• Spline

Engineering Services for Prototype Medical Devices

Updated: Feb 23

The purpose of medical device design is to bring innovative

products to market that improve patient outcomes. The design process requires specialized skills and is subject to strict industry regulations.


Spline’s engineering services specialize in taking product ideas and turning them into reality.


Our clients bring their vision to the table, and then our industrial design and engineering firm develops a design. Once the initial ideation is approved, we create a series of prototypes ranging from an initial proof-of-concept model to a final functioning prototype.

Do you have a fantastic idea for a new medical device or need to develop one to meet a

specific clinical need? Keep reading to learn the ins and outs of working with an

engineering company such as Spline to develop the idea and create an initial prototype.



What Are Prototype Medical Devices?


Product design prototyping is an essential part of the design process. More often

than not, the device will need to go through multiple prototype phases before it can receive

FDA clearance.


Phase 1: Appearance Model

The first stage in the product design process does not involve creating an actual,

physical product. Instead, engineers and designers work together to create 2-D and 3-D

rendered images and mock-ups which can be used to win initial funding and enable further product design.


Phase 2: Proof of Concept

The proof-of-concept phase involves creating an actual device prototype. The prototype

may not look exactly like the finished product, but that’s not necessary at this stage.

The primary goals behind creating a proof-of-concept prototype are:

● To demonstrate feasibility

● To investigate potential risks

● To select components

● To have a viable product for investor presentations


Phase 3: Alpha Prototypes

Alpha prototypes are based on the proof-of-concept prototype, and they look and

function more like the final product. The purpose of alpha prototypes is to seek out

potential design flaws and revise the product’s appearance to meet its inventor’s

specifications. Some limited user testing may occur at this phase.


Phase 4: Beta Prototypes

Beta prototypes are more refined than alpha prototypes. At this stage of product design,

the device should meet industry safety standards. If approved, it can be used for pre-clinical

testing.


Phase 5: Pilot Production

Until now, only one to five prototypes have been created during each production phase.

During pilot production, product design companies may order as many as 100

prototypes. The product should be ready for a soft launch, including further clinical trials and testing.


Pilot production is primarily designed to identify modeling, manufacturing, and assembly

issues.


Phase 6: Product Manufacturing

Once the device has moved through the first five prototyping phases and has been

cleared via clinical testing, it’s time to ramp up production. The most affordable way to

do this is to enlist the help of Chinese manufacturing companies. Spline’s engineering

services can also help clients find long-term manufacturers.


Medical Device Classes and The Development Process

The FDA breaks medical devices up into three classes based on risk:


1. Class I devices only pose minor risks to users and are subject to general

controls.


2. Class II devices may pose a slightly more serious risk to users and are subject to

special controls such as FDA pre-market approval (PMA) or 510(k) clearance.


3. Class III devices are the most highly regulated since they pose the highest level

of risk. They are subject to a more extensive PMA process.


These government safety regulations and controls are intended to protect patients and

healthcare providers. It’s essential to work with engineering services that understand

the PMA and 510(k) clearance processes. An engineering firm specializing in medical

device design can explain what it takes to gain FDA approval in greater detail.


What Does a Medical Device Engineer Do?


The job of a medical device engineer is to develop technical equipment or systems for

healthcare providers. These specialized services range from improving on-site

diagnostic equipment to wearable medical product development for home use.


Engineering Services Make Meeting Clinical Needs Easy


When product designers work with a medical product development team, they’ll get

all the help they need to turn their ideas into usable, market-ready products. The

process can take a good deal of time, especially for Class III devices.


It’s best to get in touch with Spline product development firm to discuss options and get the process started as soon as possible.


© 2021 by SPLINE Product Development

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