Sew Fine, LLC
San Francisco

Harry Shonteff

Industrial sewing consultant to the needle trades. Developing unique automated sewing machines used in the production of implantable medical devices.

Established in 1979- 2012
33 years in the industry!

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Proudly Introducing :

       

Developing the next generation of surgical sewing machines.

In partnership with the Fogarty Institute for Innovation.  The institute was Founded by Dr.Thomas J. Fogarty  an internationally recognized cardiovascular surgeon and inventor. During the past 40 years, he has acquired over 100 medical patents, including the “industry standard” Fogarty Balloon Embolectomy Catheter and the widely used Aneurx Stent Graft that replaces traditional open abdominal aortic aneurysm (AAA) surgery.
 

Sew Fine, LLC

Harry Shonteff

Re inventing the art of sewing

 Sew Fine, LLC is a small invention shop located in the hills of San Francisco. Specializing in the development  automated sewing machines used in manufacturing of medical devices. Our sewing machines are custom made not converted and are clean room compatible. Numerous FDA approved implantable and biological devices are manufactured using our sewing technologies. Harry (Founder) works as an industrial sewing consultant offering:

• Sewing machine design / industrial sewing consultant.

• Prototype shop for the development of unique sewing equipment. Primarily class 3 medical.

• Production clean room sewing workstations.

• Complete machine shop including  4 axis CNC machining.
   

Most medical devices are designed then prototyped using hand stitching. When the product goes into production often there is no sewing technology capable of producing the correct stitch in the required locations.  Class 3 medical device manufacturing is generally a combination of new technologies and highly skilled hand sewing operations. This combination of talent and technology is used to produce finished implantable devices. It is often the case that as more sewn product is required hand sewing can not keep up with the production flow. Many medical devices manufacturers have replaced much of the hand sewing with automated sewing equipment often utilizing  vision guided robotic sewing machines. This offers a  large reduction in manufacturing time, reduced labor related injuries, and a more precise sewn product. As each stitch is positioned by computer controlled motors. Also suture tensions can be monitored / controlled and digitally recorded for backup data on every stitch.
 

Sew Fine, LLC specializes in developing equipment for sewing small tubular devices (.500) used to produce  products like endovascular stent grafts and heart valves.  Also we have methods for sewing very small (.080) tubular device used on coronary stent and other very small tubular devices.

 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 I would be happy to work with your team to develop a automated solution to your sewing challenges.

Harry Shonteff
Sew Fine, LLC
Medical Sewing Solutions, LLC
San Francisco

301 Lockstitch no arm shown.   

Biological Heart Valve production. Small arm 301 stitch type.

Common class 3 stitch placements

                   Double pointed needle 205 hand stitch                              301 lockstitch small arm

 
Tissue samples.

One type of 205 hand stitching machine used in the production of various implantable medical devices.

                                           Successful projects over the years

• Endovascular devices: (AAA and similar devices) 301 stitch and 401, and the modified 205 stitch.

• Cardiovascular devices: (attaching graft material around stents) 301 stitch used on FDA approved Heart Valves, stent grafts, and covered coronary stents.

• Urological devices: (tissue based sewing).

Vascular deployment: devices (used to precisely deploy Endovascular prosthetic devices in the human body) on FDA approved devices.

Lessons learned working with class 3 medical devices.

• Most hand sewing can be duplicated with automated sewing equipment

• Often changing the stitch type makes the device stronger and the more robust

• Often changing the stitch type can be (as good or better) for FDA submissions

• Most hand sewing that takes 30 minutes or more per seam is worth considering automating that stitch