Consider These 6 Things When Choosing A Medical Device Contract Manufacturer

by • September 21, 2021 • Health, TechnologyComments (0)724

Choosing a medical device contract manufacturer can be a daunting task. Whether you’re making the choice for yourself or a loved one, or as a stakeholder, it is an important decision that requires making an informed choice. Yet, manufacturer websites and information resources available are often overwhelming to navigate. However, there are key factors to consider that will allow you to narrow the scope of your research, and therefore make your decision with more certainty. Here are six things to consider:

Understanding Regulations

Medical jargon can be intimidating and confusing, and it can feel as though regulations are written in a whole other language. However, it is important to know that your manufacturer of choice is following all government-mandated regulations and meeting, if not exceeding, current medical standards. These regulations seek to ensure that the user is safe and that the device can cause no further harm to the user, while also making certain that they are functioning to standard.

Speak with your doctor or specialist about what to look for and tips on how to translate complicated lingo. Additionally, ask them for their professional advice and experiences as they may have some significant thoughts and observations. Do your own research and consider getting some insight from online or in-person support groups to learn about the experiences of others with the same or similar diagnoses. Many will be familiar with specific pieces of regulations and have lived experience relating to the regulations. What brands do they trust? What do they wish they knew beforehand? Where doctors and other professionals can slip up and forget to use Layman’s terms? Clients like yourself will be able to communicate at your level.

Design Engineer Experience

For the individual using the device regularly, its form and function are of the utmost importance. Look for companies that employ a team of well-educated and experienced engineers. Well-designed devices should be ergonomically sound and contribute to an enhanced quality of life. Legitimate device manufacturers will have qualified engineers who are well-versed in their field and the requirements of the consumer, and whose accreditations can be discovered on their website or via professional networking platforms like LinkedIn. Copycat models can seem more cost-effective, however, these can cause new problems in addition to failing to address the immediate concern. They can also just be uncomfortable because instead of using precise ergonomic measurements, they mimic the major brands.

Innovation, Technological Proficiency, and Facility

Most clients want turnkey solutions that can offer the highest quality of life. Modern innovative solutions have done incredible things for the medical world and the millions around the globe who depend on medical devices for daily living. However, not all medical devices are created equal, and this is in part related to the technological experience of the engineer teams and access to state-of-the-art tools and facilities.

Evaluate the length and quality of experience of each manufacturer’s engineering team. Take in their innovations; what are they contributing? In addition, consider the manufacturing equipment and processes. If it is possible, you may want to visit the manufacturing site to learn more about production. Technology has made it possible for medical devices to be tailor-made to the client in many cases, so learn about your options and what is possible.


Biomedical waste has been a mass contributor to global waste with single-use instruments and transitory devices being the standard for decades. With the growing concern around the climate crisis, considering the impacts of medical device waste can easily be made an important part of your choice. This consideration may seem challenging in the field of medicine, however, the industry leaders who are managing medical device manufacturing company PolarSeal have already taken steps to ensure and advocate for sustainability at all stages of their production, from the first moment of production to actual consumer utilization. Examine the manufacturer’s green plan and ecological footprint. What are their waste and recycling policies? Are they using reusable energy sources? Do in-house capabilities allow for reduced product distances and shipping optimization? What is the shelf-life of the product, and can the materials be repurposed? If not, how is the device disposed of?

Supply Chain Management

How easily you can access the device should also be a significant factor in your decision. This not only involves the distance between yourself and the manufacturer, but also the product miles between the manufacturer and their vendors. This can significantly impact the cost of the device.

Evaluate the manufacturer’s supply chain. You want the manufacturers’ costs to be high on quality of materials, not on transit. Proximity to the manufacturer and their vendors, can also impact accessibility to support should your device malfunction, or if you require enhancements. 

The company may manufacture in your country, and therefore adhere to regulations. However, these regulations relate to locally produced goods, which means imported materials aren’t subject to the same rules. Many products coming from companies in China and other large exporting bodies are manufactured with materials that are banned in the United States and other Western countries.


Cost is inevitably one of the major factors in the decision-making process when it comes to choosing a medical device, whether or not you have medical coverage. Having medical insurance doesn’t necessarily mean your device will be covered as many insurance plans cover a percentage or fixed rate. However, while cost is an important aspect for most, it shouldn’t outweigh quality. It’s a fact that in the majority of cases where medical devices are concerned, you get what you pay for. However, many manufacturers offer various models at different price points, as well as with characteristics and features.

Like most things, the more features, the more you can expect to pay. Yet, in a reputable company, all versions of a device will have been developed under the same regulatory points and company standards and should come with a warranty. Finding a positive solution doesn’t require breaking the bank, and many of these options are still customizable.

At the end of the day, you want a device that suits your needs and allows you to live life to the fullest, and with modern innovations, there’s no reason why you can’t. Yet it can be so easy, and expensive, to get caught in the fray. Doing some homework before any commitment will help you to make the best decision for you. After all, you are the expert in your own life!

Photo by ThisisEngineering RAEng on Unsplash



Comments are closed.