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Friday, March 13, 2009
Inside Medical Devices
Retracing a medical device's discovery-to-market process
By James M. Connolly
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From inspiration to revenue, the path of a medical device is likely to be marked by bumps, breakthroughs, misdirection, redirection and refinement.
To provide a view of how one family of devices is navigating through research, development and, eventually, clinical testing before getting to market, executives from MicroChips Inc. in Bedford, provided a review of the life cycle for its implantable chip devices. MicroChips has two devices in development, a glucose sensor designed to alert people with diabetes to significant changes in their glucose levels, and a drug-delivery device designed to provide daily parathyroid hormone treatments over a period of time to spur bone regrowth in osteoporosis patients.
Inspiration
Some ideas come out of long hours of labor in a lab. This one came from the tube, and not a test tube, in 1993. “The whole idea for MicroChips came about while I was watching a program on PBS about microprocessor technology, and I thought that you could use chips for drug delivery,” recalled MIT researcher and entrepreneur Robert S. Langer.
Langer, who lays claim to 640 patents, shared his idea with another MIT professor, Michael J. Cima, an expert in materials processing. After their initial discussions, Cima mentioned the idea during a lecture to a small group of students.
In the audience sat John T. Santini Jr., attending a 10-week MIT summer program between his junior and senior years at the University of Michigan.
“He put up his last slide saying that he and Bob had this interesting idea for using chips for drug delivery. It was a single slide with a simple drawing of the concept of reservoirs on an implanted chip that excited me,” said Santini. The future CEO of MicroChips went on to experiment with a rough device. It didn’t work, but Santini returned to MIT as a grad student a year later to work with Cima and Langer again.
The team
Santini earned his Ph.D. in chemical engineering, and continued research into a microchip-based drug delivery system. In late 1998, the team received its first patent for multi-reservoir devices.
That first patent was one in a series of moves to protect the company’s intellectual property, noted vice president for business development Maggie A. Pax. “John is extremely strong in the IP field. A key milestone for us was protecting that asset. The quality of our patents made it possible for funding to be acquired,” she said.
Today MicroChips holds more than 30 U.S. patents.
With Langer, Cima and Santini on board, the MicroChip team still needed a partner who could provide financial backing. In the fall of 1998, Langer brought in Polaris Venture Partners founding partner Terry G. McGuire, who provided seed money. “I don’t think we had to sell him very hard. I just invited him over and introduced him to John and Michael. He looked at the research, and I think he wanted to get involved.” said Langer.
Today, Langer, McGuire and Cima remain active as board members.
The company
The year 1999 was crucial for MicroChips. The founders launched the company, developed a drug delivery microchip that had 36 reservoirs, and published a technical paper in the magazine Nature. That article put the company and its concepts on the map. The night before the issue was published, Santini and the team were featured on ABC World News Tonight. “What the paper did was create a public awareness and excitement. We showed we could marry chips and drugs,” said Santini.
But the company was still in the research phase of life.
In 2000, MicroChips recognized that it had to incorporate micro-electromechanical systems technology in place of traditional integrated circuits. MEMS better enabled the reservoir concept and simplified development. Later, the company added wireless technologies and developed hermetic seals for the reservoirs. Now the company was in development.
“We spent several years figuring out how to make it in volume, and making sure that the wells opened when they were supposed to,” said Santini.
Development
By 2006, when MicroChips published a second technical paper, the device in development was completely wireless, but it still carried some bulk, at about two inches in length. In the subsequent years, developers have cut the size about in half and have worked in more custom components, such as a battery, wireless antenna and circuitry.
At the same time, the company had to make a decision: which applications to pursue.
Santini notes that the founders saw potential for using the chip technology in areas such as sensing, long-term delivery of drugs, and “rescue devices” to save a patient in crisis.
Rather than move directly into drug delivery, MicroChips shifted its initial focus to building sensors, a glucose monitor. “We turned the crank on diabetes mid-decade. It was a business decision, not a technical decision,” according to Santini.
Pax said executives looked at various markets, and considered issues such as market growth, the regulatory environment, opportunities for financing and whether insurers have defined reimbursement. That research involved conversations with providers, as well as looking at work done by other companies on the regulatory and reimbursement fronts. One such company, MedTronic Inc., which sells a short-term glucose monitor, is one of nine investors in MicroChips.
The MicroChips glucose sensor now in development is designed with a series of wells housing small sensors covered by a seal. As each sensor is unsealed, body fluids enter the well. If there is a glucose issue, or signs that the wearer could be heading for a hypoglycemic condition, the sensor is designed to alert the wearer through a wireless connection to a handheld receiver so they can take action. The goal is to have each sensor work for three weeks before another of the 20 sensors is activated, enabling a year of operation.
Next Steps
Santini hopes the device can move it into human trials this year. “We had our first meeting with the (U.S. Food and Drug Administration) in December of last year. It was a positive first meeting, a get-to-know-you meeting,” he said.
Once the company requests and gets FDA approval to start human trials, MicroChips is likely to run three-month and six-month trials before working its way up to a one-year trial. Its goal is to have the sensor device implanted for a year at a time through an outpatient procedure.
Following the glucose sensor in the development stream is MicroChips’ osteoporosis therapy device. Rather than a sensor that collects body fluids, the device is designed to release parathyroid hormone from its wells. The device would take the place of a current injection pen, which elderly patients must remember to use each day.
So, with one device being prepared for human trials and one in earlier development, MicroChips is turning its attention to other products, and licensing deals, some of which already generate revenue. Santini is considering drug delivery to the eye and rescue devices, such as those that could deliver a chemical defibrillator to heart attack victims or replace epinephrine pens.
“Never before have long-lived devices had the ability to continuously sense chemical conditions from within the body. And, never before has precisely controlled delivery of proteins and peptides been achievable with 100 percent compliance,” said Santini, who sees MicroChips’ technology as a platform for a new class of intelligent medical devices.
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