Insights on Achieving a Digital Transformation

Manufacturers of traditional hardware medical devices who want to connect their products to smartphones and the cloud face sizable challenges. Overcoming those 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 on the nitty-gritty of digitizing existing medical device hardware organizations. Keith Gausmann, Partner at BLUR, Bernhard Kappe, CEO and Founder of Orthogonal, and Randy Horton, Chief Solutions Officer at Orthogonal discussed the following topics:

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.

Looking to begin your digital transformation? Orthogonal has helped companies assemble an Agile medical device software development team primed to navigate quality and regulatory challenges. Schedule a call now: https://orthogonal.io/contact/