FHC's Custom Surgical Platform Wins Medical Design Excellence Award, cont.

FHC's microTargeting Platform is an innovative surgical device and planning system that has the potential to transform functional neurosurgery from a marathon surgical event that routinely immobilizes an awake patient for up to 12 hours, into an out-patient scanning visit followed by a shorter surgery. "We believe that patient customized surgical fixtures are an idea whose time has come," says Ron Franklin, FHC's Stereotactic Technology Development Manager. "They improve the quality and outcome of healthcare delivery for both patient and surgeon."

With the Platform, a surgeon can plan and validate the procedure before the patient arrives for surgery, thus minimizing the time spent in the operating room. For the patient there is the benefit of free movement and relatively greater comfort. And finally, for the hospital, the inexpensive custom Platform completely replaces the large stereotactic frame and cuts costs.

Employees at FHC, a small company located in rural Maine, take the award in stride. "FHC has been serving the neuroresearch community for more than 35 years-developing new microelectrode configurations, amplifiers, and positioning devices to meet clients' evolving research needs", explains FHC president, Fred Haer, "and we have carried this design philosophy over into our clinical products."

At first, FHC engineers simply tried to develop a new stereotactic device that was more comfortable and accurate, when they realized that they were working within the framework of a mechanical technology more than a century old. So, the team looked for a way to break down the frame. "We looked at emerging technologies and found in one a new way to design intelligent customized structures and in another the ability to manufacture them rapidly," Mr. Franklin explains, "and then created a custom interface with state of the art medical imaging and surgical planning software." Dr. Joel Franck, a Maine neurosurgeon and Mr. Franklin developed this innovative customized interface technology called STarFix™ (Surgical Targeting Fixtures). They believe that the unique customized fixtures can be utilized in other applications including spine and bone reconstruction surgeries.

Two mT Platforms can be used side by side,
as shown, for simultaneous bilateral surgery
-a procedure that can not be performed
with a traditional stereotactic frame.


MDEA entries are evaluated on design and engineering features including innovative use of materials, user related functions that improve healthcare delivery and change traditional medical attitudes or practices, features that provide enhanced benefits to the patient, and the ability of the product development team to overcome design and engineering challenges so the product meets its clinical objectives. Mr. Haer adds, "While FHC is proud of the innovative design of the microTargeting® Platform System, it is especially rewarding to see our designers and engineers recognized with a Medical Design Excellence Award."

FHC's team and the other 2004 MDEA winners will be honored at a ceremony this June at the Jacob Javits Convention Center in New York City where the Gold and Silver award recipients will be announced.

News Release
For Immediate Distribution
May 31, 2002

FHC, Inc. acquires sales, technical support and manufacturing rights for Axon Guideline 3000A Intraoperative Microrecording System.

In a joint announcement, Axon Instruments, Inc. and FHC, Inc. revealed that FHC will, effective June 01, 2002, assume the sales, technical support, and manufacturing responsibilities for the Axon Guideline® clinical product line.

"Axon Instruments is focusing all of its efforts toward instrumentation for the drug discovery process. However, we wanted to make sure these excellent products continued to be offered," said Andy Blatz, Ph.D., Axon Instruments Vice President for Cell Based Screening. "By transferring the Guideline System to FHC, whose product mix matches the intraoperative recording, stimulation and data analysis requirements of the functional neurosurgeons and neurologists who use this technology, we assure our clinical customers of the continued quality service and support for which we are known. Many of our customers already use FHC's microelectrodes, so supplyline issues will be minimized."

 "Axon Instruments is recognized as a 'gold standard' instrument manufacturer in the research, neuroscience and biotech markets," Mike Graffam, FHC Engineering Manager, said while at the Axon Facility overseeing the inventory transfer. FHC Allen Groleau, added, "By adding the Guideline System to our stereotactic positioners, guidance systems, and technical support we will now be able to offer a complete, FDA cleared, procedural solution for targeting during movement disorder surgery."

Axon Instruments, Inc., located in Union City, California and Melbourne, Australia, was founded in 1984. It produces a broad spectrum of instrumentation and software for genomics, cellular neurosciences and cell-based screening. In genomics and cellular neurosciences, Axon is already widely recognized as a pre-eminent manufacturer. The company's goal is to produce a range of superior yet affordable instrument and software systems for drug discovery ained at the pharmaceutical industry, biotechnology companies and academic researchers. Axon Instruments is a California corporation listed on the Australian Stock Exchange (symbol: AXN.AX).

For more information, regarding Axon products, please call Al Walter, PhD. (510) 675-6200 or alw@axon.com.

  FHC, Inc. is a privately held corporation located in Bowdoinham, Maine. Founded in 1970, FHC manufactures and markets Neurocraft(TM) microelectrodes, electronic and mechanical instrumentation and data analysis products to neuroscience research investigators who use extracellular methods and microTargeting
, FDA cleared, products to functional neurosurgeons and neurologists.

 

FHC Adds ISO 9001:2000 Upgrade to MDD and FDA Certification Systems

Bowdoinham, Maine, USA--Following the closing meeting of a company-wide audit conducted by ITS/SEMKO on August 21, 2002, FHC Quality System Officer Dr. Lee Margolin announced that the company had been recommended for ISO 9001:2000 certification. Companies that are currently compliant with the 1994 version of ISO 9001 are required to complete the upgrade by December 31, 2003 in order to maintain their certification.

“This represents a huge team effort”, Dr. Margolin stated. “Our eight person transition team has worked for the last 6 months to meet the new standard! The effort required a complete revision of the company’s Quality Policy Manual as well as the revision of numerous procedure and process documents. This certification is significant because only 10% of the companies that are compliant with the 1994 ISO standard have achieved certification to the updated 2000 standard. The process was complicated by the fact that all changes had to be consistent with the FDA’s Quality System Regulation as well as the European Union’s Medical Device Directive to which the company is also certified.”

Human Resources Coordinator Ruth Harris explained, “We are especially pleased because the new ISO standard emphasizes customer satisfaction, continuous improvement and the importance of our human resource assets in terms of both contribution and continual training. These have always been a priority at FHC and have enabled us to more than double our staff in three years.”

FHC, Inc. is located on the banks of the Cathance River in Bowdoinham, Maine. Its team of 44 designs, manufactures, and markets microelectrodes, electronics and mechanical instrumentation for research neuroscientists and clinical neurosurgeons worldwide. FHC’s trademarks NeurocraftÔ and microTargeting proudly bear the “Crafted in Maine to be the world’s best!” statement.

 

 microTargeting Drive System

Introducing our elegantly simple microdrive for precise positioning of microelectrodes followed by DBS or lesion electrodes during functional neurosurgical procedures. Adaptors for most stereotactic systems are available, as well as insertion tube systems designed for quick and accurate electrode placement without time consuming measuring beforehand. The microTargeting Drive features a maTrix™ arrangement of guiding channels so that up to five tracks (on 2.00mm centers) can be mapped without adjustment of the stereotactic.

“Innovation through collaboration!”

 
FHC Inc. 1201 Main Street, Bowdoin, ME 04287
Tel: 207-666-8190, Canada & US 1-800-326-2905,
Fax: 207-666-8292, email: fhcinc@fh-co.com

Rev. January 14, 2008