Medical Product Design

FDA officials comment on clinical trials for medical devices

by Chris Ross Posted Apr 11, 2017 In Medical Product Design

The medical device development process has many important differences from the path for creating a new drug. In regulating new prod [...]

MindFlow Design Earns Internationally Recognized ISO 9001:2015 Certification

by Chris Ross Posted Apr 04, 2017 In Medical Product Design

MindFlow Design, a leading product developer for medical, life sciences and consumer health companies, has earned ISO 9001:2015 certification for having high-quality management systems that meet a highly respected international standard.

Certi [...]

ISO Certification for Product Design Firms: Blessing or Curse?

by Chris Ross Posted Apr 04, 2017 In Medical Product Design

As  we at MindFlow Design were investigating whether to pursue ISO certification, we were surprised at the antagonism toward ISO that was on display in some quarters of the product design industry. Critics were saying that the ISO certification process [...]

4 keys for preparing a medical device submission to the FDA

by Chris Ross Posted Mar 01, 2017 In Medical Product Design

Submitting innovative medical products to the U.S. Food and Drug Administration Center for Devices and Radiological Health is a complex and len [...]

When Worlds Collide: Invasion of the Consumer Product Marketers

by Chris Ross Posted Feb 21, 2017 In Design Strategy, Medical Product Design

The medical device and consumer product worlds have collided.  We saw evidence of this recently at the

Understanding the new FDA guidances on medical product communications

by Chris Ross Posted Feb 07, 2017 In Medical Product Design

On January 18 2017, the U.S. Food and Drug Administration released a pair of draft guidances on medical product communications. These rules could have significant implications for the ways manufacturers present

Research predicts growth for mobile health devices

by Chris Ross Posted Feb 02, 2017 In Medical Product Design

There are numerous promising signs for the use of innovative products in mobile health. From scientific research out of Stanford Un [...]

Research finds wearables can warn of illness

by Chris Ross Posted Jan 30, 2017 In Medical Product Design

Users monitor their own health and fitness every day with wearable devices, collecting a variety of data on their vital signs and activities. Now, it seems that information may be able to accomplish far more than helping exercise buffs set goals for their next [...]

What draws consumers to buy digital health products?

by Chris Ross Posted Jan 13, 2017 In Medical Product Design

A study from eMarketer predicted that 39.5 million American adults will use wearable devices on a monthly ba [...]

How can seniors benefit from wearable technology?

by Chris Ross Posted Jan 08, 2017 In Medical Product Design

Digital health products that track physical activity levels, heart rates and other relevant data can assist people of all ages and lifestyles in maintaining their well-being. However, as a study in Health Affairs noted, there's still much work to be done in [...]

How will Xcertia affect the future of digital health products?

by Chris Ross Posted Jan 08, 2017 In Medical Product Design

On December 12, 2016, four organizations announced the beginning of a collaboration intended to develop and promote best practices for digital health apps. The nonprofit corporation, called Xcertia, was officially unveiled at the Connected Health Conference hel [...]

Innovation and specialization drive the future of wearables

by Chris Ross Posted Jan 06, 2017 In Medical Product Design

The market for wearable technology continues to grow and change as consumers find useful ways to incorporate these products into their lifestyles. According to International Data Corporation, total shipments of wearable devices

Wearable devices lead survey of fitness trends

by Chris Ross Posted Dec 13, 2016 In Medical Product Design

According to the American College of Sports Medicine, wearable technology will be the biggest trend in fitness for 2017. These findings, published in the ACSM's Health & Fitness Journal, came from a survey of

5 steps for making your medical product look “less medical”

by Chris Ross Posted Dec 12, 2016 In Industrial Design, Medical Product Design

"Just don’t make it look medical." As we research what people want in a home health product, this is what we hear most frequently. Typically, this distaste for a medical look becomes a bedrock client requirement. [...]

How will new legislation affect digital health products?

by Chris Ross Posted Dec 09, 2016 In Medical Product Design

Indications suggest digital health technology has an important part to play in the future of healthcare. A recent study from business consultants Frost & Sullivan predicted that revenues from mobile health products would