QuickConsult Can Solve Your Product Development Problems

So, you have the world’s best napkin sketch. An A+ medtech concept. A plan for a medical device that could save patients today. Now what? Seeking advice, help, ideas and strategies from expert networks can save you time, money and headaches—and QuickConsult is ready to help you today.

Your team is busy developing, creating, brainstorming and ideating what the medtech industry needs next—what patients need to get back to living a healthy life. You have revolutionary plans for medical technologies and you don’t have time to waste. This is where QuickConsult comes in. We cut out the time, risks, costs and middlemen associated with traditional consulting firms. We are innovating how you find the product development experts you need so you can go on doing what you do best.

QuickConsult is an expert network that runs deep and wide: We have a diverse number of experts across all categories in the medtech industry. From regulatory consulting to product development, our experts have been there and done that. From ex-FDA to Fortune 500 VPs, the breadth of knowledge and experience you’ll find through QuickConsult is unbeatable. Our experts have been there and done that.

When it comes to product development, we can provide expertise for specific tech types, specific device standards, and so much more. We can serve you with your product development needs for one question or the long haul—we’re your on-demand product development staff.

Why You Need Product Development Advice and Expertise

Whether you’re part of a med dev startup or Fortune 500 company, the chances are good that you’ll encounter roadblocks and questions you haven’t been met with in the past. When developing a medtech product, you’ll have to take into consideration regulatory, quality, clinical, reimbursement and marketing factors—all of which can be overwhelming facets in the process.

Medical device development is more regulated than standard product development, and rightly so. When developing any type of medical device, you have to be well-versed in regulatory frameworks and hurdles. Being able to prove regulatory compliance is crucial, as well as proving why users need your product, showing how you manage complaints and product changes, documenting minute details, and realizing that product failures can dramatically affect patients.

While developing a medical product, safety is priority. Seeking the highest safety standards can be complex, though, as there are a lot of different factors to consider. You have understand and abide by national FDA regulations, and if you plan to go international, you have to know the ins and outs of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). Not only do you need to be immersed in the intricacies of these regulations, but you also need to keep up to date with them. Complying with so many moving parts  can cause delays in product development as you work to understand what needs to be done to achieve compliance. Don’t risk noncompliance—which could result in fines, company shutdowns or even jail—and seek help from our regulatory experts today.

Our Experts Know Product Development

The life cycle of a product from concept to creation is a long and winding one. Don’t get bogged down by trying to be your own expert. Our on-demand experts are available for one or few questions, many questions, or even prolonged engagements. It’s like adding a supplemental product development expert for only as long as you need them. Some of our consultants’ areas of expertise include:

  • Development specifications
  • System architecture
  • Industrial design
  • Interaction design
  • Regulatory compliance
  • Product Development Process (PDP)
  • Tolerances
  • Test equipment
  • Design of Experiments (DOE)
  • Engineering characterization
  • Device-specific standards
  • Test methods
  • Endoscopic devices
  • Laparoscopic tools
  • NOTES devices
  • Access devices
  • Emergency care systems
  • Infusion systems
  • Clinical diagnostic devices
  • Respiratory therapy
  • Drug delivery systems
  • Electrosurgical devices
  • Urologic ablation
  • Nerve stimulation
  • Blood management devices
  • Tissue securement devices
  • Ultrasound devices
  • Physician Assist devices
  • Dental products
  • Oral appliances
  • In-home rapid diagnostics
  • Women’s health products
  • Remote monitoring
  • Diabetes care
  • First aid & pain management

Experts for Every Step of Med Dev Product Development

The Stanford University Program in Biodesign conducted a one-year study that examined how medical technology is brought to market. Researchers studied a product’s introduction to market, its approval for use and enhancements made over time. According to this study, there are five phases of medical product development—all of which you need to know how to navigate to have a successful product.

Predevelopment, Phase 0

Before a product is even drawn up, a need among patients, physicians and healthcare providers needs to be understood. This comes through discussion, observation or even personal experience. This is where you determine if creating a medical device for the needs you see is, basically, worth it. Is it a good opportunity? Is the market size viable?

Phase I: Initiation, opportunity and risk analysis

You see a need for your device, now to consider the risks for moving ahead. This is where you would conduct a preliminary market analysis, a financial review and an assessment of your competitors and their products. Weighing your risks before advancing is crucial, and our experts can help you understand all of the risks that may make an appearance.

Phase II: Formulation, concept and feasibility

Now is when you develop your core team, a general plan and even a timeline for project milestones. Record-keeping begins and research and development gets underway. Phase II relies on brainstorming and 3D CAD models of the device are developed.

Phase III: Design and development, verification and validation

Starting after device concepts and prototypes have been made, the team creates a verification and validation (V&V) test matrix. Risk management is crucial in this phase, especially in regards to quality, manufacturing and R&D. You also need to be sure your manufacturing facility is in compliance with good manufacturing practices per the FDA. Submitting design and test data to the FDA and other regulatory bodies for review and approval.

Phase IV: Final validation and product launch preparation

Phase IV focuses on formal design drawings, final product verification and validation, sales launch preparation and regulatory approval. A litany of standards need to be met in regards to product drawings, design, materials, packaging, labels and more. Quality systems need to be established. Don’t get caught in the confusion of paperwork, standards, requirements and more as your product proceeds along its development life cycle. Getting in touch with QuickConsult today could make sure you hit every product development landmark in stride and conducted seamlessly.

Phase V: Product launch and post-launch assessment

The initial success of your product will be proven in hospitals, labs or physician offices. Pending its success, your product will be marketed for widespread use. Now you must manage staying in compliance, complaints, product changes and more. Keeping a strict paper trail and staying ahead of the regulations game will serve you well here.

No matter what stage of product development you’re in, QuickConsult can assist you. Whether your question is quick or in-depth, our experts have successfully implemented product developments from beginning to end.

QuickConsult Is Your Medtech Product Development Expert

QuickConsult experts have experience across numerous product and therapeutic areas, including but not limited to cardiac rhythm, cardiovascular, diabetes, ear, nose & throat, gastroenterological, general surgery, medical supplies, neurological, orthopedic, patient monitoring and recovery, reconstructive / plastic surgery, spinal, surgical innovations, urological / urogynecological, vascular therapies and mobile apps. Their expertise spans management- to executive-level backgrounds in Fortune 500 organizations to startups.

“Outstanding concept. Offering a ‘light’ version of consulting focused on med device fills an obvious gap in the industry.”

– Mark Wright, Director of Research and Development at Boston Scientific

Helpful Links

When does the ‘R’ end and the ‘D’ begin for medical device companies?

FDA – Frequently Asked Questions About Combination Products

EU – Borderline Products

3 Tips for Incorporating Risk Management Throughout Medical Device Product Development

Mapping the Medical Device Development Process



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