Big news from Prodct! In 2025, we’re flipping training on its head. Whether you’re a scrappy startup or a big-name company looking to rediscover your edge, our new approach to medical device training is designed to meet you where you work—and play. We’re talking hands-on learning in product development, risk management, operations, and quality systems. Forget endless conference room sessions; think hikes, happy hours, hybrid sessions, and everything in between. Real-world problems demand real-world training. Get ready to tackle the tough stuff, connect with your team, and maybe even have a little fun along the way. This is training, Prodct-style. https://lnkd.in/eKBNVy_E #MedicalDevices #StartupSpirit #DoingBigThingsRequiresDoingHumanThings
Prodct
商务咨询服务
Boston，MA 599 位关注者
Medical Device development advisory. Hands-on and heart-forward, we believe doing big things require doing human things.
关于我们
Prodct isn't a typical advisory firm. We are a boutique, mission-based collective of medical device experts with rolled sleeves, kind hearts, and provocative spirits. We help early stage medical device, diagnostic, and therapeutic companies by creating bespoke strategies and providing thoughtful advisory services. We focus on product development, risk management, operations scale-up, and Quality Management Systems (QMS) supporting it all. We backup our own advice by deploying resources to help you execute. Learn more at https://prodct.dev or contact us via LinkedIn.
- 网站
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https://prodct.dev
Prodct的外部链接
- 所属行业
- 商务咨询服务
- 规模
- 2-10 人
- 总部
- Boston，MA
- 类型
- 私人持股
- 创立
- 2018
- 领域
- Product Development、Development Strategy、Manufacturing Strategy、Medical Devices、Companion Diagnostics、Quality Management System Development、Engineering Organization Management、Outsource Partner Management、Contract Manufacturing、Contract Developmet、ISO 13485:2016、FDA 21 CFR part 820、FDA 21 CFR part 11、Internal / External Strategy和New Executive Coaching
地点
Prodct员工
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Daniel Squier
Medical Device Professional
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Angela DiCiccio
Intentional design with exceptional energy. Interests: creative collaborations, medical device development and regulations, polymer chemistry…
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Christie Johnson
Partner at Prodct | VP of QA/RA at myBiometry
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Pascal Werner
DTx/AI/SaMD/DiGA medical device regulatory consulting (Berlin and Raleigh, NC)
动态
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We’re excited to share that we’re working with Memsel, a team dedicated to creating impactful solutions that enhance healing and recovery for patients with traumatic wounds — including those affected by battlefield injuries. Their innovative technology and inspiring mission are truly remarkable, and we’re proud to support them on this meaningful journey. To celebrate our relationship, we've donated to the?Wounded Warrior Project. This organization provides critical support to veterans recovering from battlefield injuries, perfectly aligning with Memsel’s mission to make a difference for those in need. At Prodct, we value opportunities to support teams like Memsel who are driving meaningful change. Here’s to the start of something impactful! Learn more ↗ How Memsel is revolutionizing wound care https://lnkd.in/ez6YqsZH ↗ Wounded Warrior Project's mission https://lnkd.in/eMQWidE ↗ About the Prodct "P4G" commitment https://lnkd.in/eXvPbSPw #doingbigthingsrequiresdoinghumanthings Photo by?Israel Palacio?on?Unsplash (https://lnkd.in/eEYxCY-5)
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Prodct转发了
Risk Management doesn't have to hurt. You don't need: ? 60 page SOPs ? 8 hr. dFMEA lock-in meetings ? god, queen, and country as signatories Even if your company is big, your process doesn't have to be. What's your biggest pain point? #riskmanagement #quality #qms #medicaldevice #medtech
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Gobble for Good: Join Us This Thanksgiving ?? and let’s lace up for a cause! Prodct is excited to host our next P4G (Prodct For Good) event: a morning of gratitude, giving back, and getting active. We’ll be running, walking, and volunteering at the 28th annual SRR "Gobble Gobble Gobble" 5k, and we’re making it extra special again this year - For every participant — runner, walker, or volunteer — who joins our event team, we’ll make an additional donation to Stride for Stride, a non-profit dedicated to making races more inclusive by buying race bibs for underserved runners. If you're in the Boston area this upcoming Thanksgiving, join us! https://lnkd.in/efnp3TBR #doingbigthingsrequiresdoinghumanthings
Gobble Gobble Gobble 2024 — Prodct LLC
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Our founder, Devon C. Campbell, recently had the pleasure of surprising Etienne Nichols in a special episode of the Global Medical Device Podcast. Devon celebrated Etienne's milestone of producing nearly 100 episodes by turning the tables and interviewing the host! ?? ↗ Listen to the full episode: https://lnkd.in/eeZS_8Sc The episode is packed with practical tips and personal anecdotes from both Devon and Etienne that reveal nuanced insights for Medical Device developers, making it valuable for both new and seasoned professionals. ?? Our favorite quote: "Do not fall in love with your technology. Fall in love with the problem." Key Takeaways: ↗ Embrace vulnerability and honesty in your project updates to foster trust and growth. ↗ Avoid over-engineering by focusing on solving the right problems. ↗ Build quality management systems that are practical and useful for your team. #MedTech #MedicalDeviceDevelopment #Podcast #ProductDevelopment #QualityManagement #DoingBigThingsRequiresDoingHumanThings
Turning Tables — Prodct LLC
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Gotta repost this one from Vincent F. Cafiso
Best practices on ?????? ??????????????????...straight from a current FDAer! ???? A recent FDA panel at the 2024 MedCon conference discussed responding to FDA Form 483s and Warning Letters. “I will tell you, when you respond, don't promise everything’s going to be fixed next week. That doesn't happen. We understand that you're not going to have … a protocol written before you respond sometimes.” (-Gina Brackett) ?? Key tips from the FDA: 1. Respond to Warning Letters within 15 business days. 2. FDA 483 responses are voluntary (But you REALLY should respond to them!). 3. Make realistic and detailed commitments (Think: Underpromise and Overdeliver). 4. Provide comprehensive corrective action plans (Go beyond what FDA found). 5. Conduct thorough root cause analysis. 6. Clearly state immediate containment actions. 7. Maintain open communication with the FDA (Send monthly updates if needed). ?? Bonus tips: 1. Ensure your documentation is perfect. 2. Review historical performance to show continuous improvement. 3. Outline proactive measures exceeding compliance requirements. 4. Regularly update employee training records. 5. Involve cross-functional teams in response preparation. 6. Integrate risk management into responses. ???????????? ?????????? - what is ONE tip you would give folks responding to their 1st 483? ~~~ If you found this interesting or helpful, consider Reposting ??; follow me Vincent F. Cafiso and click the ?? so you don't miss future content.
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?? Is humility the missing ingredient in your medical device startup's success? In the milestone 50th episode of the “Let’s Talk Risk” podcast, Naveen Agarwal, Ph.D. and Devon C. Campbell reflect on the impact of humility, holistic planning, and balancing feelings associated with the exhilarating highs and challenging lows of product development... Any one of which could be the key to your medical device startup success. Curious to learn more? Listen to the full conversation. ↗ https://lnkd.in/ecZa98qg #doingbigthingsrequiresdoinghumanthings
Humility. Key to startup success? — Prodct LLC
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?? Hungry to learn about QMSR and risk? We got you covered. By far, our 3?? most frequently accessed resources are those featuring Christie Johnson and Edwin Bills, ASQ Fellow, RAC exploring #QMSR and #RiskManagment Quick Links: ↗ Greenlight Guru webinar featuring Christie, Ed, and Etienne Nichols — https://lnkd.in/esiF5P4Y ↗ Feb 2024 MedDevice Online article "FDA QMSR Through The Lens Of Risk Management" by Christie, Ed, and Jayet Moon — https://lnkd.in/e3kj5iPE ↗ May 2023 MedDevice Online article "The Intersection of ISO 13485 and ISO 14971 Under the Proposed FDA QMSR" by Christie and Ed — https://lnkd.in/eETjqBcE
Hungry to learn about ISO 14971 and QMSR? — Prodct LLC
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In Episode 133 of Subhi Saadeh's Combinate Podcast, Devon shares the transformative journey behind the founding of Prodct and our unique advisory approach. ↗ https://lnkd.in/dTJAeEjR
Let’s get personal — Prodct LLC
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We're heading to MedCon 2024 presented by AFDO/RAPS Healthcare Products Collaborative and co-sponsored by the FDA. Keep an eye out for Christie Johnson and our Advisory Board member Edwin Bills, ASQ Fellow, RAC!
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