Finding the right staff augmentation vendor can be the difference between project success and setbacks. But with so many options available, how do you choose which fits your needs?
In this article, you will learn nine critical factors to consider when evaluating a medical device staff augmentation vendor.
9 Key Factors to Assess the Capabilities of a Medical Device Staff Augmentation Vendor
Although the critical needs will vary, here are some factors you must consider:
1. Technical Expertise
It's understandable how challenging it can be to find talents with exceptional medical software development skills. However, that doesn't mean you should ignore critical evaluation of potential hire expertise.
Your staff augmentation vendor must have practical and relevant knowledge. Also, some firms focus on specific MedTech areas. Evaluate these two core areas to decide whether their technical expertise fits your needs.
Relevant engineering disciplines
Look for a staff augmentation company with a broad team of engineers across different medical device product needs. They should have an engineering team with biomedical, electrical, and software development skill sets. A vendor with such technical expertise is ideal, especially when you require a full team for a short-term project. For example, if you're developing a new ECG monitor, you'll need a team with strong signal processing skills. This is a critical component in the design and implementation of effective ECG monitoring systems
Experience with medical device standards
Your MedTech software development partner must have experience building products with standards like ISO 13485 and IEC 62304. They shouldn't just know these standards but also have a proven track record of implementing them in diverse projects.
You can ask questions like:
- How have you applied IEC 62304 to ensure software safety?
- How do you integrate ISO 13485 requirements into your development processes?
The answers will help you measure their understanding of these standards and procedures.
2. Industry Experience
Medical technology devices aren't just another tech product. This industry is unique because of regulatory demands, patient safety concerns, and clinical considerations.
So, unlike in most industries, your staff augmentation vendor must have experience outsourcing domain experts to companies in your niche. You can't just get any software developer to build your product.
They must be MedTech trained with real projects to show. When evaluating their industry experience, you can review these areas to get in-depth insights.
Review their track record in MedTech projects
Look beyond the number of projects and focus more on the types of devices they've built. Confirm if they have developed Class II or Class III devices and therapeutic areas in which they have worked.
A staff augmentation company with talent experienced in your niche can make the difference. If you are looking for a MedTech outsourcing company with experience building Class II devices, we're here to help.
We’ve partnered with many Silicon Valley clients to develop FDA-approved class II B software for a cellular wireless-based ambulatory cardiac arrhythmia device connected to cloud servers for 24/7 real-time heart monitoring.
Reference checks with previous Medtech clients
This might be a chore, but you should go beyond reading case studies and speak with your chosen MedTech staff augmentation company's past clients. This step helps you gain insights into the vendors' working procedures, communications, and other details. You won't find these in a case study or client testimonial. Moreover, reviews and testimonials can be easily fabricated.
3. Project Management: Ensuring Compliance-Ready Transitions
Medical device staff augmentation requires transfer-focused project management to prevent FDA audit gaps during vendor transitions. At ITR, we follow a well-structured approach that guarantees that deliverables are immediately usable by your internal team while maintaining full regulatory compliance.
Critical Implementation Requirements
| Requirement | Medical Device Specifics |
|---|---|
| Sprint Deliverables | |
| Validation Protocols | |
| Transition Readiness |
Best Practices for Managing Augmented Teams
If you manage an augmented team, your deliverables must be FDA-compliant and ready for immediate use.
Structure work into modular sprints where each component is:
- Self-contained with complete DHF documentation
- Validated on production-equivalent hardware
- Delivered with cybersecurity penetration test results
Test and Validate Throughout Development:
Conduct real-time verification testing aligned with:
- IEC 62304 software safety classifications
- ISO 13485 quality management requirements
- FDA design control expectations (21 CFR 820.30)
Document Key Decisions & Workflows
Include in every sprint closure:
- Risk management reports per ISO 14971
- Traceability matrices for requirements → tests → DHF entries
- Containerized test environments matching FDA submissions.
4. Talent Skills Stack & Engagement Model
After you've vetted the outsourcing company and are satisfied with their skills and expertise, it's time to inquire about their talents. You must ask about their skills and how they're developed and deployed.
Here are some areas to consider:
Key experience levels
Confirm whether they offer a mix of talent and experience levels. Having a vendor with an entry-level, mid-senior, and senior engineer on standby is more effective. This ensures you can get all your MedTech talent needs from a single source.
If using agile methodologies, make sure that your team has experienced scrum masters or agile experts.
For example, if your traditional medical device company is developing its first smart, connected device, you'll need a staff augmentation company that can provide a balanced team. This might include:
- Senior IoT Architects: To design the overall system architecture and security.
- Mid-level IoT Engineers: To implement the core connectivity features and troubleshoot issues.
- Entry-level IoT Technicians: To assist with testing and deployment, learning from more experienced team members.
This mix confirms you have the expertise required for complex design, efficient implementation, and knowledge transfer within the team.
ITR boasts a diverse talent pool, including engineers with proven management experience from Silicon Valley. This type of experience means you aren't just getting engineers but professionals with real management experience, which is valuable for a small team.
Type of talent training methods
Another area you should check is how the MedTech talent augmentation vendor keeps their talent up to date. You should confirm if they hire talent one-off or have a hub. Also, ask if they provide ongoing training programs or certifications for these talents in-house.
Having a partner that provides these add-ons ensures your talent is always up-to-date on implementing emerging MedTech technologies and trends. The results of this extra are easier integration, innovation, and problem-solving skills, which leads to faster time to market,
5. Cultural Fit
Technical skills alone aren't enough when evaluating augmented staff. You also need to check if they fit into your company culture. They should be able to join your in-house team and integrate seamlessly with fewer issues. In this stage, you want to check communication, collaboration, and adaptability measures.
For example, our augmented staff can start using your design tools as soon as you grant access. If your organization hasn’t set up the necessary tools, we can provide remote access to ours to accelerate your workflow.
Some questions you can ask include:
- How do you ensure effective communication?
- Do you use collaboration tools that integrate with your systems?
- Do you offer daily stand-ups, sprint planning sessions, and code review processes?
- How quickly can you adapt your templates and processes?
It's often difficult to check for talent and cultural fit when working with a staff augmentation company. That's why, at ITR, we provide a 20-hour free trial technical development augmentation service. This free trial allows you to see whether our talents fit your systems and experience how they function.
You can get started here for free. No hidden charges and no contract terms.
6. Compliance and Security Measures
The burden of staying compliant with diverse MedTech regulations makes international expansion a difficult undertaking. Depending on your product and target market, you should consider FDA regulations, HIPAA, EU MDR, GDPR, and more.
You must partner with a company with broad regulatory experience. They can provide experts familiar with various regulatory frameworks and help you navigate complex submission processes.
Here are some questions you should ask:
- Can you help with preparing 510(k) submissions?
- Do you understand the differences between CE marking requirements and FDA approvals?
- Are you familiar with EU MDR requirements?
At ITR, we provide compliance and regulatory assistance to ensure you meet all standards. With our support, you can reduce delays and meet development deadlines without exceeding budget.
You’ll get expert guidance on risk-benefit tradeoffs in Quality Assurance and Regulatory decisions. We can assist with internal and external audits and support pre-market clearance, approvals, and responses to the FDA and other regulatory bodies.
7. Data Protection and Confidentiality Measures
With cybersecurity threats in more sophisticated forms, you can't ignore data security in MedTech projects. That's why you should also evaluate how your staff augmentation vendor maintains data protection and confidentiality.
Do they offer legal documents to keep all information confidential? Your project, patient data, and more are at risk if they don't.
Make sure to do the following as well:
- Ask about their data handling procedures.
- How do they ensure patient data privacy?
- What about your intellectual property?
- How do they handle inventions made during the project?
- What about background IP?
You should prioritize a staff augmentation company with robust cybersecurity measures and clear data-handling policies. A staff augmentation company that adopts a cybersecurity framework like the NIST Cybersecurity Framework (CSF) 2.0 will be able to provide support in governance and risk management practices.
A reliable staff augmentation provider should support your cybersecurity policies while ensuring compliance with FDA pre-market and post-market guidelines.
This includes offering tools and methodologies to assess risks, identify vulnerabilities, and implement security measures that protect your organization and its users.
8. Scalability and Flexibility
As project scopes expand or timelines accelerate, you'll likely experience one or both of these: your team becomes under-skilled or understaffed. In both situations, you want to have a staff augmentation partner that can quickly provide more technical talent to fill the gaps.
If you feel your project will likely have a broader scope, here are some things you should look for to determine whether the MedTech staffing company is equipped:
Check their range of talent engagement models
You should confirm if they have in-house talent or if you must hire for every request. The standby in-house hires, primarily stationed in hubs, are better equipped to start work immediately.
If the vendor hires on a need basis, they cannot immediately pair you with new talent, which will delay the project. So, hiring a company with standby in-house talent that can fit in for short-term scaling needs without a lengthy recruitment process is best.
At ITR, we have hubs in different locations with about 100 MedTech talent ready to fill any gaps in your team. Our decentralized hub model guarantees access to top-quality talent from different locations at a cost-effective payment structure.
9. Cost Considerations
While cost shouldn't be your only consideration, it's undoubtedly important to understand the financial implications of your partnership. You should consider the pricing model and contract expectations.
Some questions you can ask are:
- Does the price cover time and materials?
- Do you offer fixed-price options for specific deliverables?
- How do you handle scope changes?
- Are there minimum engagement periods?
- How easy is it to scale up or down?
- What are your terms for project cancellation or pausing?
Covering all angles and getting clear answers to your questions is essential.
If you are looking for a staff augmentation service for short-term engagement but are not ready for long-term commitment, ITR can help. We offer flexible payment plans that allow you to scale your needs quickly and cancel without hidden charges.
What Should You Prioritize Based on Project/Company Needs?
Every project is unique, so your most important needs will vary. But here's some general advice on how to choose must-have features when assessing a MedTech staff augmentation company:
- If you're a startup developing your first device, prioritize flexibility and cost-effectiveness.
- Scalability, quality management, and technical expertise are key factors for mid-size companies upgrading legacy devices.
- As a large corporation, focus more on scalability and robust compliance measures.
Regardless of your category, you must consider your project's specific needs, timeline, and budget constraints when weighing these factors.
Hire Top Talent for Your MedTech Development Project with ITR
At ITR, we understand that choosing the right staff augmentation partner is critical. That's why we offer a free 20-hour trial of technical development services. It's a risk-free way to see how our expert team can integrate with yours and drive your medical device project forward.
Ready to reduce cost and time to market for your medical device development project?
Start a 20-hour Free Trial or Book a free consultation.
