A Bit about CrossWind

The 2016 revision to ISO 13485 may have profound implications for the medical device industry. The updated standard will alter the way device makers interact with suppliers, from supplier selection to the management of supplier relationships. Speaking as the Quality Systems Director of CrossWind Machining (component manufacturer for the medical device industry) and just completing our ISO 13485:2016 Certification, the new 2016 revision (from 2003) is all about mitigating risk from every aspect of the medical device manufacturing process . And with ISO 13485:2003 no longer being valid after 2019, suppliers are having to decide how much time & money they are willing to put into separating themselves. What the new Standard Says About Risk One particularly   notable change with ISO 13485:2016   is the addition of more explicit risk management requirements. Companies will be required to consider the risk associated with a device from conception through its use. Device make...

With new technology comes change in the way we do everyday things.  For instance I spend about 5 minutes, before I even get out of bed, checking the weather for the week, reading through my emails and texts, checking my Facebook updates, and maybe even playing a word or 2 on Words With Friends.  Sometimes I’ll text my husband or one of my sons about something that needs to be taken care of or to ask co-workers if they need anything for the shop on my way in and then update my shopping list.  I haven’t even left my bed yet and I’ve already done so many things that I couldn’t have done, from the comfort of my bed, without my smartphone.  Now I did have to spend a few hundred dollars on this phone so that I would be able to do these things, but it saves me a lot of time searching the internet or reading a newspaper (which hardly anyone does anymore anyways) for the exact same information.  Not to mention, when I show up at work I won’t have to turn around ...

             Recently I have been looking into 3D printing for Crosswind Machining.  There is so much buzz all over the news and internet about it and I wondered if we could benefit from adding it to our shop floor. I think companies need to always be open to change.  Not only so that we make quality products with the machines that we already have, but also looking for ways to improve our capabilities to serve our customers with new ideas and new technology. As a matter of fact our Quality Policy states ”… to consistently surpass customers’ expectations in both quality and delivery scheduling.  We make every effort to continually maintain and improve our system.” That includes looking at newer technologies like 3d printing.  After doing quite a bit of research I have no doubt in my mind that this technology will play a large part of the manufacturing industry in the next 10 years.  Additive manufacturing is being utilized...

E ffects on the body Effects on your mood Effects on Behavior    ·    Heart disease    ·     Asthma    ·     Obesity    ·     Diabetes    ·     Headaches    ·     Gastrointestinal          Problems    ·     Alzheimer’s Disease    ·     Accelerated Aging    ·     Premature Death ·     Anxiety ·     Restlessness ·     Lack of motivation or focus ·     Feeling overwhelmed ·     Irritability or anger ·     Sadness or depression ·     Overeating or undereating ·     Angry outbursts ·     Drug or alcohol abuse ·     Tobacco use ·     Social withdrawal ·     Exercising less often ...

This week, as I was searching around for inspiration for our blog, I was feeling extremely uninspired.   I really do try and find a subject that relates to CrossWind’s field (swiss screw machining,  manufacturing , medical device components, etc), but also to blog about things that are interesting to people that aren’t in those fields themselves.   Nothing was calling out to me this week and I was feeling very frustrated.     Then I happened to hear a conversation between 2 employees about needing skilled workers and how hard it is to find one that has experience working with the tight tolerances that we do and I started thinking about where other companies find their skilled workers.   Do they take years to find what they’re looking for like CrossWind has?   Do they try staffing firms?   Do they start looking overseas for talent?   This isn’t something that is just limited to our field.   This is a problem that almost all industri...

In the medical device industry, before a product is realized, there are generally multiple prototypes made.  This can get very expensive.  With the technology of 3D printing becoming more and more available how do you know if that's what you want to use for your prototype?  Should you have it machined?  What about injection molding?  What’s the most cost effective?  What will get to you faster?  Today I will discuss the pros and cons of all 3 methods. First of all let’s look at 3D printing.  3D printing is explained as such: “ The creation of a   3D printed  object is achieved using additive processes. In an additive process an object is created by laying down successive layers of material until the entire object is created. Each of these layers can be seen as a thinly sliced horizontal cross-section of the eventual object. ”.  There are obvious pros to this.  Making only a couple of pieces is relatively cheap.  ...

A couple of months ago I started to hear of machine shops going out of business and even hearing from some of our vendors that their business was also slowing down.  CrossWind, however, had so much work that our machinists were all working  50+ hours a week and still scrambling to keep up with customer demand.  Our shop is (at the moment) 100% medical device components.  Not that we stay away from other industries, that’s just the niche we’ve found ourselves in.  Unfortunately, we’re not killing ourselves trying to complete all jobs on time like we were in recent history.  Now we’ve found ourselves just trying to get enough work in to avoid laying people off.  We’ve even had calls from one of our biggest material vendors asking if we needed to order anything.  We’re not a very big shop so I know we aren’t one of their largest customers.  For them to be calling us looking for orders, they’ve got to be in a similar boat as we are.  Also, ...