Avoid Costly Missteps and Oversights with the Right Medical Device Development Partner

It doesn’t matter if your medical device company is a hungry new startup or a seasoned industry leader: There are times when you need to augment your in-house team’s capabilities. Whether you need help with user interface design, engineering, usability testing, or all of the above, the success of your medical device hinges on selecting the right partner (or partners). And, especially if you are looking to outsource a variety of disciplines, you’ll need to decide whether to piece together a team of different suppliers — or invest in a single, turnkey design and development partner.

Here’s what to consider before making this important decision.

Selecting Medical Device Development Partner: Three Choices

When it comes to hiring external partners to augment your team’s medical device development capabilities, you have three options:

1. Hire an individual consultant. The decision to hire an individual consultant — such as a single mechanical engineer or industrial designer — makes sense when you need to meet a very specific, contained, and singular need. For example, you might hire individual consultants simply to add bandwidth or temporarily increase that side of your existing team. Alternately, you might find that an individual consultant makes sense if you want access to a very specialized skill set that is only needed for a small portion of the project. While hiring an individual usually costs less, doing so comes with some inherent risks. What if something unexpectedly happens to them? What if they are suddenly less available due to other commitments? Or what if you simply need to scale up your support beyond what one individual can provide?

2. Hire a specialized company. Hiring a specialized company, such as an industrial design or user research firm, is typically more costly than contracting an individual consultant. However, you get the benefit of having multiple experts contribute to your solutions. Additionally, you can scale up (or down) your level of service as your needs fluctuate. And, on a related note, you can usually expand the breadth of services as needed, too. For example, if you hire a mechanical engineering company, you may find that they have other useful capabilities, such as prototyping or verification testing services.

3. Hire a turnkey medical device design and development company. Finally, you can choose to partner with a full-service design and development company. This is how we define our work at MPE (Formerly Mindflow Design). Turnkey partners offer a suite of complementary services — including all of the skills and capabilities required to design and develop medical devices. These organizations are larger and more complex than a specialized company. They are also more than the sum of their parts. Remember, they are built from the ground up to handle a wide range of design and development needs. They understand the nuances and regulatory processes associated with medical device design. Which means they can help your organization take the right steps at the right time. Additionally, you get the benefit of the proven processes that these organizations have in place to ensure experts in different fields work together in unison to achieve your goals. Lastly, many turnkey providers hold Quality Management System (QMS) and ISO 13485 certification. In the event that you decide to designate them a critical supplier, these certifications mean you can be confident they will pass the necessary quality audit.

What Level of External Assistance is Right for Your Medical Device Company?

The decision to piecemeal your external support team or invest in a turnkey provider depends on a variety of factors.

What are your needs now — and in the future?

You know what your needs are right now. But what about during the later phases of the medical device development process?

The truth is, what you need today may only be the tip of the iceberg. Try to look past your immediate requirements and consider what other areas you might need help with over the project life cycle. At MPE (Formerly Mindflow Design) , we often begin our engagements with clients by focusing on a single service, such as research, engineering, or UX/UI. Only later do they realize that they want and need to expand our work’s scope to include additional services.

To get the big picture, you’ll likely need to touch base with each manager overseeing the individual business functions that will contribute resources to the project. These conversations can be surprising. For example, you may discover for the first time that your project needs resources for anything from mechanical engineering and industrial design to human factors engineering and instructions for use.

How familiar are you with the medical device development process?

If you are new to medical devices, it will be harder to anticipate your full scope of needs from the outset.

That’s perfectly understandable. But it’s also a major risk.

You see, the medical device development process is riddled with complexities and regulatory requirements. In this world, missing a step can mean a catastrophic hit for your budget and project timeline.

Because that’s true, you need a guide as much as you need a subject-matter expert. In fact, finding a development partner who knows what needs to be done — and in what order — is almost more important than finding one who knows how to do it.

Let’s say you put together an external support team by hiring a mix of individual consultants and specialized companies. There’s no guarantee any one partner will have a full understanding of the medical device development process.

In fact, we’ve had clients come to us after they designed a device and ask if we can retroactively recreate the necessary FDA Design Controls procedures. When we ask how they managed to skip these critical steps, they inevitably explain that they hired a handful of individual consultants or a design firm that doesn’t specialize in medical devices. As a result, no one advised them properly until it was almost too late.

By hiring a full-service design and engineering firm like MPE (Formerly Mindflow Design) , in contrast, you gain access to an experienced team with a holistic, soup-to-nuts understanding of what’s required to take a medical device to market. When assessing turnkey providers, look for ISO 13485 certification. This is the only sure sign that a company is qualified to offer comprehensive medical product design and development services.

Established companies versus startups

A turnkey partner can benefit either a startup or an established company, albeit in different ways.

As we just explained, startups need turnkey partners because they need help understanding the what of medical device development. Yet startups often make the mistake of hiring individual consultants to solve compartmentalized problems. Each consultant advises on their small piece of the project without understanding how it fits into the big picture.

The highest value a startup gets from a turnkey partner is access to a comprehensive understanding of what needs to be done, as well as a proven process for getting there. For example, at MPE (Formerly Mindflow Design) , we use a sophisticated set of project diagnostics to quickly gain a 360-degree view of our clients’ projects. In doing so, we identify gaps and missing pieces and prescribe the right strategy to achieve their business goals.

Unlike startups, established medical devices companies are often just looking to extend their bandwidth for the duration of a project. However, there are often other issues lurking just under the surface. A turnkey provider is most effective for established medical device companies that:

• Haven’t brought a new medical device to market in years or even decades. Companies like these often find that their R&D teams have evolved into “maintenance” teams. They are more skilled at sustaining and refining existing products than innovating new ones. They may also be unfamiliar with today’s standards and regulatory requirements.

• Suffer from outdated or insufficient internal processes. Without the right process in place, no amount of money will lead to a successful outcome. Companies like these are looking for a new — but proven — way of doing things.

Why Hire Individual Musicians When You Could Hire an Orchestra?

Imagine you are planning a lavish party, complete with live classical music. Would you hire twenty individual musicians and ask them to show up at the same time prepared to play Mozart symphony number 40 in G minor? Or would you hire an established orchestra with a demonstrated ability to perform the composition? Sure, the individual musicians may have the skills and access to the sheet music. But the symphony’s full potential won’t be reached without a conductor to lead the musicians and many hours of practice.

Want to learn more about how MPE (Formerly Mindflow Design) can give you the full orchestra experience of medical device design and development?