New technologies could be next wave of opportunity in Silicon Valley

By Fred Seddiqui, Special to the Town Crier

My uncle, a man in his late 40s, was on his way to work one morning when be began to feel weak and dizzy. Moments later, he fainted.

A physician, he decided to drag his feeble body a few blocks to the hospital where he worked. He was evaluated in the emergency room and found to have bradycardia, a condition that causes the heart to beat much more slowly than normal.

Within minutes, a cardiologist began a minimally invasive procedure to place a Medtronic pacemaker in my uncle’s chest. His heart immediately responded and resumed its usual tempo. That was 10 years ago, and since then my uncle has been in good health.

For more than 20 years I have worked in the medical device industry and I am continually astonished at the technological progress that is changing the lives of people of all ages, genders and races. Pacemakers alone have gone through many significant improvements over the years, stimulating millions of hearts so that people could be restored to health after developing conditions that previously would have been disabling or fatal.

Lately I have noticed many more people at work, at social events and at the gym mentioning that they have had procedures involving implantation of biomedical products that have extended their longevity and improved their quality of life.

We live in an era of explosive population growth, with the most rapid increase occurring in the aging population because of lengthening lifespans. Even among younger age groups there are jobs and leisure activities and more and more competitive sports that present high risks to health.

As a result, there is a pressing and growing need in the United States and throughout the world for research and development focused on the next wave of technology in the life sciences.

There are many physicians and other health professionals with ideas that could result in development of new and improved tools, parts and devices. They are a resource just waiting to be tapped.

The exponential growth in demand for medical technology presents tremendous opportunities, but in this segment of the economy - unlike other sectors - the supply and demand curves will never reach equilibrium without long-term strategic planning.

Creating new products in the life sciences takes several years and is different from other capital equipment or consumer products. These differences result from unique requirements for the products:

• Materials must be biocompatible.

• Devices must be sized and customized for patients.

• New products must have significant clinical impact to justify their development.

• Product development must include careful assessment of risks and potential collateral damage.

• New products face unparalleled regulatory scrutiny.

• Critical expertise from a number of disciplines is essential to meeting these challenges.

Engineering medical products requires a multidisciplinary approach. It takes a team of not only electronic and mechanical engineers but also biomedical, chemical, material and reliability engineers, as well as experts in computer science, imaging technology and other fields.

The Scientific Advisory Board for a company consists of physicians and other professionals with extensive clinical experience. The involvement of this team of medical pioneers from a very early stage of development is essential to the proper design of something that ultimately becomes a working product. Their involvement in presentations and publications is also essential for the introduction of a new product to other clinicians.

Experts in regulatory issues and quality assurance are also essential. They have the specialized knowledge of Food and Drug Administration regulations and the enormous amount of testing and validation required for approval of medical devices.

Experts in marketing of medical devices and other life sciences products are also employed to provide understanding of hospital and clinical environments. They determine features and benefits, perform competitive analyses, establish the positioning of products, work with other experts to plan and implement initial usage in clinical settings and then manage initial sales.

They also help coordinate publications by the physicians of the Scientific Advisory Board and organize technical symposia to expose other physicians to the new products. Additional specialized marketing teams support product introduction in the clinical environment, with strategies that include visits to physicians’ offices, hospitals and ambulatory surgery centers.

In addition, companies in the life sciences need the same array of business skills as any other corporation. The individuals involved must have expertise most specific to life sciences and importantly, they need to know how to work as a team.

In my experience with a number of startups in the medical device industry, I have spent tremendous amounts of time training technical teams to work in cross-cultural relationships.

For example, one of my companies pioneered a complex computer-imaging system and developed a non-invasive method of detecting early ischemia in the heart. To facilitate the process, I hired a technical expert specializing in the development of such systems and named him to lead a small computer science team working with medical data.

The development process sometimes required him to compile information while one of our scientific advisers was operating on patients. However, he often had to cool his heels in the waiting room before the physician became available. In some cases, the meeting would be canceled altogether. After one too many of these episodes, the man stomped into my office and said he was no longer interested in the job because he was not respected by the doctors, who didn’t even seem to realize that they had kept him waiting.

This was where my experience in the medical industry came in handy. I explained that it was certainly not intentional but that there are many urgent issues that the doctors must attend to, most of which tend to occur when it is least convenient. A man used to set hours with time off for lunch would not necessarily have deduced this from his own experience.

This is an example of one of the many complexities in the process of introducing a new diagnostic, therapeutic or implantable product to the market. It generally requires several years of intensive work and considerable expense. As a result, the ever-increasing need for new medical devices and technologies far outstrips our ability to produce them.

One logical solution is to provide more support for emerging device companies. Throughout the nation, important nurturing is often provided by business incubators that work directly with entrepreneurs. These organizations, most privately funded, do an excellent job of promoting new companies and products and helping to develop new leaders. The government offers some help, but participation requirements are very difficult to meet.

We need more leaders and teams of experts with sufficient funding to develop new companies and products. We must develop mechanisms for training experts in diverse fields to understand the nuances of the health sciences and to work in teams to solve medical problems. Then we must connect them with investors who understand the life sciences.

An excellent model for training is operating at Stanford University. The Biodesign Group brings together experts from technology, medicine, entrepreneurship, business and marketing to work on the prototyping of medical devices. Through this process, each participant learns to understand the other disciplines and their critical value in building products and creating business units. The group works with physicians and attends real-life procedures to learn about the critical elements that affect patients.

This successful model should be expanded. By creating additional government and educational programs that train individuals from diverse fields to work together, we can begin to meet the need for teams to develop products in the life sciences. By adding investors to the mix, we can accelerate the process even more.

Such an approach will have enormous value both to small startups and to large companies, which can provide much of the necessary funding by sending their executives and employees to participate in the program.

The demand for life sciences products is growing, but the supply can’t catch up because the product development process is on a much slower timeline.

While it is unwise to rush the development of products, it would be extremely advantageous to create a more efficient process for training experts who can conduct product development safely, ethically and successfully.

Most of the funding and leadership for such efforts will come from the private sector. There’s no better place to focus the work than right here in Silicon Valley. The Valley has long been a hub for innovation and technology and has always been quick to respond to needs in the market as well as to trends and dynamics of the economy.

Silicon Valley pioneered a decade of innovation in semiconductors and then in the computer industry and Internet technology. Now it is crucial for experts and entrepreneurs in medical technology to take advantage of new opportunities and lead the next wave of innovation.