Through its business area Trelleborg Sealing Solutions (TSS), Trelleborg has finalized the acquisition of Wisconsin-based Anderson Seal LLC, a privately owned seal distributor and value-added service partner.
Through its business area Trelleborg Sealing Solutions (TSS), Trelleborg has finalized the acquisition of Wisconsin-based Anderson Seal LLC, a privately owned seal distributor and value-added service partner.
The acquisition supports Trelleborg Sealing Solutions’ growth strategy and expands the delivery and service of seals, gaskets, and custom-molded products for original equipment manufacturers (OEMs) in industries such as medical/life sciences, automotive, and hydraulic. Anderson Seals has an office and warehouse in New Berlin, Wisconsin, with 2015 sales of approximately $17 million. www.tss.trelleborg.com; www.trelleborg.com
BD, Apax Partners to launch global respiratory business
BD (Becton, Dickinson and Co.) and Apax Partners have launched a joint venture – Vyaire Medical – a standalone, global respiratory solutions company. The closing finalizes the sale of 50.1% interest in BD’s Respiratory Solutions business to funds advised by Apax Partners, a global private equity firm. Vyaire Medical includes all business lines within BD’s Respiratory Solutions business, including ventilation, respiratory diagnostics, vital signs, and airlife, and will have estimated annual revenue of more than $800 million. BD will retain a 49.9% minority interest in the new company.
BD’s Respiratory Solutions facilities will transfer to the new company, including locations in Yorba Linda, California; Palm Springs, California; Plymouth, Minnesota; Mexicali, Mexico; Cotia, Brazil; Hoechberg, Germany; and Shenzhen, China. The new company will employ more than 5,000 associates around the world. www.vyaire.com; www.bd.com; www.apax.com
UDI expands to the EU
Features - Compliance
European manufacturers can learn from unique device identification (UDI) experiences of U.S. and U.K. medical device markets.
Earlier this year, medical device manufacturers could only speculate about the impending changes of the new European Medical Device Regulations. Now that the draft versions have been released, manufacturers are in a better position to prepare before the regulations are formally adopted. The texts confirm that among the new measures to be implemented is unique device identification (UDI), a system to precisely identify medical devices through distribution and use. Introducing UDI to Europe is no small feat. However, manufacturers do not have to start from scratch – they can draw from the experiences of the medical device industries in the U.K. and the U.S.
In 2013, the Food and Drug Administration (FDA) published the final rule setting out a series of compliance dates for UDI requirements in the U.S. To allow manufacturers to implement UDI in stages, the FDA set out a seven-year rolling timeline. The U.K. National Health Service (NHS) provides a second model for manufacturers, with the Department of Health publishing its e-procurement strategy in 2014, imposing its own version of UDI.
Like the NHS, the FDA brought in third-party issuing agencies to assign UDI codes. These organizations are GS1, a global barcoding organization; the Health Industry Business Communications Council (HIBCC); and the International Council for Commonality in Blood Banking Automation (ICCBBA) for medical products of human origin. The FDA also runs the Global Unique Device Identification Database (GUDID), which was created so that every medical device with a device identifier (DI) could be logged into a single system.
By launching UDI measures, both the FDA and the NHS sought to increase patient safety and improve transparency and efficiency of hospital care. In addition to these benefits, manufacturers stand to benefit in several ways by meeting UDI requirements, offsetting the costs that implementation entails.
Where to begin
Preparing for UDI is a process requiring considerable time, money, and resources. Careful planning from the outset will help avoid unnecessary, avoidable costs.
Manufacturers should begin by conducting an assessment of existing products to find out if they are already complying with UDI regulations or if they will be compliant before the deadline. They should then develop a companywide strategy to achieve compliance rather than isolating UDI activities, as the compliance process should involve multiple departments and functions.
The strategy should include:
Assigning labelers responsible for the GUDID account
Contacting an issuing agency to obtain a complex prefix
Obtaining appropriate Dun and Bradstreet (DUNS) numbers or verifing that database information is correct
Creating, transmitting, and tracking GUDID submission data to meet UDI requirements
Determining a GUDID submission option, either GUDID web interface or HL7SPL submission
Proper implementation will produce significant benefits for manufacturers, so appoint a dedicated team and project manager with external support where necessary. An external consultant with comprehensive knowledge of UDI can help prevent fines, recalls, rejections, and unnecessary delays.
Taking advantage
The overarching aim of integrating UDI into company systems is to adopt more thorough tracking and inventory procedures, and the advantages go beyond compliance with regulations. Creation and management of a platform for tracking, cataloging, and entering information required for UDI compliance will improve all internal processes.
Efficient tracking platforms will increase the visibility of counterfeit products, while enabling better management of trunk stock and consignment inventory. In addition, a database of every manufactured device allows closer scrutiny of product portfolios, making it easier to spot outdated products that should be removed.
Comprehensive databases will prove invaluable in the event of mergers and acquisitions. Both companies involved in a proposed union can use UDI information to perform preliminary checks and risk assessment, likely speeding up the process while giving peace of mind about the transaction.
Patient safety is strengthened by improved medical device traceability. One illustration is that hospitals can use UDI data to verify which devices are used by staff on individual patients. In cases involving contaminated devices, for instance, hospitals can quickly identify and treat affected patients.
Finally, UDI will contribute significantly to post-market surveillance activities. When products have to be recalled, the absence of sufficient data prevents manufacturers and medical staff from gaging the full extent of the problem. UDI will allow faster and more precise identification of defective devices.
Pitfalls of non-compliance
Implementing UDI in the U.K. and the U.S. has raised technical, operational, and administrative challenges. This is why, in the early stages of UDI proposals in the U.S., there were mixed opinions among medical device manufacturers.
Negative reactions were fueled by the scale of labelling and operational changes which UDI implementation requires. Some manufacturers did not like the extent of oversight now afforded to the FDA, while others considered the UDI measures an effort to bring the device industry up to par with the pharmaceutical industry’s anti-counterfeit and serialization methods.
Complacency toward UDI is not an option, as tardy compliance may have serious commercial consequences. In the event of non-compliance, the FDA can fine culprits or even ban manufacturers from selling their products across state lines, and it can prohibit European manufacturers from importing devices into the U.S. These sanctions can lead to a loss in sales and damaged reputations. In extreme circumstances, customers might not accept a product without UDI, and sometimes the manufacturer might have to abandon the product all-together.
Conclusion
In light of the consequences of non-compliance – and the potential benefits to be reaped from implementation – medical device manufacturers should not hesitate to kick-start a UDI plan. Each business should consider how it can address its specific needs in this evolving environment. Correct and early implementation of a UDI system will help manufacturers keep up with existing and new products.
As UDI improves post-market surveillance, proactive companies will be able to address glitches faster and gain a competitive advantage. Establishing UDI systems with a view to bolstering existing processes, such as post-market surveillance, will produce the most gains. The long-term returns of UDI are expected to outweigh the initial investment.
About the authors: Steve Cottrell is president of Maetrics and can be reached at 610.458.9312 or scottrell@maetrics.com. Madris Tomes is CEO of Device Events and can be reached at 240.424.8562 or madris@deviceevents.com.
High-precision, automated 3D scanning inspection system
Departments - Technology Prescription
CyberGage360 facilitates in-line, near-line process inspection, and incoming/outgoing quality assurance applications for parts less than 200mm x 100mm, with a resolution of 50µm.
CyberGage360 facilitates in-line, near-line process inspection, and incoming/outgoing quality assurance applications for parts less than 200mm x 100mm, with a resolution of 50µm.
A highly precise, 360° automated 3D scan of complex shaped parts with accuracy to 25µm can be generated in less than 3 minuntes by incorporating CyberOptics’ 3D Multi-Reflection Suppression (MRS) technology that inhibits measurement distortions, the automated CyberGage360 brings greater accuracy and faster scanning speeds to industrial parts inspection. The system’s design eliminates human error and provides consistent results compared to manually operated measuring technologies. One click enables factory-friendly operation with minimal training by automatically generating an inspection report including a comparison to a CAD model.
There are many issues to consider when talking about wearables in the medical device sector – from technology advancements to the risks a company can face – so those entering the arena need to be prepared and protected on all fronts. Patty Nichols, second vice president of Medical Technology Underwriting at Travelers sat down with Today’s Medical Developments magazine to help explain the nuances in this fast-growing market.
Today’s Medical Developments (TMD): What is the growth potential of wearables?
Patty Nichols (PN): The growth potential of wearables in the medical and health care industry is extraordinary. Specifically, some of the biggest quality-of-life improvements from healthcare wearables include the promise of detection, prevention, and treatment of chronic disease, as well as the ability to reduce healthcare costs.
In fact, Swiss research firm Soreon expects the wearables market to top $40 billion by 2020 in the healthcare industry alone. The ability of wearables to improve quality of life and reduce the cost of care are key factors that will drive growth in the healthcare and medical sector. As a result, an increasing number of technology companies are aggressively pursuing the wearables opportunity in this sector, as are many emerging startups.
TMD: What are the major risks faced by medical device makers entering the wearables space?
PN: Medical device makers face three main categories of risk in integrating wearable technology.
Cyber risk – Often defined as the risk of financial loss, business interruption, or reputational damage due to an organization’s failure to properly secure the data held within its information systems. It can occur as a result of a cyber criminal’s attack, an ineffective information technology (IT) policy, a failure of IT security software, or even a disgruntled employee. Nearly all high-profile data breaches lead to proposed class action lawsuits and wearable device manufacturers can certainly be among the defendants in such suits if a device is alleged to have contributed to a breach.
Bodily injury risk – In order for wearable devices to deliver on the quality of life benefits they promise, they must be used as intended and function properly at all times. Should a wearable device ever fail, the device maker could be liable for bodily injury risk or damages from a resulting injury, illness, or even death of a user or patient. Wearable manufacturers should understand and mitigate the risk of a product liability claim.
Technology errors & omission risk – Despite a wearable device maker’s best efforts to manufacture and market a reliable product that people can use to enhance their quality of life, things can go very wrong. In addition to bodily injury, a company can be held liable for economic losses arising from the failure of a device to work as intended, due to an error; omission; or negligent act. Wearable device failures can impact business continuity, reputation, and other factors. Companies that understand the unique nature of this risk category can better protect themselves from liability claims.
Given the rapid pace of technological change, it is important to note that companies involved with wearable technology are unlikely to ever fully understand and eliminate their current or emerging exposures. However, safety features, data protection measures, effective contract risk management, and good design decisions can help companies significantly reduce their exposure to some of the major risks we see today.
TMD: Which types of coverage should companies consider in order to mitigate these risks?
PN: To effectively manage their exposures to these three main categories of risk, medical device makers should consider the following insurance options:
Information security coverage, which provides coverage for critical cyber risks. Coverage options vary, but most include network and information security liability, as well as communications and media liability. Companies can also opt for many first-party expense reimbursement coverages, including data restoration, business interruption, computer and funds transfer fraud, crisis management, and security.
Product liability coverage, which provides coverage for loss arising from bodily injury risk. Available options cover consumer fitness tracking devices, as well as doctor-prescribed medical wearables.
Errors & omissions (E&O) liability coverage, which protects against damages that a medical device manufacturer must pay because of economic loss resulting from its products or its work and caused by an error, omission, or negligent act.
TMD: Which steps should medical device manufacturers be taking to secure their wearable products from cyber threats?
PN: While the FDA is not aware of any patient injuries associated with cybersecurity incidents, nor is it aware of hackers purposely targeting any specific medical devices or systems in clinical use, that does not mean medical device manufacturers can ignore these risks.
The FDA has issued a series of guidance documents to assist medical device manufacturers in mitigating and managing cybersecurity threats which include:
Medical device manufacturers and healthcare facilities should take steps to ensure appropriate safeguards. Manufacturers are responsible for remaining vigilant about identifying risks and hazards associated with their medical devices, including risks related to cybersecurity. They are responsible for putting appropriate mitigations in place to address patient safety risks and ensure proper device performance.
Hospitals and health care facilities should evaluate their network security and protect their hospital systems.
In addition, medical device manufacturers can protect themselves from potentially facing product liability and other claim types by designing simple, yet effect security features into their devices. This can include:
Bluetooth encryption. Bluetooth offers an encrypted Application Programming Interface (API) when exchanging data between a device and its target data store, but not all companies take advantage of this feature because it decreases battery life.
Encrypt critical data elements. The most critical pieces of data transferred between wearable devices and data stores are user IDs, passwords, and PIN numbers. Avoid transferring these data elements in plain text, which has no encryption measures at all.
Secure the cloud. Data is often transmitted from a wearable device to a smartphone and then to a cloud data store. Virtualized clouds can secure data with multiple diverse operating systems, each operating within a different security context. Banks often secure depositor payment details this way and wearables companies should consider similar functionality.
About the author: Elizabeth Engler Modic is the editor of Today’s Medical Developments. She can be reached at 216.393.0264 or emodic@gie.net.
Medical 3D printing
Departments - Medical Infographic
One of the fastest growing sectors adopting 3D printing/additive manufacturing is healthcare.Different technologies and materials produce a range of medical devices, catering to the demands of personalized medicine.
Elizabeth Engler Modic
