Initiatives for Medical Device Manufacturing

Posted on by Scott Manea in ISO Standards, Medical Device Manufacturer, Process Validations Leave a comment

Traceability and Validation – Important Compliance Initiatives for Medical Device Manufacturing in 2017

 Some of you who read our Blog posts are quite well-versed in the ‘in’s and out’s’ of medical device manufacturing. It is a highly-regulated and quite diverse industry.

Most cutting-edge medical part manufacturers possess stringent process standards they employ in order to maintain a lean and measurable balance while adhering to stringent ISO 13485 Regulations, a Certification earned by C-Axis.

This Blog entry discusses 2 areas of Classification that certainly assist a company like C-Axis to remain at premium performance levels, while assisting our customers in experiencing greater amounts of success both now and into the future. 

Here’s how it works…

As a part of our ISO 13485 Registration, we must employ complete “traceability”. That means, from the point any material enters our facilities, it must be documented and that type of traceable notation and analysis is ongoing throughout the manufacturing process and, in some cases, all the way until it reaches the surgeon’s hands.

Here is how our Regulatory Entity explains an overall look at Traceability and Identification under our ISO 13485 Certification:

According to the ISO 13485 standard, the manufacturer is expected to establish the systematic identification of its business activities and process outputs throughout the material flow into categories and characters that are in accordance with predefined needs. The objective of the identification is to ensure that products at all levels and stages of the realization process will be identified regarding their production, change, and quality status. The identification shall also eliminate the risk of mixing products, parts, or materials from different origins or with different status. Products with incorrect identification could be incorrectly submitted to a process, delivered to the customer, or may initiate contamination of other products. Through the assignment of activities, means, measures, and identifiers throughout the material flow— such as codes, tags, or product serial numbers—they will be uniquely identified. The production elements that are to be identified include:

  • Raw materials, components, and parts
  • Materials used for the production
  • Lots or batches
  • Finished goods
  • Defective or returned goods

Any human entity wants to be validated, right? It’s in most of our DNA. A medical device manufacturer is no different…well, maybe just a little.

The act of “Validation” within medical device production goes fairly deep and is an integral component of the regulatory standards toward performing at maximum compliance.

A leading Compliance Entity defines “Process Validation” as this:

Process validation is an essential part of medical device manufacturing but doesn’t always receive the attention it deserves (and requires). The regulations provide the requirements (FDA QSR 820.75 and ISO 13485 7.5.2), but often manufacturers don’t completely understand them and don’t fully implement them. The consequences can be audit findings from a Notified Body or Inspectional Observations on an FDA 483.

Medical Device Manufacturer’s should validate processes when they do not verify everything the process produces. Process validation means knowing the range of process inputs that assure the process produces only conforming product.

At C-Axis, we choose to remain ISO13485 AND FDA Certified. Process Validation is an incredibly important part of what often separates a standard manufacturing company from a totally-dedicated medical device manufacturing serious player.

In the world of manufacturing medical devices, there are several “Classes” of device creation mainly based upon what and how the device will be used; we have outlined 2 important Classes here.  In a future blog entry, we will discuss how each of these Classes can affect the regulatory process…interesting information, right? We think so.


Medical Manufacturing Process

Posted on by Scott Manea in 3D Printing, ISO Standards, Medical Device, Medical Device Manufacturer, Prototype Development Leave a comment

The Single Most Important Part of the

Medical Manufacturing Production Process?

Especially When Considering the Extremely Detailed and Highly Precise World of Medical Device Manufacturing.

 How does a medical device manufacturing company receive the information to make valid decisions regarding how to ultimately manufacture any detailed medical device part?

And, before considering the actual process of medical manufacturing, that manufacturer must maintain a quality-efficiency compliant with stringent ISO standards; they must take into consideration the budget requirements, the delivery schedules and every step of the manufacturing process in order to perform the all-important “Design for Manufacturability” studies.

For some, this “up-front work” just to get a part set-up correctly, in the initial phases of the production process, can be a challenging task.

That’s why, in any “best practices” manufacturing arena, to set-up and integrate a dedicated department which is solely responsible for taking a drawing and creating something that can be measured (for all the above requirements) is absolutely essential.

Welcome to Prototyping at C-Axis

Prototyping has changed dramatically over recent years. Staying on the cutting-edge has made C-Axis a leader by utilizing strict prototyping standards; it has continued to maintain itself as an integral part of a continuing success-track for the company, to the benefit of every one of our medical device customers.

Within the prototyping stage, we are basically measuring everything and that does not only concern the actual size of any part!

We are measuring for compliance regarding how the part will be used, does it fit the desired requirements set by the customer, are there better ways to conduct the process not only to improve the part’s integrity, but to save time in the process to meet or exceed delivery deadlines, which can ultimately save cost.

Might there be a better material choice to use over what may have been initially specked; and a thorough, solid, deep analysis of the basic ingredients for design effectiveness.

Most everything and anything imaginable are questioned in the prototyping phase.

By the time the prototype becomes the model for how the final parts will be produced, it’s proven worth is beyond measure.

Without having those first parts to scrutinize, not much can be determined in order to solve any issue or potential problem – up-front; as one major goal of the prototype-process is to help eliminate surprises down the road. Prototyping can do that.

Many medical device manufacturing companies are utilizing 3D Printing as an important, integrated prototyping tool. C-Axis is no different. 3D Printing is, in itself, a constantly changing medium.

Having some of the best product designer’s on-staff also helps, along with cutting-edge CAD/CAM software to assist in uncovering optional production variables, potential problems and barriers. It is all a part of a truly defined and diverse prototyping department within a forward-thinking, medical device contract manufacturer.

Thanks for visiting the C-Axis Web Blog. Watch for another Blog Installment next month, the subject will be all about our incredible medical device production facility in Puerto Rico. “Te veo el mes que viene!”

C-Axis New York MDM Trade Show

Posted on by Scott Manea in Medical Device Manufacturer, Trade Shows Leave a comment

You’ll Find C-Axis Contract Medical Device Manufacturer at Booth # 258

MDM East Trade Show in New York Tuesday June 13 to Thursday June 15

 


Enhanced Medical Device Technology

Posted on by Scott Manea in Medical Device, Medical Device Manufacturer Leave a comment

The C-Axis, Medical Device Manufacturer – ENHANCED TECHNOLOGY SERIES, Vol. 3

 Without any doubt, in order to stay as current as possible and to remain at the top of the game, any Medical Device Manufacturing Partner must consistently look at the internal functionality of their facilities.

We must analyze each work station for maximum reliability and capability, and then draw conclusions to expand, delete, enhance or blend manufacturing abilities. This must be done to gain the greatest return for customer investment, confirmation of their particular needs and requirements, and in some cases, to make sure we have the better chance at saying ‘YES WE CAN DO THAT’ when customers present C-Axis with their many technical drawings, ideas and often multiple iterations within their own development process.

In the medical device manufacturing field, this has become increasingly evident as we are confronted with incredibly intricate detailing. The fine-details, including extremely tight tolerances, the juxtaposition of holes, slots and grooves, the various metals to allow for maximum end-user success and the exactness of what has become known as ‘true precision’ is becoming more and more commonplace.

Therefore, it is with great pride we present #3 in our exclusive C-Axis Enhanced Technology Series.

As many of you know who read these Blog Entries regularly, the Enhanced Technology Series is meant to give readers a greater understanding of what we can do, but often the reasons why these additions or enhancements were made.

Rest assured, a lot of thought goes into each acquisition.

Most technology that exists today is not cheap. But, in the final analysis, most all decisions are made to gain greater, more effective and efficient capability for our valued Medical Device OEM customer and ultimately providing the means to help them save lives.

So, we have 3 technological enhancements to share with you today. All are housed in our Minneapolis facility (our 2nd facility is located in Puerto Rico).

ATTENTION TO PROCESS EFFICIENCY:

A short time ago, we decided to add a particularly robust machining capability by installing the 12mm Multi-Axis Swiss-type Automatic Lathe. This is a machining marvel in terms of what it can do, especially when operated by the manufacturing experts at C-Axis.

The new Swiss optimizes complex machining of small diameter, difficult to cut materials while using a multi-axis controller for high-speed complex machining.

The high output spindle outputs extreme efficiency. The C-axis control combines the main and sub-spindles with applications of various tool units enabling secondary machining in vast array of combinations.

* The Swiss can drill extremely small holes by mounting a high-speed rotary tool with drilling speeds up to 12,000 revolutions.

* Faster machining, versatile tooling, precise, powerful machining

* 2-axis controlled gang tool post can be fitted with several turning tools and power-driven attachments

* Y, B, and E axes of control enhance our capability to produce complex parts in difficult steels, alloys, metal materials

* A 9-axis controller

* Machines parts up to 13mm

IMPROVING SHOP FLOOR EFFICIENCY:

Next up in this 3rd Series is our addition of a particularly effective internal tooling selector system called a Tool Bin System.

For many years, machinists needing specific tooling to conduct their particular requirement had no other way to seek the proper tooling than to go find it.

Here, every tool is in its proper place, everything is automated, logged, computerized and cross-checked.

We know where every tool we use and own is at any given time.

We are organized at C-Axis. Everyone benefits.

This storage unit offers secure inventory control, accountability of tool usage, and flexibility in storage options.

* Cut tooling inventory, often by 50% or more

* Decreases spending on new tools by up to 30%

* Reduces our administrative costs significantly, by as much as 90%

* Integrate Tool Bin Systems with the NOVO app to monitor real-time
inventory during process planning

ENHANCING PRECISION AND TECHNOLOGY:

We saved the best for last; a few weeks ago, we received our brand new Mitsubishi WIRE EDM Station.

As a reminder, Wire EDM is a CNC machining process whereby an electrified, very thin wire is submerged in water and is surrounded by a ring of current allowing for the smallest and most precise multi-axis cutting paths. The process is extremely attractive inside medical device manufacturing.

Our new MD+Pro III utilizes a completely new non-contact, friction-free round linear shaft motor system to drive the X & Y machine axes through an all optical fiber servo system.

The MD+PRO III is a revolution in Wire EDM technology and was specifically created for optimum performance inside advanced medical device manufacturing facilities.

It is with these types of innovative enhancements in manufacturing technology that provides C-Axis greater ways to reach more specific goals and requirements of our valued customers.

The objective is to always say “YES” when any customer asks, “Can you do that?”

Not only can we do that, we can do it on-time, on-budget and often at greater ranges and tolerances of precision; due, in large part, to our consistently growing manufacturing technology.

Also, see:

ENHANCED TECHNOLOGY SERIES, Vol. 1

ENHANCED TECHNOLOGY SERIES VOL. 2

Zeiss O-Inspect

Cold Jet i3


C-Axis Medical Contract Manufacturer Puerto Rico Trade Show

Posted on by Scott Manea in Medical Device Manufacturer, Puerto Rico, Trade Shows Leave a comment

C-Axis Medical Contract Manufacturer 

Looking Forward to Seeing You June 1-5


C-Axis New York MDM Trade Show

Posted on by Scott Manea in Medical Device, Medical Device Manufacturer, Trade Shows Leave a comment

C-Axis Medical Contract Manufacturer will be in Booth # 258

Looking Forward to Seeing You in New York June 13-15


C-Axis Boston Trade Show

Posted on by Scott Manea in Medical Device, Medical Device Manufacturer, Trade Shows Comments Off on C-Axis Boston Trade Show

C-Axis Medical Contract Manufacturer will be in Booth 348

Looking Forward to Seeing You in Boston May 3-4 2017

 


Medical Device Manufacturing Transparency

Posted on by Scott Manea in Medical Device, Medical Device Manufacturer Comments Off on Medical Device Manufacturing Transparency

Transparency within the Medical Device Community

 We at C-Axis wanted to set the record straight regarding our usage of the word, transparency. It’s important. So much so, that it has greatly assisted us in our growth within the medical device manufacturing community.

 Transparency has become a hot-word over the past few years. The one thing wrong with the word may reside in the fact it can often mean different “levels” of transparency to different people and companies.

This is true both within a company’s internal structure and when sharing information with customers. That is true, because our customers have told us, not because it’s what we think.

Transparency to us is automatically coupled with two other areas of importance: honesty, and openness. This means, if we have an answer to a question, it will be our best answer, and never a guess.

C-Axis does not guess, or make-up an answer to appease, our communication will be given freely, without reservation with honest content.

We have come to understand that “communication” can only be truly achieved when both parties involved confirm exactly what the other is stating.

To experience full communication, especially within the world of medical device contract manufacturing, our interaction may contain confirming questions and answers which eventually lead to the level of synergy required. That is the consistent goal, and we are good at achieving it.

Truthfulness is also a current buzz-term, especially when considering the use of “alternative facts”.

At C-Axis, there are no “alternative facts”, only real, honest, truthful and transparent facts. That is how we talk with each other, and that is how we share with our customers. It works best.

From prototype development through important concurrent engineering phases, all areas of medical device product development must have “completeness” in meaning.

When information that is shared, is information to be believed, planned-upon, given the highest credibility and is always found to be correct, only then can we claim we’ve provided full-service to our customers.

We have found, when considering precision manufacturing, especially for the medical device community, it’s actually quite easy to be very accurate with our answers and communication both internally and with every customer. This is a business born from exactness, where the smallest of detail overlooked will reveal itself quickly.

Having the proper quality initiatives in-place, tested and in-tact vastly assists us in achieving this level of communication integrity.

Find out why your medical device or part design and production-methodology could be in better hands by calling C-Axis for a thorough, honest and transparent review.

C-Axis Cleveland Trade Show

Posted on by Scott Manea in Medical Device, Medical Device Manufacturer, Trade Shows Comments Off on C-Axis Cleveland Trade Show

C-Axis Medical Contract Manufacturer will be in Booth 1026

Looking Forward to Seeing You in Cleveland March 29th & 30th 2017 at the AD&M/MD&M Trade Show!

C-Axis Cleveland Trade Show March 2017


C-Axis MDM Trade Shows

Posted on by Scott Manea in Medical Device, Medical Device Manufacturer, Trade Shows Leave a comment

Come See Us at the World’s Largest MedTech Event at the Anaheim Convention Center!

Come See the C-Axis Team TOMORROW thru THURSDAY in Booth #1754