Developing a new medical device is a massive undertaking. These projects often require millions of dollars in investment and several years to complete. The finished product isn't your average consumer-level gadget. It's a device that will potentially save lives while advancing the healthcare field. The FDA requires it to be proven safe and effective. In Europe, CE requirements are similar.

It's not a process you should take lightly. There are many moving parts, and every step from initial design to manufacturing demands excellent skill to complete. Pair that with the intense scrutiny medical devices go through on their path to FDA clearance or approval, and you're looking at an ultra-complex process ahead of you.

Every decision counts. One of the most critical choices is the device design services company you'll work with to bring your ideas to life. These consultants and third-party firms turn strategic plans and requirements into tangible products.

Many of these companies are vying for your business. So, how do you choose just one to produce your device? Here are some crucial details to consider when selecting the best medical device design services company.

Expert Connections

Building an FDA-approved medical device isn't easy. It's a long and complex process that requires utmost skill and attention. The design services consultant you work with should be familiar with the regulatory environment and have partnerships to help you navigate it.

A design company that works closely with regulatory experts can make all the difference. Instead of going back and forth with multiple third-party firms, you can take advantage of an existing professional relationship, and it's not just about overcoming regulatory obstacles. The design services company should be familiar with the regulations to better work with a third-party regulatory firm.

While a big part of FDA compliance occurs at the design level, designers must follow good practices established by Quality System (QS) Regulations. The design company must be intimately familiar with the regulations, even though they partner with Quality experts and can connect you with all the right people to make your development cycle as smooth as possible.

Familiarity with Design Control

Understanding your device's FDA risk classification goes a long way. You can choose a design service company that works with products in that classification. That way, you know the firm has the degree of expertise you require.

Another important consideration is a consultant's familiarity with design controls. Design controls represent a standardized approach to the development of medical devices. It's about maintaining a controlled design process and ensuring the finished results meet all specified requirements.

It's a subsystem involving many steps like risk analysis, verification testing, validation, and more. Each part of the process is crucial, and design control requirements are mandatory for Class II and Class III medical devices planned for the US and most markets worldwide. A good design service company will understand design controls and take the necessary steps to fulfill all requirements. You don’t want to discover late in the design that the work did not meet the requirements of the FDA or CE.

Time Management Skills

Time management is a big deal in product development and manufacturing. Time is money, and going over schedule can set your project back significantly.

Minor errors and delays can send you back to the drawing board for medical devices. They can throw off the entire FDA approval process and make it impossible to hit your target launch window. On top of all that, time management issues can cause your budget to balloon beyond repair.

A good design services firm will work to save time and money. They should have a systematic approach to project management and operate like a well-oiled machine to streamline the design process, avoid delays, and save as much money as possible. A key part of this is recognizing risk early and mitigating it.

It's not just upfront efficiency, either. Crossing the finish line and meeting production goals is about avoiding last-minute changes, taking care of unknowns early, and committing the right resources to get things done quickly and efficiently.

A Solid Project Proposal

Every partnership should start with a strong project proposal. The proposal is the start of your relationship. It's an opportunity for the firm to tell you why they are the right people for the job.

But more importantly, the proposal should show a clear understanding of the project. Medical devices are more complex than standard wearables or consumer-level goods. They must accomplish specific tasks, provide measurable results, and comply with FDA regulations. Comprehensive development proposals should be well-thought-out and include all the detailed information you need.

During the design and development phase, you likely spent considerable resources creating product requirements for your medical device. Proposals are based on product requirements. You can create the requirements document in-house or have the consultant help you create it.

Experienced design companies will use the requirements to develop a solid proposal that assures you of quality design solutions to come.

Effective Risk Management

It doesn't matter what type of medical device you're creating. There are inherent risks involved. We're not just talking about FDA risk classifications. We're also referring to risks that could derail your project.

Many things can go wrong when designing or manufacturing a product. All it takes is one issue to force you back to square one. Not only does that waste time, but it could expand your budget so much that you have no choice but to scrap it. That situation happens more often than people realize.

A good design services partner will identify design risks early to avoid problems and project setbacks. From identifying technology that is risky to selecting parts that will be available, a reliable consultant will recognize and address those issues.

There are many ways to approach risk management. It can involve everything from strategic component selection to completing in-depth feasibility studies. Design engineers should do their due diligence to ensure that the final product arrives as expected.

Frequent Communication

Good communication and regular status updates are basic expectations you should have with a design partner. Unfortunately, not every company prioritizes frequent communications. Radio silence can be troublesome with a project as complex as creating medical devices. It can leave you worrying about the state of your project and whether the investment you made is in jeopardy.

All involved parties need to keep open lines of communication and expect to communicate frequently. You need more than basic status reports to keep your project on track. Your design consultant should also keep you consistently informed about the schedule and cost. Even minor setbacks can cause a rippling effect. Before you know it, the design process experiences a delay that forces the budget to balloon. Keeping up to date on that information is critical.

They need to update you on progress, reach out in case of issues, and ask for help when necessary. A design company that believes they can handle every obstacle without communicating with you will likely make costly mistakes.

A Proven Track Record of Success

Lastly, don't forget to ask for references and look at past work. Medical device design companies have to gain experience one way or another. But you don't have to take a risk on a novice company.

We're talking about potentially millions of dollars on the line. Experience and proven competency in the field are paramount.

Take a look at previous projects the company has done. Ask questions about their process and gain insight into how the company works. Going to proven providers with a history of producing high-quality medical devices will give you—and your investors—more peace of mind.

Turn to Voler Systems for Your Medical Device Design Services

Voler Systems is an experienced device design services company with over four decades of success. Our well-defined process and proven method have helped many companies develop medical devices that support and advance modern healthcare.

If you're developing a medical, wearable, or IoT device, contact us today to discuss why Voler Systems will be the right choice for your design services partner.