The Leading Edge of Imaging Technology

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.

Although Myriad provides a number of different products and services, our primary product offerings are medical imaging and illumination systems. As such, our employees use many terms, on a daily basis, that are common to the optics and medical fields. A number of these terms may not be familiar to our new and potential customers. So the next couple of our blog entries will be devoted to their descriptions and definitions.
We’ll begin with scopes, or probes, as some people refer to them. Scopes are used to inspect/view objects that are inaccessible by any other standard method. Scopes are technically referred to as ‘borescopes’, or ‘boroscopes’; and are primarily used in industrial applications. Borescopes used for viewing within the human body are known as ‘endoscopes’.

There are two main types of borescopes/endoscopes: rigid or flexible.

Rigid endoscopes are usually somewhat larger in diameter (10mm – 12mm), and shorter (12 – 16 inches) than flexible scopes. Rigid scopes are usually constructed using glass rods and lenses for the imaging elements. Sterilizing methods for rigid scopes include autoclaving, as well as all the other usual processes. The single most detrimental feature of a rigid scope is that excessive flexing during use, will shatter the rods, and or lenses, and render the device useless. Being rigid also limits the use to ‘straight line’ access; there can be no looking around corners. On a couple of occasions, Myriad has been asked manufacture a short, rigid endoscope, with an unusually small outside diameter of 2mm – 3mm. These endoscopes used flexible image fiber for the image transmission.

Flexible endoscopes or borescopes are more commonly much smaller in diameter (1mm – 3mm), and range from several inches long, to as much as 30 feet in length. A more generic term used for these flexible devices is ‘fiberscope’. The imaging component is fused glass/quartz multi-mode fiber. Most flexible endoscopes can be sterilized by all the usual methods, except autoclaving. The flexible scope is obviously not subject to the same bending issues as rigid scopes. In fact, bending is where flexible endoscopes shine; allowing viewing around corners in tight spaces.

In our next blog entry, we’ll discuss illumination systems.

Like most companies manufacturing medical products, Myriad has to operate under the guidance of certain standards. In October we underwent our annual ISO 13485 audit, conducted by BSI. Some of the areas reviewed were: corporate management, our quality system and manual, incoming inspection records, tool and equipment calibration, CAPA’s, and traceability records. The result of the one day audit was that we passed, and retained our ISO certificate for another year.

In November, at the request of one of our medical customers, we were audited by TUV to determine if Myriad was compliant to JPAL: MHLW Ministerial Ordinance No. 169, 2004.  JPAL is the Japanese equivalent to America’s FDA.  Being compliant would allow any of our customers to sell their Myriad manufactured product in Japan. Our customer was pleased to get a report that confirmed that Myriad is compliant to the JPAL standard, as well as to ISO 9001.

And then, to close out our year, in December, one of our customers conducted their own on site audit of our overall quality system. The auditor found no deficiencies in our procedures and documentation; and issued a statement that declared that Myriad met all of its quality requirements.

Blog Post by
Danna Mancini
QA & Engineering
Myriad Fiber Imaging

On Thursday night, November 17, Jim McDonald and Danna Mancini attended the November monthly meeting of the New England Section of the Optics Society of America. The meeting was held in the Photonics Center, at Boston University. The topic for the evening was – Smaller Is Better: Ever-Shrinking Optical Components Enable Novel and More Capable Medical Devices. The presenter was Randal Chinnock, Founder & CEO of Optimum Technologies, Inc.

Myriad Fiber Imaging was one of three corporate sponsors supporting Mr. Chinnock’s presentation. The company provided a 0.90mm diameter, flexible image scope, and a small LED light source, for demonstration purposes.

Some of the many products and technologies presented include: ground and polished lenses as small as 0.25mm in diameter, glass right angle prisms measuring only 0.18mm, miniature flexible endoscopes 0.50mm in diameter, plastic injection molded lenses, 0.65 diameter battery powered LEDs, and less than 2mm diameter ‘camera-on-chip’ image scopes.

Myriad’s staff is constantly evaluating emerging parts and processes for possible impact on the imaging and illumination marketplace. So, while all the products and technologies were presented as stand-a-lone components, Jim and Danna were specifically interested in how they could be combined with current Myriad offerings, to make new and unique products. Shortly, Myriad will acquire samples of some of the items introduced at the meeting. We will then test these components, assemble them into prototypes, and attempt to create new imaging and illumination systems.

If we are successful, you will be the first to hear about, here on our blog. Stay tuned.