Before launching regulated devices, you need the right capabilities and infrastructure. Aligning legal processes, roles and a SaMD-specific quality management system may require you to make, buy or seek partnerships.
Should you launch a SaMD product out of the gate? Could you move faster by releasing a device that’s a precursor to your SaMD? If so, what’s required? The answers lie in an integrated business, product, architecture and regulatory strategy.
Choosing the right vendors for your partner ecosystem is critical. From algorithms to electronic health records, consider what you want to own, your needs and abilities, your goals and product roadmap, as well as the competitive landscape and how you might pivot in the future.
It takes extra time and resources to run software-oriented quality checks, complete processes and unpack any insights before the design control phase. Carefully sequencing these tasks is a key factor in the success of your SaMD solutions.
Efficiency requires alignment—on everything from product definition and modular architecture to regulatory strategy and evidence planning. Parallel work on the UX, development, human testing, clinical studies and regulatory outreach can unlock speed and fuel your path to growth.
Making sure your device is adopted by patients, clinicians and other end-users takes more than good design and marketing. SaMDs need to work in the real world and dock into various clinical and IT settings, which may require many partners and commercial pilots.
Gain everything you need to advance your operation quickly, whether you’re new to SaMD or ready to scale. We’ll connect you with accelerators to manage quality management system and software development life cycles, shaving months off your timeline.
Move faster and avoid costly missteps by looking holistically across technology diligence, product definition, feature development, intended uses, risk classification, regulatory paths and your approach to evidence.
Meet all the different regulatory profiles and evidence requirements you need to remain flexible as you grow into new geographies or functional areas.
While the regulatory mandate of design control limits the use of Agile methodologies, we can help you find ways to make smart product changes without delaying the Waterfall approach of hardware medical devices.
Integrating the way we plan and learn from human factors testing and clinical studies helps us harness the real-world evidence (RWE) and real-world data (RWD) needed for market adoption and post-market studies.
With a partner ecosystem that spans the globe, we can help jump-start commercialization plans and coordinate with launch teams, clinical study and pilot partners. After the launch of your SaMD solution, we’ll handle outsourcing to keep your teams focused on market growth.