Supplier Selection for Early & Mid-Stage Medical Device Companies

Selecting the right medical device supplier is a critical part of a company’s Supplier Management System. In this guide, we’ll break down how to identify potential suppliers and assess whether they’re the right fit for your needs. The best way to ensure long-term success is to have a structured selection process in place—read on for the key considerations and best practices!​

The Importance of Internal Supply Chain Partner Selection Processes

Selecting the right help for your medical device business is a feat all on its own. Equally important is ensuring that the supplier is the right partner for your company. Despite global regulations and mandates on supplier quality management, medical device companies still need their own internal, structured process to select the right supply chain partners. 

With an established method for selecting a medical device supplier, a company can shorten the selection journey and move forward with clarity. This also mitigates the chances of making the wrong decision, a mistake that could potentially create significant impacts on project timelines and budgets. With the high-risk nature of many medical products, mistakes that are not caught could have grave consequences, impacting actual human lives.

Considerations for Determining the Process

1. Consider the Regulations & Standards

In the dynamic MedTech Industry, standards and regulations change frequently. Before establishing a selection framework, take some time for a thorough refresher on the quality requirements for your given global region. A good place to start for USA & EU is ISO 13485:2016, section 7.4. Additional insights can be found in CFR 21 Part 820.50, subpart E. (purchasing controls), although it perhaps is not the leading indicator as of 2025. For companies that follow this regulation, MDSAP: Chapter 7 can also provide insights.

TL;DR: Check out ISO 13485:2016, section 7.4, CFR 21 Part 820.50, subpart E. (purchasing controls), and MDSAP: Chapter 7 for refreshers on regulations & Standards

2. Simplify

Systems are easier to follow and remember when they are simple. After reading all those regulations, you may feel overwhelmed by all the details. Take a deep breath, focus on essentials. A streamlined selection process encourages faster adoption across the company, regardless of size.

3. Internal Procedures

Medical device companies should strive for a purchasing structure that aligns appropriate decisions with justifiable needs. This is especially important if the supplier being considered falls within the 'critical supplier' category.  Outline internally exactly who can perform supplier qualifications, as well as who can approve suppliers.

4. Define Supplier Criteria

It is essential to clearly define the necessary criteria before considering options. An established, standardized list of criteria to refer to will help to:

• ask the right questions
• gather all necessary information
• quickly compare capabilities across several supplier options

This will also help remove bias: a focus on just the data will overcome human tendencies to get distracted or make decisions based on less relevant or supplemental characteristics.

Another method to consider (depending on the supplier) is a Supplier Questionnaire or a Request For Proposal (RFP) process. Both are useful to quickly obtain needed information.  Typical items to request from a potential supplier include:

• Product specifications or service offering
• Detailed documentation on the product, service, or suppliers' internal processes
• Information on internal management, such as supply chain process and partners
• Certifications
• Key capabilities and potential holdups

5. Experience & Expertise

Prioritize partnering with suppliers who already have experience in the intended industry, or even a niche within that industry. By vetting for experience and expertise, companies with a ‘figure it out’ or 'give it the old college try’ perspective can be more easily avoided. Referrals and references will be key, especially when considering a supplier in the elusive ‘critical few’ supply chain partner list.

Reach out to others in the industry or local industry associations to seek referrals and also learn who to avoid. Take the time to read reviews and gather intel from trusted sources before calling potential suppliers. Although this may be time-consuming or tedious, this will probably save time in the long run. While sites like Thomas.net and Google can provide this information, they can also be overwhelming.  Overall, the most useful information is unbiased or comes from trusted resources

6. Proactively Learn About Supplier Behaviors

When speaking with a potential new supplier, try to connect those who will be most involved with your work, not just the company salesperson. This is crucial, as once the relationship is established, the people actually delivering the service or product will be most involved, not the salespeople. When considering a supplier, pay attention to:

• What is their communication like? 
• Do they respond quickly?
• How do they handle mistakes they’ve made?
• What is their customer retention rate? (if they don’t keep customers long that should be a big red flag)
• Find out how long their employees have been with the company.  A company experiencing consistent turnover should be concerning. You will likely have to be much more involved: helping coach and direct new employees to ensure the work is done properly. You want to avoid training your supplier's new employees just so they can bill you for it. 
• Where does your project stand in terms of priority to the supplier? Not all clients are treated equal, even if they say otherwise. 
• Do they have consistent business processes in place? Stay away from companies that seem disorganized or get frazzled easily.

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In working with a critical supplier, it’s vital to learn about their business continuity plan. It should address a wide range of potential roadblocks, emergencies, or delays, outlining what to expect when situations arise that could impact fulfilling their obligations.

7. Determine Risk

Add to your supplier selection process a risk assessment phase. Give a risk score to every supplier you consider. Don't forget to weigh their involvement with your product and end user. Categorizing risk usually falls into two buckets: non-critical and critical. Greenlight Guru has a great resource to articulate these categories and risk tiers in its article ‘Ultimate Guide to Supplier Management for Medical Device Companies’, see image below:

8. Perform Audits

A good rule of thumb is to audit all suppliers; this helps to keep yourself, procedures, and systems honest and consistent. Generally, it is recommended to audit any supplier providing components, parts, or raw materials, regardless of their risk-level. This will ensure you are in compliance with standards (such as ISO 13485).  Audits can be done both onsite or offsite; critical suppliers require a much deeper dive into their capabilities and processes to ensure compliance and risk mitigation. Once an audit is performed, it is vital to finalize the process, showing a clear determination of said supplier. Be prepared to provide acceptance or rejection and the justification for the decision.

It's important to note here that not every supplier requires a formal audit—especially non-critical Tier 3 suppliers, particularly those that provide services.

9. Select A Supplier

You've made it this far! You've gotten your referrals, you've clearly defined the criteria they must meet, evaluated their suitability, and included a notation on the potential risks of working with each one. You now have your shortlist of suitable potential partners. Before jumping in and making a final decision, take a moment and think big picture. Is there an opportunity now, or shortly down the road, to be looking at economies of scale?  Meaning, can one of your potential suppliers fill more than just one need? Try to select a supplier that can offer multiple capabilities. This may be the better partner:

• less points of contacts and companies in your supplier database
• a supplier would have incentive to provide better pricing, as you'd be giving them increased reliable business
• increased efficiency 

A potential drawback to this approach is that with a singular supplier dominating a particular portion of your business may this give them leverage. While single source suppliers aren’t uncommon, it’s advisable to balance immediate as well as upcoming needs to determine what will be appropriate for this partnership.

10. Agreements & Onboarding

You should never enter into a business relationship with a supplier without a signed contract—no exceptions. While contracts cover many aspects, some key considerations include product or service guarantees, indemnification, no-change clauses, audit transparency, pricing, and intellectual property agreements.​
 
After contracts are signed, onboard the new supplier with a thorough and arms-open approach. Congratulations! You have decided to go into business with this new supplier, treat them like gold. Establishing good relationships is essential for the MedTech world. Schedule a formal onboarding meeting and invite all key stakeholders from both companies to attend. Key discussion items should cover:

• how the two companies will successfully work together
  
• areas of opportunity in the next 6-12 months
  
• points of contact
  
• aligning expectations
  

While this may seem excessive, think of supplier relationships as an extension of your team. The way you approach and manage these partnerships will directly impact the outcomes you achieve.

11. Requalifying Suppliers

When creating your supplier selection process, it’s considered good measure to include a ‘requalifying process’ to ensure your company is managing its suppliers consistently and diligently. Utilizing a standardized scorecard to capture performance data will make this process easier to manage and act on.

Closing Notes

Most supplier selection programs don’t have a clear process for evaluating and pricing products, materials, or services. Larger companies tend to have more data and structured approaches, but at the end of the day, cost and likability only go so far. If a supplier can’t consistently perform, neither of those factors matter. More often than not, paying a little extra upfront for the right product, service, and relationship is well worth the investment in the long run.
While cost is important, it’s usually not the driving factor when picking suppliers. In many instances, it is worth the additional costs to get better performance and a solid working relationship

As Benjamin Franklin said, “The bitterness of poor quality remains long after the sweetness of low price is forgotten.”

Need help refining your supplier qualification process? Let’s talk.

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THE MEDTECH PROBLEM SOLVERS