Nine Questions to Ask When Considering an OEM Partner

Why do you need an Original Equipment Manufacturing (OEM) partner?

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 – all within a market that’s saturated with competitors – is enough to take the excitement out of innovation.

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.

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’re hitting all the bases.

1. Do you offer start-to-finish customization options? If yes, what are they?

The right OEM partner should enable your company’s 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 should include simple component alterations, modified reagents, molecular synthesis, novel consumables, white labeling, custom packaging, and everything in between.

2. How do you minimize supply risks like backorders?

When considering your commercialization strategy, it’s vital that you minimize your vulnerability to supply chain risks. A supplier with global coverage should offer manufacturing redundancies and multiple distribution centers for a secured supply. 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.

3. How do you ensure that your products and solutions are high quality?

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) are crucial to protect you from costly trial and error due to defects, variability, and lot-to-lot conformity.

4. What are your areas of expertise and what field-specific resources do you have for me to leverage?

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’ll 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.

5. What does your quality management system look like?

To meet compliance regulations– especially with a global product– 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, approval, and market launch.

6. Do you have access to commercial rights?

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.

7. Are you well-known in the industry, both in my region and globally?

Whether you’re 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).

8. Will I have one dedicated team and point of contact?

Even if you’re 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 that has thousands of supporting “experts” at their fingertips.

9. What is your goal as you’re helping me get to market?

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—not a transaction.

Finding the right OEM partner

The Thermo Fisher Scientific Genetic Sciences OEM and Commercial Supply team believes that getting your product to market should feel exciting, not draining. We bring the expertise and knowledge needed to understand your business, the marketplace, and the industry at large.

When you have a solid partnership as the foundation of your commercialization strategy, you find that you make it to market faster, wiser, and without the added stress and compounding cost that comes from trying to do it all on your own.

The bottom line:

The right OEM partner should help you accelerate your impact on the world, while improving revenue generation, profits, and peace of mind.

Discover Solutions That Are Custom Built Just for You

Related Links & Resources

• Four Things You Should Know About Customized OEM Solutions – Related article
• Three Steps You Can Take to Navigate the IVDR – Related article
• Genetic Sciences OEM and Commercial Supply – The partner your innovation deserves.
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