So, you’ve got an idea for a medical product, or a business that wants to produce and manufacture one, and you’re thinking about getting it into circulation. Well, there’s never been a better time to get involved with such a product, especially with the COVID-19 pandemic.
Lots of companies and movements have appeared over the last year offering all kinds of products but, while essential and what the world needs right now, there are some hoops to jump through and rules to follow. If you’re ready to get going, these are the facts about manufacturing a medical product that you need to know.
1. Think About Power Options
How are you going to power your device?
As a medical device, having power at all times is one of the most essential aspects you need to be thinking about. How is energy stored in the battery, and how is this going to affect the radio wave frequency of the device?
There’s no point in having a medical device if it dies quickly and can’t do its job, so you need to be thinking about making your device as power-efficient as possible.
2. Does Your Device Meet Environmental Compliance?
I’m not talking about being safe to recycle after use (although that’s another consideration). I’m talking about how compliant your device is in medical situations where it’s going to be used. Is it safe for being used at home, at work, out and about, and in hospitals?
Can it be used indoors and outdoors? Is it waterproof? Does the technology affect any other devices? Is it affected by other devices? You need to consider all of this.
3. Be ISO 13485-Compliant
Of course, no product gets to be used right off the bat; it needs to be subject to quality controls and must reach certain recommendations and requirements. A great way to do this is to make sure the manufacturer you’re using is ISO 13485-compliant, or that your company is if you’re manufacturing the products yourself.
“This certification means that quality control measures are being upheld, all aspects of the process have been tested for quality and performance, and acceptable standards are being met. If the standards aren’t met, then your medical device won’t be accepted, so make sure you’re researching the most current guidelines and what you need to be meeting,” explains Jason Turner, a journalist at State Of Writing and Paper Fellows.
4. Cost is Everything
There’s no denying that you’re going to be designing and manufacturing to a budget, and your customers and users will be shopping and buying on a budget. So, putting two and two together, you need to make sure you’re making your product as affordable as possible, all while retaining quality.
To do this, you can start by creating a list (some recommend a pie chart) of all the components of your device and then seeing which are the most expensive. You can then work top to bottom to see where you can save, and how you can cut your costs as much as possible.
5. Consider Data Communication
Back in the day, medical devices used to have custom displays that would relay data. Smartphones have become increasingly popular for this task, but it’s really up to you and your device. However, whatever approach you take, there are several things you need to be aware of.
“First, what kind of reader are you using? This refers to a custom screen (which could even be a screen on a Fitbit, for example), a smartphone or a computer,” shares Nick Harris, a tech marketer at Oxessays and LiaHelp. “Then, how are you transmitting data? Wearable ECGs, for example, require tens of kb/s continuously, but will only log data several times per day in one go.”
You then need to think about how the customer or patient is using this data. Will it be a seamless, hands-free experience or does it need to be a more manual process? There are pros and cons for whatever approach you take, but you’ll need to decide which is best.
