The One Question that Matters Most When Selecting a Medical Device Contract Manufacturer
The instinct is to evaluate medical device contract manufacturers the way you would evaluate any vendor: issue an RFP, compare responses, select the best, however you define it. The leading proposals will look reassuring. Every credible manufacturer should show you a current quality management system, ISO 13485 certification, IQ/OQ/PQ skillsets, traceability, regulatory strength, and the capability to handle your device class. But here is the uncomfortable truth: those things prove a manufacturer can execute work that is (or should be) well understood. They do not tell you enough about what happens the day an unexpected challenge arrives that no one saw coming.
And on a genuinely novel device, one always arrives.
So how do you find the right contract manufacturing partner for your novel medical device before you are committed to them? Oliver Puttler has the one question to ask.
Reshoring a Medical Device? Make the Move Count Twice
Long-distance shipping and tariff uncertainty remain real supply chain considerations especially inclusive of medical devices. Momentum for reshoring medical device manufacturing back to the U.S. keeps building, driven by tariffs, the supply chain fragility exposed during the pandemic, and geopolitical tension.
If your current device carries known, unresolved problems like complaints, an aging design, mounting manufacturing costs, supplier obsolescence, or competitive pressure that is eroding market share, this is the right time to couple reshoring with Gen 2.
The Manufacturing Contract Mistakes That Derail Medical Device Projects (And How to Avoid Them)
You’ve spent months perfecting your medical device concept. Your tolerances and specifications are well defined, your funding is in place, and your verification, validation, and regulatory submission are complete. A contract manufacturer sends over their agreement, and you’re ready to sign.
The problem: contract terms and conditions can be the difference between a smooth path to market and a costly manufacturing nightmare.
Most first-time innovators, whether working from a garage, a university lab, a startup, or a clinical practice, don’t have the resources available to understand what should be included in a manufacturing contract until something goes wrong.
In Part 1 of a two-part guide. Carrie Randa demonstrates how to recognize a true contract for services from a qualified medical device manufacturing partner.
Case Study
Situation
A client required a partner to design, develop, and establish manufacturing for commercial launch of an improved mechanical venous thromboembolism device that leveraged existing system accessories.
Successes
- Integrated project teams prioritized design for manufacturability and supply chain optimization, supporting development and controlled builds which were key to achieving 510(k) submission within 1 year from project kickoff.
- Leveraging this optimized design and strong supplier relationships, Veranex then utilized its internal manufacturing capabilities, including its Class 8 cleanroom, to successfully produce over 1000 commercial units to meet critical product launch needs.
- This rapid and efficient transition from prioritized design and regulatory submission support to full-scale manufacturing, ensured the client's quality device was ready for a successful commercial launch.
Services by Veranex
- Early discovery
- Product design ideation
- Rapid prototyping and testing
- Human factors and usability testing
- Manufacturing
- Regulatory
Pre-Mature Infant Humidification Device
Situation
The client needed Veranex to support pilot and initial commercial manufacturing of a pre-mature infant humidification device while they established a new manufacturing facility for long term production.
Successes
- 80 pilot units produced and distributed domestic and internationally
- Managed supply chain and commercial manufacturing for 1000+ units annually
- 4 years of interim commercial production support to a successful manufacturing transfer with seamless output.
Services by Veranex
- Manufacturing solutions
- Product Development
- Design Quality & Quality Assurance
- Supply Chain Management
- Project Management
Benchtop Immunofluorescence
Situation
A start-up needed their benchtop immunofluorescence device to be first to market to gain market share.
Successes
- Veranex composed a strategy to meet demanding timeline goals by enacting a short validation phase to move to manufacturing launch sooner, allowing the start-up to realize over $50M in revenue and over $20M
- Purpose built manufactured devices that are fully traceable with ISO13485 controls were released to market for 4 years.
- Veranex has supported over 75 changes that have been implemented in 14 releases from continuous DFM on manufactured product by responding to field issues via rolling up and releasing design changes.
Services by Veranex
- Manufacturing
- Design Quality & Quality Assurance
- Supply Chain Management and Procurement
- Design and Engineering
Engineering and Development
Manufacturing success starts long before production. See how our integrated Product Development expertise builds manufacturability into your device from concept, saving you time and cost down the line.
Preclinical Services
Need controlled builds to support your preclinical studies? Our manufacturing capabilities seamlessly integrate with our Preclinical Services to provide the precise units and documentation required to accelerate your research.
Testing and Prototyping
Rapid iteration is key in early development. Our Labs and Prototyping capabilities work hand-in-hand with manufacturing to provide quick, high-quality prototypes and testing, accelerating your design validation before scaling production.
Clinical Investigations
Your clinical trials require reliable, compliant units. Partnering our manufacturing team with Clinical Services ensures you receive the controlled builds and streamlined support necessary to keep your clinical investigations on track.
