2014 Medical Device Establishment FDA Registration (cont'd)
VICTORIA, British Columbia (December 27, 2013) – StarFish Medical announced successfully completion of FDA establishment re-registration in December 2013. The FDA requires contract manufacturers to register their facilities in addition to individual devices. This is the second year that StarFish Medical completed its Medical Device Establishment FDA Registration in support of contract manufacturing for Zephyr Sleep Technologies, a company that develops, manufactures and sells medical devices that improve the treatment for obstructive sleep apnea (OSA).
“StarFish Medical’s quality system meets the requirements of CFR 21 Part 820, the Quality System Regulations specified by the FDA” according to Vesna Janic, Director of QA/RA of StarFish Medical. “FDA has a new requirement that contract manufacturers have to register their establishments. Along with our earlier ISO 13485: 2003 Lead Auditor certifications, this FDA registration underscores our commitment to Quality Management Systems and delivering regulatory success for our North American clients and their medical devices.”
Jason Dolynny, Director of Manufacturing notes: “Medical Device Establishment FDA Registration for our contract manufacturing enables our Canadian and US clients to ship FDA registered products directly into the US market to their distributors without taking physical possession of the products. Combined with our class 100,000 clean room capabilities we are poised to handle all types of assembly and manufacturing of complex electro-mechanical medical devices. ”
7 Digital Hospital Trends for 2014 (cont'd)
In 1999, I had to source, negotiate, and implement an integrated monitoring system for ICU. This basic system networked bedside computers to a central nursing monitoring system and was considered innovative, effective and clever.
Fifteen years later, electronic medical files and data sharing between imaging modalities, laboratory tests, pharmacy prescription listings, and MSP formulary plans provide basic input to clinical decision making. Here are some previews and aspects of the fully digital hospitals that I believe are on their way.
1. Patient control: the patient will control the room environmental conditions using an iPad and be able to video link to communicate to a nurse. No more nurse call bell.
2. Elimination of manual data entry: vital signs of blood pressure, temperature, O2 sat, respiratory rhythm, ECG or EEG outputs will all be automatically communicated to electronic medical charts.
3. Significant reduction of paper: the final stage of e-health programs’ implementation will see printers become redundant. Electronic medical records in primary care physicians is the first visible sign that the wall of paper charts will soon completely disappear. Is your doctor still using paper?
4. Virtual Health Services: original telemedicine and telehealth systems will slowly be replaced by social medical platform for simpler and cheaper systems. The iPad will have it all.
5. Improved Connectivity: it was not long ago that centralization was the goal, but the new reality brings it back locally. Standalone systems connected to hospital data management systems will disseminate information outside the walls of the hospital to support near and far located practitioners. These mini integrated systems create a powerful network.
6. Use of Data for Population Health: with the abundance of data, government effort is in a great position to focus on tracking disease propagation in populations, informing health care professionals of novel effective therapies, dissipating drug alert and adverse effects, etc.
7. Less Invasive Procedures: Patients want speedy recoveries. Software engineers will need to continue developing smart systems to provide surgeons and interventionists with 3D visual representations of internal organs, and enable remote visual access to surgeons needing to participate in the procedure.
The integration of medical technologies not only support improved and cheaper health care, it provides the day-to-day information required for decision making in therapies and preventing programs. The key for software engineers and systems architects is to ensure that protocols remain standardized, data clean and communication effective. Medical professionals better keep abreast of technological advancements to maintain their surgical skills and clinical relevance. Despite technology being powerful, it remains a tool - and just a tool - needing consideration, analysis, and judgement involving the human mind. Well at least, that’s a comforting thought for all of us moving into the digital health era.
10 Most Read StarFish Medical Device Blogs of 2013 (cont'd)
10. FDA Recognition Standard List Number 30 for Medical Devices by Vesna Janic, gets straight to the point. On January 15, 2013 the Food and Drug Administration (FDA) published an updated list of standards the Agency recognizes for use in premarket reviews of medical devices. Vesna provides a quick review of highlights and areas that warrant close attention.
9. 5 Tips for FDA 510(k) Medical Device Regulatory Clearance by Vincent Crabtree, stresses the importance of considering Regulatory all the way through the development process, and not try to ‘bolt on’ compliance at the end. It also includes great tips and advice developed over the years for efficient 510(k) submission.
8. Medical Device Internal Auditing – Making Friends with “Bad News” by Annelies Tjebbes, knows an internal audit will help you pay closer attention to detail in your project organization in future, and will hopefully open your eyes to the benefits of documentation. She dispels three popular myths and suggests an equal number of tips to get the most out of an internal audit.
7. The True Cost of Medical Device Product Development by Vincent Crabtree, explores two different strategies for developing medical devices – the Smart-Way and the LeapFrog way. Vincent previously discussed the differences between Proof of Concepts and Products in another post. This entry covers the stages in-between proof of concept and units out the door – how many steps to a final product?
6. Winning Project Management Practices for Medical Device Development by Martine Janicki, shares best practices learned medical device risk planning, risk engagement itself and mitigation implementation. “Managing the expectations of all involved is now very high on my list of project priorities.” Martine discusses the need to communicate to team members, the project owner and any other important stakeholders.
5. 7 Tips for Efficient Medical Device Submissions to IEC 60601 Edition 3 by Vincent Crabtree, draws upon experiences working for clients submitting their electrical devices for IEC60601 Edition 3 electrical safety testing. 60601 Edition 3 takes mandatory electrical safety testing to a new level as many of the risk management requirements specified in ISO14971 are reviewed as part of the test. This blog includes Vincent’s top tips for preparing documentation for 3rd edition 60601 testing for Legacy products.
4. How a Project Management Office (PMO) Helps Effective Medical Device Development by Martine Janicki, tackles the role of a “PMO” (Project Management Office). The term appears ever more frequently in engineering firms, but is still not well understood. Martine explains what a PMO does, how they impact medical device development, and what the PMO looks like at StarFish Medical.
3. Inexpensive prescreening strategies for medical device EMC compliance by Bjarne Hansen, is packed with ideas and examples of simple and inexpensive tools an electrical engineer can build to enable quick EMC prescreening. Medical devices containing electronics require Electromagnetic Compatibility (EMC) testing to ensure they can be used in the intended environment without causing other equipment to fail nor failing themselves.
2. Margin Matters by Scott Phillips, remains near the top of reader clicks two years after posting for its succinct examination of medical device margins. Scott explains: “As part of our initial dialog we ask a bunch of clarifying questions to get under the hood and understand how potential partners and clients have addressed the main influencers on product definition. Often we find an area that could be strengthened and one of the most common is in design for margin.”
1. Date Format Quandary for FDA UDI for Medical Devices by Vesna Janic tops our 2013 reader list. Published in August 2012, perhaps the reason for its popularity is summed up in her opening sentences. The FDA proposed a rule that requires a unique device identifier (UDI) to be placed on the label and packaging of a marketed and sold medical device. It turned out that internally at StarFish, the required date format caught the attention of our engineers more than any other requirement.
That completes our most read StarFish medical device blogs of 2013. What other favorites do you have from our 90 StarFish Medical blog posts? I’ll share reader recommendations in an upcoming post.
Mike Camplin is Director of Marketing at StarFish Medical and he reads every StarFish Medical blog multiple times before they hit our website.