Skip to main content

Author: Amber Hilfiger, Director of Operations and Senior Quality Engineering Consultant

As the global demand for medical devices grows in parallel with a continually evolving regulatory landscape, the need for expert medical device outsourcing is stronger than ever.

A recent market analysis report finds that medical device outsourcing is expected to grow at a compound annual growth rate (CAGR) of 10.4% from 2020 to 2027.

Expected updates to ISO standards and the recent regulatory changes in Europe will drive significant demand for quality assurance and regulatory affairs outsourcing services. The quality assurance segment is anticipated to register the fastest CAGR during this period.

The best person for a full-time position at your company may not have the niche expertise required for a particular project, and you must look elsewhere.

Outsourcing your quality assurance (QA) and regulatory affairs (RA) services is about much more than finding a low-cost solution to submitting paperwork. Look for a thought partner whose real-world knowledge and mastery of industry protocols will help guide your organization along a path to future success.

Following, I’ve compiled answers to some of the most frequent questions we receive about outsourcing:

  • Can you describe common problems that outsourcing can help solve?
  • What are the benefits of outsourcing?
  • How do I know if outsourcing is right for my company?

Why Outsource?

Depending on your organization’s size and the resources available to your team, you may want to consider entering into an outsourcing agreement for two primary reasons.

Resource capacity: For start-ups and small-to-mid-sized medical device manufacturers, you may not have an immediate need for a full-time dedicated resource on staff to handle the QA/RA work that needs to be done. Further, you may not have the funding for a full-time position, or you may simply have an overflow of work for a short period.

Expertise gap: As medical device projects become more specific, specialty expertise is often needed. The best person for a full-time position at your company may not have the niche expertise required for a particular project, and you must look elsewhere.

Top Three Benefits of Outsourcing

Outsourcing QA/RA services helps medical device manufacturers solve their resource issues and access the expertise when and where they need it.

Here are the top three benefits of outsourcing:

  1. Ability to scale capacity. Grow and shrink QA/RA services to fit your needs as your company evolves to maximize your budget.
  2. Far-reaching experience. Access to better, more qualified people with a broad range of QA/RA experience. You’re not just hiring one person; you’re tapping into a wealth of knowledge and expertise across consultants. For example, when you outsource to QA Consulting, you also have access to our microbiology expertise.
  3. Affords peace of mind. Outsourcing QA/RA services to a medical device consulting firm that shares your values for quality excellence allows you to focus on other areas of your business.

Is Outsourcing Right for Your Medical Device Company?

Below are some additional considerations to determine if outsourcing services is the right direction for your medical device company:

  • Your company seeks guidance in developing a strategic vision for QA/RA services.
  • You have had difficulty recruiting and/or retaining experienced professionals in these positions.
  • You want to maximize your budget.

The final piece of advice I give medical device manufacturers considering outsourcing is to see the partnership as a learning opportunity. When you engage a consulting firm, you are investing in a deep well of knowledge and experience. Listening to and teaming up with your thought partner will help you achieve the highest standards of quality and avoid future roadblocks.

Seek a Thought Partner Who Understands Your Business

Every quality assurance and medical device regulatory affairs consulting engagement looks different depending on your company’s needs and where you are in the product life cycle.

With more than 100 years of combined experience, you can feel confident the QA Consulting team has the medical device quality systems knowledge and expertise to help you meet your business objectives. Our team has worked with various medical devices, including heart valves, orthopedic implants, stents, transcutaneous electrical nerve stimulation (TENS) units, bone density measurement software, and more.

QA Consulting can design a custom outsourcing solution that takes into account the type of medical device and your business objectives. Engagement can be as short as one month or last for several years. One of the many benefits of outsourcing to QA Consulting is that we’re always available for consultative advice on new projects or to follow up on the work we’ve done with you.

Contact us to discuss if outsourcing is right for your company.