One of the goals we have for our medical device engineering projects is to ensure a high-quality medical device that is delivered at an exciting speed-to-market.
At Genesis, we have an ISO 13485 2003 Certified Quality System through which we develop medical devices.
In the beginning, we do engagement with the end user to define what are the user requirements for the product. Those requirements are converted into what we call Design Inputs. The Design Inputs then are converted into specifications, which we refer to as Design Outputs.
The product testing is completed according to protocols that we create, develop, and follow up on. While most of the testing is completed by one of our strategic vendor partners, we do a small amount internally as well.
Bringing A Medical Device From Concept To Product
One of the biggest areas of importance in medical device engineering is the ability to envision an idea. Being able to pull from our customers, inventors, or surgeons the needed information to be able to turn that product idea into a reality, and into a concept that actually is workable.
Once a product has been envisioned, we will typically create CAD models. Then we typically develop prototypes through 3D printing.
Next, we’ll perform various testing in our facilities. This is often through Sawbones, or Engineering Sawbones testing to see the concept. As needed, we’ll make further refinements.
Finally, we’ll develop the prints, create prototypes for a surgeon to try and get their feedback.
FDA Project Planning
A lot of the medical device engineering that’s valuable is the project planning.
There is so much that goes into what we do in our world of medical devices. With the FDA, there are so many requirements, how do you accomplish all of that in a timely and costly fashion?
Fortunately, this is an area where we have a great deal of experience and work through on a daily basis.
Medical Device Intellectual Property
Creating valuable Intellectual Property or I.P. is one of the major things that we do.
Getting a patent is actually a relatively easy thing to do. Getting a good patent is difficult to do!
A patent attorney in the patent office will gladly grant you a very specific patent. However, this is typically not best, and we have helped many entrepreneurs with this process.
Medical Device Manufacturing Methods
Each engineer is responsible for is making sure that whoever is manufacturing our products manufactures it appropriately.
When the engineer creates something, they have to make sure that those design inputs or that design intent is accomplished through manufacturing.
Throughout our history, we have developed and delivered product through various manufacturing methods including:
- 3D Printing
- Injection Molding
- Raw Machining
- CNC Machining
- Swiss Lathe
- Surface Treatments
Completing the Process
Additional related operations that are involved in our drive the development process include:
- Product Validation
- Risk Assessment
- Supply Chain
- Manufacturing Access
- Quality Systems
- Payment Processing
Our Medical Device Engineering Experience
The individuals within Genesis represent over two hundred patents and innovations.
Our team has developed a large number of medical devices within the orthopedic market and outside of the orthopedic market.
Specifically, we represent a substantial percentage of devices that are sold in the shoulder arthroplasty space (around 40%).
That development experience does lead to inventions through a creative process that leads to filed intellectual property, filed patents, issued patents, etc.
In the end, this means that we have the ability, experience, and resources to begin with a blank sheet of paper that results in a successfully commercialized medical device.