Developing A Plan to Succeed

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Bringing a Medical Device to Market

The process of bringing a new medical device to market, or commercialization, begins with identifying a need or problem through a personal or professional experience. Product concepts at all stages of development can come from a variety of sources: cardiologists with a more effective monitoring device, physical therapists with a new assistive product, experienced engineers applying a new sensor, surgeons who’ve developed life-saving guidance technologies, or patients who’ve discovered an unmet need in point-of-care — the list goes on. What happens when the decision is made to translate the idea into a product?

Ideation, building, and testing are the fun and exciting parts of a developing product concept. However, successfully transitioning an early-stage idea to the medical device and consumer health marketplace is often an intimidating process for even the most experienced entrepreneur.

You may find yourself asking:

Where Do I Start?

First, inventors in the medical field face higher entry risks. Regulatory hurdles, additional IP considerations, and reimbursement challenges all combine to delay your time-to-market and pose an increased risk to stakeholders. New devices require careful business planning and risk-mitigation strategies at all critical phases of development to reach consumers as quickly and successfully as possible. Involving the right expertise early on can help to reduce this risk by ensuring subsequent efforts are focused and features are validated, and a solid business plan, licensing path, or exit strategy is developed.

Over 20 years, we’ve acquired a deep understanding of the regulatory requirements, business decisions, and legal challenges which stand between medical device prototypes and successful marketable products. We’ve worked with over 500 early-stage consumer health and medical device innovators to transition their concepts to competitive offerings.

Our process involves building a true understanding of your potential customers, appreciating their challenges and the value your product provides and evaluating strategies to most effectively deliver your product. We know the fastest ways to achieve the proper regulatory requirements for your medical device, and how to facilitate the appropriate reimbursement options.

The Value of a Strategic Approach

The commercialization strategies for consumer health and medical devices are fundamentally different than other products, even if they share common technology. Factors such as regulatory requirements, diverse payment models, and multiple stakeholders present additional challenges for these products that require careful planning and risk-mitigation strategies to reach the market. The right expertise at this critical phase helps ensure that subsequent development efforts are focused and features are already validated. As a partner in your success, our expertise falls into three main categories:

Business Plan Development 

Your medical device business plan should be the starting point for your success. We start with a Need, Opportunity, & Market Analysis to ensure your product deliverers the exact product consumers need. Determining the size, segments, and competitive landscape of your prospective market requires careful research and provides insight into threats and opportunities stakeholders face. Our financial analysis and proforma financial development, along with our fundraising experience can help you show potential investors exactly what they need at each stage of development. By developing a solid business model, we help solidify exactly what you’re going to sell and who you’re going to sell it to — and can help determine your optimal method of market delivery, from licensing to production. Our expertise can help determine: 

  • What is a price point market can bear? 
  • The value for the stakeholders in my specific market? 
  • Will I sell my product myself, or, will it go through a distributor? 
  • Should I consider licensing my technology? 
  • How do I identify and get in front of the correct customer base? 
  • How do I convince them to make a purchase? 

Read all the details of our Business Development Support Capabilities, or contact us to learn more about how we can help you with every stage of your product development process. 

  • "This framework has made the process of taking an invention from the lab to market more understandable for our researchers."

    Robert Gallo Director of IP and Licensing at Health Research Inc
  • Simbex combines great listening skills with strategic thinking into a work project and process. Targeted research, focused on critical data points kept us on time and on track. Each expert seemed to bring great detail as well as a connection to the others on the team.

  • Every member of the Simbex team that I interacted with was highly engaged and effective. Work with them and great results will follow!

  • The Simbex team provided us with very thorough, sharp insights for reimbursement and pricing strategy. Not only did they provide us with answers and recommendations but made sure we were asking the right fundamental questions. The final deliverable included an ultimate recommendation from multiple viable options with pros and cons, timeline, and steps clearly laid out for each.

  • Surpassed all our expectations and would use them again on all of our future projects without hesitation!

  • Rick and his colleagues at Simbex are experts in their field indeed. They were able to provide excellent education as they guided our situational assessment process. They demonstrated great flexibility and ingenuity to deliver an analysis that exceeded our expectations. We are very grateful to them for their expert guidance.

Clinical Verification, Regulatory, & Reimbursement Strategy

The Clinical Verification and Validation phase of your device’s development includes a Clinical Rationale Review and Clinical Workflow Assessment. This research provides the backbone for the acceptance of a medical product or treatment, gathers current supporting evidence for your proof-of-concept, and builds a strong rationale that will help to get buy-in from stakeholders. It is also crucial to develop regulatory and reimbursement strategies. Your plan for achieving US Food and Drug Administration (FDA) clearance also outlines who will pay for this product, whether it can be reimbursed by public or private payers, or if it must be paid for out of pocket.

This important stage of the product evaluation process helps to answer questions such as:

  • How does my device fit into the clinical workflow?
  • What is the medical device classification?
  • How do products in my medical device class get reimbursed?
  • How does a purchasing organization get reimbursed?
  • What is the fastest regulatory pathway for my product?
  • What are the appropriate predicates for my consumer health product?
  • When do I initiate FDA regulatory conversation?
  • What are the appropriate regulatory standards that this product will need to meet?

Read an in-depth overview of the Clinical Verification and Validation Process, or, contact our team and ask about how we can assist with clinical trial management, your regulatory plan, reimbursement options, FDA or EU MDR classifications, and more.

Technology Development 

Our Technology Development capabilities ensure you have the proper IP protection for your invention, and help you understand the technical aspects of your competitor’s offerings. Of equal importance is determining the certifications, classifications, and quality systems required for your new medical device are crucial to ensuring your reach the market as efficiently as possible. In addition, producing a well-thought-out product requirements document can help establish correctly specified requirements while removing unnecessary complexity or redundancy. Lastly, you must ensure your device will transfer smoothly to the manufacturing process — and that the required materials, methods, and functionality are well documented and prepared for the next stage of your production process. We help you manage questions like: 

  • Do I have freedom to operate? 
  • What other competitive technologies exist in my market? 
  • What are the quality system requirements? 
  • What level of documentation is required for my product? 
  • What certifications will be required? 
  • What ISO classification should I conform to? 
  • Does my product requirements document detail all the functionality that the customer will need? 
  • Does it include all the certification requirements? 
  • Does it clearly diff between have/nice to have? 
  • What manufacturer should I use for my medical device?  
  • What will be the production volumes? 
  • What is the cost of goods sold (COGS) for my new device? 

Read more about how we can help you with the Technology Development Stage of your new medical device or consumer health product, or contact our team to discuss any stage of your product’s needs.  

Need Strategic Assistance?

Commercialization Centers

Since its founding, Simbex has been helping innovators de-risk their product development through the experience we have gained in our own product development efforts.  Over the past decade, two federally funded commercialization centers have leveraged Simbex experience to help over 500 product ideas in the pediatric and rehabilitation markets.



Translation of Rehabilitation Engineering Advances and Technology

TREAT’s mandate is to help the inventors overcome hurdles in the commercialization process. Funded by the National Institutes of Health (NIH), TREAT offers a variety of assistance programs to assess products, technology, or services and define objective measures and milestones.

Learn More: www.treatcenter.org



New England Pediatric Device Consortium

NEPDC, funded from 2013 to 2019 by the FDA’s Office of Orphan Products Development (OOPD), is a multidisciplinary, multi-institutional, collaborative consortium that provides infrastructure, expert consultation, and execution of technology translation and commercialization to innovators of pediatric technologies.

Learn More: www.nepdc.org

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