Click to watch Regulatory Compliance Associates medical device consultant, Dr. Stephen Coulter, discuss the common tools & processes used during product development. Early stages of new product development include analyzing user needs & translating design benefits into long-term patient efficacy.
Developing an original product idea is difficult but many common tools & processes are consistently used. The early stages of product development include analyzing user needs and how those translate into design inputs.
Product Development Strategy
Ideation and product development life cycle research can help you identify user needs. Additionally, increasing the quality of an existing product is often a successful new product development strategy. Your solution doesn’t have to be a radically new idea.
Does it have a substitute product that can take market share? Or, can you combine the features of multiple products during the product design process to make a combination product that patients prefer more? Could a product design consultant help answer these questions & provide knowledge transfer?
Product Development Cycle
Start by asking your cross-functional team an initial question: “What do we need to change to achieve success during the product development cycle?”. Product development strategy includes modifying existing systems & processes to accelerate efficiency. Refine your model or process based on the unique types of product solutions in your pipeline.
Product Research
Being able to understand & explain why your solution addresses a user needs statement is inherent to launch sales success. Interactive activities can be useful for improving creative conversation during market development strategy sessions. Further, voice of the customer (VOC) research consistently helps target the patient population in mind.
Finally, using VOC to identify early adopter audiences & the audience’s most important needs can increase early interest in your solution. Begin the sales process by determining core messaging ahead of the launch ramp-up based on device claims & if the regulatory submission is approved.
Market Development Strategy
User needs are the foundation of any successful market development strategy. Yet, being able to commercialize a new solution based on user needs using a team experiencing process problems is never an easy task. It requires the Engineering Team & Operations Team at the listening table earlier in the process than later.
Product Design and Development
A critical to quality objective early in the new product development process is removing everything but the essentials. Research your users needs to create design inputs for a product that patients both need & generates revenue.
Product Planning Process
After a business case is determined in the waterfall method, the product planning process begins cross functionally to validate product ideas via new product development research. What user needs will accelerate a successful product launch the fastest?
Innovative product design means addressing honest opinions from your target audience to validate your medical device solves a problem. The product development management team must be convinced the product can win in the commercial marketplace sooner rather than later.
Software Product Design
Success during the launch of a software as a medical device is often found at the heart of the product development plan. Any new product design must incorporate value added for the audience in one way, shape or form. This can include lean product design as some of the most effective software in the industry is not complicated.
Software as a Medical Device
Consider the regulatory differences between a tangible product and a technology product very carefully. For example, Software as a Medical Device (SaMD) has changed the marketplace by increasing both clinical research success & primary care delivery. Include process improvement sessions during internal meetings where a collective group deciphers what the user need statements mean to their team.
Agile Product Development
The vision for development begins with a minimum viable product, or MVP, during early software conceptualization & development; what is the business case of commercialization? How do we learn faster while making real time efficiency changes?
Digital Product Development
Product development teams must answer several questions before undertaking product design. Further, one focal ask is are successful processes already in place for medical product development.
Do you have a RACI chart to show who is responsible, accountable, considered, and informed? Finally, a clear cross-functional understanding of timelines & milestones can help guide expectations during MVP product development, which can be stressful based on the speed of common work.
MVP Agile
MVP (Minimum Viable Product) a widely accepted concept in software development in digital product development. However, our medical product design discussion will take a different direction – what is the regulatory affairs process?
A project management software development team should deliver a safe, efficacious solution with the objective of delivering patient value. Define your value through a regulatory strategy based on device claims, clinical evidence, and how both help the patient population.
Regulatory Compliance
Software as a medical device involves regulatory compliance based on multiple, widely accepted global standards.
- This includes:
- ISO 13485
- IEC 62304
- IEC 62366
- ISO 14791
The product development engineering team is responsible for the software process. Any prototype development assistance should begin with a regulatory compliance perspective of claims and predicate devices.
Prototype predicate concepts begin with identifying the current risk class & why use cases help validate your proposed risk class during regulatory submission. Finally, consider younger product developers who may have never been through regulatory approval in their career. FDA readiness training can be a powerful tool that increases marketing approval & how to carefully identify and isolate risk hazards.
Regulatory Pathway
Planning the build for a product requires a regulatory pathway that includes risk management considerations based on the risk class. Create as much detail as possible during this prototyping and design inputs phase of NPD.
Product development companies, like Regulatory Compliance Associates, can help identify the correct predicate device based on a risk gap analysis. Diagrams should include material ingredients that need to be sourced to create the product. This can help you determine the risk category of the product (e.g. patient daily use, HCP specialty use, etc.) and corresponding patient hazards.
About RCA’s Medical Device Consulting Services
The regulatory compliance process surrounding the medical device industry involves a strict adherence to pre/post market information throughout a device’s life cycle. Even a single compliance issue you have can turn into a significant effect on your business. Regulatory Compliance Associates can help guide you through any stage of the medical device consulting process, with capabilities during product development through the regulatory clearance/approval of your product.
Our team of over 500 medical device consulting Experts — including former FDA officials and regulatory compliance leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. Regulatory Compliance Associates works with international Fortune 100 companies, venture capital start ups, and companies of all sizes and shapes. Our regulatory compliance solutions for law firms include remediation for warning letters, FDA 483’s, import bans or consent decrees. Very few regulatory compliance services have the same regulatory compliance expertise in a variety of medical fields.
Medical Device Cybersecurity
For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if Regulatory Compliance Associates medtech consultants do not implement good IoT cybersecurity and FDA cybersecurity protocols.
At Regulatory Compliance Associates, we offer a wide variety of services for medical devices security to help ensure that your product is protected from cyber-attacks. With a well-planned design, along with full visibility of product development and the supply chain, Regulatory Compliance Associates medical device consultant Experts can help strengthen your device’s cybersecurity. We partner with medical device companies in each phase of the design cycle. The RCA medical device consulting team understands protecting inputs from threat exposure and hardening outputs for regulatory compliance & FDA submission approval.
- SaMD Consulting
- Threat Modeling
- Proof of Concept
- Quality Assurance Services
- TIR 57 & TIR 97
- ISO 62304
- ISO 27001
Regulatory Affairs
Regulatory affairs is Regulatory Compliance Associates® backbone. We handle more regulatory consulting submissions in a month than many manufacturers do in a lifetime. Our regulatory compliance consulting Experts have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.
As a trusted regulatory affairs consultant, our FDA veterans and regulatory consulting team represents Regulatory Compliance Associates® as one of the top medical device consulting firms. We’lll help you navigate the medical device consulting difficulties associated with new product submissions. Regulatory Compliance Associates® medical device consulting company has expertise in both the approval process and post-approval support.
- New Product Approval
- Post-Approval Support
- Outsourced Staffing
- EU MDR
- Combination Products
Compliance Assurance
Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® can help.
Our network of over 500 medical device consultant & FDA, MHRA & EMA veterans are industry professionals offers a unique blend of expertise. This allows Regulatory Compliance Associates® to handle both simple and complex regulatory compliance challenges within medical device consulting companies.
- Gap Assessments
- Internal Audits
- Employee Training
- Notified Body Response
- Data Integrity
Quality Assurance
Regulatory Compliance Associates® is globally reknown for quality assurance services, including quality system assessments, strategy, implementations, and quality metrics to ensure continuous improvement. Each Regulatory Compliance Associates® medical device consultant is a quality expert with experience spanning major corporations and start-ups. RCA’s quality assurance services experts know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.
In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At Regulatory Compliance Associates®, we offer you the quality assurance services you need to monitor these processes and ensure quality compliance every step of the way.
With more than 20 years experience working with medical device consulting companies, Regulatory Compliance Associates® trusted medical device quality assurance consultant team is fully equipped to handle your unique QA needs.
- ISO13485
- 21 CFR 210
- 21 CFR 211
- Outsourced Staffing
- MDSAP
- Facility Validation
- Equipment Validation
- Quality Metrics
Remediation Services
Regulatory Compliance Associates® is widely recognized within medical device consulting companies & the life science industry for our remediation services & support. Regulatory Compliance Associates® ability to help companies successfully resolve complex regulatory challenges have a proven track record of success. Our medical device consulting services include significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.
- Regulatory Action
- Regulatory Compliance
- Regulatory Enforcement
- Warning Letter
- 483 Observation
- Oversight Services
Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our medical device consultant expertise and experience that makes partnering with Regulatory Compliance Associates® a competitive differentiator in the remediation space.
- Quality System
- Technical File
- Design History File
- Data Integrity
- cGMP
Strategic Consulting
Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates® medical device consultancy can help ensure a successful project. Regulatory Compliance Associates® due diligence consulting can deliver your project on time, on budget, and you’re never embroiled in a costly mistake.
Our medical device consultant Experts are industry Experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.
- Manufacturing Optimization
- Product Lifecycle Management
- Mergers & Acquisitions (M&A)
- Due Diligence
- Device Vigilance
- Risk Management Plan
- Product Complaints
- Medical Information
About Regulatory Compliance Associates
Regulatory Compliance Associates® (RCA) provides medical device consulting to the following industries for resolution of life science challenges:
- Life Sciences
- Pharmaceutical
- Biologic & Biotechnology
- Sterile compounding
- Medical device
- Lab Testing
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.
As your partners, Regulatory Compliance Associates can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
- Founded in 2000
- Headquartered in Wisconsin (USA)
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021
About Sotera Health
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.
Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.
We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.
Commitment to Quality
Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.
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