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 lasersI 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