Are you worried that passing FDA regulations for your medical device are going to slow time-to-market and cause your team massive headaches?

Speed to market is an enormous competitive advantage for organizations in the device manufacturing vertical. Avoidable delays can result in hard and soft costs to your company, which include loss of competitive advantage or regulatory fines.

While the best eQMS and knowledge of regulatory requirements can help you comply with FDA cGMP, your organization may also opt for some expert assistance. Leaning on a consultant to guide you through the process can make things easier and provide peace of mind. We'll show you several strong options for FDA consultants who specialize in the medical device manufacturing industry so you can find the best fit for your company.

6 of the Best FDA Consultants for Medical Device Manufacturers

Smart companies hire FDA consultants before they're in trouble to ensure they set up their quality management systems (QMS) correctly. Organizations most commonly hire an FDA consultant when they're facing FDA action or challenges with a product submission because existing QMS systems were inadequate. It often takes an independent set of eyes to see things clearly and make real change. The quality management and leadership team can quickly become entrenched in "the way things have always been", and a consultant can add an invaluable outside perspective.

Read on to unlock profiles of several options to consider when you're trying to hire a medical device manufacturing consultant. When possible, customer feedback is included. While third-party online reviews can be an essential tool to research prospective consultants, many firms do not have published customer reviews on websites like Vendop.

Positive online reviews can provide evidence that a consultancy does effective work, but they shouldn’t be the only tool used in the decision-making process. To verify a consultant’s work record and capabilities, consider sourcing customer feedback by asking for customer case studies, or better yet, a customer interview. Consultancies should be willing to provide evidence of their participation in similar projects and connect you with prior clients for one-on-one conversations.

NOTE: The firms below are well-respected, but you will want to do your own due diligence as you select a partner.

1. MWA Consulting, Inc.

MWA Consulting offers consulting services for FDA compliance, clinical improvement, training, and workshops. Per the website, they offer “a full range of services in GCP, GLP, and GMP compliance from development through commercialization." Team members all have significant industry experience, including leadership at major pharmaceutical companies and startups. Client reviews or online testimonials are not made available online. Project history by this consulting firm is listed online but includes:

  • GMP practice training sessions for R&D personnel
  • Performing internal and external audits
  • Validation of laboratory equipment for compliant testing
  • Providing regulatory support for a 510k filing

2. MDI Consultants

MDI is a "premier" consultancy with a record of serving over 1,000 clients in the medical device and pharmaceutical industries. Since 1978, the organization has fielded a consulting team with significant experience as former Quality Management department leaders. A list of current and former clients is offered online, which includes significant enterprises and smaller, research and development-focused startups and scale-ups.

While there are no reviews of MDI Consultants published on third-party review websites, the firm’s site offers client testimonials. One prior client praised the firm for their “excellent efforts and commitment in assisting us to obtain 510(k) clearance,” stating the MDI Consultant’s team helped compliance issues that could have resulted in additional cost or delayed clearance.” Another client at a medical instrumentation company wrote they “wouldn’t think of experiencing an FDA audit without MDI’s assistance.”

RELATED READING: The 5 Best Medical Device Quality Assurance Training Options

3. Emergo

Founded in 1997, Emergo is a highly specialized consulting firm which offers vertical support in helping medical device and IVF manufacturers of "all sizes" bring products to US markets. The firm provides fully customized, flexible support to medical device manufacturers of all sizes, which includes "small, startup" companies. Their consulting services include:

  • Training on regulatory requirements and quality systems
  • FDA 510(k) submissions for clearance
  • Responses to FDA investigational submissions and requests for classification

The third-party review website Vendop, for professional services firms, has two anonymous reviews of Emergo’s services from international device manufacturers. One client described the team as “extremely knowledgeable,” and praised the firm’s fast turnaround time and responsiveness. According to reviews, the firm provides a single point-of-contact to streamline communications. New call-to-action

4. Ken Block Consulting

Ken Block is an international consulting firm which exclusively serves medical device manufacturers. Founded in 2005 by Ken Block, this firm offers decades of experience in FDA interactions and relevant roles. The agency has three office locations in Texas, France, and Japan. The firm specializes in four categories of consulting services:

  • Regulatory Strategy
  • Regulatory Submissions
  • Interaction with FDA
  • Marketing and Labeling

Customer testimonials and a client list are not offered on the firm’s website, and aside from one five-star Google review, third-party reviews are unavailable.

5. Smith Associates

Founded in 1994, Smith Associates is a consulting firm which specializes in support for manufacturers of medical devices. The firm is headquartered in Crofton, Maryland and has “over 100 years” of industry experience. Smith Associates consulting services include the development and implementation of quality management systems and support for FDA submissions and interactions throughout the company lifecycle. Support is offered for organizations of all sizes.

While third-party reviews are not available, the Smith Associates website includes a published list of US and international clients. Also, an extensive project list portfolio is offered, which includes hundreds of case studies categorized by the type of medical device to assist prospective clients in finding relevant customer experiences.

RELATED READING: What is the Best ISO 13485 Quality Management System Software?

6. The Weinberg Group

Founded over 35 years ago, the Weinberg group specializes in helping device manufacturers and other life sciences companies “achieve their device and drug development goals.” Weinberg Group offers a team of FDA Consultants and FDA Compliance Specialist Consultants to help organizations develop strategies for regulatory compliance, submission, and remediate existing compliance issues. This includes a specialized focus on pre-submission meetings and device submissions for manufacturers seeking FDA approval.

The firm offers online resources for more insight into their services. However, no client list, testimonials, or case studies are published on the website. The consulting firm's Facebook page has eight published five-star reviews.

Hire the Right Medical Device Manufacturing Consultant

Client reviews and testimonials are critical to help evaluate prospective consultants for FDA submission. Before you make a final decision, it's also essential to understand whether a firm can work with your existing QMS to create change. This can be particularly important for device startups and scale-ups who are working to implement a right-sized eQMS system like Qualio. Ask if a prospective consultancy is familiar with Qualio or your QMS. Would they recommend your QMS?

In some cases, big consultancy firms may have a specific recommendation for QMS systems because they're most experienced with that software. This can result in a QMS which isn't the best fit for your organization's size and stage. And, you'll have delays and the added hassle if you have to implement a new system.

It's vital to hire a consultant that is a good match for your company and has experience in the startup space. Not every consultant has a successful track record of helping organizations like your own, and providing support for SMB is much different than enterprise consulting for major device manufacturers. 

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Published by Robert Fenton June 4, 2019
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