Choosing a design or contract manufacturing partner is the start of a long two-way relationship.
Tor Alden, HS Design
Regardless of the type of medical product you design, at some point you will need to decide which design house or contract manufacturer is best for you. OEMs, although highly funded startups, all face the same issues when preparing to transition from design to manufacturing.
The cycle from design to manufacturing is accelerating. On average, a typical product development launch takes two years from concept to regulatory approval. This two-year period may initially seem like a long time, and you may not feel an urgent need to engage a medical solution partner, leaving the selection decision to wait until the development cycle matures. However, time and time again we have seen a tendency to rush the development process to arrive at a prototype without engaging moulders or fabricators, which has resulted in disappointment in aesthetics, assembly methods and costs.
Proper and early due diligence is especially important if you are a startup. Your organization may not yet have approved vendors, the discipline to review past vendors, or even experienced staff. Startups are lean and fast by nature. Once the startup receives its Series A or B funding, the plan is to get to market as quickly as possible. Does the company have an experienced program manager on the team who can identify ideal solution providers, or are you at risk of falling too soon with a provider that is not suitable for you? Similarly, the suppliers you can target might be apprehensive about taking on the project depending on volumes, capital cost and go-to-market strategy.
There are as many developers of medical technology, diagnostics, pharmaceuticals and consumer health products as there are specialist contractors. So let’s look at potential questions medical technology designers and managers should ask when considering medical solution providers.
1. Is my contractor the right size or scalable?
A company always tends to exceed its growth objectives. This idea is based on the assumption that a supplier with a global presence and high volume capabilities will be secure as your production volumes increase. Even the biggest companies fall into this trap.
It’s ideal to find a global contractor who has scope for your product growth, but acts cautiously on initial volume and cost targets. It is essential to measure the appetite of a supplier for your company. Sometimes a smaller contract manufacturer will not only be more aggressive on schedule, but will also overcome the problems of getting that larger OEM. Ask the contractor to tell you what their sweet spot of unit production per year is and what their ability to scale up and down is.
2. What specific features does my product need?
The idea that all contract manufacturers are the same couldn’t be further from the truth. Depending on the product, this can include micro molding, assembly, complex fluidics, packaging, sterilization, clean room molding – the list goes on. Finding examples of what the vendor 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, will instructions for use (IFU) be provided? What additional services do they offer? It is essential 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 meets all the criteria on paper. However, how their QMS system is integrated and tracked can differ significantly. Look for a supplier who can point to their quality and regulatory manager and ask them to discuss their certificates, traceability, and inventory, quarantine, and shipping capabilities. Are they GMP, ISO 13485 or FDA registered? Are their procedures regularly criticized by internal notified bodies and customer audits? Strict quality management ensures consistent delivery and inspires confidence in customers.
4. Does the solution provider offer holistic services from design to manufacturing?
While you may have spent a lot of time choosing your design company, keep in mind that some design companies are more manufacturing-focused than others. Incorporating a design firm into a subcontractor will reduce the need for rework. Design and manufacturing processes differ, and ensuring the manufacturer is in a meeting early will prevent rework. Do they have in-house moulders 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 history with the contract manufacturer?
Most ISO 13485 medical product development companies have audited quality processes, but not all of them are user-centric or manufacturing-centric. If the company lacks experience in molding and manufacturing, it may not have existing relationships with subcontractors. Early onboarding of the contract manufacturer with the product development firm is key to making the experience as holistic as possible. Ideally, the medical solutions provider can show successful case studies of projects moving from design to production companies.
The devil is in the details
Trust your gut, but base it on facts. If possible, visually inspect the factory before selecting it to assess the quality of the supplier from the appearance of the tooling, moldings and assembly floors – and even the entrance hall. Resist the urge to select based on clever recommendations and presentations. Once you have chosen your medical solutions provider, prepare for a lasting relationship of trust. The possibility of moving 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. Additionally, all regulatory work, design history, tooling and material knowledge will need to be transferred, leading to another round of testing and validation.
Tor Alden leads SteriPack’s user-centric product development group as global vice president of design, human factors and development. His expertise focuses on more than 30 years in the design, development, research and human factors of medical, life science and consumer healthcare products. Alden earned his bachelor’s degree in Industrial Design from Syracuse University and earned his Master of Science in Management of Technology (MOT) from Stevens Institute of Technology.
The opinions expressed in this article are those of the author alone and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.