With the demand for fiber-optic endoscopes and machine shop services continuing their healthy growth, Myriad has decided to add another CNC lathe to our machine shop. Endoscopes and borescopes obviously require a lot of machined cylindrical components. Our machine shop also produces quite a number of round parts for their machine shop services customers; both large parts and small parts. Ganesh machining centers have worked well for Myriad in the past, so we chose a Ganesh Cyclone-32 GTS. We also purchased the optional bar feeder, for continuous raw stock running of the machine. This new machine will help Myriad to maintain the level of quality and on-time delivery, that our customers have come to expect from us.
Another interesting group of customers making use of Myriad’s collection of experiences, skills, and technologies, is the aerospace industry.
One customer, Rolls Royce – Jet Engine division, asked Myriad to design and build 16 high temperature fiber scopes to be used in the development of new jet engines. These scopes would be inserted into various locations within the engin while, while it was running, to analize its performance. The proximal ends of all 16 fiber scopes were then brought back to a single digital camera. Myraid also designed and manufactured a computer controled x-y stage to position each individual scope to the camera.
Another AeroSpace project completed by Myriad, was a imagescope designed to image in the IR spectrum. The company was Boeing, and the application was for analizing the flame burn efficiency of the rockets on the space schuttle.
In a project developed directly with NASA, myriad designed and assembled an imagescope to inspect fiberoptic connectors used to link different modules of the International Space Station to each other. Each connector had to be varified as to being clean and without debris before being launched into space aboard the schuttle.
Not long after the events of 9-11, Myriad was contacted by Ball AeroSpace to help develop an fiberoptic viewing system that would allow the flight crew, in the cockpit of a commercial jet liner, to see what was going on in the main cabin. The main advantage of such a system being that it couldn’t be tampered with, without the crew being aware of such tampering. Myraid designed and built a prototype for Ball AeroSpace to test in an actual plane.
Myraid Fiber has also completed projects with several other AeroSpace companies such as General Dynamics and Pratt and Whitney.
Our next blog entry will deal with yet another equipment acquisition for our machine shop.
During the fourth quarter of every year, the senior staff here at Myriad reviews our facilities and equipment status. We’re looking at wether we need to upgrade or replace any equipment, as well as initiate any maintenance programs for the building.
In 2012 we repainted some of the offices; giving them a new coat of matte white. We then had the floor in the medical endoscope assembly area cleaned and waxed. The employees of Myriad take great pride in maintaining a clean and bright work environment.
In December we decided it was time to retire one of our CNC lathes. The Hardinge Quest CHNC machine was a 1984 model; and it was getting tired. Many of the parts that go into the medical scopes and illumination systems that we manufacturer require some fairly tight tolerances; so it was time for an upgrade. We purchased a brand new Hardinge Quest CHNC 42 lathe. Staying with the same brand and model allowed us to retain and use the old bar feeder on the new machine.
At Myriad, we are always on the watch for safety issues. So, we were very pleased with all the additional safety interlocks incorporated into our new lathe. We expect to now have many years of safe, productive, and quality machining, from this latest addition to our machine shop.
It’s that time of year again, and all of us at Myriad would like to wish our customers, vendors, and friends a very safe, and joyous holiday season. Hopefully, you’ll find the time to spend some quality time with your family and loved ones.
Today the senior staff will spend some time reviewing 2012; what went great, and what didn’t go as well as we would have liked. Then we’ll make plans for areas of improvement, to implement in 2013. We’re looking forward to some new product development next year, as well as continued production for a number of our regular customers. 2012 was a good year for Myriad, and we’ll be working hard to make 2013 even better.
Just a reminder: Myriad will be closed from noon today, through January 1st. We’ll be back at work on the 2nd, kicking off another year of providing quality products and services for our customers.
See you all next year.
For the last two years, Myriad Fiber Imaging has undergone a “surveillance” audit of our quality system and documentation. These audits usually occur early in the fourth quarter. This year our audit was conducted during the last week of September. The earlier date was due to the fact that this would be a “re-certification” audit, and would require the BSI auditor to be on site for two full days. The two days were needed in order for the audit to encompass all twenty sections of the ISO standard.
During the course of the audit, the auditor took a tour of the Myriad Fiber facility. This included all the manufacturing areas where our customer’s endoscopes, borescopes, couplers, Fujikura image fiber, and accessories are assembled, packaged and shipped. He also reviewed our quality manual and records thoroughly. From time to time, he would indicate an ‘area for improvement’ for us to review. In the end, he declared us compliant with the ISO 13485 standard, and approved Myriad for a new three year certificate.
Myriad’s quality system has also been audited and found compliant to; ISO 9001, and the Japanese standard: MHLW Ministerial Ordinance No. 169, 2004.
Although Myriad’s primary business is medical device contract manufacturing, we also provide a wide range of products and services to a number of other industries as well. On a regular basis, Myriad assists other companies with the machining of individual components, and undertaking some contract assembly projects. These customers either don’t have an in house machine shop, or a specific machining expertise, or their facility is too busy to handle an increase in workload.
For example, Anderson Power Products of Sterling, MA is a global manufacturer of electrical connectors. Over the years they have turned to Myriad for machining support when their in house machine shop has been too busy working on new plastic injection molds, or repairing existing molds. Myriad has provided machined prototype components, fixtures and gages, and replacement parts for their automated assembly machines.
Another of our machining services customers has been Bose Corporation, the world renowned stereo speaker company. They requested that we machine and assemble a custom piece of test equipment. We machined the parts to their stringent specifications, assembled five test stations, and delivered the final systems two weeks ahead of promised delivery date; minimizing their down time, and keeping their production on schedule.
Gradient Lens Corporation is another customer of Myriad that also happens to be a competitor. They manufacture industrial borescopes. But, that doesn’t prevent us from doing business with them, and providing machined components from time to time. Photonis USA, a leader on photo sensor technologies and night vision components, also relies on Myriad for high tolerance, complex parts machined from various engineering materials.
All of the companies that I’ve mentioned here are large, well known organizations. But, we also collaborate with small business too. They might be well established companies, or start-ups looking for help with developing their new products. Advanced Technical Development (ATD) of Worcester, Ma is a small consulting firm that works primarily with individual inventors, or small companies. For about 10 years, Myriad has supplied ATD with many machined parts for their customer’s prototypes.
So, if you need contract machining, keep in mind that Myriad will work with you to produce large quantities, small quantities, or even a single part. And remember, Myriad’s machine shop services are covered by our ISO 13485 Certificate.
Whenever staff members of Myriad begin project discussions with a new customer, we at some point review terminology. If everyone isn’t interpreting the words and phrases the same way, there’s going to be misunderstandings, disappointments and mistakes. In this blog we’re going to review some of the most used terms with regards to endoscopes. The attached figure/drawing is numbered to match the following terms.
#1) Distal End – This is the end of the scope farthest from the viewers eye, or CCD/CMOS camera.
#2) Angle of View – The angular displacement from the physical axis of the scope.
#3) Field of View – The conical viewing area of the scope provided by the system optics.
#4)Fiber Illumination – The area lit by the illumination components, usually larger than the viewing area.
#5) Working Diameter – The largest diameter of the scope that is inserted into the body, directly or through a sheath.
#6) Working Length – The maximum straight length of the scope with a maximum diameter equal to the working diameter.
#7) Strain Relief – A short section of extra sheathing, located next to the scope body, used to minimize strain/stress on the imaging fibers.
#8) Scope Body – The main structure of the scope incorporating the proximal optics, and terminations of the image and illumination fibers.
#9) Light Post – Standard ACMI, Wolf, Storz, or Olympus adaptor for connection to a light source.
#10) Eyecup – Used for viewing by eye, or with a coupler, attaching to a video camera.
#11) Proximal End – This end of the scope is closest to the viewer/camera.
As Myriad Fiber Imaging has grown and expanded over the last few years, the physical inventory of raw materials, purchased components, and manufactured parts, needed to produce our customer’s image scopes and illumination systems, has grown considerably. In addition to those items, Myriad also manufactures and sells a number of accessories; such as light post adaptors, light sources, and optical couplers. Keeping track of all these materials and parts has become an important factor in our day to day operations. To facilitate the management of our inventory, Myriad rolled out a new computerized inventory control system a couple months ago.
Myriad wanted a specific look and functionality for the inventory system; so our system is a customized program created in Microsoft Excel. The user interface looks exactly like the standard form our technicians use to record and kit the parts required to build a customer’s product. Once a technician locates the proper section of the inventory database corresponding to the endoscope or other product, the first action they can take is to review how many of the needed parts are currently in stock. Then they can either remove a certain number of parts from the inventory; or as in the case of an incoming inspector, add parts to the existing count.
Having this accurate and up-to-date inventory available to all of Myriad’s employees has made it easier and quicker to provide quotes to customers, prepare purchase requisitions to our vendors, and better estimate production delivery times.
Myriad, its customers, and its vendors will all reap the benefits of this new tool.
When attempting to view inside a cavity with a borescope, (whether that cavity is inside a wall, a machine, or human), in most cases it’s going to be pretty dark. That’s where illumination systems come into play. Illumination systems can be incorporated into a borescope or endoscope, or constructed as a separate, standalone entity.
While the illumination fibers can be arranged in a variety of configurations, when incorporated in a flexible scope, the most common geometric pattern is an annular ring surrounding the imaging fiber and lenses. This will provide the most evenly lit field of view. Obviously, the more illumination fibers that can be stuffed into the scope’s maximum diameter, the more light there will be for viewing.
A light/illumination sheath is a separate device that encloses the illumination fibers, and mounts/slides over the borescope or endoscope. This set up allows for use of the scope with or without illumination, depending on the lighting situation.
A light cable is a flexible cable that transmits light from a light source to a scope. Some cables incorporate fibers as the transmission medium, others use clear liquids. Light sources can be bench top systems powered by AC outlets; others are hand held LED units powered by rechargeable batteries.
Light guides (or pipes) are usually rigid devices that bring light from one location to another, where the geometric relationship between the two locations remains the same all the time. These units are usually made up of many illumination fibers fused, or potted together, and bent into a specific shape.
The illumination fibers used to manufacture these devices are provided in two different materials: plastic or glass. Plastic fibers are less costly, but have a lower light transmission rating. Glass fibers are usually more costly, but provide a much better light throughput. In addition, plastic fibers have an Numerical Aperture (NA) of .5 while the borosilicate glass fibers can range from NA .4 to NA .86. That allows the light to spread out and illuminate the target area the fiberscope or borescope needs to see.
Coming up in our blog, we will have an entry were we discuss the different sterilization methods available for medical devices. In another entry, we will present our newly launched custom inventory control system.
On Monday, February 6th, Myriad Fiber Imaging was audited by the United States Food and Drug Administration (the FDA). This audit was not conducted as a result of any complaints from a customer, nor because of any defective products manufactured by Myriad. This was a standard, random audit routinely initiated by the FDA for any company registered with their organization. Myriad is registered with the FDA, and had last been audited by them about 10 years ago; so we were due.
During the audit, the auditor reviewed our quality system and procedures including: the quality manual, internal audits, shipping & receiving processes, management review meeting minutes, CAPA’s, equipment calibration, and training records for our employees. He also examined numerous documented records that verified that our procedures were in place and being used effectively.
At the completion of our FDA audit, the auditor was satisfied that Myriad had a robust quality system in place, and that the employees understood the procedures, and implemented them on a day to day basis. The auditor didn’t find any major non-compliance, and saw no reason to issue any 483’s. An official report will be issued by the FDA in a few weeks; when we will post it on this website.