Touring a contract manufacturer’s cleanrooms and other spaces will help you choose the right partner. [Photo courtesy of HS Design]
Choosing a contract design or manufacturing partner is the beginning of a long, two-way relationship.
Tor Alden, HS design
No matter what type of medical device you are designing, at some point you will have to decide which design house or contract manufacturer is right for you. OEMs, although highly funded startups, all face the same issues as they prepare to make the transition from design to manufacturing.
The cycle from design to manufacture is getting faster and faster. On average, the typical product development launch takes two years from concept to regulatory approval. This two-year period may seem like a long stretch at first, and you may not feel an urgent need to engage a medical solution partner and wait until the development cycle has matured to make the selection decision. However, we have consistently seen a tendency to rush the development process to get to a prototype without involving molders or manufacturers, leading to disappointments in terms of aesthetics, assembly methods and cost.
Proper and early due diligence is especially important if you are a startup. Your organization may not yet have approved suppliers, the discipline to review previous suppliers, or even experienced staff. Startups are inherently lean and fast-moving. Once the startup receives its Series A or B funding, it aims to get to market as soon as possible. Does the company have an experienced program manager on the team who can identify the ideal solution providers, or do you risk the pitfalls of jumping in too early with an unsuitable supplier? Likewise, the suppliers you target might have concerns about taking on the project due to volume, investment costs, and go-to-market strategy.
There are as many developers of medical device, diagnostic, pharmaceutical and consumer health products as there are specialized contract manufacturers. So let’s look at the potential questions medtech designers and managers should ask when considering medical solution providers.
1. Is my job shop the right size or is it scalable?
Companies always tend to exceed their growth targets. This idea is based on the assumption that a supplier with a global footprint and high-volume capabilities is secure as your production volume grows. Even the best-known companies fall into this trap.
Finding a global contract manufacturer that has reach as your product grows but is cautious about initial volume and cost targets is ideal. Measuring a supplier’s hunger for your business is paramount. Sometimes a smaller contract manufacturer is not only more aggressive about the timelines, but jumps through problems by winning over that larger OEM. Ask the contract manufacturer to tell you what their sweet spot is for producing units per year and how they’re able to scale up and down.
2. What specific capabilities does my product require?
The idea that all contract manufacturers are the same couldn’t be further from the truth. Depending on the product, it can include micro molding, assembly, complex fluidics, packaging, sterilization, clean room molding – the list goes on. Finding examples of what the supplier is currently doing is always a good first step. Make sure your supplier has a process in place for everything. Do they offer turnkey or consignment preferences? If final packaging is required, do instructions for use (IFUs) need to be provided? What additional services do they offer? It is important to understand the safety, sustainability, supply chain and accessibility of the manufacturing partner.
3. Are regulatory and QMS systems in place?
In today’s highly competitive and regulated marketplace, chances are you have a medical solution partner that ticks all the boxes on paper. However, how their QMS system integrates and provides tracking can differ significantly. Look for a vendor who can refer to their quality and regulatory manager and have them discuss their certifications, traceability, and inventory transportation, quarantine, and shipping capabilities. Are they GMP, ISO 13485 or FDA registered? Are your procedures regularly criticized by internal Notified Bodies and customer audits? Strict quality management ensures consistent delivery and builds trust among customers.
4. Does the solution provider offer end-to-end design-to-manufacturing services?
Even if you’ve spent a lot of time choosing your design company, remember that some design companies are more manufacturing-oriented than others. Integrating a design company with a contract manufacturer reduces the need for rework. Design and manufacturing processes differ, and early manufacturer attendance at meetings eliminates rework. Do they have their own molders or do they rely on outsourced services? What is the knowledge of medical resins and prototype tools?
5. Does your current product development partner have a track record with the contract manufacturer?
Most ISO 13485 medically oriented product development companies have audited quality processes, but not all are user or manufacturing oriented. If the company lacks design and manufacturing experience, it may not have existing relationships with contract manufacturers. Early integration of the contract manufacturer with the product development company is crucial to make the experience as holistic as possible. Ideally, the medical solutions provider can demonstrate successful case studies of projects progressing from design firms to production.
The devil is in the details
Trust your instincts, but base yourself on facts. If possible, visually inspect the facility before choosing it to judge the quality of the supplier by the appearance of the tooling, mold and assembly floors – and even the entrance hall. Resist the urge to choose based on recommendations and elegant presentations. Once you have chosen a medical solutions provider, you should be prepared for a long-term, trusting relationship. The ability to move your product to another supplier once in production is a daunting process and will test the relationship between an OEM and the contract manufacturing partner. In addition, all regulatory work, design history, tooling and material knowledge must be transferred, leading to another round of testing and validation.
Tor Alden leads SterilePack‘s user-centric product development group as Global Vice President of Design, Human Factors & Development. His expertise is based on over 30 years of experience in the design, development, research and human factors of medical, life science and consumer healthcare products. Alden received his bachelor’s degree in industrial design from Syracuse University and his master of science in management of technology (MOT) from Stevens Institute of Technology.
The opinions expressed in this post are solely those of the author and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its contributors.
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