“The science is sound. Years have been spent researching the potential of this new medical product. Energy medicine offers novel solutions where other options are lacking. Now what? The long goal has always been commercialization, but the research team isn’t likely to know or know how to do it. What steps do I take? How long and how much additional resource will be needed ? I know I’ve been thinking about the clinicals but now what are the details? Do we have a regulatory strategy? Can I optimize the process doing some steps in parallel, where are the potential pitfalls? Do we have resources identified to handle the range of requirements? Risk, risk, and more risk! What have I forgotten and what don’t I know?”
Device classification is central to the entire effort. You’ll need a regulatory plan it’s the path you intend to take to deliver a safe product. You must define the risk, mitigation and then classification, for the product. Classification has a huge effect on costs and time. But, how about risk to the business plan, after all they do say “time is money”. Classification directly determines the regulatory requirements. Do you need 513(g) declaration (you do)? The Request for Information can be a significant effort. Do this too early, with insufficient documentation and risk being placed in a more rigorous risk situation. Do this too late and it can impact your plans for clinical trial and effect the ability to raise capital. The risk of the device for the patient and user are critical, but don’t fail to consider the risks to your business plan.
Do you believe your device to have nonsignificant risk (NSR)? Congratulations, now prove it! You’re going to need to defend the risk statement. There are a limited number of possibilities. Nonsignificant, premarket notification and premarket approval, each with increasing layers of regulatory complexity . No matter which class, you need to defend your classification. The process and complexity can become significantly more demanding depending on device classification. By that I mean more costly and time consuming. A lot more costly and time consuming.
Do you know the fastest route to market – 513(g), 510(k), PMA, or De Novo? How about 21CFR 820, ISO13485, IEC62304 and IEC 60601-1? If you don’t know these now you will soon learn. Really just a fraction of the relevant standards you’re going to need to understand. All about managing and controlling risk! It’s a lot to absorb, it is unlikely you will become expert in all this stuff, you will need help, you will need a team, a team of experts! You need to work with experienced people you can trust to intertwine as a cross functional team working to understand and control your risk profile.
Regulatory filing is going to take a lot of time (money). Depending on the outcome of 513(g), an IRB may be part of your future. Now how much documentation and hardware do you need for a clinical trial? Depends on the risk. A significant milestone is creating a Design History File DHF and a DMR (now Technical File). The design process will take you through many steps, including needs assessment, design input and design output, with internal loops to verify the design meets the needs. In this process you characterize and mitigate risk, good quality management processes are critical.
You will need clinical evidence. Are you ready to demonstrate safety and effectiveness? From the device end, we talk about Prototype, Pilot and Production the 3 P’s. Each representing incrementally increasing cost, time, and risk. The device you will need is a critical detail for your trials, it’s the output of a process to make hardware with minimal risk. It has to be safe for the operator and the patient. A risk-based design process with planned internal reviews must be carefully documented. It will be reviewed in detail by an informed 3rd party. But risk exists in other processes as well. Supply chain risk, manufacturing risk, warehousing, distribution, and service are all elements of your risk profile. You don’t need a market ready t to do trials. But what will you need? It’s a risk-based decision built on the opinion of experts.
Trials have been defined and scheduled. What phase are you at? How many centers? How many devices? What do you need for deployment and support? Remember training is critical. Now you will learn if the device is as useable as the designer’s intent. It’s all about reducing the potential for mistakes in practice. Risk is managed by simplifying controls, reviewing ergonomics, and effective user communication, are these optimal? You controlled risk and cost by careful application of the standards at the appropriate stages of your clinical trial. But, depending on multiple variables the required activities run the gamut. The trial itself is a huge risk, a kind of make-or-break event, remember cash is flowing!
Congratulations, after lots of work and anxiety your product is approved! Are you ready for the market? Chances are that if production, marketing, and distribution were on the back burner you’re in trouble.
The plan to get to market should have been made early on so that you are now ready to execute. This can be the ultimate risk for your product. Imagine getting through all the years of toil to prove the product is good and still face ultimate failure from the risks associated with the marketplace. Is your product competitive? Does the opportunity exist for the product to succeed? Even when you’ve got the right stuff you still risk ultimate failure for lack of a sales plan. It’s a long journey starting with an idea that ends in a medical procedure that improves patient’s lives.
Are you ready to take the risk?
BW Tek Medical is well established, boutique designer and manufacturer of light-based medical devices. We have provided design, regulatory and production services to manufacturers for over 25 years. If you wish to discuss a project or an idea, CONTACT US today!
