fda-investigating rev1

Keeping Pace with Demand without Sacrificing Quality

With demand for medical devices mounting as the population ages, manufacturers find they must increase production of their products while complying with stringent manufacturing requirements and ever-increasing regulations.  It’s vital that medical More »

ipad pic

Mobile Network Communicator: Existing or Custom Device?

Part 4 of 6-part series “Interfacing medical devices to the mobile network.” Our previous post in this series introduced elements of the solution to interfacing medical devices to the mobile network – More »

Home health communicators

Connecting the Right Medical Device – Can You Hear Me Now?

Part 3 of 6-part series “Interfacing medical devices to the mobile network.” (Graphic courtesy of Tormoen, Inc.) With the use of mobility technology for remote monitoring, gray areas and unknown variables are More »

Mobility technology

Mobility Technology: Bringing Change to the Medical Industry

Part 2 of 6-part series “Interfacing medical devices to the mobile network.” The Introduction of Unknowns The use of mobility technology is bringing change to the medical industry and at the same More »

Graphic courtesy of Tormoen, Inc.

Interfacing Medical Devices to the Mobile Network

Part 1 of 6-part series examining the issues and challenges that the medical device industry faces in utilizing the mobile network as part of healthcare monitoring systems. (Graphic courtesy of Tormoen, Inc.) More »

Insulin pen

Electronics Manufacturing Expertise Enhances Device Manufacturing Capability

Post 2 in a 2 part series: Electronics Find Critical New Role in Drug Delivery Devices. Adding electronics to drug delivery systems is changing the status quo in healthcare. Recent advancements from More »

Keeping Pace with Demand without Sacrificing Quality

fda-investigating rev1

With demand for medical devices mounting as the population ages, manufacturers find they must increase production of their products while complying with stringent manufacturing requirements and ever-increasing regulations.  It’s vital that medical device manufacturers keep pace with demand without sacrificing quality because people’s lives so often depend on the complex devices.

Mobile Network Communicator: Existing or Custom Device?

ipad pic

Part 4 of 6-part series “Interfacing medical devices to the mobile network.”

Our previous post in this series introduced elements of the solution to interfacing medical devices to the mobile network – the device/communicator. It addressed challenges associated with using existing consumer devices such as smart phones as part of a Class II or Class III medical device solution. The fundamental issue is – and always will be – focused on the intended use and labeling of the device. What function does the existing mobile device perform as part of the medical system? Is it in the critical path? If the mobile function went away, would the device still operate to its intended use? Is the device actually diagnosing, providing warnings or alerts, or even taking action on treatments?

Connecting the Right Medical Device – Can You Hear Me Now?

Home health communicators

Part 3 of 6-part series “Interfacing medical devices to the mobile network.” (Graphic courtesy of Tormoen, Inc.)

With the use of mobility technology for remote monitoring, gray areas and unknown variables are being introduced into the medical device ecosystem. Until now, the industry has worked under relatively known scenarios where evaluation and documentation of issues affecting safety, efficacy and security are more or less contained within the physician/patient/device ecosystem.

Mobility Technology: Bringing Change to the Medical Industry

Mobility technology

Part 2 of 6-part series “Interfacing medical devices to the mobile network.”

The Introduction of Unknowns

The use of mobility technology is bringing change to the medical industry and at the same time introducing gray areas and unknown variables into the medical device ecosystem. Until now, the industry has worked in familiar scenarios where evaluation and documentation of issues affecting safety, efficacy, and security are more or less contained within the physician/patient/device ecosystem. Using an extended system of communication devices, mobile networks, and multiple data access and evaluation points opens the possibility for new risks.

Interfacing Medical Devices to the Mobile Network

Graphic courtesy of Tormoen, Inc.

Part 1 of 6-part series examining the issues and challenges that the medical device industry faces in utilizing the mobile network as part of healthcare monitoring systems. (Graphic courtesy of Tormoen, Inc.)

There is no doubt that we are in an amazing and challenging transition period in healthcare. Reform initiatives have demanded an intensive examination of current, accepted methods of care delivery to find more cost-effective, value-based methods of disease management and treatment. The goal:  drive better patient outcomes while taking significant costs out of the system.

Electronics Manufacturing Expertise Enhances Device Manufacturing Capability

Insulin pen

Post 2 in a 2 part series: Electronics Find Critical New Role in Drug Delivery Devices.

Adding electronics to drug delivery systems is changing the status quo in healthcare. Recent advancements from electronic drug patches utilizing disposable electronics to electronic wireless systems tracking a patient’s glucose and insulin levels are driving the paradigm shift in drug delivery devices. Utilizing manufacturing partners that are experts in electronics design and manufacturing greatly enhances production of these hybrid devices.

Electronics Find Critical New Role in Drug Delivery Devices

Diabetic items

Post 1 in a 2-part series: Electronics find critical role in drug delivery devices

Wireless technologies that power today’s cell phones, smart phones, tablets and other consumer electronic devices are finding a new role as the conduit between in-home medical devices and staff or databases in hospitals and doctors’ offices. Wireless-enabled drug delivery devices offer huge potential to address several critical healthcare issues – cost escalation, provider shortages and proliferation of chronic conditions – while offering patients the convenience of using their familiar phones and tablets to transmit medical information to their providers.

How to Take the Guesswork out of the Material Selection Process

injecton molding material process pic

Advancements in materials science research along with new process technology have increased a designer’s capability in choosing and selecting the right materials for medical product development. Although the material selection process is generally a successful one, there are a few pitfalls to avoid.

For instance, it is human nature to remain loyal to tried-and-true methods that worked satisfactorily in the past. The challenge is to find a balance between proven materials and innovative but potentially riskier ones. To stay on top of the newest offerings, designers should routinely consult with material suppliers, which are constantly developing and launching new products. Suppliers – and particularly their R&D departments – work on the leading edge of specific material technologies and provide guidance (of course, slanted toward their own products).

How to Focus on Launching the Next Breakthrough Product

Design & product development

Post 6 in a 6-part series: Why Partner with a Medical Design & Manufacturing Services Company

Since the beginning of 2010, the case for outsourced medical device manufacturing has become increasingly relevant, thanks to greater availability of venture capital and strong demand from China, India and other nations. Assigning a project to a design and manufacturing services company can act as a seamless extension of in-house manufacturing capability. A project can be outsourced to a manufacturing partner allowing in-company resources to focus on core competencies such as research and product development.

How a Medical Device Company Can Accelerate Regulatory Compliance

Injection Molding

Post 5 in a 6-part series: Why Partner with a Medical Design & Manufacturing Services Company

Ensuring that medical devices are user-friendly, compliant with Federal Drug Administration (FDA) regulations and safe for consumers of all ages must be the overarching goal of any medical device firm that desires to market their products and technology. In 2011 the FDA began to lay down the law on mobile medical applications.  Medical application developers now have to apply for FDA approval for apps making medical claims. Another initiative the regulator unveiled is a medical device safety system to create a unique device identifier label to help track defective products and make recalls more efficient.

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