Design For Medical

Medical devices require a different set of skills and specialty knowledge to create a successful design. Whether you are working on a complex power instrument, forged and finished surgical tools, minimally invasive technology, or even a simple blade, SPARK has the experience to get you going in the right direction. With experience in orthopedics, general surgery, plastic surgery, minimally invasive surgery, dental, and more, SPARK has seen it and done it.

Human Factors

Designing medical devices is the ultimate challenge in human factors. You are always designing for at least two people: the patient and the clinician. Ignore the needs of one and your device will fail. The stakes are high and you are liable for your devices out in field. We will observe medical staff work flow and patient positing to understand completely the nuance of preference and performance in medical device design.

Material Selection

Did you know that the FDA does not “approve” materials? The burden of proof for selecting bio-compatible materials for any specific application is up to you. Whether it is one of the many grades of stainless steel, plastics, ceramics, or other material, SPARK brings many years of experience in selecting proper materials that have been successfully used in a breadth of devices.

Regulatory Documentation

The path to market for a medical device is not always clear. You don’t want to get too far down the road only to realize that you should have been building a Design History File years ago. For established firms, SPARK can work within your quality system and integrate right into your development team. For start-ups, SPARK can get you prepared for the road ahead, avoid common pitfalls, and connect you with the right regulatory experts to help ensure that your product can eventually be legally marketed and sold per all regulatory bodies.

Single Use / Reprocessed Devices

Sterility and cleanliness are key in medical devices. Whether your device is going to be terminally sterilized, single-use, or cleaned and reprocessed, SPARK understands the strategies used to do it right. Considerations like packaging integrity and sterility, or making sure your device can withstand autoclaving and washer disinfection cycles are all vital to success. SPARK puts it’s experience in every design, so your device is ready to go out of the package.

Working With Medical Experts

Are you a surgeon, physician’s assistant, nurse, researcher, or other clinical expert with an idea? Whether you are starting with a blank sheet or a handmade prototype, SPARK can rapidly bring you to a stage where you have a production grade device that is ready to begin the verification and validation process. We can even help connect you with potential contract manufacturers or possible acquisition or licensing opportunities.

Core Capabilities

Medical Design

Overview