Medical Device Development and Professional External Resourcing: How to Manage Product Development in Times of Economic Uncertainty

 In Medical Product Design

Reaching innovation/development benchmarks and launching new products are critical performance indicators for companies in the medical device world.

However, downsizing and reorganization are afflicting many in this industry. You may have fewer resources and yet you must meet essentially the same KPIs. Doing more with less is not always possible.

Flexibility in resourcing is important as you navigate this challenging economic landscape. Supporting your development teams with cross-functional industry experts can provide greater flexibility and efficiency, allowing you to drive excellence in innovation and improve your teams’ performance while keeping your fixed costs under control.

The Case for Engaging Subject Matter Experts to Support Your Medical Product Development

Staff reductions in development and engineering teams mean the remaining professionals have reduced capacity to meet deadlines. Reporting, meetings, and documentation requirements can consume enormous amounts of time from team members who would be doing development work. With an external partner in your corner, you have experts at the ready to pick up that slack, make your teams more efficient and bring new perspective to the challenges they face.

Engaging outside experts to support highly complex and evolving business functions is standard practice. Think legal services or financial strategies. It can provide your company with expertise that allows for state-of-the-art project management and completion by leveraging an external team of experienced professionals who understand your project’s needs. Likewise, that team can offer a crucial outside perspective on your medical product development process, contributing knowledge of industry best practices and awareness of evolving technologies and regulations.

Having an outside partner at your disposal provides a solution to one of the common challenges in the medical device sector: irregular resource requirements. Some project phases call for large teams of people to get the work done while other periods of product development are less demanding. When you have access to external support you are less likely to have to resort to layoffs or to bringing on new staff. You can keep your internal departments appropriately staffed and supplement with your external team during high-demand periods.

Benefits of Engaging Medical Device Development Professionals

The right external partner can seamlessly plug into your process just when you need them. Intimate familiarity with the requirements, the processes, the options, the materials, new innovations and the obstacles to avoid can help your team be more efficient.

À La Carte Resourcing and Support

Simply because a Professional External Resource (PER) can consult with you throughout the entire lifecycle of your project doesn’t mean they must. It’s up to you to decide where and when to fill the gaps and support your teams. That’s what makes external resources such a viable solution to internal resource constraints. Engaging a professional external resource can provide you with:

  • Increased flexibility. The team can fill in gaps downsizing may have left in your internal teams and empower your teams with outside perspective and full life cycle awareness. As an example, your HFE person (even if they are a team of 1) may become the spoke of the wheel in your usability analysis, leaning on HFE expertise for study design, recruiting, implementation, report writing and use of our dedicated “Living Lab” facility. You can get the project completed more quickly, with professional oversight and results.
  • Predictable costs and timelines. You will know ahead of time how long and how much your engagement with an external partner will be, which can reduce unwelcome surprises. While employees availability may fluctuate, your external partner has an entire organization to draw from, ensuring continuity to your project.
  • Reduced requirements for fixed internal costs. Salaries are an immense line item on every company’s balance sheet. Reduce these fixed costs by working with a flexible contractor.

Professional External Resourcing (PER) is a powerful instrument to apply to your development challenges. PERs can provide access to the most up-to-date subject matter expertise in the industry, drawing on decades of accumulated experience across hundreds of different projects, all within the medical device design and development sector. You’ll work with a team that has a broad perspective on potential solutions to development problems that may arise throughout your project.

Getting Usability Engineering Right

A specialized Human Factors Engineering (HFE) team is an example of the value that a Professional External Resource can bring to your team when you need it most. HFE is not just a test required by the FDA for clearance of a medical device. HFE is a process throughout the development life cycle that ensures products are made for the intended user, and focuses on reducing use-related harms. A cornerstone of the HFE process is performing usability studies. Performing formative and summative studies on par with the requirements of the regulatory bodies is exacting and time-consuming. These studies often require facilities most companies don’t have in-house. Conducting your usability process and testing alongside external professionals is more likely to result in a timely and successful submission of performing formative and summative studies on par with the requirements of the regulatory bodies that remains within your budget.

Given the challenging times in the industry, you don’t want to discover usability issues in your validation study that will require you to go back and re-design parts of your product. That can be both expensive and time consuming. A well thought out plan of smaller and less costly formative studies will help ensure that your validation study confirms your risk reduction plan. It’s important to work with professionals who understand how to get the most out of your investments in risk mitigation. It’s important to work with a group that understands the importance of conducting your usability testing well and at the appropriate phases of development.

Data from FDA Pre-Symposium Workshop: CDRH Workshop “Human Factors and Usability Engineering in Medical Product Design & Development” (2019) shows that only a small percentage of 510(k) submissions are approved on first review. And a large majority of observations and requests for revisions or more data are due to incomplete or insufficient usability testing and documentation. When working with an external partner, it’s important that they provide you with the needed documentation to secure your chances of a successful submission.

The Importance of Meaningful Human Factors Engineering

Creating a usable, safe and effective product also matters beyond getting approval on your 510(k) submission. Reducing medical errors starts by conducting robust usability testing with well-written testing protocols and comprehensive documentation.

Testing to the FDA’s standards and de-risking your product as much as possible requires expertise, personnel, subject recruiting, training, and specialty facilities. Almost every company outsources their clinical studies. Usability testing is just as critical.

Don’t overlook the value of entrusting the important tasks of risk reduction and analysis — usability testing — to an external expert. A professional Human Factors Engineer needs to be part of the development process much like any other engineer.

Navigate Industry Uncertainty With an ISO 13485 Certified Contract Development Partner

Changing dynamics in supply chain management and international relations have taken a toll on the MedTech industry, often forcing layoffs. But this reality doesn’t have to impact your company’s ability to innovate and meet launch deadlines.

Engage an external contractor like MPE to fill in the gaps on your teams while keeping fixed costs at a minimum.


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