How to Choose a Third-Party Analytical Lab

You need an independent accredited third party laboratory to provide analytical services to support your medical device manufacturing operations. But which lab do you choose? With so many choices, how do you choose the right one?

The choice of which vendor to select is crucial, because you are choosing a partner to trust with your reputation and integrity. Reputation and integrity are the foundation and structure of a business; if these qualities are lost, the damage can be irreparable. Choosing the lowest price provider or the one in closest proximity doesn't assure you of the quality needed to preserve your reputation and integrity.

Making the Choice

To choose wisely and reduce anxiety and concern, you need a systematic and specific process. The following is a guide to selecting the most appropriate analytical partner.

Step 1: Make a List. Start by making lists of positive and negative indicators of attributes of the desired laboratory (see suggestions made in Table I). Enter these into the first column of a spreadsheet. Columns will be for potential candidates being considered. We will build this matrix for final scoring of the potential candidates.

Step 2: Ask Questions. The next step is to formulate some basic questions to assist with your ranking and selection. Here are some examples:

Step 3: Get Answers. Now let's get some answers. Start with the candidate's Web sites and make note of what you find. A word of caution: Although company Web sites are a ready source of information, remember care must be taken to separate advertising hype from verifiable facts. Look for specifics such as accreditations, scope of work, industries served, materials frequently tested, and a list of major clients.

Now it’s time to make some direct calls to candidates to supplement your data. Be prepared to provide them with a list of the basic testing you require, including the type of materials involved and the specifications you need to meet. Include your desired turn times for each type of test and the expected frequency of your sample submissions.

Ask questions, including the names of clients who you can contact. When calling the references, ask them to verify the basic positive indicators and questions you asked the candidates. .

Step 4: It’s Data Time. At this point you’ve collected the basic data you need. Now it’s time to score the candidates. Go back to your basic spreadsheet and headline the next columns with the names of each candidate or simply label them Lab A, Lab B, etc.

Establish a numerical grade for scoring. For display purposes, Table II uses 1 through 5, with 1 being the lowest and 5 the highest score for each positive indicator, and the same formula is used for negative indicators.

Follow this simple systematic process and you will be amazed at how apparent the correct lab choice becomes. In addition to saving time and cost, you will have a well-documented record of the process.

Maximizing Value

Now that you have selected a lab partner, it is important to learn how to make the most of what you receive from them on an ongoing basis. Here we will examine the process to prove how simple it is to increase that value by building a collaborative relationship.

Partnering is a fundamental shift in the way value is created. The shift is from value that resides in the product or service to value that is created for both parties through the experience of the buyer interacting with the seller. The idea is to move from the traditional buyer-seller relationship to one of mutual collaboration and trust through openness and communication. It is essential that the participants develop common objectives and desired outcomes from the relationship.

Relationship Basics

Quality, speed, ease of doing business, and cost frequently define value for both manufacturers and laboratories. Rank in importance tends to follow this order with little variation.

We will evaluate ways to enhance these key values, but first it is essential to understand some basics in how clients and laboratories operate. It's all about time, which in turn is the primary cost generator.

In testing laboratory operations, the time that lab personnel spend on performing a test tends to be relatively fixed and is generally not the major consumer of time in the process. The bulk of time is spent on sample login and sample preparation. Login involves clearly defining what is to be done, along with specification review and preparing the instructions for the work centers involved. Sample preparation may include sectioning, machining, grinding, mounting, polishing, or preparing the material in solution. Conducting the test and report preparation are the last and often the most rapid operations conducted.

Here are some practical ways the manufacturer can positively affect reduction in time, which reduces cost before even entering an order. This preplanning can assure quality, reduce time and costs, and add to ease of doing business for both partners. Preparing the order accurately and completely is the role customers play that can have the biggest affect on maximizing the value received.

Step 1: Sample Requirements. Start by finding out from your lab partner what the minimum and ideal dimensions are for the test samples you will need tested. Submitting an unusable sample has significant time and cost implications for both partners. At this point you should also learn what sizing and machining the lab will do before testing. You may be able to use this information to submit samples that eliminate or reduce time in a step the lab would need to take.

Step 2: Prepare the Test Order. Point out exactly what you want done and what specifications are required, including the type of material submitted and the required specification revision testing levels. Many specifications are long and may contain requirements for several tests, some of which may not be required by you (the customer), so be as specific as possible. Your lab partner will appreciate it greatly if you furnish a part print or schematic drawing to show how the part should be sectioned for testing, and detailing where the testing is to occur. Be sure to include sample dimensions, configuration, and orientation of the test piece, along with heat treat condition and heat number. End user and product end use are also very important. Specify the number of photos you will need, if any, and clearly identify and label each sample.

To further assist with the order preparation process, many testing laboratories provide order submittal forms and check lists that are useful in ensuring that you are providing the information they need to quickly serve you with accurate, cost-effective data.

As you are preparing your testing order, questions will arise, and it’s important to contact your lab partner immediately. Quickly clarifying concerns up front can save untold time, cost, and anxiety for both partners further down the road.

Here is a tip on what not to do when submitting your order. The temptation is very strong to enter the phrase "test the same as last time" on your order. Your lab partner will often frown on this practice and ask for detail. Remember, your lab partner’s entire operation revolves around receiving and issuing precise data and eliminating risk. There is an easy and accurate way for you to submit the same type of material for the same tests on a repeat basis without resubmitting all of the redundant detail. A solution that is positive for both partners is to place a "blanket order". If you have a need to periodically submit testing requirements for the same material to be tested to the same specifications, you can prepare a "blanket open order" and send new releases referencing this open order each time you submit samples. When you submit the blanket, you can control it by specifying that it is to remain open for either a specific time period or be for a specific amount of money. This method saves time in order preparation and paves the way for guaranteeing price for a specific period.

Some companies shop each test order and do business with multiple labs. Commitment to one lab partner reduces administrative cost and eliminates shopping time.

Step 3: Establish Metrics. So far we have looked at building a partnering relationship based on accuracy in communication that saves time in several ways. Now let's establish some measurement metrics that will verify the increase in value we seek. The relationship you are building obviously creates value, but for measurement purposes we will convert all value gains to cost metrics You will need to do a little more homework here as each company is different. Establish some cost estimates for certain activities such as the following:

Step 4: Done! Following the basic guidelines put forth in this article can greatly enhance the value you receive from your material testing dollars. Working with your lab partner in this manner to build a true collaborative communications relationship will assure that value continues to build for both parties. As you learn to fulfill each other’s important needs, shared cooperation will successfully replace negotiation as a way of doing business.