Medical device industry has enjoyed tremendous growth and is considered a safe heaven for stock investors during turmoil market. The drivers for this growth are aging population, emerging economy in developing countries and new technologies.

Demand for safer and more effective medical devices, as well as products to improve quality of life at more affordable cost are basis of competition in this industry. There have been block buster devices in the recent decade, such as drug eluting coronary stent, kyphoplasty balloon and robotic surgery tool that significantly improve the mortality and morbidity of patients suffering from heart disease, back pain and prostate cancer.

Despite the on-going invention of new treatment methods and complex devices, there remain unmet needs for treating many debilitating human diseases such as chronic heart failure and stroke. As well, despite years of research and development, daily blood sugar level measurement by diabetic patients still requires a finger stick. These unmet medical needs represent huge opportunities for the industry and the inventors/entrepreneurs.

While growth opportunities in the medical device market continue to attract investors, entrepreneurs and professionals from other industry sectors to enter this industry, new government regulations, insurance reimbursement policies, and political climate represent new challenges for the players.

This presentation will cover the above topics in more detail and hopefully to provide an opportunity to network with engineers, investors, academic researchers, and government officials to help develop Taiwan’s medical device industry.

As the number of elderly populations raised, increasing in the incidence of chronic and debilitating disorders encountered more in the recent years. The demand of the implants and advanced medical devices are also likely to increase. Since the elderly is likely to remain active longer, more sophisticate and advance wellness are needed to fulfill the demand.

Among the younger age groups, the need is growing to treat disorders that result from the over exercise or chronic conditions that relate to their lifestyles.

Medical devices industry will need to change and follow the way of medical community that face to the evolving of society structures and medical conditions.

As with the development of artificial hearts, and the development of other artificial implantable organs would alter the transplantation research and medical biotechnology.

Recent advances in medical devices, combined with improvements in electronic and medical equipments, have created previously unforeseen opportunities for using interdisciplinary medical devices, such as the pocket size of Acuson P10 product with a stethoscope ultrasound for immediate diagnoses of critical conditions.

The use of stents in the treatment of cardiovascular disease is an example of a typical innovation of surgical bioengineering.

Finally, it is worth to note that the recent advance in bioengineering of various surface treatments of dental implant has created an evolutionally changes for the newly treatment modality in dentistry.

The IT technology of Taiwan is very good, but its application in the field of medical care is limited at this moment. The trend of population aging is obvious and its associated problems are imminent IT technology for long-term care can help to save a lot of money and manpower. Based on the previous know-how Taiwan has the capacity to produce a lot of high value medical devices with relatively low price and high reliability.

The IT and biomechanical technology can be applied to help the patients with various disabilities, such as hearing, vision, smelling (for people with special jobs) and paresis or paralytic limbs.

Various alarm systems monitoring physiological conditions of the drivers, pilots and shipmasters can be developed to prevent accidents and to ensure safety of the journey. Biological instead of the pharmacological stimulants can be used to accomplish an important task without causing physiological damages.

Technology can be combined with surgery in many ways. For example, transposition of a sensory flap to the sacral area with augmentation of pressure sensation from an amplifier can prevent pressure sores in the vulnerable areas of bed-ridden patients. The same principle can be applied in the upper extremity to make patients feel comfortable in using such devices. To prevent infection , if such devices should be put inside the body, it can be hidden in a safe space which is created prior to the insertion of the implant. The cavity should be large enough to prevent tension in wound closure, but small enough to obliterate dead space, and this can be combined with antecedent transposition of local flaps. Tension-free closure and healing of prior local flaps can prevent infection and to ensure the safety of implant insertion.

Medical instruments have a lot of room for improvement. Taiwan has a great potential to renovate these instruments. If medical doctors want to devote to the development of medical devices with engineers, this could be the next peak of business for the future of Taiwan.

From Ideas to Products
How to Release the Innovation Power of Physicians?

Endotracheal intubation is an important invasive procedure in medical practice. With the knowledge of differences in anatomic structures between the trachea and the esophagus, we conducted an animal study to evaluate the usefulness of endotracheal cuff pressure in distinguishing endotracheal and esophageal intubations. Experimental results confirmed that the cuff pressure in the esophageal intubation was significantly higher than that in the endotracheal intubation under the same inflated volume from 1 to 10 ml. This may provide the basis for an adjunctive, simple, rapid and reliable method to verify endotracheal intubation.

The idea is valuable in increasing the safety of tracheal intubation, but how can physicians do in the subsequent development processes?

I met Professor Chen on the web forum of Chi-Mei Medical Center and Southern Taiwan University of Technology. Chi-Mei Medical Center granted the seed money for the research project. We developed a prototype machine and two SCI articles had been published.

In Taiwan, medical practice is keeping in the cutting edges and electronic manufacturing is the leading industry. If the innovative power of medical professionals could be released, Taiwan would produce dream medical devices with high value and low cost for the world.

As a hand surgeon, I am interested in seeking the appropriate, novel surgical techniques. More recently, we focused on minimally invasive surgery by using intraoperative monitoring by ultrasonography, and developed several novel surgical techniques in reduction the fracture, releasing the trigger digit and carpal tunnel syndrome, and preventing iatrogenic nerve injury during operation (Chern TC & Jou IM; in JBJS [Am. Edi]; 2002, Chern TC & Jou IM; in PRS; 2005, Jou IM & Chern TC, in JHS [Eu. Edi]; 2006, Shen PC & Jou IM; in JBJS [Br. Edi], 2008, Chern TC & Jou IM; in JHS [Eu. Edi], 2008). Because of the effectiveness of these techniques, we have undertaken over five thousand cases of trigger digit and carpal tunnel syndrome in the past eight years. In addition to the beneficial results in clinical practice, the rapid accumulation of these cases has also brought forth several basic studies on these disorders in collaboration with the Institute of Biomedical Engineering, the Department of Occupational Therapy, and the Department of Computer Science and Information Engineering & Medical Informatics of this University. These interactions have also vigorously explored the researches in designing, producing the new surgical instruments and training system to improve technique hands-on and trainee competence related to our novel surgical techniques and tried to patent the products and/or the surgical techniques.

There are many important steps to be taken, decisions to be made, and pitfalls to be avoided before success can be achieved in the medical device industry.

This presentation will detail the history of an actual medical device start-up company that navigated its way through the process of building value (including a midpoint turn around) and was then acquired by a global orthopedic company.

Start-up companies in medical device industry will experience unique challenges in product development, quality system implementation/compliance, and governmental regulation management towards product commercialization or IPO. Three key elements to build solid foundation for a successful medical device start-up in the strategic and feasibility phase of product development life cycle will be detailed. The drivers to enhance company values in the subsequent phases will be reviewed. The roles of a start-up and their challenges will also be discussed.

• This plan based on the medical university integrates the industrial field, academic field, and governmental resource to develop the high value and quality medical device industry.
• The main targeted is to develop the dental medical device, orthopedics medical device, and cosmetic surgery medical device. Establishing southern medical device industrial cluster is to provide the excellent opportunity to upgrade the traditional manufactures’ skill and competition.
• The goal is to develop the policy of Executive Yan to build the three「targeted biotechnological science parks」to cultivate the industrial cluster.
• The core spirit of the plan is to persuade potential enterprises to set up in science parks by collaboration of industrial field, governmental resource, academic field, research centers, and medical centers.

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• Soul, Human, Body
• CLT Involvement in
• Healthcare and Medicare
• Application of High Resolution LCD in Medical Environments
• Application of High Resolution LCD in Medical Environments
• Commitment and Vision

Product Strategy on DENTAMERICA

To succeed in the medical device industry, DENTAMERICA focus especially on the product’s application and customization. We encourage the imagination and seek every opportunity for the future products. During the R&D process, we always have the customers’ needs in mind and build a platform for testing and catching the thoughts from doctors.

For the current market segmentation, we look for the niche and consider the age, gender, average income of doctors and government policy of healthcare and medical education in different countries. On the way toward globalization, we expand the product lines and insist to launch new products quarterly both from core technology and OEM suppliers all over the world.

The idea of FET-diode x-ray was first proposed by Jack Kingsley in 1983. Digital x-ray image technologies, including digital rad, mammography, cardiac, and vascular systems, are getting matured and becoming very benificial to human being due to the better image quality for clinical judgment, lower required dose imposed on the patients, real-time and computer-aided detection, and lower cost without the need of film and chemical. All x-ray image systems use the same x-ray detectors mainly composed of photodiodes and TFT arrays. Taiwan state-of-the-art LCD manufacturing facilities and a-Si panel technologies not only open up the opportunity to produce highest-quality yet lowest-cost x-ray detectors and but also have flexibility in capacity for future growth with minimal or without new capital investment.

Ophthalmic Medical Device

Medical Device Directives
Quality System
Examples of Harmonized European Standards for Medical Devices Essential Requirements Satisfy Customer Focus Meet Regulatory Obligation

Some Perspectives on the Development of Medical Imaging Technology

Medical device Industry has become a newly blooming industry whose global market value is more than 230 billion US in 2006. Especially, medical imaging sector is one of the most profitable fields and has provided more than 65 billion US in products and services in 2006. The growth rate and profit margin of medical imaging industry are much higher than the conventional industry. Nowadays, most of the developing or developed countries in the world have been concentrated their efforts and resources on developing the medical imaging industry. However, this industry highly depends on the integration of three high tech industries including electronic and information, biotechnology, and high accuracy machinery. Thus, it is considered with high technology barrier and highly capitalized. However, all these requirements are not restrictions and can be well resolved in Taiwan. All three high tech industries are strong and the industry leaders are with great motivation to develop this new industry in Taiwan. Therefore, this forum can be a good chance to discuss all the related events including opportunities, experiences, market situations and possible actions in helping the development of medical imaging industry in Taiwan.

The Experiences of a Biomedical Engineer in Promotion of Medical Device Industry

As being involved in biomedical engineering research and teaching for 20 years, to promote the medical device industry in Taiwan is always the major goal in my mind. There are two folds for this: one is for creating the new job market for the biomedical engineers, and the other is for producing Taiwan-Branded medical devices for economic development. In the past, the government has been launching so many strategic plans and supports for this area. However, it seems to me that no significant effort was observed. Due to the mature of biomedical engineering, it may be the right time to integrate all the resources from both government and non-government organizations for facilitating the research and development of medical devices. From my past experiences, there are many factors that may significantly affect the establishment of medical device industry. They are summarized in the following for reference:

• Physician involvement and Clinical needs
• System integration and Creative designs
• Regulation support and Clinical trials
• International marketing and Global links
• Intellectual property and Technological transfer
• Long-term supports and Business management

In addition, the manufacturer, physician, and technologist need to play their roles in promoting the medical device research and development. The associated agencies of government should help to clarify the regulations and approvals. The universities also should establish the appropriate education programs to cultivate the required specialties. Finally, I sincerely hope that the medical device industry in Taiwan may be really established in the near future.