Tactics, hindsight, and predictions in medical device development December 14, 2010 Frank Ingle, Ph.D., PE Instruments for Science and Medicine, Inc. (ISM) Love is not enough To get funded you need: Large potential market Freedom to operate Reimbursement To develop a successful product you need The right target Do the difficult part first Rigorous design reviews Shake and bake testing philosophy Pilot runs until the documents can make it Medical Devices remain a growth area Trends in medical devices •Combining instruments from different manufacturers into a system with added capabilities. Stimulate nerves and muscles everywhere Vasculature goes everywhere: use it for minimally invasive access. Home medical care at lower cost. • Computer controlled exercise for knee joint replacement. • Easier, pain free, more effective than PT. Personalized Dx and Tx. • Customize drug to patient’s unique genetic contents. • Problem: how to afford clinical trials for small patient population? Robotics for patient care • With increasingly aged population, Japan and China will need this before we do, but our time is coming soon enough. Robotic surgery Quicker patient recovery time, but will it become cost effective? Vanity devices – patient pays cash. Cellphone medical apps But how will FDA regulate them? Cellphone GUI with external electronics for Dx and Tx. The main reason why companies fail: they aim at the wrong target and hit it squarely. To succeed, everything has to be right: Technically feasible. Customer wants it. Manufacturable. Material and labor available. Large enough market. Adequate profit margin. IP control or at least freedom to operate. No regulatory barrier. Low barrier to entry. It’s not that you do not know what to develop. What you know is wrong. Talk to the customer directly to learn what they need. The problem: Real life is not like a homework set. • No one tells you the problem or constraints. • The more technical risk, the more difficult it is to get funded. • Medical device regulation requires “Design Control” which is time consuming and expensive. • A false start will waste precious resources. • So how do I start? How products are born • Usually an inventor has a vision and recruits others to join him. • He might be right, but usually it is only a starting point. • The idea might be right, but poor business strategy could kill it. The occasional stroke of genius Invisalign The physics is with you, but how do you get personal solutions manufactured and distributed cheaply and accurately? Another stroke of genius: Kyphoplasty. Early success, but will the FDA allow it to be a 510(K) product? Obvious, but they got there first. SoundID Bluetooth “hearing assist device” NOT a “hearing aid” A hammer looking for a nail: MMR on-site liquid nitrogen source We can design and build miniature extreme refrigerators, but who needs them? Dermatologists everywhere. How to identify the target The user tells you what he THINKS he wants. However, there may be a solution he would like even better. How can you best meet his “needs”, in contrast to his stated “wants”? Brainstorming, crude prototyping, show and tell: iterate until you find the right target. Development: the first step must be right. You have limited time and money. Wrong problem or wrong solution: the longer you are stuck, the more it will cost to recover. Hold frequent design reviews to find your errors, not to compliment your brilliance. Big companies vs. little ones • Big companies – – – – – – – – Huge sales force Low cost manufacture Proven Quality System, but legacy products cause continual headaches SLOW! Bureaucratic Employees tend to be there for life, recycled despite mismatch Threatened by small companies’ new products More effective at acquisition than product development. • Little companies – – – – – – – Blazingly fast Highly innovative Single product focus Minimally compliant, do not meet big company’s quality standards Very thinly financed Overqualified employees bound by stock options Hope to go public (unlikely) or be acquired Get the help you need • Evaluate your strengths and weaknesses. • Do what you do best – use others to do what they do best. • Define the needs of the new project. • Recruit helpers to fill the holes. • Hire full time help only as you need it. • Supplement with part time help or consultants. • Define now how you will later reward them. IP position: Only monopolies are funded. •Talk to “luminaries” about the potential need. •Patent searches for potential patent conflicts. •Invent unique solutions if possible. •Redesign the product if there is a conflict, if possible. •Brainstorm and form a “picket fence” around your preferred method. •File “provisional patents” ($100) frequently, before you talk to any outsiders, like ESPECIALLY VCs. Move quickly • Simulate where you can, but only if it is faster than prototyping. • Ask your friends for advice. • Risk management is one of your best engineering tools. • Engineer if you can, from: – past designs from competitive products – manufacturer’s data – application notes – Published designs • But invent or control IP or you won’t get funded. Proof of concept – buy down the risk • • • • • • • Try to prove it does NOT work. If you cannot, then physics may be with you. Define the essential mechanism and challenge it. Start with “Friday afternoon” POC tests. Design as little as possible. Build a crude model. Use borrowed equipment and canned software if possible. • Review the experimental design with your cohorts. • Write a summary lab report, with attachments. Risk Management is your best engineering tool. It might have prevented this: 1950: Scientific medicine is king. Newborns routinely given oxygen. All become blind. And this: No polio vaccine until 1962. No medical device law until 1976. No risk management on the “iron lung” All these patients died the same day. All products are systems Use systems engineering “V” model Design reviews All errors must be found and fixed. You want your friends to find your errors before your enemies do. Design and build sequential prototypes • • • • Snapshot needed for each prototype. Engineering docs on each prototype. Test each prototype. Review results and decide what changes to make. • Report with summary of what went wrong and what you plan to do for the next one. • Iterate until results meet requirements. Shake and bake: break it and then fix the weaknesses Pilot run Production environment and personnel Verifies that the documents can build the product Key R&D concepts to remember • Fail fast and fail cheap – time for more tries. • Do the impossible part first. • If you can solve the difficult problems, the rest will be more predictable. Nothing comes easily. • Have a Plan A which will make you a hero, and a secret Plan B to save your job if Plan A fails. Storms on the horizon for medical products: • Uncertain regulatory requirements and reimbursement. • How to pay for clinical trials of personalized treatments with small patient populations? • How to balance patient needs with available government resources? • Increasingly long product cycle time: conflict between development speed and compliance. Potential Game Changer: Medical Tourism • A substantial fraction of US population has minimal or no medical insurance coverage. • OUS procedure cost 1/5 to 1/10 of US. • Longer hospital recovery stay provided. • Accreditation agencies reduce the risk of a bad choice. • And maybe you can get in some tourism along the way. Questions?