About Lee Leichter Expertise Manufacturing, Outsourcing, Regulatory (FDA), Quality systems and problems, Exporting, Start-up Issues, strategic planning, Distribution, etc.
Experience Employment history: Over 25 years in the industry
Question I have a design for a new kind of syringe. One that will make it easier for diabetics and those of us who need to do our own injections. This will be for use in all applications where a needle needs to be used. But I have 1 hitch so far. I have the overall design, but the details need I will need assistance from an engineer. How do I go about getting this started from design to manufacturing? Any ideas will be greatly appreciated.
Answer Todd,
Congratulations. I hope your design turns out to be a winner. First, you should be very careful about protecting your intelectual property. It may be wise to seek patent protection, but if it is too soon, get all with whom you share the idea to sign a confidentiality agreement.
As I do not know your location, I do not know if there is an organization or university that may be helpful in providing assistance in your area. As a start, sign on to www.devicelink.com. Click on "Directories" and click on Consultants or North American Suppliers. You should get information on a large number of firms that can provide assistance. This is the largest directory for the medical device manufacturing industry.
After the product has been developed and you have manufactured prototypes, you will need to get it cleared through the FDA. Each step you take will add value to the idea. At some point you should approach the large manufacturers (BD, Terumo, etc) if you do not want to manufacture it yourself. If you want to manfacture and market it, that is a longer story.
Good Luck - As I do a lot of work with diabetes products and syringes, keep me informed and I may be able to provide more assistance.
