Want to get into Medical Device Manufacturing?

Medical Device Manufacturing is a somewhat different ballgame than industrial manufacturing or other processes.  If you have interest in becoming a company that builds medical devices here are a few tips of what your customer will look for in a machine shop to manufacture medical devices.

- CLEANLINESS!!  This is most important when choosing a medical device manufacturer.  If you own a machine shop with leaks and is scattered and cluttered, chances are they will keep shopping for a tidier medical device manufacturer.  Most will keep cleaning logs and do routine cleaning checks to ensure that their parts are being manufactured in a clean environment.

- Tolerances are extremely tight when manufacturing medical devices.  There are a whole new set of regulations for medical devices generally.  While you are often just making nuts and bolts, you do not have the luxury of any of your parts falling outside the given tolerances.  A solid QA/QC program is a must.  Once the part is used, it is obviously very difficult to get back...

- Materials are rarely friendly.  In my experience, medical device manufacturing often entails working with metals and materials that do not machine as well such as titanium.  Often, you are factoring in large tool wear, high tool costs and intense machinist involvement.

- Quality Checks are extremely strict when you are manufacturing medical devices.  There are probably few companies that will require logs similar to medical device companies.  Expect a time consuming log, and factor that into your quotes because the time spent in QC will be substantial in this industry.

- How to Prepare  The best way to prepare your business to accept medical device work is to familiarize yourself with the following to documents:

1) GPM Manual 5th Edition (Good Machining Practices Manual, 5th ed.
2) Medical Device Quality Systems Manual

Applying the information found in these two documents will prepare you to enter the medical device manufacturing field and gain the confidence of new customers.