10 Things You Need to Know about Manufacturing FDA-Approved Medical Devices

Manufacturing FDA-Approved Medical Devices
There are many critical elements to quality manufacturing of FDA-Approved medical devices

The purpose of the Food and Drug Administration (FDA) is to safeguard the health of the American public through the regulation of certain products, including medical devices and food-processing equipment. Health Canada has a similar mandate.

The FDA and Health Canada have full federal authority to ban and recall any products deemed dangerous.

They can also suspend or revoke registration or licensing of an establishment, effectively shutting down manufacturing facilities. Investigations can lead as far as criminal prosecution.

As outlined in a Business Case for Quality at a recent Pharmaceutical Quality System Conference, there are many costs of non-compliance, including:

  • Direct costs (e.g. scrapped materials, production time)
  • Remediation costs (issue identification, correction and reporting)
  • Regulatory action costs (legal, logistical)
  • Market share costs (lost opportunities)
  • Reputational costs (loss of goodwill)

According to FDA regulations, “the finished device manufacturer”, or the OEM, “bears overall responsibility for the safety and effectiveness of the finished device and must control all contractors under 21 CFR 820.”

It’s obvious that a government-issued, publicly visible ‘stop-production’ order can be catastrophic to a customer base, a brand, and a bottom-line.

So how do OEMs evaluate their processes and supply chains when commercializing a new medical device?

And how can OEMs looking for a manufacturing partner for a medical device assess whether the EMS provider is compliant with the Quality System Requirements and Current Good Manufacturing Practices critical to passing an FDA audit?

We can offer some tips based on our own experience manufacturing FDA-approved medical devices and other products in highly regulated industries.

 

3 Things You Need to Know about
Manufacturing FDA-Approved Medical Devices

    1. A Gap Analysis Will Protect Your Investment

      Knowing the right way forward begins with understanding your current state.

      A Gap Analysis will require you to have an intimate understanding of the regulation and identify where you have procedural inadequacies.

      A good manufacturing partner will ultimately help you address some of these gaps.

        • Go through each step of the regulation.

       

        • Identify and size up the gaps in your documentation system first, then look at the implementation gaps.

       

      • Find an expert resource for advice, don’t reinvent the wheel. Consultants and other resources are available to help you address a particularly weak area.

 

    1. Get Your Team On Board

      Similar to many practices that stem from technical initiatives, it’s not enough if it’s only the management team that understands the implications of the regulations. We can’t stress this enough!

      Everyone with their hands on FDA-approved product needs to understand the consequences of deviating from procedure.

      For example, a production associate may not realize the full significance of a Line Clearance Procedure…until a process deviation results in product mix-up, which results in a product recall. Or maybe until two similar labels get confused, which results in a patient receiving incorrect care.

      Waiting until the “until” is not acceptable!

        • Roll out comprehensive communications programs to connect the product with the end customer.

       

      • Ensure everyone involved in building FDA-approved medical devices understands the impact of their work!

 

Good team communications and documentation are essential elements
Good team communications and documentation are essential elements
  1. Build a Robust Training Program and Keep Complete Training Records

    There’s perhaps nothing more critical than traceability to the process of manufacturing regulated products like medical devices.

    Because of product significance and legal liability, a document trail is essential.

    More importantly, should an adverse event take place, visibility of the processes and parties involved can help save lives.

      • Ensure that you have properly defined which documents constitute your Device Master Record (DMR) and Design History File (DHF) to avoid iteration.
        (Hint: if you aren’t familiar with the DMR and DHR, go back to your Gap Analysis. Alternatively, contact our Creation Design Services team who can walk you through the development process).
      • Construct a solid system for conducting and controlling training that accounts for all people that touch your product as it’s being manufactured.

     

    • Once training is completed, make sure that your training records are well-defined and available for review by an auditor or other party.

    If you need additional resources in constructing your training program, today there are many good courses available. We recommend AAMI (Association for the Advancement of Medical Instrumentation) for a variety of programs that are taught by experienced regulatory professionals and endorsed by the FDA.

Manufacturing top-quality medical devices takes a great deal of preparation, expertise and commitment. At Creation, we know that the investment is worth it.

We are very proud to partner with medical device OEMs who do so much to employ technology to improve the lives of people around the world.

Our first blog post dedicated to this important theme outlines the first three things you should consider when deciding how to manufacture your FDA-approved medical devices. Stay tuned for the next installment!

Success & The Transformation of MedTech

Changes to the MedTech Industry and Importance of Quality
Changes to the MedTech Industry and Importance of Quality

Transformation of MedTech

No matter your political opinion of the changes underway in the MedTech industry, one thing is clear: just as it already has, change is gonna come.

Many industry analysts point to new business models, increased innovation and a more holistic view of the medical ecosystem as the way forward.

In truth, isn’t that just good business?

After all, who wants to invest in, work for, partner with, or buy from, a company that doesn’t include empathy and advocacy for its end customers as a key driver of its value proposition?

We figure our customers are already doing some pretty amazing things for the business communities they serve.

In the case of our Medical customers, it’s possible that they’re already a step ahead of their competition given that it’s quite clear that they view these ‘business communities’ at their most elemental…the individuals whose lives are ultimately enriched and bettered. We’re proud to have partners like this.

It’s also clear that our Medical customers are strategists and innovators, always looking for new ways forward. It only follows that, in order to keep offering the best services to our customers and their end customers, EMS providers like Creation also need to keep pushing the envelope.

For our Medical partners, we believe this means offering solutions specifically focused on reducing R&D costs and time-to-market:

  • Expert full-product design and integrated manufacturing specifically for Medical Devices
  • Lean practices and leadership
  • Ready access to real-time data through a customer portal
  • Premium quality and technical expertise

 

Having FDA-registered business units, our most recent in our manufacturing locations in Milwaukee, Wisconsin and Lexington, Kentucky, for example, is one of the ways Creation is enabling our customers to move forward quickly and confidently.

As the MedTech industry continues to evolve, perhaps one of the most important characteristics an EMS provider can have is a customer-focused approach that mirrors the customer-focused approach that drives the Medical industry.

For Creation, this means taking an interest in, and having an understanding of, the industry drivers that help our customers anticipate requirements and capitalize on opportunity.

So, what drives your own value proposition?

USA FDA Registration for Creation Technologies

FDA registration for Creation Lexington
Creation Technologies FDA

We’re really excited to announce FDA Registration for Creation’s Lexington manufacturing location! Lexington is the 5th Creation manufacturing facility to receive FDA registration, and our 1st business unit in the USA to be FDA-registered.

As Andy Hyatt, our Executive Vice President, says in a recent press release, we’re committed to doing whatever we can to help our partners succeed. For our Medical Devices customers and other OEMs with electronic devices requiring FDA approval, ‘whatever we can’ means Creation having ISO 13485 registration and FDA compliance in our business units.

You can read the full press release here: https://www.creationtech.com/Upload/news/Creation_Technologies_Receives_FDA_Registration_in624798454.pdf

The Changing Medical Devices Landscape: Compliance & Social Media

Medical Devices: Creation Technologies Receives FDA Registration
FDA Registration increasingly important in OEM-EMS Provider relationships

One of Creation’s fastest growing segments is the Medical Devices market, and it’s an extremely exciting one.

Compliance & Innovation

For many reasons, it’s clear that the Medical industry is being transformed. I don’t think it can be overstated that, now more than ever, strong partnerships between OEM and EMS provider are critical to innovation and time-to-market.

After all, as the demand chain goes, so must the supply.

Fundamentally, the need for compliance is at the forefront. With the recent changes in FDA requirements for medical device registration and listing, more contract manufacturers will be seeking FDA registration to prove compliance capabilities.

(A small plug: recently, Creation’s Mississauga business unit became our 4th North American manufacturing facility with FDA registration. 12 of our13 manufacturing business units are ISO 13485-certified, and Creation Design Services is both ISO 13485 and ISO 14971-certified. You can read the press release here: Creation Technologies Receives FDA Registration).

At the same time that increasingly exacting regulatory requirements are challenging Medical Device manufacturers to keep raising the Quality bar (how high is high?), technological innovation continues to drive industry innovation.

For instance, the potential of micro electromechanical systems (MEMs) and the trend toward personalization are inspiring the new era of Connected Health, or the transformation of healthcare as we’ve known it through the increasing use of new wireless technologies.

For EMS providers like Creation that have extensive Communications experience, this intersection of what were once distinct vertical markets is exhilarating. And, of this subset of EMS providers, those with sophisticated Design capabilities have the opportunity to play an absolutely vital role in design and development of new modalities.

Medical Devices & Social Media
How will innovations in communication change the Medical Devices industry?

Social Media & The FDA

At Creation, we’ve seen our Medical OEM partners taking a more holistic view of patient care, which is one of the things enabling them to outpace their competition in this environment.

But is there such a thing as too inclusive, too “customer-centric” when it comes to the Medical Devices industry?

On the subject of personalization and ‘on demand’ use, it’s fascinating from a marketing and communications standpoint to see the breadth and type of information that’s being shared today in this highly regulated industry.

There’s an interesting interview with Tom Abrams, Director of the FDA Office of Prescription Drug Promotion, about the potential impact of social media and the much-awaited FDA guidance on its use (possibly slated for summer 2014).

As someone involved with social media and digital communications strategy, I was struck by one of Abrams’ comments:

“Our objective is that when you present claim information, it should be balanced with appropriate material, such as risk information. It should not just say all good things about a product and leave out the risk.”

While the focus of the interview is primarily on how pharmaceutical companies are using social media to communicate with their consumer audience, what strikes me is that Abrams is calling for a ‘balanced approach’ to social media use in the Medical sector.

Current information consumption statistics tell us that the longer the message is, the more diminishing the returns. (On that note, I hope you’re still reading!!) Similarly, many social media platforms have a very short character limit for updates in order to maximize activity and optimize the user experience from an architecture standpoint.

While this is almost certainly a chicken-and-egg scenario, the fact remains that attention spans are dwindling and so ‘balanced’ approaches are highly uncommon. Hit ‘em hard, hit ‘em fast, and with just one key message. Not several. Not inclusive, and balanced.

I’m very curious to see what the FDA’s social media guidelines will entail, and how people and companies will respond.

What do you think? How will this increased focus on compliance – in production and communication – affect a company’s ability to innovate? Will Medical Device manufacturers be thwarted in their quest to connect with the patient to develop solutions that best fit their needs? Or will avenues like expanded at-home diagnostics revolutionize the industry?

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