1 The Company
1.1 Description
Johnson and Johnson is the parent company of Ethicon Endo-Surgery. Johnson and Johnson has
around 12,000 employees with around seven and a half billion dollars of sales per year. Ethicon
is a company under Johnson and Johnson, which was incorporated in New Jersey in 1887.
Ethicon is a global medical device company, and has been a leader in surgical suture sales for
over 100 years. Ethicon has locations in over 50 countries and employs over 9,000 people.
Ethicon Endo-Surgery (EES) is a subsidy of Ethicon, and is recognized as a world leader in the
manufacturing of minimally invasive surgical instruments. Ethicon Endo-Surgery was formed in
1992 to focus on innovation with regard to minimally invasive surgical tools. Ethicon EndoSurgery is very committed to innovation and has a world renowned educational facility, the
Endo-Surgery Institute, located in Cincinnati, Ohio. At the institute thousands of surgeons and
other medical professionals receive training on the latest surgical procedures along with
education on other healthcare delivery and administration issues. EES has around 6,000
employees and four billion in annual sales. The regional sales make up about 45% of the profit
and international sales make the remaining 55%. The vision is “Transforming Patient Care
Through Innovation”. The core products include surgical stapling products, energy based
devices, endoscopic surgery devices and breast biopsy products. EES has manufacturing sites in
Cincinnati, Albuquerque, and Mexico along with sales and distribution offices in over 50
countries.
2 The Project
2.1 Project Description
Interventional Radiologists (IR) currently perform tumor ablation using standard techniques such
as Radio Frequency (RF) ablation, Cryoablation, Chemoembolization, and excisional biopsy.
These techniques all have drawbacks that relate to invasiveness, length of procedure, healing
time, and consistency of treatment. Ethicon Endo has developed a novel ablation tool nicknamed
Faraday that aims to solve these problems. Research has shown that the Faraday system can
speed the ablation process by 10 -100 fold which can reduce treatment times from hours to
seconds. Faraday also promotes substantially faster healing of the ablated region compared to
RF ablation. The zone of treatment of the Faraday system has been quantified through research
which leads to a consistent ablation zone in patients, this is not a property that RF, Cryoablation
and Chemoembolization exhibit. Finally, the Faraday system is able to differentially target the
cell membrane or the internal cell structure, something other treatments are not able to do. The
Faraday system aims to reduce the time of the ablation procedure, allow fast healing of the
affected region, and provide confidence to the IR of the accuracy of the treatment.
Unlike other ablation treatments, the Faraday system does not provide a visual indication of the
treated tissue. This poses problems for the IR because the lack of visual feedback can result in
over treatment of the area, treatment of an area outside of the tumor zone, and treatment of an
entirely different organ. To solve this problem, Ethicon has developed a Finite Element Model
(FEM) that predicts the zone of treatment from the Faraday system. The scope of our New
Product Design and Business Development team is to incorporate the FEM of the affected zone
and a static image such as a CT scan in a way that is useful to an IR.
Our visualization system will perform two useful functions described here: 1) A CT scan can be
taken of a patient on the operating table. The IR can scroll through the CT images to find the
location of the tumor. The IR can then move a mouse pointer over the CT image with the tip of
the mouse pointer representing the tip of the ablation probe. As the pointer moves over the
image, a treatment zone based on the FEM is instantly overlaid on the CT image showing the
affected zone. The IR uses this visualization to determine the best place to put the probe. In this
capacity our visualization system acts as a preoperative planning tool. 2) Once the ideal probe
placement is found, the IR can insert the ablation probe into the patient and using either a realtime guidance system or multiple CT scans can place the tip of the probe as close to the
preplanned point as possible. This point is marked on the CT scan with a mouse click and the IR
then starts the procedure and real-time visual feedback is given to the IR to show the treatment
zone. This is useful because hitting the ideal point on the patient may not always be possible so
the next best solution can be found during the operation. Also, the probe may need to be moved
to multiple points to ablate the tumor completely. The visualization of the affected zone is then
useful to ensure complete ablation of the tumor as well as ensuring no areas are over treated or
mistakenly treated.
The visualization solution will take the form of a hardware device. The hardware will consist of
a screen to provide visual feedback to the IR, an input peripheral such as a mouse to select
treatment zones both preoperatively and during the operation, a processor such as a Field
Programmable Gate Array (FPGA) to perform the FEM calculations and create the data for the
display. The hardware will be compatible with current imaging modalities such as CT, MRI, and
ultrasound.
3 The Context
3.1 Existing Solutions:
Currently, there are several minimally ablation techniques used to treat affected tissue. While
radiofrequency (RF) remains the most dominant among the medical industry, many physicians
are using methods involving ultrasound, microwave, cryotherapy, and lasers.
In an RF ablation treatment, needle electrodes are position into the tissue and an alternating
current is applied which produces ionic agitation, frictional heating, and cell death [1]. This
technology is used across the board, from prostrate treatments to liver treatments.
Aiming high-intensity focused ultrasound (HIFU) on an ablated tissue is a relatively accepted
method of destroying infected cells. The HIFU transmission will cause the cell to heat to very
high temperatures, like in the RF treatment, which destroys infected tissue.
The Harmonic Technology from Endo-Ethicon is a unique example of such an ultrasonic
treatment. This system applies electromagnetic energy to a piezoelectric transducer that then
drive blades used to remove infected cells [3]. This system does not heat the cells but rather
mechanically tears and removes the ablation.
Microwave ablation applications heat the infected zone to very high temperatures and are most
affective where tissue impedance is high, leaving poor conductivity, both thermal and electric
[2].
There currently is very little information on lasers…I will add to this sections
Cryotherapy is unique among the different treatments in that instead of heating the tissue, it
freezes it. These extremely cold temperatures work in the same way as high heat applications.
[1] http://www.bmj.com/cgi/content/full/334/7602/1056?grp=1
[2] http://radiology.rsnajnls.org/cgi/content/full/2471062123v1
[3] http://www.harmonic.com/dtcf/pages/HarmonicTechnology.htm
3.2 Competitors
Recently Tyco Healthcare has become Covidien which is a ten billion dollar global healthcare
company. Valleylab is brand under the Covidien name and a competitor in the ablation industry
which currently manufacturers a Cool-tip RF ablation system.
Boston Scientific also has an RF ablation system called RF 3000 Radiofrequency Ablation
system. Boston Scientific is a large company with over 25,000 employees and revenues of over 8
billion per year, the endoscopy arm under Boston Scientific is a direct competitor to Ethicon
Endo-Surgery.
Who is the other competitor who has the ablation device already around?
3.3 Information Sources

www.bmj.com/cgi/content/full/334/7602/1056?grp=1

radiology.rsnajnls.org/cgi/content/full/2471062123v1

www.harmonic.com/dtcf/pages/HarmonicTechnology.htm

www.medgadget.com
A.2 Company Products
HARMONIC
Description: A handheld ultrasonic device that can simultaneously cut, coagulate, coapt and
cavitate tissue. Harmonic offers a safe and efficient alternative to electrosurgery.
Figure 1: Harmonic hand tool. www.harmonic.com
How it works: The system uses ultrasonic waves to stimulate cutting blades to mechanically
vibrate. These vibrations occur at 55,500 times per second and when they come in contact with
tissue the vessels are coapted.
Figure 2: Temperature comparison of harmonic to other technologies. www.harmonic.com
Figure 3: Tissue affect of Harmonic system. www.harmonic.com
Figure 4: Harmonic compared to a competitor product. www.harmonic.com
Figure 5: Harmonic vs. electrocautery. www.harmonic.com
Hand tools that utilize Harmonic technology:
FOCUS
Figure 6: Harmonic Focus. www.harmonic.com
WAVE
Figure 7: Harmonic Wave scissor grip. www.harmonic.com
ACE
Figure 8: ACE 23cm pistol grip. www.harmonic.com
Figure 9: ACE 36cm piston grip. www.harmonic.com
Curved Shears Pistol Grip
Figure 10: 34cm Pistol Grip. www.harmonic.com
Figure 11: 45cm pistol grip. www.harmonic.com
Figure 12: 36cm curved active blade. www.harmonic.com
Figure 13: 36cm knife down active blade. www.harmonic.com
Figure 14: Laparoscopic shears scissor grip. www.harmonic.com
Figure 15: Open shears scissor grip 14cm curved active blade. www.harmonic.com
Figure 16: 32cm dissecting hook. www.harmonic.com
Figure 17: 14cm curved blade with protective sleeve. www.harmonic.com
Figure 18: Sharp curved blade. www.harmonic.com
Figure 19: Ball coagulator. www.harmonic.com
Capital Equipment
Harmonic
generators
Figure 20: Generator 300. www.harmonic.com
Figure 21: Harmonic generator cart. www.harmonic.com
Figure 22: Foot switch for generator 300. www.harmonic.com
Figure 23: Hand piece for generator 300. www.harmonic.com