 Special thanks to Medical Design & Outsourcing for covering our press release with our new office in Minneapolis Saint Paul (MSP) Minnesota. Stay tuned for more news and updates as we continue to grow our presence and support in MSP. Square-1 Press release link at MDO: https://lnkd.in/gzeCd-Py #pressrelease #expansion #minneapolissaintpaul #minneapolis #medtech #news #medicaldevice #consulting #growth
0 Comments
Medtech Snapshot Part 2:2 continues the discussion as Trisha Aure covers considerations when transitioning from 21 CFR 820 to ISO 13485.
Hear how due diligence and training play a crucial role in the transition process and the impact it has on our employees. #iso13485 #regulation #compliance #fda #21CFR #riskmanagement #medicaldevice #medtech #news #podcast #snapshot #regulatoryaffairs Our most recent Medtech Snapshot features product development executive Barry Fulkerson as he takes us through his strategy of obtaining user needs data on the cheap and how creating a patient advisory board can help get you there.
We have archives! To watch and listen in to our past Medtech Snapshot episodes visit https://www.sqr1services.com/white-papers/category/snapshot #userneeds #medtech #snapshot #medicaldevice #productdevelopment #conceptdevelopment #patient We're breaking the mold!
Medtech Snapshot returns with an enticing debate as #RAQA medtech industry experts Stephanie Rallis-Daw, RAC, CQE, CMDA and Robert Lahaderne, MBA spar on the topic of "When starting a new job/ project, what is the most common medtech compliance shortfall you can expect to encounter at your new company?" New to Medtech Snapshot? Check out our archive of past episodes at https://www.sqr1services.com/white-papers/category/snapshot covering topics in R&D, Quality, Clinical and Manufacturing. Honey for your eyes and ears, friends. #medtech #snapshot #podcast #medicaldevice #compliance #quality #regulatory #documentation #training Sanjay Shrivastava, Ph.D. joins us on Medtech Snapshot to talk about medical device contract manufacturing partners - when to strategically engage them, especially if you are a startup, and the importance of "keeping the end in mind" throughout the process. Interested in catching up on our past Medtech Snapshot discussions? Visit #medicaldevice #medtech #snapshot #contractmanufacturing #contractmanufacturer #outsourcing #startup  The quickest way to overcome a business challenge is to get help from those who are experienced in besting your beast! The team at Square-1 Engineering is comprised of a variety of technical and project management professionals who are subject matter experts in the areas of NPD, Quality, Compliance and Manufacturing Engineering. Learn more about how we can solve your work and project problems today to get you back on track!
 Selecting the right medical device contract manufacturing partner is a critical decision that can significantly impact the success of your medical device development and production process. There are many advantages which come with working with a contract manufacturing partner, chief among them is it can potentially help you get out to the market quicker without having to go vertical, building up your own production system internally. The right partner can also offer cost savings as a result of their established supply chain partners, ability to scale and expertise in developing similar products. While those advantages can indeed be a blessing to a maturing business, landing the wrong partner can also be a curse. For this reason its vital device companies utilize a strategically planned process for how they are to approach and select a new contract manufacturing partner. The more due diligence one can do on the forefront the better the likelihood will be you will see success on the back end. Here are some important criteria to consider when evaluating potential contract manufacturing partners: 1. Experience and Expertise: Look for a partner with experience in manufacturing similar medical devices. Their expertise in the specific type of device, materials, processes, and technologies is vital to ensuring a smooth production process and high-quality output. 2. Capabilities and Facilities: Evaluate the contract manufacturer's facilities, equipment, and technological capabilities. Make sure they have the necessary infrastructure and resources to meet your manufacturing needs and scale as your project progresses. (HINT - learn about their employees. If they have high turnover with their internal staff this could create problems for you in the future) 3. Supply Chain Management: A robust supply chain is crucial for consistent component availability and cost-effectiveness. Assess the manufacturer's ability to manage the supply chain efficiently, including sourcing components, managing inventory, and handling potential disruptions. 4. Flexibility and Scalability: Consider the partner's ability to adapt to changes in project scope or production volume. A flexible partner can accommodate adjustments in design, production, and scheduling, which is important in the dynamic field of medical device development. MEDTECH SNAPSHOT: CONTRACT MANUFACTURING In this episode we are joined by Innova Vascular's CEO Sanjay Shiravastava who takes us through several pointers on when to consider finding a medical device contract manufacturing partner to aide in your go to market strategy. Here from Sanjay on why it's "important to begin with the end in mind". 5. Regulatory Compliance: Ensure that the contract manufacturer has a solid understanding of regulatory requirements, such as FDA (or equivalent) regulations, ISO standards (e.g., ISO 13485 for medical devices), and any other relevant local or international regulations. They should have a track record of successfully producing devices that meet these requirements. 6. Quality Management: A strong quality management system is crucial for medical device manufacturing. The partner should have established quality control processes, including inspection, testing, documentation, and corrective action procedures. They should also have a history of adhering to quality standards and maintaining good manufacturing practices. Their data and practices should be transparent and they should be open to you reviewing this information. 7. Geographical Location: The location of the contract manufacturer can impact shipping costs, lead times, and the ease of visiting the facility for inspections or meetings. 8. Intellectual Property Protection: Ensure that the contract manufacturer has protocols in place to protect your proprietary information and intellectual property throughout the manufacturing process. Do they work with a competitor of yours, if so how will they ensure your IP and product is protected? 9. References and Reputation: Research the manufacturer's reputation in the industry. Seek references from other companies they have worked with and review their track record to gauge their reliability, performance, and commitment to quality. 10. Cost and Pricing: While cost should not be the sole deciding factor, it's important to have a clear understanding of the pricing structure, including setup costs, unit costs, and any additional charges. Pricing should be clearly laid out and defined in your contract; stay away from partnerships where things seem murky and or inconsistent from a pricing perspective. 11. Long-Term Partnership Potential: Consider whether the contract manufacturer is interested in building a long-term partnership and is willing to support your future projects and iterations. 12. Employees and Training: Be mindful of how their employees are treated, trained and managed. High turnover at a contract manufacturer may mean you find yourself constantly involved int he training process to ensure the operators and assemblers working on your product are working as expected. The more turnover that occurs the more training that will need to take place, which means your partners training methods and consistently is critical to your success. High turnover and poor training will inevitably lead to yield problems. Before making a final decision, it's advisable to visit the contract manufacturer's facility, meet their team, and discuss your project in detail to ensure alignment and understanding. Taking the time to thoroughly assess potential partners will increase the likelihood of a successful and fruitful collaboration in medical device manufacturing. In this episode of Medtech Snapshot we're joined by SPARK Neuro COO Marinela Gombosev as we sort through the opportunities and challenges in adopting machine learning (ML) and artificial intelligence (AI) technologies in the medical device space. Listen in as Marinela provides additional perspective on the considerations for adopting this technology within our current health system and its stakeholders like the FDA, clinicians, etc.
Enjoying these quick 3-minute discussions? Be sure to check out our past Medtech Snapshot episodes at https://lnkd.in/gFwF9GYN #medtechsnapshot #medtech #snapshot #AI #machinelearning #medicaldevice #artificialintelligence #fda #healthcare What we know to be true is root cause analysis (RCA) plays a vital role in the development, manufacturing, and use of medical devices. When we are able to successfully identify and address the underlying causes of failures or errors, using RCA as a tool in your operation helps to improve the safety, reliability, and effectiveness of medical devices. When done correctly, RCA has a significant impact on medical devices by enhancing patient safety, improving design and manufacturing processes, ensuring regulatory compliance, driving product improvement and iteration, mitigating risks, and supporting post-market surveillance efforts. While all of this may sound common sense, what's most important is when RCA is used and done correctly. In this episode of Medtech Snapshot we're joined by Quality Executive Robert Lahaderne to talk Root Cause Analysis (RCA)! Hear how Robert shares his perspective on the impact Root Cause makes to a medical device organization when it is done correct versus when it is done incorrectly and how rushing through FMEAs and hazard analysis creating unnecessary challenges down the road. #rootcauseanalysis #rootcause #medicaldevice #medtech #fmea #hazardanalysis #patientsafety #riskmanagement Get Medical Device Project Support Today The quickest way to overcome a business challenge is to get help from those who are experienced in besting your beast! The team at Square-1 Engineering is comprised of a variety of technical and project management professionals who are subject matter experts in the areas of NPD, Quality, Compliance and Manufacturing Engineering. Learn more about how we can solve your work and project problems today to get you back on track! [Click Play] Gallup indicates 70% of startups fail in the 1st 5 years. What are
your thoughts on these six strategies to improve the chances of commercializing your startup or getting acquired? #medicaldevice #startup #lifesciences #outsourcing #reimbursement #valueproposition #marketaccess #strategiesforsuccess #strategy #commercialization #acquisition Want to get through your remediation project successfully? Doing these two things helps dramatically increase your chances of success. #fearlessmedtech #remediation #fda #medicaldevice #medtech #quality #compliance #QMS About the AuthorTravis Smith is the founder and managing director of Square-1 Engineering, a medical device consulting firm, providing end to end engineering and compliance services. He successfully served the life sciences marketplace in SoCal for over 15 years and has been recognized as a ‘40 Under 40’ honoree by the Greater Irvine Chamber of Commerce as a top leader in Orange County, CA. Categories
All
Archives
August 2024
|
RSS Feed
Visit Square-1's
|
|
