Research and development is the cornerstone of growth in the medical device industry. R&D funding is available; however, the issue isn’t availability as much as availability for marginal improvement. The question to ask is, “Will a marginal improvement reduce costs for the patient and caregiver?”
Researchers from NC State and the University of Houston (UH) are hoping to solve the “disconnect” between the mind’s signals and the response (or lack thereof) from a prosthetic device with a new four-year, $1.2 million collaborative project funded by the National Science Foundation (NSF).
We see funding for new medical devices driven by private investment from individuals or private companies. These bold investors are capable of quick decisions as they meter the funding to match progress and discover the real market opportunity.
Navigation devices used by blind people today lack the ability to operate indoors and other areas where GPS is not available, and are unable to help the user deal with items that aren’t part of maps, such as crowds and cars. Auburn University is building a prototype device...
A lens invented at The Ohio State University combines the focusing ability of a human eye with the wide-angle view of an insect eye to capture images with depth. The results could offer surgical imaging that enables doctors to see inside the human body like never before.
The financial pressures medical device OEMs are facing are very real. They’re experiencing reduced reimbursements from the government and insurance companies, increased taxes, and global competition. As a result, new business models are evolving to ensure new product innovation is not stifled and, most importantly, patient safety is not compromised.
While Metrigraphics LLC certainly does not speak for the medical device OEM industry, as a custom contract manufacturer of leading edge micro components, we certainly feel the impacts of various external elements on the ebb and flow of R&D and innovation activities of the OEMs.
As OEM’s streamline to meet financial pressures, top level designs will be emphasized but second and third level particulars will adhere more closely to a suppliers understanding of their present capability. The particulars are under a fine balancing act and vision outside will require a thorough knowledge, down to the step-by-step production process to lean out waste.
On this episode of The Pulse, brought to you by MDT TV, we’re removing brain tumors with robots, using MetaboShield to help obesity, regenerating heart tissue, and pairing glucometers with smartphones for ease of use.
Making sure patient information is secure begins with coding on the package. No matter to whom the medical device is targeted—for a specific patient, hospital, or doctor—the coding placed on the package is the first part of the data set used to track the device.
While the adoption of electronic health records helps healthcare facilities streamline data collection and retention, it also presents challenges when it comes to security. Traditional paper file storage in healthcare facilities is being replaced by computers and portable electronic devices that are often more exposed to threats.
The inherent insecurity of many medical devices was highlighted in a recent FDA and Homeland Security alert. Over 300 devices have been identified that utilize a hard code password, creating a huge security loophole. With so many medical devices now collecting and storing patient data, this raises the question of how secure is the data stored on these devices?
On this episode of The Pulse, brought to you by MDT TV, we are regenerating limbs, building better brain implants, engineering 3D tissue, and measuring consciousness.
When it comes to HAIs, material suppliers are assisting device makers in a several ways. First, we’re developing materials with properties to withstand the aggressive cleaners needed to reduce bacteria and fight the spread of infectious diseases.
Welcome to the Pulse, brought to you by MDT TV. Today, we're implanting an MRI-safe spinal cord stimulator, sorting blood with a microchip, building robots out of biocompatible hydrogel, and making hydrogel move with light.
The highly aggressive sterilization methods used on medical devices to help combat healthcare-associated infections (HAIs) are harsh and can cause color shift. Medical devices that become discolored from sterilization can comprise patient safety and public peace of mind.
Welcome to the Pulse, brought to you by MDT TV. Today, we’re patenting new biomaterial to make artificial bones, creating pain-free prosthetics, using ultrasound waves to improve your mood, and using magnets to steer stem cells.
As a manufacturer, the UDI rule allows us to take more than 30 years of experience in the development of marking and imaging technologies to satisfy a critical need in a new market. In terms of assisting our customers in their efforts to become compliant, we now offer the MPX-90M impact printer.
The FDA UDI rule will standardize the way the medical device industry identifies its products, which is a foundational step toward utilizing companies who offer higher value, more complex solutions. Engaging these solutions is critical to helping manufacturers secure supply chains, deter counterfeiting, and ensure patients have access to safe medical devices.
In reference to the UDI rule, the FDA estimates more than 1,200 companies are in need of equipment or have already implemented direct part marking into production. Of the 1,200 companies, roughly 700 are medical implant manufacturers, while the remaining 500 produce multi-use devices, such as surgical instruments.
The following standard must be met for all medical products intended to be used in the home: IEC 60601-1-11, which is “Medical Electrical Equipment—Part 1-11: General Requirements for Basic Safety and Essential Performance—Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment.”
From a test engineer’s perspective, understanding final requirements, application, and quantifiable goals for testing before a protocol or test plan is executed is crucial to the success and efficacy of a device used directly by the patient.
One recurring challenge in designing products for use directly by the patient is the difficulty in predicting long term aspects and the impact of a given medical device on a diverse group of users due to their varied characteristics and sensitivities, as most new medical technologies have limited information related to their long term results and side effects.
The biggest challenge for many medical device designers is selecting sensors that can help them optimize designs for size, cost, and complexity. A modular sensor design provides a single device that can be optimized for a variety of markets or customers, enabling a designer to select the right sensor with the appropriate functionality.
In today’s global market, lack of effective communication through the value chain is the greatest obstacle to successful home device design. To gain an advantage in the market, OEMs are continuously outsourcing component design and procurement. By doing so, OEMs increase the number of different entities involved in the value chain.