Creating Manufacturing Partnerships for Medical Devices

By Victor Wong, Head of Commercial at Flexi Versa Group

During the time we’ve been successfully helping startups and brands in the medical device sector we’ve identified a few factors that have allowed us to become partners of real value. There are many, and as with all manufacturing the devil is in the detail, but perhaps the most important two drivers of success are early engagement and the vertical integration of design and manufacturing services.

The medical device industry is somewhat unique in its demands, starting with the way a product is designed, right through to end of life. Having a manufacturing partner that can be there from cradle to grave is essential. Our most successful projects have been where we have engaged at the ideation stage and where we have stayed closely associated with the project throughout the entire lifecycle.

It all starts with design

Maybe it sounds obvious, but if there is little or no engagement with a manufacturing partner like Flexi Versa at the start, there is a strong likelihood that the design will not be suited to modern manufacturing methods. The result is a substantial delay in the launch of the product, much higher costs and a design that may not meet the needs of the market. The remit of good industrial design is to create a product that is fit for purpose, easy to manufacture at whatever scale is needed, economic and robust. That means design for manufacture (DfM) and design for supply chain (DfSC) need to be considered as early as possible.

Over the last few years the industry has seen numerous disruptions to the supply chain and the manufacturing ecosystem, starting with the US-China trade war, closely followed by the pandemic and most recently component shortages. This has brought a new issue to the fore – that of design for disruption (DfD). By recognizing current and potential shortages we are able to design products that have parts with multiple sources and hence greater supply chain security.

Our job at the design stage is to ensure we collaborate in the co-development of the product as a proof of concept, through several iterations of a prototype, onto products for clinical trials and product evaluation for certification and compliance, and finally to a factory ready package. This often means electronic design, plastics design and parts selection, and at this stage our broad skill base proves really valuable and vertically integrated design and manufacturing comes into its own.

An integrated approach

Many EMS companies offer PCBA, but only a handful offer the full array of services needed to create and manufacture a complete solution, ready for market. For medical device companies it is important to partner with a company that can. A simple checklist might include:

• PCBA – yes most companies will offer printed circuit board assembly, but make sure it has the required approvals
• Plastics – having the plastics designed and manufactured alongside the PCBA and box build will help ensure the entire product meets the standards required and assure you have a single source of responsibility
• Ingress protection and elastomeric sealing – for many medical devices an understanding of IP ratings and sealing solution is often essential
• Design and engineering – make sure your manufacturing partner understand the demands of design and engineering in this arena
• Compliance – this might be one of the biggest hurdles, experience here is absolutely key
• Sourcing and supply chain – your partner will need to be able to source the parts you need, be they electronic components or custom parts, the way they manage the initial procurement as well as supply chain disruption will provide a real test for the partnership

Lastly, it’s a process

Probably the most unique part of developing and launching a medical device is the process. A partner should understand the process and be able to help you create and navigate the roadmap from ideation to launch. This means the design and product roadmap, but also the regulatory roadmap. Harmonizing these complex roadmaps will ensure that when you have the required approvals you’re ready to launch a successful product.

We’ve been here before and helped numerous companies along their journey. If you’d like to learn more about the process and talk through some examples reach out to me at victorwong@flexisb.com.my

About Victor Wong
Victor Wong spent much of his early career at HP working in reliability and then purchasing before a move to contract manufacturing with Solectron, who were later acquired by Flextronics, now known simply as FLEX. Victor held several positions in account management and business unit management at FLEX before he joined Jabil as a senior business unit manager in 2011. Now with more than 16 years of EMS experience he leads Flexi Versa Group’s business development as their Head of Commercial.

About Flexi Versa Group

Flexi Versa Group is a Southeast Asian contract manufacturer partnering with global consumer electronics brands as a turnkey and components manufacturer with specialist experience in the audio and consumer appliances segment. Flexi Versa Group is vertically integrated with capabilities including printed circuit board manufacturing, precision components services (die cut, RFI/EMI, thermal solutions, printing), polymer processing such as thermoplastic and thermoset injection molding, elastomeric solutions, woodworking, wire harness manufacturing, and acoustics solutions, as well as box build and final assembly and test. A footprint in six Asian countries, developed over 25 years and multiple blue chip customers across multiple segments including medical, consumer electronics, industrial and automotive are testimony of the group’s continued success.

For more information visit https://www.flexiversa.com/