This may seem obvious, but from the earliest days, you and your team should be working toward the 1st milestone, and that milestone should be fabricating your initial prototype and conducting your beginning animal studies. Also, clearly define and recruit the executive team who will be driving the company, develop an early game plan and execute it and incorporate best practices into your work. With that, I invite you to take a look at a recent article that I wrote and posted on this topic: https://www.linkedin.com/pulse/what-ive-learned-early-stage-medical-device-funding-tips-thornton/

Make sure the intended use of the device is well defined (best done by cross-functional team) and meets true use/user need!

Early and open discussions with your raw material supplier to ensure right resin/compound is recommended to meet needed requirements

Cost of manufacturing relative to potential reimbursement once you have established that it is truly innovative and necessary.

ADNAN ASHFAQ Clifford Thornton if you give me your email address I will send you an article I wrote about this subject

I think we need to be looking for data early in the product development process that can feed our market access efforts. Finding sources to better describe the value that the technology will deliver throughout the patient pathway and that will meet the needs of clinical and economic healthcare stakeholders.

Annas Al-Omari, CLPM In the early stages, it is important to implement a good non-clinical study.
Non-clinical studies can provide a large sum of data for the device life cycle.
Another factors to consider; does the start-up have the means, resources, skilled workers to setup a consistent process to be able to manufacture the device?
It's also important to set up a post marketing plan for any issues that might arise. The earlier you plan for the outcome the better.

Crossfunctional dialog between all disciplines is critical. Communication from the Marketing group, QA/QC, technical team (EE, ME,SE...), suppliers and all third party contributors will help keep the product commercialization on target. Any delays or Murphy sitings can be eliminated through strong communication.

Document everything!

Document and design and development process early in life cycle. Identify applicable electrical, wireless, performance and safety testing early on.

Thank you very much for that rich comment, Stina. I completely agree given that I have a product management background. I don't know if you would agree with this, but I think administering/ executing a "focus group" with the specialty physicians or surgeons who will use your device would be very fruitful.

Awareness, interest, understanding, action. Brainstorm with clinical advisors on how to achieve. It’s different for every market and product. Be sure to know the buying and selling processes clearly.

Hire an experienced engineer to lead your Team. Someone who has been in the industry, and will see mistakes, or deviation's from course BEFORE they actually happen. It's so common for a start-up to "save" money by hiring brilliant, but inexperienced engineers fresh out of school, without investing in solid leadership. Money is always important, but the most valuable and irreplaceable resource, when trying to get a new product to market is Time. A promising Team, with a cutting edge product, without proven leadership, will waste precious time chasing ideas that a senior engineer would have already dismissed as failure-prone.

One aspect that is often overlooked is accuracy of forecasting market adoption. When a product is truly the “next revolution,” it will require deviations from SOC. There are not only clinical “concerns” from the market - but dont discount human concerns. Behavior is not changed immediately, regardless of how “revolutionary” the product may seem.

Focus on Target market, plan the activity, brainstorm( best practices), look at your budget, personnel and implementation. Conducting post Marketing and most important, document all activities.

Thank you very much to all contributors thus far! No doubt, a wealth of insights from experts. The most obvious trend, in terms of comments, is the need for "early data" as per Paul Bradley to provide some early validation of your device claims and how it is an improvement over prior art. Very interesting point from Annas Al-Omari, CLPM regarding "non-clinical" studies. As a PM I can appreciate that. Clearly the system must be able to be replicated consistently and doing this can also help a team determine what the best components are and which OEMs they should contract with. And as Keili Lawrence and Abdus-Salaam Muwwakkil pointed out, the high importance of documenting the entire process, from start to end. I am definitely on the same page on that being a Lucent Tech Alum. That's definitely a best practice and pretty much a requisite for medical devices. I think in terms of making things worthwhile at the end of the day, Jonathan Sabata made an excellent point (cost/reimbursement).

Well, you certainly have asked an important and potentially complex question. The response could include many aspects involved with a successful launch. I will provide about as simple and basic a reply as possible - yet one I consider the most critical.

Start with the most important question in business - Why?
Why was the product developed?
Why will the target market want to invest in it?
Why will it add value in a growing value - based healthcare market?
Why was the price point set at its level?
Why will the involved stakeholders modify how they currently enhance clinical and economic outcomes with the product over existing competitors, processes, and standards?
Why will the proposed marketing plan gain interest to help position the value of the product in the intended manner?

Obviously, there are many questions. But at the core of every decision is the answer to the very basic question - Why? If you ask it enough, you will eventually get the best solutions and strategies to position your product for optimal success

Rainer Moosdorf MD PhD Revolutions have become very rare, also in the medical device industry. They wouldn´t need any special launching and marketing at all. For real innovative products, the first step is to show the - medical - need, then you don´t need a show. Secondly, have a respected medical board of top specialists in the field. Their recommendations will be heard. And - start with realistic prices for different markets. Reimbursement differs significantly in the countries and really entering and penetrating the market needs an according pricing. And - have a team of known reliable distributors.

Dipl.-Ing. EUR-ING Detlef G. Reddig - Expert Artificial Intelligence Go-To-Market Strategy, .....

An issue I have faced while building prototypes for startups is often times, the scope of work is not fully defined. As the engineering team dedicated to building your first working proto type, it is imperative that the functional description is developed and covers all aspects without any grey area. No assumptions and all aspects must be quantifiable. Often times, the entrepreneur does not understand the importance of this process and think this is a 30 minute exercise. Taking a short cut here is detrimental.

More gems of wisdom coming in regarding this topic. Thanks to all contributors. Some very fundamental and key insights were offered. John Berry pointed out some critical market questions, such as the justification for your device, defining the value equation, and getting the target price right. Rainer Moosdorf MD PhD highlighted the need to be clear with the medical need and recruiting a medical board of specialists in order to support your claims. And Andy B. McCall and Jason Pendergrass emphasized the make or break issue of the right engineering leadership and team. Missteps here can cost valuable time and also the "functional descriptions" per Jason, must be cemented explicitly. As we can see a lot of traps to fall into in this process, therefore the right expertise, discipline, and leadership is required to give your device and company the best shot.

Katie Bates http://www.citomedical.com/workingWithCito.html#project-anchor

Communication and process is important inside the company. Need to have a good strategy with regards to 510k, PMA, ISO regulations to get your company generating revenue.

If the product is new, you need to create your market because physicians don’t know what they don’t have. There was a great piece on NPR recently talking about how Listerine was originally a floor cleaner. Bad breath wasn’t a problem. They had to create a market for mouth wash by making bad breath a problem. In medicine, this would be partnering with leading institutions and proving the utility of your product.

Lastly be customer obsessed and follow an Agile development processes like extreme programming or scrum. Let the design evolve and don’t approach new product design like a big company. Be nimble, engage your customer and deliver.

James Bell, MBA First, go talk with 100 customers before you start developing a solution. Fall completely head-over-heels with the customer's problem. A lot of entrepreneurs "know" (read that as their customer discovery is n=1, and they're the one) what's needed. That's just an opinion. From an opinion, they build a beautiful, shiny object nobody will buy. Customer discovery yields facts. Facts > opinons. Use facts.

Second, build a stellar team. Don't look for the cool guys and gals. Don't get enamoured with the smooth people. Pick team members who are willing to tell you you're wrong when you're wrong. Pick people who can criticize each other but get along and enjoy working together. Build a team with a diversity of experiences and backgrounds, but build a team that collectively has expertise in your space. Pick a team that can own the space. Fill knowledge gaps with experts--mentors and advisors.

Third, execute. A plan without execution is a fantasy, and failure to plan will get you somewhere but isn't likely to get you where you want to go.

Fourth, a bonus, but a critical point: as a startup you're working to get to dollar one, dollar two, your first ten customers, and a repeatable, sustainable sales and business model. Never forget this.

James Bell, MBA (cont.)

Third, if you don't know regulatory and reimbursement, find experts who do. Don't guess.

Fourth, execute. A plan without execution is a fantasy, and failure to plan will get you somewhere but isn't likely to get you where you want to go.

Fifth, a bonus, but a critical point: as a startup you're working to get to dollar one, dollar two, your first ten customers, and a repeatable, sustainable sales and business model. Never forget this.

Michael Tar Payer approval is now more important than regulatory approval. The very early “bare bones” stage is the most critical, because it is easy to fall in love with an exciting concept that isn’t a good fit for this value-based environment. Look at recent “wins” and model their behavior. Most of them have a very strong business case. Can you turn an inpatient into an outpatient, or can you migrate surgeries from the hospital to the clinic? If you deliver better outcomes, how does that deliver an economic benefit? Your benefits need a price tag, because your device will have one too.

Gary Robidoux Passion, surround yourself with passionate people who thrive on helping others, your success is emanate.

Gary Robidoux Passion, surround yourself with passionate people who thrive on helping others, your success is emanate.

Daniel John Define your 1. Intended Use/Target Population & Country/Market Size/Reimbursement Strategy, 2. Regulatory Factors (all countries), 3. Design/QA Factors, 4. Verification/Validation Factors [In-Vitro/In-Vivo] including technical/biological/clinical, 5. Manufacturing/QA-QC Factors, 6. Time to Market (highly dependent on regulatory as well), 7. Marketing Strategy/Plan, 8. Resources for all 7, 9.Based on all 08 factors, what profits can be expected based on sales forecast. Based on this do a detailed feasibility study. Since this is a disruptive technology a more detailed approach is required since medical device regulations may not be available yet, making more complications for launch. So feasibility of technology to be regulated [new validation methods might be required which can/need be standardized] and technology being marketable has to be reviewed in detail. Requirement of clinical trials/level of evidence should be confirmed and included in the analysis.

Julie Omohundro I'm intrigued by the focus on "launch" in the title, even more so given the reference to "commercialization success" in the text. Can't you have a successful launch that ultimately doesn't lead to commercial success?

I also find myself wondering what kinds of comments you might have gotten if you had left "launch" out of the question entirely.

Many thanks for the very deep insights and critical issues to focus on from Michael Tar and Daniel John. If you are serious about this, you and your team cannot afford to ignore or put these issues aside. Julie O. -great point and this certainly makes one pause and think about this. Clearly with 9 of 10 start-ups failing, there has been and there will be quite a good number of these. And perhaps, these might break some ground for innovation and open the door to new tech and techniques. But, given that Angels and VCs want a strong ROI, and a start-up might be planning multiple device launches going forwards, therefore aiming to build a good "Rep", the start-up leadership team is most like aiming for "commercialization success". Failure to do so will probably sink their ship immediately after commissioning and hence severely limit market opportunities going forwards. For example, Elixir Medical Corp., who is privately funded by lead investor, Invus Group, they have placed a bet on BVS.

Given that I received a number of responses emphasizing the importance of developing a clear pathway to reimbursement approval (CPT code assignment), for your new medical device, I researched this issue. I found one paper on this topic of particular interest and value by Nancy J. Stark, PhD and Dr. Vincent Jaeger, "Reimbursement Strategies for New Technologies", http://clinicaldevice.typepad.com/cdg_whitepapers/2011/05/reimbursement-strategies.html. With that, I thought I would share it with all of you involved in this conversation.

Courtland Imel Clifford,
I have enjoyed the comments and feedback. It is clear that you must have a market, before you create a product. I always reference the endoscope guys that added the best camera, the clearest picture, the easiest to use endoscope on the market. Clear issue forgotten - who will you purchase your $1,000,000 scope with no reimbursement. They didn't last long after FDA clearance, but were fun to watch in the interim. Oh, yeah, impossible to clean. But man it was slick! Thanks, courtland

Beluh Mabasa Ginting Most importantly, the manufacturer should be able to explain the intended use of medical devices base on the 2life cycle of medical device, the class risk of it is use, the traceability of the CAB and demonstrate to comply with standards of medical devices such as basic standards, group standards and product standards and fulfill what has been set by regulatory to get market access.

Dymphy van der Wilk Some critical success factors we found to orchestrate and command a succesfull launch of a new medical device are: Understanding of project objectives, including economic targets. Avoid drift in design requirements, leading to ‘scope creep’. Get insight in realistic lead times of various processes like manufacturing and testing. Plan resources for communication and transfer of the results. And understand the project risks. Additionally, uncertainties have to be identified and monitored throughout the project and measures should be defined on beforehand in terms of time buffers and financial resources in order to handle issues accurately when they occur. This all must be incorporated in the project plan and related to the business case. I hope this helps.

A comprehensive, well thought out, and precise plan for medical device launch, Dymphy van der Wilk. I think the identification of the uncertainties is an excellent point. It certainly sounds like you and your team have gained a great deal of expertise in and through this process. Thanks very much for your inputs.

Cuitlahuac Velazquez To begin, compare to similar approved products in the market to make sure the intent and purpose of the device is equal and or better.

Michael Tar The successful launch happens long before the launch — the earlier the better. There needs to be a win for the patient, the payer, and the provider, in that order. Look at recent startup exits and you will see this pattern.

Wojtek Smoczynski Focusing on a successful launch without having a strategy and a plan for successful commercialization is one of the mistakes companies do. The other which I observed, is lack of patience - rushing to the market without developing enough medical data, required to build the trust and to convince medical environment and the payers to a new technology or innovation. Successful registration and even successful launch is not enough to be successful with commercialization...

'Always begin with the end in mind.'
We use a 21 step new product process when designing, manufacturing and moving a new or next gen product to market. We gather as much information at the start as possible; asking (sometimes difficult) questions to all involved. Determining budget, regulatory path, labeling, packaging and realistic annual forecast are all important to a timely and successful launch.

Based on my experiences the most important thing QUALITY. System quality is especially important for a device that is marketed as the "next revolution" in a medical specialty and/or represents a disruptive technology". Furthermore to minimize risk roll the device out slowly in stages.

Thanks to all for the latest, excellent contributions. Per Michael Tar, the device must have superior utility; pre-planning is key. There needs to be a winning proposition for all stakeholders. Per Wojtek Smoczynski, you can't have a successful launch without having a strategy and plan for successful commercialization (i.e. please refer to the discussion with Julie O. above). Also, you need to be patient and take time to accumulate and arm yourself with the necessary data (great insights!). Per Michelle Fleming, pick your target and work backwards; be rigorous about your due diligence. From Allen Scholnick, the importance of quality cannot be understated, especially if a "system" is involved and is disruptive. Also, to minimize risk, roll-out the device "slowly in steps". Key takeaways: -Disciplined and patient data collection, -Focus on quality, -Got to focus on market success from the get-go, -Craft and convey a winning value proposition to all stakeholders.

Understanding the guidance criteria related to your product and where you would like to initially launch can help build a time line from from final design to submission and beyond.

Well...I'm not a senior executive, but I have been directly responsible for several critical aspects of the process including design and development. A laser focus on what we are trying to build and deliver is essential. Scope creep is a killer. Knowing regulatory and quality expectations is also essential and these cannot be circumvented. So getting a very experienced team to plan and execute around the required standards and laws that are applicable to the device saves a lot of time during the approval pricess in the countries you want to sell in. The biggest part of that is to show the clinical benefit of the new product in a data driven and unambiguous way. Also... building quality systems that aren't just compliant, but are tailored to a small company and streamlined to the bare essentials saves valuable time as well.

For me...working with senior executives that understand this and have the courage to forge ahead anyway makes these products succeed.

Salvatore Domenic Morgera Once again, we ask the question, " Of what value is a successful product launch when over 75% of the products launched over the last 2-3 years and those in the pipeline that we are aware of (and we are aware of most) have not been born of a research investigation rooted in fundamental principles?" If they had been, we would not have a plethora of devices, some recalled and some not therapeutically effective at all, and we would have a better understanding of those diseases and dysfunctions that impact a large percentage of the population.

Even the best of ideas need to be FDA approved when it comes to medical and so make sure the team understands this process as well as the target market. Also, if you are already a medical device manufacturer have an idea of how much the new disruptive technology will cannibalize existing product sales. Best to have some thought leaders in well known research facilities involved and ready to help promote the new technology.

This is a complex subject and I've written a number of articles on it in Medical Product Outsourcing magazine. You can find them on my LinkedIn profile or on our website. My next article in the May issue is also on this subject.

Managing expectations and being able to support your product and customer.

Robert Christensen FDA approval

In one sentence: the sucesful switch of focus from engineer driven- to commercially driven activities.

Hi Anja - I think you made one of the most valuable and pertinent overriding points. Per your point, you can engineer the best Formula 1 race car in the world, but if you don't put the right driver behind the wheel it's all for nil.