Vice President of Business Development — Life Sciences, DataArt
Technology implemented well is greatly increasing our ability
to understand the human body and how to care for it. In 2015,
next generation genetic sequencing techniques will be revolu-
tionizing diagnosis of infectious disease, but the FDA’s recent move for tighter
regulation of laboratory developed tests may slow progress. As this technology
becomes readily available, it will speed up diagnosis and eliminate diagnostic
errors. Telehealth virtual doctor visits will also begin to bring back low cost,
at-home virtual visits, making physicians more accessible and reducing the
time and effort it takes for a patient to receive the care they need. We also see
mHealth and wearable technologies advancing quickly in healthcare, as they
are being used to improve the quality of data collected in clinical trials, and
improving the lives of patients with chronic conditions like diabetes and heart
conditions. These are just three trends out of many advances that will provide
early prevention, quicker diagnosis, and better overall healthcare. MDT
CTO, Beahm Designs Inc.
As the medical device industry continues to face complex
challenges in new product development and launch, the trend
in 2015 will increasingly migrate toward automation at every
level of the supply chain. When we founded Beahm Designs
in 1990, the industry was so new that companies routinely
kluged solutions together to get the job done. Beahm Designs’ initial product
line actually emerged 30 years ago as a solution to this problem.
With catheter designs becoming smaller and more complex while
manufacturing processes requiring higher precision and repeatability, automation has begun to extend to every level of the manufacturing process.
As ISO and similar certification compliance requirements remain stringent,
medical device manufacturers are put to the test every time they attempt
to bring a new product to market.
In response to customer demand, our challenge in 2015 is to automate
as much of the manufacturing process as possible, eliminating the possibility of user error, increasing throughput, and protecting the operator from
injury every step of the way. MDT
VP of Medical Products, TÜV Rheinland
It is estimated that 500 million smartphone users worldwide
will use healthcare applications in 2015 – from using the phone
to detect glaucoma in the eye to taking cardiac measurements.
The users include healthcare professionals, consumers, and patients. In contrast, only about 100 of the almost 100,000 mHealth apps on the market are
approved by the U.S. Food and Drug Administration.
Patient data stored on many apps is the prime target for cyber theft and
is worth 10 times more than credit card data on the black market. To help
protect consumers from cyber theft and the app provider from liability if the
data is stolen, developers will be turning to cybersecurity experts to help ensure the devices are designed with security in mind and in compliance with
the FDA’s “Mobile Medical Applications Guidance for Industry and Food
and Drug Administration Staff” issued on September 25, 2013. Additional
regulations may also apply depending on how the app is used. MDT