Message from Scott
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Welcome to our first NPI Issue. Our NPI team have tackled many challenging projects over the years. We're pleased to share client feedback on two of their recent efforts.
Clark Tedford, CEO of LumiThera, describes his company's experience in transferring their ophthalmic medical device from prototype to CE approved production in a new case study.
Inventor Joseph Guo tells how our NPI team helped him bring a new, minimally invasive surgical procedure called thread carpal tunnel release (TCTR) to market.
Our video and blogs feature StarFish Medical NPI & Quality Assurance experts sharing tips and insights on a variety of NPI issues.
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Thanks for reading.
Sincerely,
Scott Phillips
CEO
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First-to-Market strategy, trade-offs and tips for medical devices
By Henry Ho
In a previous medical device company, I worked on a project where First-to-Market (FTM) was a deemed a priority for the company’s survival. To meet that highly compressed timeline, we decided to skip the phase-gate process and replace it with a FTM production release strategy.
There is no pain-free way to release first to market strategy medical products. You pay now or pay later, and in FTM it is much more painful when you have to pay later. However, you can create a first to market production release strategy to minimize the pain.
READ MORE>
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A “Pressing Issue”- reliability testing in medical device development
In the complex world of medical device development, we often lose sight of the fact that the true performance of a design cannot be accurately gauged by a single test on a single device. Any first year stats student will tell you that the smaller the sample size, the less confident you can be that the result is repeatable.
Reliability testing is one of the tools that saves money by helping to produce a high-quality device. READ MORE>
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5 tips for production transfer readiness
We asked our new product introduction (NPI) team to reflect on their collective experiences transferring medical devices from design to production. Their 5 top tips for production transfer readiness are listed below.
READ MORE>
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Why PFMEA is important early in the design cycle
It behooves designers to look at the assembly processes early, with a focus on how to stop critical faults or those that are likely to happen. Process Failure Modes and Effects Analysis (PFMEA) is a tool to assess potential process failure points during assembly and how the failures could be felt or observed by a customer. A ‘customer’ is not just an end-user, but any further user in the production line, or anyone in between.
READ MORE>
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No, a wellness device can’t save your life (not directly, anyway)
Be sure to understand the distinction between medical devices and wellness devices.
READ MORE>
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The Bleeding Edge and 510k approvals
Should we stop approving devices that may have side effects?
READ MORE>
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U.S. Food and Drug Administration grants De Novo FDA clearance for the MATRx plus™
September 4th, 2018. Zephyr Sleep Technologies Inc. (Zephyr), an innovation leader in bringing new products and technology to the field of dental sleep medicine, is announcing the U.S. Food and Drug Administration (FDA) has granted a De Novo request for the MATRx plus™ a new class of medical device – the first ever “at-home” class II medical device to identify obstructive sleep apnea (OSA) patients suitable for oral appliance therapy.
READ MORE>
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GROWTH 500 2018 ranks StarFish Medical 66th fastest growing manufacturing company
Canadian Business and Maclean’s ranked StarFish Medical on the 30th annual Growth 500, the definitive ranking of Canada’s Fastest-Growing Companies.
READ MORE>
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Outsourcing in Clinical Trials Pacific Northwest
Virginia Anastassova, Regulatory Affairs Manager, StarFish Medical, will present Best approaches to vendor partnerships to effectively manage medical device trials at Outsourcing in Clinical Trials Pacific Northwest on 16 October 2018 in Vancouver BC. Registration and more information
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LSBC Investor Summit 2018
LifeSciences BC and Lumira Ventures are proud to partner in presenting the "Investor Summit 2018" to be held in Vancouver on Thursday, October 25 at the Fairmont Pacific Rim. Read more here
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University of Victoria
StarFish BioTech Manager, Nick Allan, will present The importance of in vitro diagnostics at University of Victoria on October 26th, 2018. Nick is presenting to Chem 212 students at the invitation of Dr. Harmen S. Zijlstra, Seasonal Lecturer, Department of Chemistry.
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Washington State Life Science Summit
Registration is open for the 14th Washington State Life Science Summit! Join leaders from Washington state’s life sciences community as we discuss what’s ahead for our industry. Mr. Mark Alles, Chairman & CEO of Celgene is this year’s keynote speaker. Registration
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Medventions Lecture Series
StarFish Medical COO, John Walmsley, will present 7 Keys to Successful Medical Device Development as part of the Medventions Lecture Series. The lecture discusses Medical Device Design & Prototyping and is scheduled for Thursday November 1st from 5:00-6:00pm at Sunnybrook Health Sciences Centre.
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University of Southern California
Scott Phillips lectures on Medical Device Commercialization November 1, 2018 at the University of Southern California in Los Angeles CA. The lecture is part of an ongoing series curated by George Tolomiczenko, PhD, MPH, MBA, Assistant Professor of Clinical Neurology and Biomedical Engineering, Administrative Director, HTE@USC & Co-Director USC Coulter Program, Health, Technology & Engineering Program.
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Mechanical Engineering Manager (Victoria)
Reporting to the Director of Product Development, this position defines and maintains the vision for the Mechanical Engineering function at StarFish. This position will focus primarily on managing the team and products, but will also spend time in business development – being creative, working with clients and shaping projects. Learn more
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VP of BD East, Charles Garcia attending RESI Boston #biotechweekboston
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Software/Cyber Security panel at the 2018 Washington State Medical Device Summit in Bothell, WA includes StarFish Software Engineering Manager, John Turner.
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Great to see execs from two former #MDPlaybook companies speaking on stage at #TheMedtechConference: Soundbite's Steve Arless and Conavi's Stefano Picone
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Scott Phillips and Charles Garcia meet with John Crombie Founder and President of UpStart at #TheMedtechConference in Philadelphia PA.
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Congratulations to all of the teams and to first place team, Vivec "Forensic Nurse Examination Program"-Hack" Well done, Dr. Stephanie Willerth and the organizing team for #HealthHackathon
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Guess who sponsored the hackathon beer?! Nick Allan and Dr. Stephanie Willerth enjoy a well deserved break.
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Alena and Deanna handle quality control for fall treat day in Victoria.
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Toronto labels their fall treat goodies just to make Victoria jealous...
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Victoria wears orange shirts in celebration of first nations people, every child matters and recognition of the legacy residential schools.
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TNT Paintball in Colwood BC! Social Committee fun.
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