Technically, the purpose of the FDA-required product requirements document (PRD) is twofold:
[vc_row][vc_column][vc_column_text]New medical devices offer fresh opportunities for your company to improve health outcomes, push the boundaries of medical innovation, and grow your business. Who wouldn’t be excited about that?
But medical devices also carry varying levels of risk that [...]
[vc_row][vc_column][vc_column_text]As a leader in the medtech space, you have two primary concerns on the road to medical device commercialization:
Time to market — how quickly the product can realize ROI
[vc_row][vc_column][vc_column_text]Medical devices are complex to develop. The process can take months for a relatively simple product to years for something more sophisticated.
As a company bringing medical devices to market, your priority is to develop a successful, safe, and effective p [...]
[vc_row][vc_column][vc_column_text]From a medical device development perspective, the goal of human factors engineering, usability, and user experience activities is the same: To release a product that meets users’ needs in a safe, effective, straightforward, and delightful way.
But the [...]
Focusing on usability as you develop a medical device is paramount. Without properly considering user needs from the get-go, you risk creating a product that doesn’t meet user expectations and consequently falls flat in the marketplace. Unfortunately, it’s all too easy to misstep when it come [...]
[vc_row][vc_column][vc_column_text]The success of home health products can be measured in much the same way as any other medical device: How well does the product work? To what extent does it improve health outcomes? How are sales? But, unlike medical devices for clinical settings, home health pr [...]
[vc_row][vc_column][vc_column_text]It’s a consequential decision to hand over the responsibility of designing your medical device to an outside team — even if it’s only for part of the project. You need to have a lot of trust and confidence in the firm you hire.
MPE (Formerly Mindflo [...]
If you’re reading this, you probably have a viable idea for a new medical device — and that’s exciting. You’re ready to launch a startup and get your product into the hands of the users who need it most. But beware. Bringing a medical device to market is a years-long process full of compl [...]
[vc_row][vc_column][vc_column_text]Should any digital design agency develop your medical device user interface?
In a single word, no!
That may seem too definite a statement to make, yet it is the correct answer.
For several decades, the medical and healthcare industry has und [...]
[vc_row][vc_column][vc_column_text]How do you have to clean medical devices? And why is that process so complicated? It boils down to a few questions:
Why do you need to sterilize or d [...]
[vc_row][vc_column][vc_column_text]Human factors and usability activities play a vital role in medical product development. Not only do they help provide insight for development, they are also closely tied to risk management and regulatory requirements.
We often encounter medical device m [...]
[vc_row][vc_column][vc_column_text]It doesn't matter if your medical device company is a hungry new startup or a seasoned industry leader: There are times when you need to augment your in-house team’s capabilities. Whether you need help with user interface design, engineering, usability testing [...]
If you’re planning to bring a new medical device to market, your first order of business is to determine how your product will be classified by the Food and Drug Administration. As you likely already know, the FDA oversees the production of all medical devices in the United States. The FDA's me [...]