It takes time, resources, and tenacity to get a product to market. Dealing with competing priorities, project dependencies, impending regulatory changes, product variability, supply shortages, and supply delays \u2013 all within a market that\u2019s saturated with competitors \u2013 is enough to take the excitement out of innovation.<\/p>\n
An OEM partner is what sets apart the most successful companies. Instead of juggling the complexities of commercialization yourself, you can choose the right partner to do it with you. Partnering with an experienced supplier and an established global team enables you to break free of the cost, quality, and time constraints that delay your commercialization.<\/p>\n
When it comes to finding the right OEM partner, there are some non-negotiables. Here are nine questions to ask them to see if they\u2019re hitting all the bases.<\/p>\n
The right OEM partner should enable your company\u2019s success, not detract from it. They should provide you with the resources, expertise, and problem-solving skills needed to bring your vision to fruition under your company name, brand standards, and strategy. Their customization options<\/a><\/strong> should include simple component alterations, modified reagents, molecular synthesis, novel consumables, white labeling, custom packaging, and everything in between.<\/p>\n When considering your commercialization strategy, it\u2019s vital that you minimize your vulnerability to supply chain<\/strong> risks. A supplier with global coverage should offer manufacturing redundancies and multiple distribution centers for a secured supply<\/strong><\/a>. With this, they need to cover operational logistics like product demand variability, manufacturing downtime, and scaling up with growth. The right partner may even eliminate the need to invest your time and money in self-manufacturing.<\/p>\n Picking the right products and solutions is as essential as choosing the right company to partner with. A partner that is a world leader in serving science is an expert in the manufacturing process with all the associated quality checks and standards required. High-quality materials, quality checks, and global standards (i.e. manufacturing facilities that meet ISO 9001, ISO 13485, and ISO 14001 certifications<\/a>) are crucial to protect you from costly trial and error due to defects, variability, and lot-to-lot conformity.<\/p>\n Look for an OEM partner that invests in their technology, industry leaders, and training services. Your partner should have a broad range of platform technologies that can address a wide set of requirements, clinical applications, and diagnostic markets. You\u2019ll also want them to have global field support and training services needed at their disposal to maximize your efficiency. When combined with a team of experts who advocate on your behalf, you may be enabled to improve development timelines, minimize roadblocks and delays, and ultimately decrease your time to market.<\/p>\n To meet compliance regulations\u2013 especially with a global product\u2013 it is essential that you partner with a supplier which has a robust quality management system (QMS). This includes having the necessary certifications (e.g., ISO 13485, FDA registered manufacturing sites, etc.) as well as processes that adhere to the highest regulatory standards. These processes should include material quality assessment techniques, and proven minimized batch variability. They also need to have legal and financial experts to support your submission<\/a>, approval, and market launch.<\/p>\n For a smoother commercialization path, your OEM partner should provide you the appropriate commercial use rights for the components you receive from them. These rights minimize launch delays and any associated legal issues that can arise from not being granted the correct approvals.<\/p>\n Whether you\u2019re selling in one country or throughout the world, your OEM partner should have the global logistics, distribution, and manufacturing sites to support your unique business needs. Having a partner with a global presence allows you to limit the rising costs associated with transportation. And your large global supplier should ideally have regional and local expertise that can assist and guide you through the intricacies of commercialization in your chosen region(s)<\/a>.<\/p>\n Even if you\u2019re working with a company that has reach on a global scale, you still need to feel like your partnership is personal. Ideally, you want to work with one dedicated account team<\/a> that has thousands of supporting \u201cexperts\u201d at their fingertips.<\/p>\n The goal of your partnership should be for your OEM team to provide you with the capabilities you need while freeing up your time and resources, allowing you to focus on your areas of genius, rather than the fine print. Ultimately, this relationship should feel like an actual partnership\u2014not a transaction.<\/p>\n <\/p>\n2. How do you minimize supply risks like backorders?<\/h3>\n
3. How do you ensure that your products and solutions are high quality?<\/h3>\n
4. What are your areas of expertise and what field-specific resources do you have for me to leverage?<\/h3>\n
5. What does your quality management system look like?<\/h3>\n
6. Do you have access to commercial rights?<\/h3>\n
7. Are you well-known in the industry, both in my region and globally?<\/h3>\n
8. Will I have one dedicated team and point of contact?<\/h3>\n
9. What is your goal as you\u2019re helping me get to market?<\/h3>\n
Finding the right OEM partner<\/h2>\n