Sew Fine, LLC
San Francisco
Custom made sewing/suturing machines!
for class 3 medical devices:
Sew Fine is a company specializing in hand crafted sewing equipment for unique applications. Many products are designed and prototyped by hand stitching. When the product goes into production often there is no sewing technology  capable of producing the correct stitch in the required location. We develop sewing equipment for the products that can not be sewn by conventional technology's. Our experience started with designing sewing factories and the related specialty equipment (trade secrets) in industries ranging from Haute couture, furniture, golf bags, cold air inflatable, class 1 medical and class 3 medical devices. Our primary focus in in the medical industries but we are open to working with other custom sewing projects.
For many years class 3 medical device manufacturing has been a combination of new technologies and highly skilled hand sewing operations. This combination of talent and technology is used to produce finished implantable devices. Many medical devices manufacturers have replaced much of the hand sewing with automated sewing equipment (vision guided robotics). This offers a  large reduction in manufacturing time, reduced labor related injuries, and a more precise sewn product. Numerous types of class 3 medical devices have been approved by the FDA using Sew Fine's sewing technologies.
 We have developed several clean room sewing/ suturing workstations used in the production of coronary care devices. Our expertise range from biological prosthetic to angioplasty  products . We work directly with our customers to develop custom made sewing equipment to replace many hand sewing presses, one seam line at a time. We offer medical device consulting for sewing/ suturing, design and modeling, prototyping and production sewing/ suturing equipment. We have a complete machine shop including  4 axes CNC machine center.
Sew Fine specializes in sewing small and very small tubular medical device. We are interested in working on extremely challenging sewing applications. If you have a sewing project that can not be sewn with conventional sewing technology we would be happy to work with your team to develop a automated solution to your sewing challenges.

 

Harry Shonteff
Sew Fine, LLC
San Francisco, CA
mailto:shonteff@sbcglobal.net

Endovascular prosthetic devices manufactured with our technology:

 

 Stent grafts, AAA and thoracic, endovascular deployment devices, several  cardiovascular devices from biological valves to stents.  All devices above have approval from the FDA and or the European CE mark.

Workstations for small tubular devices:

Our small arm lockstitch sewing head is custom made for each application.  This unique machine is made for sewing small tubular devices .400 ANSI and larger and can also be used for sewing very small diameters .050 ANSI.  The holding and indexing fixtures are custom for each seam line. We have developed a number of  sewing workstations for sewing small and very small implantable devices using this technology.
 

Common class 3 stitch types


1. lockstitch:  (301,303,308 or 315)
2. Handstitch: (205) double pointed needle or mechanical needle.
3. Overedge: (501), and (502) stitch have been used to sew small tubular devices, and biological sewing. 
The contact components of the sewing device can be cleaned or replaced between lots to prevent cross-contamination. Reusable parts can be autoclaved. Disposable parts can be sterilized.
4. Chainstitch, (101)

5. Chainlock: (203) .                                                                              

                     

 

The picture on the left shows a 205 hand stitch with a double pointed needle. The same stitch can also be done with a mechanical needle. This stitch duplicates the hand sewing that is common in medical device manufacturing. The picture on the right shows the types of tubular devices that can be sewn with our small arm lockstitch machine.



Sew Fine, LLC is a developer of custom sewing equipment used in the production of class 3
Medical devices. Industrial manufacturing and a Consultant to the needle trades in
the refinement of processes to expedite production.

29 years of continued creativity and development in the art of sewing

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Contact Information:

Harry Shonteff
Sew Fine, LLC
San Francisco, CA
FAX: 415-661-4586
Phone 415-665-3447

E-mail Shonteff@sbcglobal.net
 
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