Growth-stage medical device OEMs look to us when they’re:
- Anxious about missing product launch timelines
- Lacking the resources and expertise to invest in manufacturing infrastructure
- Worried about maintaining quality during fast growth
- Struggling to ramp up production
- Frustrated with their existing CMO’s poor performance
- Not a good fit for large contract manufacturers that don’t understand their unique needs
We solve those problems by:
- Assigning you an executive-level project coordinator who has the resources to execute fast
- Providing you with a dedicated project team composed of all the key functions required to get the job done
- Ensuring your project plan is tailored to your company’s unique requirements
- Providing you with a manufacturing scale-up plan that reduces costs over time
- Prioritizing quick problem solving and flexibility to change on a dime
“Our existing contract manufacturer couldn’t service us as we grew. We looked at large CMOs. They talked a good game, but they didn’t really care about our business. J-Pac’s team had the capabilities we needed and a service model focused on the challenges we faced.”
– Mid-market surgical instrument company
Three things make us different
Deep technical knowledge
We don’t just make stuff. We’re engineers who understand your industry and the commercial, technical and regulatory challenges you face in bringing a new product to market. We guide you through the entire process with all the resources under one roof to get it done right.
Relationship-driven service
We stake our claim on collaboration. You’ll have an executive sponsor from day one and a program manager who is empowered to get things done.
Real scalability
Not all projects start big. But when you’re ready to ramp up, so are we. We invest in manufacturing infrastructure on your behalf and develop supply chain and workforce solutions to provide a pathway to reduced costs.
Markets we serve
Single-use medical assembly, packaging & sterilization
Benefit from our experience in many different single-use medical device technologies that require component assembly, packaging and sterilization.
Diagnostic reagent blisters
A global leader in microfluidic reagent blisters, critical to microfluidic point-of-care IVD.
We may be a fit if you
- Are a growth-stage medical or IVD diagnostic device company selling single-use products
- Want to outsource manufacturing so you can focus on your customers
- Are unhappy with your current contract manufacturer
- Require high levels of service
- Need to scale with quality
- Want a cost reduction path to plan on
Our process and pricing
- We start with a needs assessment and jointly develop a scope of work. We bring regulatory and manufacturing expertise to bear.
- We then identify engineering services required such as tooling, lab testing, package design and validation, sterilization validation, pFMEA, and equipment IQ/OQ/PQ. A typical range of expense is $25K to $100K depending on the scope of work.
- We submit a proposal that includes both engineering services and unit pricing for the volume tiers you request.
- Once you agree to the program, we receive a 50% deposit and hold a kickoff meeting to introduce you to your executive sponsor and your dedicated team of engineering, quality, supply chain and manufacturing experts.
- We execute to a project plan that you approve and establish the cadence of collaboration that meets your needs.
- Our executive team reviews the progress of your project weekly and assigns resources to address issues as they arise.
Think we might be able to help?
If you’re under pressure to launch a new medical device or diagnostic/consumable product, or need an experienced outsourcing partner capable of scaling up on your timeline, we should talk.