Leaders and CEOs of various industry groups met Tuesday to inform and relate growth problems, strategies and new developments in the industry of biomedical devices at SJSU engineering auditorium.
Tom Afzal, president and CEO of Spinal Kinetics, said there were difficulties in achieving a 510k plan in the U.S., and for that reason the product was first launched in Germany eight years ago.
“To be successful you need a chief evangelical officer, someone who recruits top people at the right time,” Afzal said. “You have to think globally as we did in introducing product in Germany eight years ago, and we received approval for the first devices replacing cervical disks, then we went on to develop devices for the lower spine.”
Startup companies have to meet all their milestones, proof of concept, experimental trials and First in Man testing, according to Afzal.
“To survive as a startup you need to either have deep pockets from venture capital or start getting money back from sales and development for reimbursement to take place,” Afzal said. “This takes longer in the American market with tougher standards set by the Food and Drug Administration.”
Samir Shah, a graduate student in biomedical devices, said he liked the conference.
“The conference gives SJSU an opportunity to interact with the biomedical device community as a whole,” Shah said.
Rob Abrams, operating partner for Sanderling Ventures, gave advice on raising capital for new devices.
“We are in an exciting time with more opportunities for health care, with the aging of baby boomers who want care, but new companies must watch their burn rate of capital as they wait for 510 approval or stricter FDA qualification rounds,” said Abrams, who holds more than 70 patents for neurological, cardiovascular stents and orthopedic appliances.
Abrams said there will be 40 million more people needing health care with the passage of health care legislation. He said there are new therapies that can scan and clean lipids in the vessels and a new company, InfraredX, that can clean out blockages in arteries.
“Some bio-med implants have failed or had problems that brought on class-action lawsuits,” said Tom Bauer, an M.D. at Cleveland Clinic. Bauer said there were failures in the manufacturing of an implantable hip joint that was contaminated by gram negative bacteria in a Texas plant.
The implants built by the company had been outsourced and a nitric acid bath had not been used on batches, causing inflammation. All had to be replaced, resulting in the class-action lawsuit that cost the company at least a billion dollars, Bauer said.
He said companies can’t be too careful in every step of the manufacturing process.
“This conference puts us on the map and gets our name out in industry,” said Erik Aks, a master’s student in biomedical devices. “It creates a forum for us in Silicon Valley.”
Students displayed posters of their graduate experiments in biomedical devices.
“We are fabricating bio-membranes to insert drugs or medicine or stem cells for treatment of various diseases,” said Ding Chen, a graduate student in biomedical devices.
Chen said that capsules are also fabricated using crab shell material as the basis, floating in a seaweed-alginate substance.
“An intended drug is mixed with liquid polymer and the polymer is converted to capsules using an air pump and flow pump,” said Raki Nagendra, a master’s student in biomedical devices.
“The capsules are time-release based, for example a terminal patient waiting for a liver transplant can orally take capsules containing liver cells that do the job and then come out naturally,” Nagendra said.
John Tang, a graduate student in biomedical devices, said the conference was excellent for two reasons.
“One, there was an opportunity to speak directly with people in industry and to ask questions about their personal experiences, and two, it gave us an opportunity to be exposed to some of the most prevalent issues in the medical device industry,” he said.
“We had many speakers specializing in many fields of the medical device industry,” said biomedical student Nick Polsaward. “We learned a lot. It’s a great chance to assist in this conference.
“So, the reason why we pursue and are interested in this field is because we want to use our knowledge to save lives,” he said. “Even though I’m not a doctor I can still help save lives.”