AMA on Contract Manufacturing & Supplier Management


Userlevel 5
Badge

Every Wednesday we host in industry leading expert to answer all of your burning questions. We call these AMA (Ask Me Anything) sessions… And since they are held on Wednesday, it’s WAMADay! 

This weeks topic is over the Contract Manufacturing and is with Mark Rutkiewicz, founder of Consiliso: Medical Device Company In A Box

After 30 years in the industry, Mark Rutkiewicz is well known for fixing Quality Systems in all sizes and types of medical device companies. And even more known for moving beyond compliance-focused functions and fixing all the other business process and information sharing issues across the company.

We hope this is a valuable, interactive session that is able to help you with the challenges you are currently facing!

If you have questions about the format, please send a message to @Etienne and let me know!
 

 


12 replies

Userlevel 2
Badge

How do we maintain control of our product and make sure that our suppliers are not “borrowing” our technology for other products that they build?

Userlevel 3

Do you have an inventory management software you recommend? We have about 100 employees, and we have 4 product lines (there are a few variations within each product line.) We have a few low-volume lines in-house (<10,000 parts per year), but send all our large-volume (>100,000 parts per year) to our Contract Manufacturer. 

Userlevel 1
Badge

Any tips on how to best evaluate contract manufacturers? 

For example, we are still in the prototype phase and aren’t using a CM right now. We’ll likely always be low-volume, so we’re not sure how a large CM will respond if/when we issue SCAR’s and so forth. Is this ever a problem for smaller volume medical device companies?

Userlevel 2

Can you advise on how to set up a bill of materials to have have an alternate supplier? Wouldn’t that require an additional verification on the part that comes from a secondary supplier?

Userlevel 2

I read your book, “Case for Consiliso: Medical Device Company in a Box” and thought it was great! Thank you for all the work you’ve done. 

There is one place where you talked about working on a defibrillator for an airplane. I can’t remember exactly how you handled it with your QMS, but it seemed like you merged the FAA & FDA QSR requirements.. Can you elaborate on how companies can do this efficiently? 

We’re a combination product (co-packed) and are trying to navigate the pharma’s GMP requirements while still staying efficient. Any recommendations?

Do you have any guidance or resources for connecting with contract manufacturers in different markets? We’ve had some longstanding partners in Taiwan but are looking into new regions such as Mexico, DR, Japan, and others. 

Userlevel 5
Badge

What constitutes a “supplier” for SaMD?

Userlevel 4
Badge

Any tips on how to best evaluate contract manufacturers? 

For example, we are still in the prototype phase and aren’t using a CM right now. We’ll likely always be low-volume, so we’re not sure how a large CM will respond if/when we issue SCAR’s and so forth. Is this ever a problem for smaller volume medical device companies?

From experience, yes it can be a problem. You need to ensure that your Quality Agreement specifies who they will handle your requests and concerns, including change orders and SCARs. Ask for references. You don’t really want to be their first “small” customer.

Userlevel 4
Badge

Can you advise on how to set up a bill of materials to have have an alternate supplier? Wouldn’t that require an additional verification on the part that comes from a secondary supplier?

Yes, each supplier’s parts need to go through first article inspection/acceptance testing according to your statistical sampling criteria and based on the criticality of the part.

Userlevel 5
Badge

What is the benefit of alphanumeric revision numbers (prototype vs. production) and is this required ?

Userlevel 1

Any tips on how to best evaluate contract manufacturers? 

For example, we are still in the prototype phase and aren’t using a CM right now. We’ll likely always be low-volume, so we’re not sure how a large CM will respond if/when we issue SCAR’s and so forth. Is this ever a problem for smaller volume medical device companies?

Absolutely this can be an issue depending on the partner you choose to work with as a CM.  As stated previously, any response to issues (timeline, etc) should be clearly outlined in your supplier quality agreement that both parties can agree upfront.  Building a relationship and selecting a supplier is the most crucial step if you aren’t going to build in-house.  If they aren’t interested in your product while you are in the prototype phase, they won’t be interested when you are finished with the design.  Finding a team that is curious about what you are doing and wants to engage early to help with design for manufacturability will be a great positive sign.

Userlevel 1

Do you have an inventory management software you recommend? We have about 100 employees, and we have 4 product lines (there are a few variations within each product line.) We have a few low-volume lines in-house (<10,000 parts per year), but send all our large-volume (>100,000 parts per year) to our Contract Manufacturer. 

I don’t know if you received an answer to this or not, however, there are about as many answers as your number of employees.  Much of it depends on how you want to integrate with your accounting software and/or other ERP software you already utilize.  I’ve managed a couple ERP integrations and depending on what systems you already have will be the biggest source of narrowing down the list unless you are willing to change everything out at the start of a fiscal year.  

Reply