Bay Area Medical Device Conference, 2011 hosted by Biomedical Engineering Society of San Jose State University http://www.sjsu.edu/gradstudies/docs/2011-BMD_Conference_Announcement_Feb_22_2011x2x.pdf drew a large attendance with over 250 attendees associated with medical device industry, in the bay area. There were 15 sponsors as well as exhibitors present on the premises. The conference opened with welcome message from Professor Guna Selvaduray where he gave thanks to exhibitors, sponsors, bay area medical device community and specifically to the students who worked tirelessly to organize this event. The conference featured interesting information on various emerging technologies and companies, its mission being to provide for the students and other professionals an exposure to emerging technologies, an opportunity to hear from entrepreneurs on commercialization of ideas, and to provide a venue for Bay Area medical device professionals to network. This conference indeed created an excellent opportunity for dialog between academia and the industry and undoubtedly the stars of the show were numerous student volunteers who made every attempt to make sure the process was flawless and exciting. Some of the sessions are summarized below. We will look forward to continuing success and increasing attendance at this annual conference in the years to come.
FDA – The Changing Landscape with Medical Devices
Craig Coombs, Consultant with Coombs Medical Device Consulting, discussed FDA: The Changing Landscape with Medical Devices. FDA’s mission is to foster innovation and assure safety and effectiveness of medical technology used on patients in the US. To that extent, FDA’s diligence has led to safety in devices that is outstanding, said Coombs. However the system is not efficient and there are big problems facing the FDA. They have burdensome classification system, unreasonable or unreachable expectations for safety and efficiency data, and inadequate data of medical devices. The burdensome system has too many goal posts or there are moving goal posts and that fosters contention in place of collaboration, said Coombs. Four main elements that are targeted, intended use, indications for use, technology, and new questions of safety and effectiveness lack consistent definition. The problems that result from this confusion leads to nearly 50% of the reviewers’ time spent on justifying classification rather than on reviewing safety and effectiveness. Additionally, immense job pressures create difficulties in recruiting and retaining personnel and nearly 40% of reviewers have less than 4 years of experience.
Coombs then went on to discuss the process that is currently being implemented to address some of these challenges. There are internal working groups and town hall meetings organized to address some of the problems. President Obama has taken great initiative to address the problems, legislative changes include FDA’s agreement of de Novo Process to streamline the process particularly for novel products and focus on developing network of external experts with other changes in the pipeline. The session was followed by Q&A.
Osseointegrated Implants for Amputees
Dr. Roy Bloebaum, from University of Utah, in a parallel session, discussed hopes and challenges of implants for amputees. Discussing the increasing incidence of this problem Bloebaum shared that given the advance of technology and other safety enhancing devices like helmets, body armor etc. in a war, it creates more survivors with severe injuries, specifically more amputees. Despite new developments in limb implants, many challenges remain. There is challenge of maintaining a proper fit, problem of muscle atrophy, stump pain, and challenge of non-physiologic loads. Oseeointegration has not gone through rigorous testing and it is premature in the US though it is done in Europe. It creates a high risk of infection. Current challenges to solve before the device becomes totally safe, are how to prevent infection, reduce rehab, offer single stage operation process, offer total joint model, and develop skeletal and skin attachments with mechanical stabilization. Technology is expected to be ready in 3-5 years time for use for war veterans.
Dr. Lisa Ferrara from OrthoKinetic Technologies discussed the use of novel biomaterials, Mechanical Testing, and the Regulatory Process that takes orthopedic products from benchtop to animal testing. Ferrara began with reviewing the details of the problem. Currently there are 11 million Americans who have at least one medical device implanted in the body. In the US annually there are 290,000 hip replacements, over 300,000 knee replacements and there are various other joint problems because as the age of mortality goes up, people experience increasing joint problems.
During early design process for orthopedic implants the team focuses on how an implant will succeed and also understand what would happen to the surrounding tissue, if it fails. Spine with an interdependence of disc and facets is the most complex for designing an implant. R&D team needs to take into account intended use of the limb, indications for use, and what is the level of risk in terms of whether it is life sustaining, life saving etc. and who would make ideal recipients. They need to conduct intensive risk analysis. During prototype and feasibility testing, they go through detailed scientific thought process, regulatory testing, and considerations of packing and how it would be delivered.
In preclinical phase, the team would assess safety. They look at issues regarding whether the device would be safe as a total system, safety of the foreign materials interacting with the surrounding tissue, and considerations of mechanical performance. Technology can be very useful at this stage. Computer modeling and finite analysis can help answer many questions and they would also do some cadaver studies. Animal testing raises issues regarding generalization. Animals are quadrupeds and humans are bipeds. Ferrara then discussed about biomaterials and their interface with the tissue and considerations of treatment of the infected tissue. Team needs to carefully consider particle size, durability, degradation, corrosion, tissue reaction, and biological response and look at all of this in a wholistic manner, said Ferrara.
Silicon Technology for an Implantable Artificial Kidney
Dr, Shuvo Roy from University of California at San Francisco discussed details of their work on development of an artificial kidney. Roy began with discussion of the key functions of the kidney. Contrary to popular assumption, kidney is not just an organ that removes waste from the body. In fact a kidney does much more than that. Key functions of the kidney include removal of the waste, regulating electrolytes, maintaining acid base balance, regulating blood pressure, and secrete hormones. Dialysis treatment only focuses on removal of the waste which leads to less than ideal conditions for the body. Roy then shared astounding statistics of the high growth rate of kidney disease. Currently there are over 85,000 kidney patients on the transplant list. About 1% of kidney patients on medicare consume 6% of the budget. Kidney disease is the single biggest line item in medicare budget. While there are increasing number of patients on the transplant list, vast majority of these patients only get dialysis treatment. While dialysis is life saving, it really only prolongs death, rendering very poor quality of life for these patients and it is exorbitantly expensive, costing nearly $75,000 per patient, per year.
Roy then went on to share the work currently under way to develop artificial, implantable kidney. It is envisioned to have 2 components, a filter system and cell bio reactor to provide some bio functions of the normal kidney that dialysis currently cannot provide. Benefits of bioartificial kidney would include 24/7 therapy so there is no buildup of toxins, freedom of mobility since one does not have to be tethered to a machine for several hours, decreased infection risk as path for pathogens to enter the body is eliminated, more physiological therapy as most of normal kidney functions are restored, and no need for anti-rejection drugs. This would truly be a major medical breakthrough and a dream come true for the patients.
Roy showed a device currently treating random sample of 58 patients. It is currently an enormous device and the next phase of the challenge is to decrease the size so that it delivers all the functions but is small enough to be implanted. Roy discussed challenges and barriers to miniaturization that include materials that would allow waste to pass but not protein, size and shape of the pores, whether they should be slit pores or round (slit pores seem to be ideal) and interaction of the device with the body. He also discussed the technology that might help solve some of the challenges including polymer membrane technology, silicon fabrication, oxidation, anti-biofouling coatings, and other advanced technology to enhance in vivo biocompatibility. Currently a large team of multi disciplinary experts is working on integrating these principles and take it to the next stage. Indeed very exciting work.
Robotic Surgery for Urology Problems
Dr. Mark Gonzalgo from Stanford University discussed promise and challenges of robotic surgery for treatment of urological problems. Sharing the statistics, Gonzalgo noted that the incidence of urologic cancers in men is as high as 250,000 cases a year in the US. Gonzalgo discussed current treatment methods for prostate, bladder, and kidney cancers. Treatment options include, 1) surgery, 2) non surgical treatment through radiation, particularly IMRT and Brachytherapy, 3) active surveillance (often for prostate tumors, 4) ablative therapies though some of that is in the works but not approved by FDA.
Surgical treatment for kidney problems focused on radical nephroctomy that evolved into laproscopic surgical option leading to decreased blood loss, less pain, and less hospital stay. Similarly, radical prostectomy evolved into laproscopic prostectomy. Both these can now be done with minimally invasively through robotics with a focus on three main goals, cancer control, urinary control, and maintenance of sexual function. Gonzalgo shared about the Da Vinci system being used that offers instrumentation with 7 degrees of freedom, 3D magnified version in high deficiency, scaling of movement, improved ergonomics for surgeon, opportunity for surgical simulation and testing, provides interface for application of additional technologies, and offers sophisticated tools like scissors that provide heat for coagulation as the cut and sophistical needles for suturing. Gonzalgo also shared how the procedure is done for bladder cancer and for kidney cancer.
The next stage development will be focusing on possibly reducing incisions even further, greater hepatic feedback to allow for the surgeons to feel the tissue etc., improved instrumentation so surgeons can use more than two fingers that they currently use, advanced real time imaging using 1080 p and other high definition technology to get real time advantage, duel consoles to enable training of surgeons more easily, tele robotics to allow for more applicability of long distance operations and reducing costs to make the systems more widely available. Robotics has altered the nature of post-operative care and with these advances indeed, it will become even more safe and effective.
Engineering Solutions for Treating Cerebral Aneurysms and Ischemic Stroke
Dr. Sanjay Shrivastava from ev3 began the presentation with discussion of current challenges and treatment options for aneurysms and ischemic stroke. Blood in the brain is fed through two sets of arteries in the anterior and posterior regions of the brain. While most blood vessels have three layers, the blood vessels in the brain only have two layers which render them very thin, adding to the challenges. Aneurysms are also different in shape, size, morphology, and location of the disease.
One treatment option that was used was surgical clipping of the clot. That was complex, invasive, and also many blood vessels in the posterior region were not easily reachable. Another option is through the use of embolic coils. These coils are femurally inserted and use to close the aneurysm to keep it from rupturing. These coils need to be flexible for 3D structure and need to be deliverable by micro-catheter. This procedure is also not totally effective, leading to 5-50% of the aneurysms to revascularize. EV3 is working on self expanding stent that is attached to a wire and delivered through the micro-catheter and if it is not delivered properly, it can be pulled back. Stent chatacteristics need to meet the key requirement for deliverability and these cannot be used in ruptured aneurysms and need to have good balance between deliverability and radical strength. A new paradigm that has emerged is flow diversion to obliterate the aneurysm by reducing blood flow and it is showing good results.
As far as strokes are concerned, 87% of all strokes are ischemic strokes. Currently available drug is the standard first line of treatment for a patient within 3 hours of the stroke. After that passage of time, the focus is on mechanical therapies targeted to retrieve and pull the clot out of the body. This is about to be approved in the US and indicates an ability to pull 90-95% of clots. Other mechanical therapies are also emerging as there is greater understanding of the disease and also increased understanding of engineering and materials, said Shrivastava.