bypass surgery to electronic devices to help people quit smoking. I also discussed key issues pertaining to medical device manufacturers such as seals and the FDA’s new recommendations pertaining to medical device cybersecurity.  The diversity of medical device inventions and procedures throughout the world helps many of us to "live long and prosper.” If you found this article interesting and useful, please share it with your colleagues and friends.  As always, I’m eager to read your comments and questions below.

Rick Fromme combines entrepreneurial enthusiasm with an insider's knowledge of the medical industry to co-found Both his drive and perspective helps provide health care professionals with a superior mechanism with which to communicate, network and market their strengths. Prior to founding, Rick operated a highly successful medical device distributorship. Other milestones in his 12-year career in the medical industry include a key position at a medical device start-up company that was later sold to the Ethicon Endo division of Johnson & Johnson. You may also reach Rick by connecting with him on FacebookTwitterGoogle+LinkedIn and YouTube.


  1. Such interesting devices being created and modified to help with the ever-growing world we live in! The magnetic waves device to help smokers quit seems very powerful and hopefully very helpful!

  2. Hacking if medical devices is one area that people are going to need to address in the not too distant future.

  3. There is a good reason this series is call fascinating, its because it is!

  4. Almost makes me look forward to CABG surgery (not really), but seriously, the depth of knowledge here is obvious, and fascinating just scratches the surface! Very well done.