Kalypso acquired by Rockwell Automation, Inc. (NYSE: ROK). Read the press release.

Medical Device Playbook:
Guidance for Manufacturing Devices in a Crisis

Manufacturing medical devices is complex, especially if you are pivoting to manufacture a new device, or manufacturing a medical device for the first time.

Efficacy, safety and quality have never been more critical, and in a highly regulated industry, all manufacturers must maintain regulatory compliance.

Understanding leading practices around regulations, processes, data and collaboration can help you get up and running quickly, and with the best possible outcomes for patients and healthcare workers on the front lines.

In this volatile environment, there has been one constant theme: a shortage of resources. COVID-19 has led to a surge in demand for the medical supplies required to diagnose and treat patients. This has created massive supply chain disruptions, impacting lives and outcomes for patients and healthcare workers.

As a result, companies are finding alternative ways to fill the demand/supply gap. Some are releasing medical device designs into the public domain, while others are partnering with companies who aren’t traditionally in the life sciences manufacturing space. These partnerships aim to increase the availability of critical components, and in some cases, non-medical device companies are pivoting to manufacture or assemble semi and finished devices.

Many companies have pivoted and stretched outside of their expertise to help, demonstrating remarkable ingenuity and compassion. It’s work like this that will help us weather this storm.

Medical Device Playbook:
Guidance for Manufacturing Devices in a Crisis

Here’s our guidance for the companies stepping up to help – whether you are a current medical device company pivoting to manufacture a new device, or you are manufacturing a medical device for the first time.

SECTION 1:
Regulatory Compliance

Make sure you are aware of the following regulatory changes and considerations.

Manufacturing and distribution of medical devices in the USA are regulated by the FDA based on classification, and each classification has different levels of scrutiny in their design and manufacturing processes. The FDA classifies medical devices in three levels based on risk associated to the device (see image).

The European Union and rest of the world have differing regulations and often follow the ISO standards such as ISO:13485. FDA requirements and guidance documents overlap and sometimes reference ISO standards but there are unique needs with each.

The FDA has issued an Emergency Use Authorization (EUA) in order to strengthen the nation’s response to the pandemic by increasing the manufacturability of specific medical devices. Europe and some other nations are making similar concessions. According to the FDA, “the FDA does not intend to object to limited modifications to the indications, claims, functionality, or to the hardware, software, or materials of FDA-cleared devices used to support patients with respiratory failure or respiratory insufficiency, without prior submission of a premarket notification under section 510(k) of the FD&C Act and 21 CFR 807.815 , for the duration of the declared public health emergency.”

While the FDA has relaxed their filing process, you still must control product realization by means of a product lifecycle management (PLM) process, following device design control guidance for the design and development, manufacturing, distribution and the use of the device.

These key aspects of PLM, along with an understanding of how regulated the processes and systems are (including verification and validation), will help ensure the products you put out on the market are safe for intended use.

Regulatory Compliance Summary

  1. Understand the classification of your device and the associated level of scrutiny

  2. The FDA regulates devices in the USA, but the EU and the rest of the world have differing regulations and often follow ISO standards
  3. The FDA’s EUA temporarily relaxes the filing process, but you still must follow design control guidance for the product development process

SECTION 2:
Medical Device Process

For those who have never made medical devices before, be ready to follow the journey of a medical device manufacturer.

The journey starts with creating and controlling a proper Design History File (DHF) with an emphasis on risk management to increase the likelihood of authorization from the FDA to manufacture and sell the device.

A well-established DHF will allow you to create and manage the Device Master Record (DMR), another FDA requirement, which will provide you with all the specifications and processes defined to effectively and efficiently build, test, package and service the device.

During the manufacturing of individual devices, the Device History Record (DHR) will be used to accurately trace the device through the remainder of its life on the market, by means of a Unique Device Identifier (UDI).

A Regulatory Information Management Solution (RIMS) capability allows you to track the regulatory data (including expiration dates, approval status, shipping flags, etc.) that you need for registration and the related submission to FDA and/or other international agencies. The submission content is traced into the DHF and DMR. Changes to the DHF or DMR (i.e. device components, specifications, manufacturing and use procedures, etc.) are integrated into this RIMS capability. This helps reduce the risk of implementing a change that will negatively impact the safety or efficacy of the device. It will also prevent failure to notify the FDA or other agencies if a change (or set of changes) occurs that requires a new approval or notification.

This will allow traceability into changes to devices, procedures and processes to outline the proper steps to be followed to minimize the risk of implementing a change that will negatively impact the design or use of the device.

Medical Device Process Summary

  1. If you have never made medical devices, prepare now to follow the correct process
  2. Create a Design History File (DHF), a Device Master Record (DMR) and a Unique Device Identifier (UDI)
  3. This will allow traceability into changes to devices and minimize the risk of making changes that will negatively impact device design or use

SECTION 3:
Post-Market Quality Integration

Maintain a robust Quality Management System (QMS) through the PLM solution.

Once you have produced a medical device and it’s being used in the field, there are still important regulations in place to ensure patient safety. A robust QMS will ensure that you have traceability into all the devices you have manufactured, which will be important as you are now subject to regulatory audits.

The QMS also provides you the ability to track all non-conformances and customer complaints in order to identify, investigate and solve any device issues. You will also be required to regularly assess the health of your quality management system by performing internal audits, checking your compliance to all areas of ISO 13485:2016, and FDA Part 820 and supplier audits, and ensuring suppliers of key medical devices are also continuing to stay compliant.

PLM has the ability to manage all aspects of the QMS and integrate into the components mentioned above, including DMR, DHF, changes and RIMS.

A healthy QMS also requires you to regularly assess the status of all your devices currently in the market, by means of post-market surveillance.

Post-Market Quality Integration Summary

  1. Once you have produced a device and it is being used, you are subject to regulatory audits
  2. Maintain a Quality Management System (QMS) to track all customer complaints and non-conformances, and investigate and solve any issues
  3. Internal audits are required to check your compliance to all areas, as are supplier audits to ensure suppliers of key medical devices also remain compliant
  4. PLM can manage all aspects of the QMS, including audits, complaints and non-conformances and integrate this back to the design control and change control processes described above

Resources and Links

We're Here to Help

This playbook is based on industry-leading practices in product development from our years of experience serving leading medical device manufacturing companies.

Together, we can work as an industry - and across industries - to get products into the market quickly, while maintaining standards for safety, compliance and efficacy.

We stand ready to help companies where it matters the most in this unprecedented time. Let us know how we can support you.

Our Experts

Dave Hadfield 2018
Managing Director, Life Sciences
Stephen Birtsas 2012
Director, Medical Device
David Wolf 2017
Director, Medical Device