The CIMIT Forum held on Feb. 5 at the Simches Research Center focused on the topic of “Cardiac Device Development,” and featured two lively presentations about the science and business of caring for those with heart disease.

Presenting were Stephen N. Oesterle, MD, senior vice president, medicine and technology, at Medtronic Inc.; and Donald S. Baim, MD, executive vice president and scientific officer, Boston Scientific Corp. Moderating was James E. Muller, MD, who is CEO of InfraReDx, Inc.

Dr. Oesterle’s topic was “Convergence in Health Care Technology: Devices, Biologics, Pharma, IT, Communications and Imaging.” He suggested that the era of implanted electro-mechanical devices is disappearing. Dr. Oesterle said that therapeutic proteins, cell therapies, interference RNA and gene manipulation – known as “biologics” – offer a realistic approach to restoration and cure for many of the same degenerative and chronic diseases that have been the focus of device therapy.

He said that in coming years, aging Americans will comprise a “locust swarm” that will be seeking new and minimally invasive ways to treat chronic problems.

Dr. Oesterle, who once was with CIMIT, said that “combination devices” – biologics delivered by devices such as catheters and pumps – will define many therapies in the next decade.

Dr. Baim, also once with CIMIT, spoke on “Challenges in Cardiac Device Development.” He noted that cardiovascular devices such as stents have revolutionized the treatment of coronary artery disease over the past 30 years. He said that the large number of procedures (1 million per year) and associated revenues ($8 billion per year) have fueled the development of the stent industry.

But Dr. Baim stated that studies challenging the efficacy of some drug-eluting stents over the last 18 months have caused a 20 percent drop in the use of such devices. He indicated that it will be difficult for the large medical device companies to regain their momentum, due to increased regulations from the Food and Drug Administration and added competition from new companies.

Medtronic is one of the world’s largest producers of biomedical devices, employing 40,000 people worldwide and annually generating around $13 billion in revenue.  The company offers products to treat a broad range of chronic degenerative diseases; and every year, the company spends about $1.5 billion on research and development.  To continue its success, the company recognizes that it must adapt with the changing face of modern medicine.  Medtronic is thinking about several medical trends that will most likely occur over the next decades.  As the U.S. population ages, for example, chronic degenerative diseases will almost certainly become more common.  As diagnostic and therapeutic techniques improve, personalized medicine will replace “population” medicine, and restorative therapies will replace the palliative therapies that Medtronic focuses on now.  Medical devices will gradually become integrated with information technology, and the role of materials science in healthcare will expand.

The medical industry seems to be entering a new era.  In the first half of the twentieth century, medical therapies were often based on the extirpation of diseased tissue or organs.  More recently, therapies have depended upon the implantation of tissue, mechanical devices, or even organs.  With the medical community’s growing understanding of the human genome, these palliative techniques may soon be obsolete.  It appears to be a “central dogma of biotechnology” that all diseases can be reduced to protein imbalances, and many different therapies, from mRNA suppression to gene therapy, are being developed to treat these protein imbalances.  Medical devices will play a major role in this new medical age because molecular therapies will be most effective only if they are combined with site-specific delivery platforms.  Implantable physiologic sensors are also poised to become valuable medical tools, and in the not-so-distant future, small implanted devices may allow physicians to monitor a patient’s condition remotely via information transmitted over existing communications networks.  In this new age, medicine will increasingly involve the integration of the physical, life, and information sciences.      

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