Finding Development Partners for Your Connected Medical Product
Finding and Keeping the Ideal Development Partners for Your Connected (IoT) Health, Wellness, or Medical Product
The nature of your product and the environment in which it is to be used will drive the kinds of partners you must identify to collaborate with you. Partners can provide very specific services to fill any capabilities gaps on your team, or you may need complete end to end services and consulting during the entire product development process. Either way, knowing how to identify and vet potential collaborators is key to successful development and launch.
1. Define all the aspects of your product including its purpose, who is using it, where, and why?
User research and responsiveness to the findings is the key to success. Depending upon your intended final, realized product, this research can include polling current customers using similar products or a prototyped version of your own, and tallying up their responses to questions such as:
- What do you use this product for?
- When?
- In what environment?
- What do you love/hate about it and why?
- What would make you love it even more?
Poll your prospective users’ sentiments to include in your plan as it makes sense. Even more beneficial is closely observing prospective customers as they engage with the product. What expression is on their faces? Do they seem to be having a good experience? Does anything cause them to halt or get stymied?
You want to work as much of the knowledge you gain from studying prospects’ behaviors and sentiments as you can into your final product plan, keeping in mind that these plans are rarely actually “final” and that you will more than likely revise it multiple times during the product development (PD) process.
[CASE STUDY] Aero Pure – From Concept to Production
From concept development to proof of concept we developed a working prototype suitable for pathogen kill testing. We supplied the expertise required to move concepts from inception to manufacturing. Read the full case study →
2. Analyze your current team and identify possible skill gaps.
Start by recording all the skill sets you believe will need to be present during development, in which technologies they must be experienced, and what level of skill they need.
For example, startup HEARSEE Mobility lacked some of the in-house engineering skills needed to produce its product for the blind or visually impaired; a micro -RFID reader in the tip of a walking cane that tells the user where they are and enables them to move with confidence and without fear. HEARSEE tells the user their location, including what floor or street they are on, estimated time to their destination, and the distance until their next turn. The small, innovative company needed an electrical engineering and RF partner to fill gaps in producing its new digital service application and working hardware and connected with IPS for this purpose.
Since your product is connected, systems architecture and embedded software are of utmost importance. Wellness equipment company Curiouser accomplished its goals with the design and prototype of its smart exercise Mirror but needed embedded software and architecture support to fully optimize performance.
Also, consider:
- What size team do you need for these and other areas of expertise necessary to the project?
- Can you partner internally, or will you need support from outside engineers and designers?
- Who will have the ultimate responsibility for managing the project? If the product is connected, what level of cloud migration skills will you need?
- What’s your intended cloud platform?
- Are HIPAA standards required?
[CASE STUDY] MIRROR is an interactive home gym mirror from Curiouser Products, Inc.
Here are some scenarios for which you might choose to seek help from partners:
- Brand new hardware or software product idea or new digital service idea
- Investigate feasibility/usability of a first-in-category technology
- Complete product redesign
- Incorporate new technology into an existing product
- Fill a gap on your team in an individual discipline(s) – ID firm looking for SW, ME, etc.
- Distributors/ 3rd party services/channel partners
- Needing particular skills to be temporarily embedded as part of your team
3. Know where to look for the partner(s) you need.
Once you’ve assessed your internal capabilities, it’s ideal to start searching for any needed outside help with any connections you may already have into the design and engineering communities. Ask others who have produced similar products to offer recommendations. Search “product development companies” or “product design and engineering companies” online. There are also listings for design and engineering companies at sites like Dexigner, Thomasnet, Core77, Digi-Key, Clutch.co and chambers of commerce, etc. Use LinkedIn and ask for references, preferably from people who are quite knowledgeable about the PD process and check those references thoroughly.
4. Vet potential partners well to make the right choice(s) for your team and effort.
Bringing a new, connected, IoT medical, health, or wellness product to market is a long process – it can often take multiple years. You and your design teams will be joined at the hip during this time, so be sure to hire team members or consultants who have great communications skills and are accustomed to adhering to a well- constructed PD process – one that especially emphasizes anything related to the product plan, quality assurance, timing, and costs.
Even though you have little control over how an outside party does business, you can still take action to ensure that you’re working with the right people and that they’re on the same page as you when it comes to your product development.
An excellent PD team must possess the medical device development experience to be fully cognizant of the need to assess and manage risk throughout the development process, while also strictly adhering to the QMS of record.
”IPS was integral to the process of designing our smart pill bottle so it would function as planned and provide patients with a seamless experience. The team’ communications and IPS’ level of transparency enabled us to develop trust and confidence that made all the difference in the productization process.
Josh SteinCEO & Co-founder, AdhereTech
5. Consider regulatory requirements/timing/costs up front in the process.
Now more than ever, we are experiencing a whirlwind of regulatory changes in the medical device industry.
Even if your product will not need the same FDA approvals required by a , depending on its use you will likely need to obtain UL certification, CE for European markets and others. It’s best to engage these agencies early in the development cycle in order to assess impacts on costs and product plan schedules.
The AdhereTech “smart” pill bottle project challenged IPS to design a product containing hardware PCB’s, an antenna, LED’s and a rechargeable battery in a very small package while meeting FCC radio regulatory requirements.
Timeline of Key Regulatory Changes Impacting Medical Devices (Source: Deloitte)
6. Be crystal clear about expectations, who will do what, when and where, and how much time and money is estimated for any outside or internal partners’ efforts.
Whether you’re working with internal talent, partners from outside your firm, or a hybrid team, be sure a thorough statement of work covering all necessary facets of the project is issued and reviewed and agreed to by all parties. Even when such a thorough SOW exists, it may well be necessary to pivot or make revisions along the way and it’s a good idea to review the document as changes occur and distribute to all parties with changes clearly spelled out.
Patient Transport System Qfix approached IPS with a prototype that needed enhancements to make it fully functional. IPS initially delivered on correcting the wiring and PLC programming, then overhauled the product to create a fully functional prototype ready for production.
7. Establish a mutually agreed-upon definition of “finished” for each phase of work.
The importance of this cannot be overstated. For example, even people with years of similar experience may have disparate interpretations of what is meant by the word “prototype”. There are lots of different kinds of prototypes, including models that simply look like what the product will be, bench prototypes which look nothing like the intended final product but demonstrate the validity of the technology to be included, and final prototypes sometimes referred to as “works like/looks like” prototypes.
Be sure all parties are clear as to what the final deliverables are for each phase of development or agile sprint, and how those are defined and interpreted by all. It’s quite disconcerting for any concerned parties to have had misconceptions about the intended goals of a project phase and to be surprised when unrealistic or incorrect expectations have not been met.
For example, our Mechanical Engineering team once issued a proposal to a camera company for the early exploratory phase of developing a connected security camera for outdoor use. The proposal clearly spelled out the end-of-phase deliverables as sketches, renderings, and a bench prototype. The client who was inexperienced in this area thought he was going to have a final, finished product designed, engineered and ready for manufacturing at the end of an exploratory phase we had estimated would take 2 staff weeks and would cost about.
8. Put everything in writing.
The importance of this cannot be overstated, either. Development efforts should leave long paper trails documenting activities, communications, changes, pivots, cost adjustments and scheduling changes. Hindsight is individual and it is human nature that we remember things differently. When assessing what went well or not on any development effort, lessons are best learned by documents describing meetings, discussions, changes to scope, materials, and product features, as well as cost and scheduling history. All team members and partners must be held accountable for having read and familiarized themselves with the content of these documents as they are issued.
9. Celebrate your successes!
The PD process can be long and arduous. Well-partnered teams generally get to know each other quite well and form a community. Do your best to keep a regular cadence to look at your accomplishments as a community, perhaps via a virtual or distanced in-person happy hour or celebratory meal. Events such as these can build and strengthen relationships, as well as provide genuine insights into what could be going better and also what’s been going smoothly.
