Digital Transformation for Medical Devices: Webinar

Randy Horton

Published on: December 19th, 2024

Going Digital: Best Practices for Achieving Digital Transformation for Medical Devices

Manufacturers of traditional hardware medical devices who want to connect their products to smartphones and the cloud face sizable challenges. While they may have a clear, strategic vision of what a successful digital transformation looks like, the tactical steps needed to get there can be less clear.

From retraining R&D teams with new tools and techniques, to updating design controls and regulatory compliance practices to cover both medical device hardware and software, to staying ahead of guidance from the FDA, there’s a significant suite of responsibilities, documentation and best practices to be dealt with.

Overcoming challenges to achieve both a strategic- and tactical-level digital transformation with high ROI is possible – especially when manufacturers learn from peers who are further along in their connected software journeys.

Orthogonal and BLUR Product Development held a webinar on October 1st, 2024 discussing the nitty-gritty of digitizing existing medical device hardware organizations. Leadership from both companies dove deep into the strategic-level requirements and shared best practices for manufacturers looking to expand into connected medical devices and SaMD.

Webinar Recording

Key Takeaway Points

1. Why do manufacturers of traditional medical devices undergo digital transformations?

- To improve the user experience through apps and visual design.
- To collect valuable patient data that can inform device improvements.
- To stay competitive in a market, either by surpassing traditional hardware devices or by keeping up with new digital devices.

2. What are the major challenges/roadblocks to a digital transformation?

- Expanding the workforce to gain expertise in new specialities, (i.e., software development, cybersecurity, data science.)
- Creating new Standard Operating Procedures (SOPs) to address medical device software development, (i.e., design controls, testing protocols, verification & validation.)
- Managing infrastructure and operational costs to support the ongoing evolution of software.

3. Why is hiring the right software engineers so important?

- Software engineering is very different from hardware engineering – you need specialists with software experience.
- Software engineers from outside of MedTech will need to be taught the tools and techniques necessary to develop safe and effective medical device software under design controls.
- Most software engineers working in MedTech will specialize in just one of three areas – firmware, connected software and data science. It’s better to hire specialists in each area rather than trying to find one engineer who is proficient in all three domains
- That said, engineers who can understand what other specialists are working on – including hardware engineers – will be able to more effectively work across the organization.
- Despite their familiarity with computers and business software, corporate IT professionals are often not a good fit for the hard and soft skills needed to become software engineers.

4. What considerations need to be made for cybersecurity?

- The FDA recently released new guidance on cybersecurity, the impact of which is still being worked through by the industry.
- In general, the guidance emphasizes going beyond just the actual device to address the wider digital ecosystem for potential threats.
- As a best practice, cybersecurity should be part of the total product development lifecycle.

Watch Webinar Recording

Speakers

Keith Gausmann, Partner, BLUR Product Development

Keith is a results-driven mechanical R&D engineer with over 20 years of experience innovating, solving tough problems and designing commercially successful products for medical, consumer and industrial use. He brings a strong focus on user experience design and integrating all aspects of product development, from idea through implementation, to ensure commercial success. Keith has extensive hands-on experience with idea generation, conceptual design, detailed design with 3D modeling (Solidworks and ProE), medical device design controls, regulatory submissions, US and Asian manufacturing, program management, data science, engineering analysis (FEA) and working within aggressive cost and time constraints.

Bernhard Kappe, CEO and Founder, Orthogonal

Bernhard Kappe is the Founder and CEO of Orthogonal. For over a decade, Bernhard has provided thought leadership and innovation in the fields of Software as a Medical Device (SaMD), Digital Therapeutics (DTx) and connected medical device systems. As a leader in the MedTech industry, Bernhard has a passion for launching successful medical device software that makes a difference for providers and patients, as well as helping companies deliver more from their innovation pipelines. He’s the author of the eBook Agile in an FDA Regulated Environment and a co-author of the AAMI Consensus Report on cloud computing for medical devices. Bernhard was the founder of the Chicago Product Management Association (ChiPMA) and the Chicago Lean Startup Challenge. He earned a Bachelor’s and Masters in Mathematics from the University of Pennsylvania, and a Bachelor’s of Science and Economics from the Wharton School of Business.

Moderator

Randy Horton, Chief Solutions Officer, Orthogonal

Randy Horton is Chief Solutions Officer at Orthogonal, a software consulting firm that improves patient outcomes faster by helping MedTech firms accelerate their development pipelines for Software as a Medical Device (SaMD), digital therapeutics (DTx) and connected medical device systems. Orthogonal makes that acceleration happen by fusing modern software engineering and product management tools and techniques (e.g., Agile, Lean Startup, User-Centered Design and Systems Thinking) with the regulated focus on device safety and effectiveness that is at the heart of MedTech.

Horton serves as Co-Chair for AAMI’s Cloud Computing Working Group, as well as AAMI CR:510(2021) and the in-process Technical Information Report #115, all of which address how to safely move medical device computing functions into the cloud. He is a frequent speaker at conferences and webinars, including events hosted by AdvaMed, AAMI, HLTH, RAPS and the Human Factors and Ergonomics Society (HFES).