Medical Device Daily National Editor

PALM DESERT, California — There’s little question that we live in an information-rich age. But even being able to assemble thousands — even tens of thousands, sometimes millions — of pieces of information on any given subject, doesn’t guarantee that it’s the right information.

ASM International (Materials Park, Ohio) has taken a big step toward assuring that the information its medical device-focused members are seeking by establishing the Materials for Medical Devices Database, which the organization characterizes as “the only materials database created specifically for medical device design.”

During last week’s annual Materials and Processes for Medical Devices Conference at the Marriott Desert Springs Resort, the society and its vendor partner, Granta Design (Cambridge, UK), demonstrated what they termed “a substantial enhancement” to the database in the form of the first elements of an Orthopedic Module to join the resource’s existing Cardiovascular Module.

The module establishes records for nearly 1,200 devices for spinal interlaminal fixation orthosis, spinal intervertebral body fixation orthosis and pedicle screw spinal systems.

The focus of the database is to enable device designers to rapidly acquire information to support device design, materials screening and various regulatory filings.

ASM and Granta, whose materials data management software drives the database, work with a steering committee of experts from industry and academia to aggregate and maintain information from thousands of citations in journals, FDA device approvals information, manufacturers’ datasheets, standards and web sites.

Don Lensner, group manager of ASM’s sales and member services center, is somewhat of an evangelist when he gets talking about the database.

“The genesis of the database was those in the device industry telling us that they wanted to have access to the broad range of information that they needed on topics such as materials selection, FDA approval paths and the like.”

In addition, ASM is “literally creating an on-line community where our members who are involved in the medical-device field will have access to forums with their peers,” Lensner said.

The target date for throwing open the electronic doors to that on-line community is 1Q08.

Lensner sees the database as a particularly useful resource for smaller companies. “In a big company,” he said, “you can pick up the phone if you’re stymied by a problem and talk to one of the other 3,000 engineers employed there.”

Noting that those chasing solutions in a start-up company “need to find the same information ... this database lets them compete with the big companies in cutting time to market.”

With the Materials for Medical Devices Database, subscribers can, for instance, screen materials by properties, applications and other key attributes, “and they can do it in minutes,” Lensner said.

Raymond Sirochman, manager of database sales and liaison to the medical device community for ASM, said people are “very impressed with the amount of information there, especially in the area of biocompatibility of materials,” a key criterion when it comes to development of medical products.

In an ASM statement on the introduction of the new Orthopedics Module, Sirochman said the announcement “shows our commitment to continuously expanding and updating this powerful new resource, first released earlier this year, under the guidance of our expert Steering Committee. Such currency is essential to our customers in the fast-moving field of medical device design.”

The database is being built on a modular basis, with the new section on spinal materials representing the first step for the orthopedics section. Resource materials on knees, hips, elbows and other extremities will follow, then new sections on pulmonary and neurological device development will be launched, and another on dental implants is also part of the development plan.

It’s not like ASM and Granta Design are likely to run out of targets. “We have over 3,600 devices cited in the database already, just in the cardiovascular and spine sections,” Lensner said.

Touching on the information-overload question, he said the “double-edged sword” is that “there is so much out there.”

That’s where having the right information comes into play. “Ours is pedigreed,” Lensner said. “[Our users] can count on what they see there – it’s peer-reviewed [and] they can have a high degree of certainty of it being reliable.”

Those who are shown demonstrations of the database, as was being done at the ASM booth in the meeting’s exhibit space, usually respond, he said, with something like “Wow, this is so on target!”

Then there are those whose primary question is, “What about this?” They are reassured, Lensner said, that ASM is “committed to quality updates” of the site. “We add or revise materials on a monthly basis, and full-scale updates are issued quarterly.”

Dr. David Cebon of Granta Design discussed the development of the database during a conference session on “Materials Information and Materials Selection.”

“Competition in the medical-device market often depends on improving the surface properties of metals,” he said. “In doing so, information is needed to assure the compatibility of materials.”

Cebon, whose work with Professor Mike Ashby at the University of Cambridge (Cambridge, UK)formed the basis for Granta when the company was spun out of the university in 1994, said he sees the database as providing “a decision-support system for designers, clinicians and researchers,” one that “helps bridge the information gap between engineers and medical personnel.”

The modules, which started with the release of Cardiovascular version 1.0 this past January, “can be integrated or sold separately,” Cebon said. As of the release of another quarterly update this coming December, the cardio unit will be in version 3.0 and there’ll be a full complement of materials in the Orthopedic module.

The database is structured to include as much relevant information as can be gathered on materials, coatings and drugs.

Case studies include finding materials used in a predicate device, examining drug-device combinations, and “fully traceable” sources of engineering and biomedical data.

The idea, Cebon said, is “to combine engineering information, medical information and mechanical/physical information into one database.”