Quality and Regulatory Consultant Selection for Entrepreneurs

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Selecting a Quality & Regulatory (“R&Q”) Consultant can seem quite daunting. Especially, if you are an entrepreneur with no prior experience with medical devices. The best advice we can give you is – Please take the time to get this right. All your hard work in technology, logistics, and marketing will be wasted if FDA finds issues with your regulatory submission and quality system.

So, let’s start with – Why do you need an amazing R&Q consultant?

Medical Device commercialization is a very complex undertaking, with many moving parts. These moving parts need to be tackled in a specific sequence to avoid rework and delays. Each medical device is different in regards to applicable regulations, standards, and guidance documents. Each organization is different in regards to number of people, their experience, collaboration and development tools, global markets, launch timelines, and available resources.

The best R&Q consultants spend time to understand specific needs of each client and recommend the best course of action.

Next, let’s discuss – What are the attributes of an amazing R&Q consultant?

Experience – They have experience with many different type of medical devices, organization types and sizes, and the entire commercialization lifecycle.

Customer Centricity – In addition to points stated in previous section, they spend a lot of time focusing on Q&R cost reduction and speeding up launch timelines. For example:

Which Q&R activities are NOT relevant to a client?
How should the client allocate Q&R resources and focus at various stages of commercialization?
Can the client change labeling and thus utilize a faster regulatory pathway?
Is it better to locate manufacturing in US or outside the US?
Is it prudent to schedule a pre-submission meeting with the FDA?

The worst Q&R consultants have a single objective – maximizing their own revenue. Therefore, they will pile on unnecessary and/or “nice to have” activities.

Availability – They are available for you 24/7/365 and via multiple mechanisms (Slack, WhatsApp, Email, Phone, etc.). They respond within a reasonable time, regardless of the size of your business.

Professionalism and Integrity – All their work products are of highest quality and delivered on time and within budget. They go above and beyond to make your vision an reality.

Finally, let’s discuss – How do you find the best consultant?

If you are on a Limited Budget: The best option is to go on UpWork. You can easily review the background, skills, education, and experience of various candidates. UpWork also shows recommendations from various clients as well as a Freelancer rating.

At a minimum – You should pick someone who has a rating above 80%, billed more than 100 hours of work, and is located in a time zone that allows rapid responses.

Ideally – Go for a rating above 90%, more than 500 hours of work, an identity performed badge, multiple certifications, and location within commuting distance to your office.

Advantages: The consultants on UpWork tend to be IT savvy, their ratings reliable, and any disputes are easily resolved by UpWork staff. They are entrepreneurs themselves, so they “get you”. With an eBay-like rating system, both clients and freelancers have a vested interest in successful outcomes. UpWork takes the administrative headache out of the equation for clients. It is a mature platform that handles federal and state tax reporting for freelancers, and also provides detailed financial reports to clients at press of a button.

Disadvantages: UpWork does not have a huge pool of highly qualified quality and regulatory consultants, because not everyone is aware of it. Clients need to put money in escrow to initiate fixed price projects, which is released upon successful completion. Freelancers may not have all the skills you are looking for, so you may need to hire multiple people and manage the project yourself.

If you are on a Medium Budget: The best option is to find boutique consulting firms focused on small businesses. You need to make sure they are reputable, have professional liability insurance, have expertise matching your needs, and adequate bandwidth to take on your project. Finding such firms can be tough, as they don’t have huge marketing budgets. Even if you do find them online, you cannot be sure of their credentials. The best way to locate these is by – word of mouth. Just ask your fellow entrepreneurs next time you are at innovation challenge or similar event.