“How should we think about quality?”

In a different context, this might be a metaphysical question. But in the context of this blog post, this is a practical question that we are asked often by budding medical device startups. So we decided to write a post to cover a key set of related questions.

If you’re a startup looking for part-time or full-time quality consulting expertise, reach out and we can introduce consultants in our network.

If you’re a quality expert looking to work with medical device startups, reach out to join our partner network.

Early Quality Responsibilities And When To Hire Full-Time

Hint: Quality is leadership’s responsibility starting on day 1. But most startups won’t need a full-time quality hire until around the time their first submission is in.

Once you’ve submitted your first device for clearance, you need to get serious about having a full-time, in-house quality owner.

Up until this point, it’s the responsibility of startup leadership to ensure that quality best practices have been implemented. This includes a foundational quality management system, properly documented design and development activities, and adequate training.

But once the first product is submitted, quality escalates to another level. You need to be ready to handle customer inquiries and feedback, your supplier management program is running full tilt, design controls are final and validated, you've started working on full commercial-sized batches of production, you will have data to monitor from a process capability and improvement perspective, and you’ll have post-market surveillance requirements.

All of these activities need well-designed systems to support them, and if you’re like every other startup out there, you’ve done very little to be fully prepared. And that’s understandable, because startups need to focus–you’ve been heads down in a loop of design -> build -> test -> improve -> test. And the closer you get to your submission, the more you’ll question your processes. Did we document that change? What should go into our submission? Did we describe that properly? What was in our label claim? Are we allowed to say that?

Hopefully, you spent some time up front building a solid regulatory strategy, and working with a thoughtful partner to implement an efficient foundational quality system. And if you did, then your submission will have a higher chance of sailing through with maybe a few clarifications requested but nothing major, and you will be able to ship product very soon.

At this point, you really need a full-time quality hire.

What To Look For in a Head of Quality

First, let’s talk about a mistake that many startups make in the form of what not to look for: the former VP of Quality from some giant, brand name company. These folks are more often than not unable to operate in the way that startups require. They won't be able to build these systems alone. They will be used to having a small army of people doing all the work for them. So please, that résumé might look amazing with those big names and big titles, but if it's been years since they actually wrote an SOP themselves, that person isn't going to actually be useful. Let’s talk about some of the qualifications that seem to work well for medical device startups.

• Mid-career with experience at large and especially small companies

• Ideally, they’ve gotten a few products to market

• Have built out quality processes from scratch

• Systems thinker with the ability to design and implement systems involving technology, process, and people

• Ability to advocate for quality and quality resources

• Network they can rely on for nuanced questions

Of course, you also want all the usual things like solid communication skills, attention to detail, leadership, and proficiency with software tools.

From an industry knowledge perspective, it’s great if you can find someone who knows your particular product or problem space. But this is a nice-to-have, and not a substitute for the other more important skills. Regulations and standards translate across product classes. In other words, the same regulations apply from band-aids to pacemakers. Of course there are more hoops with pacemakers, but the foundational quality system elements are the same across all those devices. Document control, training, CAPA, complaint handling...all the same frameworks. Just make sure you can find someone who is able to contextualize these frameworks to your particular organization.

A Few Parting Words

As you secure your startup's first full-time Head of Quality, remember that this role is pivotal not just for compliance but for shaping the culture of quality within your organization and for your overall product velocity.

The right candidate isn't merely someone with a strong resume; it's someone who can grow with your company, building scalable systems and fostering a quality-centric mindset across all teams. As you embark on this crucial hiring process, prioritize candidates who demonstrate the ability to establish and refine quality processes that can evolve with your startup's growth. Quality should be woven into the fabric of your operations from day one, and your Head of Quality is the key to making that a reality.

Keep in mind, quality isn't a department—it's a collective responsibility. The interview process should reflect this by incorporating real-world scenarios or case studies that reveal how candidates approach problem-solving, system-building, and fostering a culture of quality across various departments.

Lastly, empower your Head of Quality with the tools they need to succeed. This goes beyond moral support; ensure they have access to a sufficient software budget and resources to implement robust quality systems.

The investment in quality today is the foundation of your startup's success tomorrow. By focusing on these principles, you'll not only attract a capable Head of Quality but also set your startup on the path to long-term success beyond regulatory compliance.