A Look Back Over 2023

Our Look Back Over 2023

This year marks a milestone in our 20-year history. We bid farewell to our founder, Patricia Patterson, a trailblazer in instructional design and human factors within the medical and combination product industry. After her dedicated career, she officially retired. Congratulations Pat!

Reflecting on the past two decades, we see a women-owned business establishing a reputation for getting it right the first time. Utilizing a proven methodology that consistently delivers quality, thoughtful human factors engineering, and instructional design work.

Upon Pat's retirement, we announced our acquisition by Kymanox, a life science provider with a similar right-first-time reputation. This change brought new but welcomed challenges as we integrated into the Kymanox organization. We also said goodbye to valued colleagues who pursued new opportunities.

Looking ahead, we see a rainbow on the horizon. This past year, our team achieved more than we imagined through passion, dedication, and hard work. (And, of course, the 8,000 cups of coffee helped 😉). We are building a collaborative support network within the human factors division of Kymanox and across various departments that offer end-to-end solutions within the life sciences industry.

A Year of Achievements

This past year has been monumental for us, filled with challenges, growth, and numerous accomplishments. Some of the mentionable highlights include:

  • Industry Leadership: Merged with Kymanox to create one of the largest human factors teams in the industry, boasting over 50 human factor engineers and SMEs.

  • Global Presence: Partnered with Kymanox, our colleagues attended over 30 global industry conferences, solidifying regulatory knowledge and industry best practices.

  • Podcast Excellence: Recorded 16 podcast episodes, featuring insightful interviews with industry thought leaders. In 2024, we will continue to expand our listener base and bring new perspectives and solutions to the industry.

  • Quality Assurance: Successfully solidified our top-tier quality management system, passing audits and ensuring excellence.

  • Training Innovation: Developed training programs that not only elevated our team but also fostered strong bonds. We look forward to offering these programs in the coming year.

  • Strategic Leadership: Welcomed Rita Lin as the new Director of Human Factors Engineering, adding another former FDA reviewer with deep industry experience, to our exceptional staff.

These achievements, among others, highlight the dedication and expertise that define our team. As we head into the next year, we carry the momentum of our successes, excited for what the future holds.

Mentionable Guidances from 2023

The industry has also experienced a big year in regulatory with new guidances coming out for a variety of specialties. Here we highlight a few for review:  

Industry Voices We Appreciate

There are so many influential voices within our industry that share thoughtful and engaging input. We want to highlight and thank a few of those people who have helped support us this past year.

  • Susan Neadle, had a break out year, releasing her book, “Combination Products Handbook”. The book is a very helpful resource for your combination products journey, from pre-market development, clinical, commercialization, and all the way through post-market! And we had various colleagues as contributing authors: Stephanie Canfield, Shannon Hoste, and Fran DeGrazio. She was also one of our guests on The Factor podcast and has been the Most Watched Episode on our YouTube channel.

  • Naveen Agarwal,PhD has taken his blog, “Let’s Talk Risk” to one of most read for risk management in the industry. He also joined us this year as a contributing author to our August newsletter about Risk.

  • Edwin Bills, another influential voice for Risk Management in the industry. He was our first guest as we launched our podcast, The Factor. He is also one of our most downloaded episodes on Spotify and most watched on YouTube!

  • Etienne Nichols, shares valuable insights in a creative and engaging manner in the industry. When we first started working on a plan for a podcast, he made himself available for advice, and we are very grateful for his time.

We also want to acknowledge some organizations that we feel are doing great work to elevate students into the life sciences industry.

Conclusion

Coming into 2023, we took a good look at our mission and values. Our leadership made sure to find the perfect fit for our Agilis team, as we became Agilis by Kymanox. Every year we like to reflect on what we have learned from the industry. We share these important trends with you as we all look to incorporate this knowledge into our business practice. So much to be thankful for going into 2024.

 
 
Agilis