With the dramatic growth of the IT sector over the last decade, novel commercialization models like the start-up accelerator have emerged. A typical IT accelerator provides a small investment (usually $10,000 to $50,000) alongside rigorous...
Most people know that a major function of the kidneys is to remove waste products and excess...
As a leading supplier of acrylic-based thermoplastic products, Evonik Cyro is continually...
At Portescap, we supply motors and gearing that go into critical care home medical devices. To ensure patient safety, we use prevention, containment, and OEM feedback. During product design, we use a stage-gate system that incorporates multiple...
As a strategic supplier to medical OEMs, it is vital that Watlow remains knowledgeable of changes in market needs and regulations. This allows us to design and develop products in a rapid fashion that meet the unique requirements of the medical equipment market.
Medical professionals can agree that protecting patient information is one of their top priorities. Patients put a lot of trust into their healthcare providers to maintain that their information is never lost or stolen, and providers are subject to rigorous standards, such as the Health Insurance Portability and Accountability Act (HIPAA).
The key to protecting PHI data is education, execution, and continuous verification. The first thing is to understand your obligation as a custodian of this sensitive data. This is best done through formal HIPAA/HIPAA-HITECH training to understand the regulation.
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?”
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.
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.
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?
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.
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.
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.
As medical systems move from hospitals to homes and onto human bodies, designers need to realize their users are not professionals anymore. These new at-home users do not understand conditions that could impact measurements and the validity of measurements.
Consumer-driven user requirements for home-use devices increasingly require more than just usability, safety, and efficacy; strong insight into why the consumer needs the device is also required. From backyard sheds to universities and research groups to small and large companies alike, bright minds have no shortage of invention of medical products designed for home use.
Designers should look for a company that not only provides the right silicon, but also development tools, software, and support that are tailored for two main phases of a typical smartphone/tablet-based medical design. The first phase consists of the smartphone interface, and the second phase is the design of the medical device itself.
- Page 1