healthcare device

How 3D Printing Is Regulated In The Healthcare Industry

Table of Contents

How Did We Get Here?

The evolution of 3D printers is an interesting journey. It basically went from a science project to a necessity in the medical industry.

It’s changing everything in the medical field from pharmaceuticals to organs. The first time we’ve heard of a 3D printer making something medical related is in 1999 when scientists used 3D printing material to support live human organs.

From that point on, 3D printers have been used to create actual organs. Taking the step from creating organs to implementing is the battle the health industry is having with the FDA along with other challenges.

It’s a necessary battle though. Without the FDA, we would see more fatalities. In this article, we’re going to go over some of the ways the FDA regulates the healthcare industry.

But first, let’s see why the medical field uses 3D printers.

Why Is The Medical Industry Using 3D Printers

  • Costs

Manually creating medical parts costs time and money. We mention time because it’s important to get a device on time in the healthcare industry.

What if a patient needs a device in a certain time frame? It could be the difference between life and death in some cases.

Creating custom devices requires attention to detail. We need to account for human error, which could cause weeks in delay. It also means more money in the long run.

3D printers alleviate wasting money. A doctor can make adjustments before something is printed with a 3D printer and have the device come out perfect without dealing with human error.

This is not possible using a third party manufacturer. Another great benefit is reduced waste. 3D printer users don’t have to print something out just to restart a new one if there is a mistake. Being able to adjust during print solves this.

  • Customization

There’s also the benefit of customization. Our bodies differ in many different ways. All of us are not the same height, all of us don’t have the same sized organs. 

If a patient needs prosthetics, a doctor can measure the area and tell the 3D printer manufacturer the exact measurements needed to print the perfect prosthetic for the specific patient.

  • Time

The special customizations lead us to the time aspect. One-off customizations or productions can take time and cost money.

Businesses don’t go to manufacturers for one project. Businesses usually have to order in bulk. And, the problem with this is bulk orders can take too much time. Especially in a time sensitive situation which is common in healthcare.

In addition, feedback is critical from both doctors and patients. Outsourcing manufacturing of a medical device neglects feedback.

Having a 3D printer also accelerates the design of the device due to feedback. Not only is design development faster, the functionality improves faster.

If health professionals are doing clinical trials for a medical device, 3D printers accelerate the process.

Manufacturers can use early 3D printed parts to use in the clinical trials. It’s easier to evaluate smaller parts of a device instead of the whole device at one time.

  • Complexity

The last piece as to why 3D printing is needed for healthcare is complexity. The customization aspect relates to this. But, to be specific, instead of talking about custom medical devices, complexity is more about the design.

Material for 3D printers are mostly plastic. The material used is strong and lightweight which makes it useful for different designs.

What’s even better is 3D printers are more precise. The precision allows it to get details a regular manufacturer can’t.

Precision is also critical when thinking of integrating new medical devices. Nobody wants their design to miss any details. A 3D printer can make a specific device reality.

Getting the details right is important, especially when you need clearance from the FDA.

FDA

Innovation carries inherent risk. The problem with the medical industry is risks can equal death which is why the FDA institutes regulations.

The FDA is responsible for making sure manufacturing practices and products meet the requirements of safety. The FDA says they’re sole responsibility is medical products, but the distinction between products and practice is hard to judge.

It’s not only the FDA which gets involved with regulation. 3D printer manufacturers also have to worry about state medical boards although they’re not as relevant unless patients are filing complaints. 3D printing manufacturers have to worry about two different entities when considering what to print.

To cause even more confusion, each product which comes out of a 3D printer is put into its own category. It’s like a Russian doll of rules. 

One subset of rules or circumstances triggers another set of rules. It’s no wonder why innovation is stalled in these areas. 

The FDA also developed a risk-based framework to help assess at the point-of-care. For those unaware, point-of-care testing means testing a patient after a discussion has been made by health professionals.

There are 5 levels of risk related to 3D printing at the point of care:

1. Minimal Risk

The first level means there is little to no risk. A 3D printer can print the device and use it to care for the patient.

2. Clearance Needed By The FDA

This tier involves getting permission from the FDA to print a device. To get clearance, the FDA needs a demonstration that shows the device’s specifications can be met. 

3. Explicit Training/Instructions Needed

Tier 3 is similar to tier 2 except there are more steps. For example, if a device is going to be manufactured, there might be training involved to get it done. Another example includes labeling instructions for the end user.

A lot of situations end up in tier 3 if there’s ambiguity for the end product. This is a good way to think of what situations or devices will end up in tier 3.

4. Manufacturer In The Same Location As Point Of Care

We get into tier 4 when the manufacturer is located in the same location as the healthcare facility. This means the manufacturer is responsible for everything 3D printing related.

5. Healthcare Facility Controls The Whole Process

When the healthcare is responsible for manufacturing, processes, and more, risk jumps higher.

The FDA gives guidelines as to what 3D printer manufacturers can do to make sure they don’t violate regulations.

FDA Guidelines

The guidelines given by the FDA is split up into sections. These guidelines are made for technical devices that are made from additive manufacturing. 

There’s a lot to read in the guideline book, but I’ll go over some of them to give you an idea of what passes guidelines by going through some of the sections and subsections. This is just a summary of some of the points to give you an idea of what the FDA looks for.

This guideline includes sections for:

  • Design And Manufacturing Considerations
  • Device Testing Considerations
  • Labeling

Design And Manufacturing Considerations

  • Overall Device Design

Overall design doesn’t account for every device, consider it as a template of what the FDA looks for. 

Each device made is usually specific to its own situation which means even if the device doesn’t fill the template, it’s still possible it’ll pass.

This section basically states manufacturers have to establish procedures for monitoring and quality control. No matter how standardized or customized a device is, if it doesn’t pass the monitoring and quality control portion, it’s out.

  • Patient-Matched Device Design

Patient-matching devices are made with a template in mind depending on the patient’s size. If there isn’t a template, this is when a “performance envelope” is considered.

This envelope considers the maximum and minimum dimensions and functionality needed for the patient. 

It’s not efficient to create a custom device for each patient. For one, it takes too long, and the second reason is it’s expensive.

This is why patient-matching device design is used with templates. Using patient imaging to get the design perfect includes different factors. Here are some reasons as to why getting the design takes longer:

  • Ambiguity when matching the device to the patient’s anatomy
  • Rigidity of anatomic structures being imaged
  • Minimum image feature quality and resolution used for matching

In an ideal world, it would be nice if we could make every device fully-customizable. It takes longer, but patient satisfaction goes up. The problems stated above get in the way though.

Let’s remember that although innovation slows down if all these restrictions are put in place, the FDA’s main goal is to ensure safety. There are trade-offs with both sides.

  • Software Workflow

Another consideration to look out for is software compatibility. With technology progressing and more devices being implemented, each device might have different software.

Having incompatible software means potential errors in file conversions, or bugs. Both are bad for the end product design. 

This is why it’s important to validate the type of software manufacturers use. Sometimes manufacturers have compatible software, but then plan on changing the device’s software. Validating software workflow makes sure this doesn’t happen.

Device Testing Considerations

  • Device Description

Next up is testing considerations. The ironic part is device description really belongs in the design and manufacturing considerations.

Device description is what it says it is. Manufacturers need to state what size the device is. And, if you can’t give it a definite size, it’s the manufacturer’s job to give the array of dimensions.

Manufacturers also need to disclose any changes made specific to the patient. For example, if they need to enlarge the device by a couple of inches, the manufacturer needs to let the FDA know.

The device description criteria also includes what type of manufacturing process and post-process manufacturers use. In addition, critical features of any devices needs to be disclosed. 

Labeling

Labeling patient medical devices isn’t a huge issue. We would think it doesn’t require a lot of time, but it’s more red tape to go through.

Manufacturers need to distinguish the device by labeling the device with the patient’s name. They also need to label instructions on how to use the device. 

For example, if a patient were to use the device for walking, the instructions would include how to set up the device and how to use it.

Labeling the device should be done. It isn’t reasonable to expect every patient/doctor to operate a device instantly.

Labels can also serve as warnings to prevent patients from hurting themselves.

Balancing Safety And Innovation

We have to reiterate that these are only some of the guidelines. When you take in everything from the actual guidelines, you’ll see how time consuming everything is for a manufacturer.

What stifles innovation the most is making sure every guideline gets followed. Innovation requires creativity and risk.  

The creativity and risk elements aren’t anything new. Just look at the Wright brothers, tech startups, and more.

Manufacturers need wiggle room to go outside the box which the FDA slightly allows. On the other hand, there’s a reason the FDA put these guidelines in place.

There’s a lot to account for, especially when dealing with people’s lives which is why there are so many rules. What we need to see is the right balance between regulation and innovation.

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