Exceptional medical device project management: How women’s health startup went from late-stage development to acquisition.

Every medical device startup has a unique need, and this women’s health startup was no different. It was an owner-led company that had managed to secure angel investment for the development of a medical device designed to navigate a niche surgical procedure. The owner – who had designed the device and who was not from a medical device background – had led the company to successful early development. She was now seeking help with late stage device development, manufacture, and sales.

Enter Waddell Group. A world class medical device project management company that has delivered 45+ PMA projects, turned around failing device manufacturing facilities and brought hundreds of products to market across four continents.

Our goal, and that of our consultants, is to fast-track your product to the market while resolving any developmental and/or regulatory issues that arise during the process.

The Challenge: Get the device from development to sales.

Getting a device from development to sales is a complex project with lots of moving parts to follow and implement. Despite working 60+ hours a week, the company owner was unable to introduce her device to the market successfully while staying on top of ever-evolving medical device regulations, maintaining profitability, and funding raising. 

The device was not ready for a commercialized launch. Poor process engineering, minor product issues, and vendor development issues were causing significant rework and inefficiencies, leading to time and resource costs. 

They also needed to ensure that the device itself was manufacturable by considering factors like production costs, material costs, product aesthetics, ergonomics, packaging & assembly, etc., and making changes as required.

They had tech and organizational issues as the company/manufacturing vendor was unprepared to take on large-scale manufacturing.

The company was struggling to meet all the quality and regulatory approvals needed to move forward with manufacturing and launching the device in the market.

The launch itself required a well-structured approach that assured production volumes while ensuring quality standards were met. 

They also needed to make sure that once launched, preferably as soon as possible, their device stayed marketable long-term. 

They needed someone to develop better systems for taking on new challenges and dealing with any problems that arose during process and product development for manufacturing, and eventually, sales.

The Solution: Identify and implement a clear plan and process to take the device from early development to sales.

When approached, Waddell Group assigned the right-fit project manager to work with the owner of the company. After a 1:1 meeting, the company owner decided to work with the medical device project manager on a fractional basis. 

To start with, she(the project manager) conducted a thorough GAP analysis to understand where the women’s health startup was currently as compared to the owner’s plan for it and what was needed to bridge that gap. 

It involved:

  • – analyzing data to see if the company’s current quality and regulatory systems could match with or apply to the latest regulatory and market needs.
  • – understanding the company’s existing management systems, vendor development system, organizational structure, technology, and manufacturing facilities. 
  • – determining the changes needed to take the device from early development to commercial product development and eventually manufacturing and sales while meeting regulatory compliances.

Once our project manager understood the risks, compliances, costs, and timelines associated with the commercialization of the device, she:

  • – Worked closely with the startup’s founder, team, vendors, systems, and processes. 
  • – Took complete ownership of the project and was responsible for doing what it takes to make the project happen. Like,
  • setting the goals
  • defining the approach
  • teasing out the relevant information from subject matter experts
  • interfacing with relevant groups and management
  • ensuring team members meet their commitments
  • – Participated in the regulatory strategy, product enhancements, manufacturing, and market development of the project. 
  • – Made minor tweaks to the product to get it ready for commercialization and worked with the manufacturer to optimize the manufacturing process for better yield and lower product risk.
  • – Developed a vendor management system and managed tech support to develop the device commercially.
  • – Supported the regulatory effort with updates to product testing and submission language.

As a part of a company that has led multiple projects and worked within varied systems, the Waddell Group project manager was able to suggest changes to the startup’s current methodologies to enhance or expand their current and future processes. 

The Result: A highly profitable future-proofed company that was eventually acquired by a larger medical device company.

In a year and a half, the women’s health start-up was successfully able to: 

  • – introduce quality products to the market while staying on top of the evolving medical device regulations and quality controls.
  • – have systems and processes in place to launch timely, profitably, and with less risk.
  • – future-proof their company by identifying the gaps in their current system and putting effective safeguards in place. 

The niche product was a huge success, eventually leading to them being profitably acquired by a bigger medical device company specializing in women’s health.

And thanks to Waddell Group’s exceptional project manager, who helped the company enhance their existing product and processes.  With their support, the company achieved these results in 18 months.

Contact us today

To start or improve a project with The Waddell Group, contact us at 952.221.3333. We’ll be glad to help with your medical device project management needs.


Image by tirachardz on Freepik

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