The 3 Things Ignored in R&D of Medical Devices

April 25, 2017
.  written by 
Jón I.
Bergsteinsson
|

Previous titled: "The 3 Things Medtech Companies Ignore in R&D of Medical Devices"

1. Overview

In medical research and development, planning is everything. Yet, living up to our plan is a different story. It requires continuous evaluation of our status and progression. We spend hours in specifying the perfect validation plan, protocol, or test-process. When we are underway, we get caught in a whirlwind of status-updates, and meetings.

"By selecting the right tools, you can significantly improve the overview of your medical device validation and testing activities."

Move away from static tools, such as documents (both digital and paper-based), Excel, and e-mail. Start using modern services that allow you to share information with your co-workers or customers, in real-time. This can not only give you an overview, but the security required to keep track of important information.

2. Inefficiency and Unnecessary Costs

Which comes first, time or money? It doesn’t even matter, because for most of us (during work hours at least) time equals money. How much time do you spend on “catching up” or updating colleagues? Updating plans, templates, or overseeing how tests are progressing? Have you put thought into how much time (and money) you spend on printing, transcribing, e-mails, or old-fashioned mail? Did you e.g. know, that the price of postage stamps in the US alone has risen 900% since the 70’s, and around 20% since 2007? [ref: usps.com]

"Stop wasting time and money on outdated methods or software."

If you feel like your efficiency could be improved, you should make a change. Modern software solutions often provide more efficient methods of problem-solving – which in return, can drive innovation.

3. The Value of Clinical Data

Regardless of organizational size and device class, there's still a common belief that clinical data is somewhat irrelevant. Recognize the following question?

"Is clinical evaluation required, if a similar device is already on the market?"

The medical industry is heavily regulated, especially when it comes to higher class devices. Requirements for clinical investigation and -evaluation are increasing with the new medical device regulation (MDR). This can be troublesome for smaller- and medium-sized organizations. Being able to illustrate clinical benefits from early stages of development, and throughout the device life cycle should not be understated. Not only can such data be used for marketing purposes, but be highly relevant for due diligence. Not to mention technical and safety improvements. Are you interested in learning how SMART-TRIAL could benefit your organization? Let's have a chat, and allow us to share various case-stories, to see if you can relate.