What is the best way for medical device professionals, early-stage, and established companies to select and engage with contract manufacturers? One medtech expert has a winning formula that he wants to share with listeners of the show.
In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Mark Rutkiewicz, VP of Quality at Innovize, founder of Consiliso LLC, and author of Medical Device Company In A Box.
As a contract manufacturer himself, Mark brings a wealth of knowledge and insight to his discussion with Jon and Etienne, helping listeners understand how to navigate the selection process for medical device contract manufacturers.
Some of the highlights of this episode include:
- Characteristics to consider when evaluating a contract manufacturer include cost, plant location, services provided, complexity of product, process validation, and available technology.
- Who’s doing what? Create a quality agreement because the overlap and what’s covered under the contract manufacturer’s and medical device company’s quality management system (QMS) should interact and intermix.
- There are four levels of risk and criticality when selecting suppliers for contract manufacturing: Zero (office supplies) to Level 3 - what you do is going to directly affect the patient experience.
- Some contract manufacturers have dedicated auditors to control information. MedAccred is an outsourced organization that conducts audits of medical devices and products.
- When outsourcing to contractor manufacturers, manual work may be cheaper, but automation provides consistent and better quality products.
- A master validation plan should set expectations of how to validate the product. Modify plan, release reports, and conduct risk assessment to make a product that meets a spec.
- Contract manufacturers need to communicate to share knowledge and understanding of what a medical device/product is used for as well as the scope and process controls.
Memorable quotes from Mark Rutkiewicz:
“You can outsource all these different aspects and that’s all part of contract manufacturing.”
“The price of the part and what your volume is going to be is directly related.”
“What you do is going to directly affect the patient experience. If you mess up, they might die.”
“Contract manufacturers - we just take a little cut. We’re not making huge profits.”
Links:
Mark Rutkiewicz on LinkedIn
Mark Rutkiewicz on Twitter
Innovize
Consiliso LLC
Medical Device Company In A Box: The Case For Consiliso
How to Select a Contract Manufacturer for your Medical Device - White Paper
FDA - Device Registration and Listing
ISO Standards - Sterilization and Validation Services
