Craft enduring medical devices: seven considerations for successful SaMD

Tomasz Puk
Geoffrey Parker

by Tomasz Puk, Geoffrey Parker

Software as a Medical Device development R1hbapm

MedTech isn’t just having its moment – it’s having its decade. The global market was valued at $456.9B in 2020 and is projected to reach $800B by 2030. This growth is being accelerated by the rapid adoption of software-as-a-medical device (SaMD) and other digital healthcare solutions. 

Condition monitoring and management, clinical decision support and digital therapeutics are among the myriad companies leveraging emerging technologies to create better outcomes for patients, new commercial opportunities for businesses and improve healthcare for everyone. 

To help companies navigate the opportunities and complexities of building connected, compliant and enduring SaMD products, our HealthTech Practice experts have put together this concise framework.

Download "Craft enduring medical devices: seven considerations for successful SaMD"

What you’ll gain from this action guide to SaMD development

Get insights into how Star’s HealthTech Practice problem solves, builds award-winning solutions and helps our clients navigate the regulatory landscape. 

In this framework, you’ll uncover expert insight to help you take the best approach to SaMD development:

  • Regulatory roadmap 
  • Risk-driven product approach
  • Engineering capabilities
  • Solution architecture
  • Data management 
  • Business integration
  • Clinical performance evaluation

You’re building a sophisticated, mission-critical inter-connected system, you must have engineering resources that are up to the task.

Software as a Medical Device development Rmbabapm

Geoffrey Parker

Technology Director, HealthTech at Star

In-depth expertise from Star’s HealthTech Practice

Star’s HealthTech Practice combines product and regulatory strategy, design and engineering into one seamless end-to-end workflow. Our experts have years of experience bringing user-centric, compliant and enduring MedTech and digital healthcare solutions to market. 

We co-create seamless solutions that improve patient outcomes, optimize workflows and leverage data to promote product evolution and outstanding commercial results.

The starting point for any SaMD journey is defining proper Regulatory Strategy, when such process, functional, and documentary requirements are reflected and presented to SDLC and PLC teams.

Software as a Medical Device development Rmfabapm

Tomasz Puk

Director of Regulatory Consulting and Technology at Star

Get in touch!

Connect with our HealthTech Practice Experts now to see how we can help you start transforming your product development plan into your next big win.

Contact us

Image source: Philips

Related topics


Software as a Medical Device development Ralkbapm
Tomasz Puk
Director of Regulatory Consulting and Technology at Star

Tomasz has a proven track record of designing, developing, and maintaining complex IT solutions for the global market. Having worked in various roles including software developer/designer and R&D department manager and medical device process consultant, he combines business, managerial, and engineering skills, to provide the depth of skills and experience our clients need to launch world-class MedTech solutions. Tomasz was formerly CEO of Pro4People and helped navigate their acquisition by Star. Today, he holds leadership roles in both Star’s HealthTech and Service Delivery teams.

Software as a Medical Device development Rapkbapm
Geoffrey Parker
Technology Director, HealthTech at Star

As Technology Director for HealthTech, Geoff brings over 25 years experience designing and delivering software solutions. Dedicated to healthcare, life sciences and wellness industries, Geoff believes that technology should enhance our lives in a non-invasive manner. He enjoys working with clients to understand their business and user needs, and deliver secure, connected and engaging solutions that address the industry's regulatory requirements and deliver value to all stakeholders.

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