Why do you need a DesignDevelopment, and Manufacturing Partner?

November 17, 2020

Companies planning to bring a new medical device to market have options on how to efficiently execute their product development program. Models for product design, development, and manufacturing range from full internal staffing to full outsourcing with many variations in between. Here are key areas to consider when selecting whether to engage with a product development partner.

CE Clinical Build

Access to technical expertise and experience:  Don’t reinvent the wheel! 

To successfully develop a new medical device, you need to be laser focused on managing and reducing risk.  If you are faced with the choice of having to learn something for the first time or hiring a team that has done it before, the choice should be obvious.  It will always cost more and take longer to forge a new path, learning as you go.  Hire a team that knows your technical space and can apply critical knowledge and experience to your program. Look for a partner that can quickly ramp up a team with the right skill set to meet your schedule. Consider a partner that will bring unique ideas to the table that complement the strengths of your internal team.   

Capital efficiency:  Control burn rate by turning fixed costs into variable costs

Is your full-time team as lean as it needs to be?  Are your part-time / contract personnel as committed as you want them to be and available when you need them?  Do you really want to increase your burn rate with more full-time hires?  Are you struggling to hire qualified people?  An outsourcing partner that specializes in all phases of design, development and manufacturing can work as an extension of your team and amplify the number of available resources when you need them most.  All early-stage companies transition from initial discovery, where you need strong R&D resources, to late-stage development, when you need experienced manufacturing and quality personnel, and then to clinical operations, where you need to control burn rate.  A design, development, and manufacturing  partner can help you drive capital efficiency allowing you to turn fixed costs into variable costs and get you the right resources on your team, precisely when you need them.

Avoid building unnecessary infrastructure 

In-house manufacturing requires a significant investment in systems and infrastructure.  You will need to develop and implement full operational capabilities including warehousing, receiving inspection, cleanroom assembly, and finished-goods inventory management.  You will need to staff your operation with qualified personnel who may be underutilized in the early stages as you go through starts and stops in manufacturing needs.  You will also need to develop and implement a robust Quality Management System to effectively handle functions such as Purchasing and Supplier Management, Material Controls, Production and Process Controls, Risk Management, and Corrective Action/Preventive Actions.  Aside from the QMS, you will need an MRP/ERP system to manage materials, schedule work orders, and reconcile materials consumed in manufacturing.  Additionally, an effective operational infrastructure evolves over time based on organizational experience and continuous  improvement efforts.  Do you really want to start from scratch?  Working with a partner that has the required systems and infrastructure in place and has already developed effective and efficient processes can de-risk your commercialization strategy.  Moreover, you should identify a partner that can fully bridge from early design into manufacturing, alleviating the concern of working with a design house that  cannot carry the design into production or with a contract manufacturer that does not fully understand your device or your clinical application.

Access a network of suppliers and leverage established relationships 

Managing an effective supply-chain starts with strong relationships.  Many early-stage companies overlook the fact that suppliers willing to participate in your early development are choosing to make a long-term investment in the success of your product and company.   Suppliers use considerable resources delivering quick-turn prototypes, aligning manufacturing methods, resolving design issues, and expediting delivery.  How do you get your suppliers to work for you and jump when you need them most? Relationships.  By hiring the right Design, Development, and Manufacturing partner, you gain access a pre-qualified network of suppliers and gain the benefit of pre-existing long-term relationships.  Getting down-stream suppliers to jump suddenly gets easier.

Experience navigating Medical Device Design & Development Planning 

Bringing a new medical device to market is complex and full of challenges and pitfalls.  Regulatory requirements demand that you fully understand Design Controls, Risk Management, and Design Verification and Validation test strategies including details on Biocompatibility testing, Sterilization testing, Package Integrity testing and Shelf-life testing.  An effective Design, Development, and Manufacturing partner can put together an effective strategy that is unique to the needs of your product and company.  Most importantly, ask yourself how many people on your team have taken a program from start to finish and have experience with all aspects of product realization?  The right Design, Development, and Manufacturing partner has collectively executed hundreds of programs and can bring relevant experience in all aspects of product realization.

Medical Device Product Development Milestones

Pitfalls to avoid when outsourcing 

There are a few common pitfalls to avoid when choosing to outsource critical elements of your medical device design and development process.  Make your choice based on who can offer the responsiveness, flexibility, and expertise to navigate the unexpected turns in the program and truly function as your partner.  Interview your project’s program manager carefully and selectively.  You need a program manager that you can work with and has the right experience set.  Commit to regular meetings and periodic design reviews and be responsive for requests for information and decisions.  Indecision and scope creep will cause significant issues – keep the end goal in mind and course correct often to stay on target.  Be cognizant of when priorities shift and be willing to adjust – open communication and collaboration are essential to your success.  In essence “project management” is “risk management”, so you and your extended team should be working collaboratively to draw down risks early in the process.  In order to do so, everyone needs to have the same information available and communicate openly and often.

Overall, working with the right Design, Development and Manufacturing partner can significantly de-risk and expedite your product development program.

Contact Meddux to see how we can help you bring your innovation to life!

 

SALES INQUIRES:

Meddux® (LinkedIn)| Tony Walsh twalsh@meddux.com | +1 303.818.8925

MEDIA RELATIONS:

Partridge Communications, Inc. | Laurie Partridge principal@lauriepartridge.com | +1 508.577.2553